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ORBITA: PCI no better than meds for stable angina
DENVER – The first-ever blinded, sham-controlled randomized trial of percutaneous coronary intervention for stable angina failed to show a significant improvement in exercise time for PCI, compared with placebo PCI, Rasha Al-Lamee, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
The blockbuster results of the ORBITA trial, published online in the Lancet simultaneously with Dr. Al-Lamee’s presentation in Denver, quickly went viral, with a story splashed across the front page of the New York Times under the headline “‘Unbelievable’: Heart Stents Fail to Ease Chest Pain.” Interventional cardiology thought leaders at TCT said the newspaper piece, and a Lancet editorial commentary entitled “Last nail in the coffin for PCI in stable angina?” that accompanied publication of ORBITA, failed to convey the study’s major limitations, drawbacks that Dr. Al-Lamee readily acknowledged.
What ORBITA did
ORBITA (Objective Randomized Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina) included 200 patients referred to five U.K. cardiac catheterization labs for diagnostic angiography. Participants had to have stable angina, single-vessel disease, and at least one 70% or greater stenosis; in fact, their stenotic severity averaged 84.4% by quantitative coronary angiography.
The patients received 6 weeks of intensive medical therapy during which they were uptitrated to an average of three antianginal medications. They then underwent either real or sham PCI followed by 6 weeks of recovery, during which both the patients and care team remained blinded. Then the same assessments done before randomization were repeated, including exercise treadmill testing, the Seattle Angina Questionnaire, and dobutamine stress echocardiography, explained Dr. Al-Lamee of Imperial College London.
The primary outcome was achievement of at least a 30-second greater improvement in total exercise time following PCI, compared with sham PCI, an effect size chosen based on placebo-controlled studies of antianginal drugs. The PCI group improved by a mean of 28.4 seconds, the controls by 11.8 seconds, and the resultant 16.6-second difference made for a negative result (Lancet. 2017 Nov 2;doi: 10.1016/S0140-6736[17]32714-9).
PCI did, however, result in significant improvement in the secondary endpoint of ischemia reduction as assessed by blinded evaluation of dobutamine stress echocardiography results. The PCI group’s mean peak stress wall motion index score improved from 1.11 prerandomization to 1.03 – that is, normal – at follow-up 6 weeks post procedure while remaining unchanged in the sham PCI group, Dr. Al-Lamee noted at the meeting, sponsored by the Cardiovascular Research Foundation.
What the results mean
Dr. Al-Lamee said the ORBITA results should enable cardiologists to sit with patients similar to those in the trial and have a more informed, patient-centered discussion in which intensive medical management can be offered as an initial first-line option with an understanding that it will likely improve their symptoms to the same degree as angioplasty.
“There will be those patients who would rather avoid having to take high doses of antianginal medications with the side effects they involve, who may well prefer to have an upfront procedure with a small risk in order to reduce their pill count, and who also would rather have improved blood flow to the heart, which may have prognostic implications,” Dr. Al-Lamee said.
Carl L. Tommaso, MD, part of the panel of discussants at the late-breaking clinical trials session in which Dr. Al-Lamee presented the ORBITA findings, applauded the investigators for their ingenious study design, which included elaborate blinding techniques involving music played through headphones throughout the procedure, heavy sedation, separate angioplasty and clinical care teams, the same postprocedural instructions and discharge letter, and dual-antiplatelet therapy in both study arms.
“This is a great study. I don’t think any of us could get this study past an institutional review board in the United States,” commented Dr. Tommaso, director of the cardiac catheterization laboratory at Skokie (Ill.) Hospital.
He added, however, that he wouldn’t have performed PCI on the basis of angiographic findings alone in stable angina patients with a 9-minute treadmill exercise time.
Where OPTIMA fell short
Angiography vs. functional testing
“Twenty-nine percent of patients, we’d all agree, should not have had angioplasty because they had no ischemia,” said Dr. Stone, professor of medicine at Columbia University, New York, and director of the TCT conference.
All subjects in ORBITA did indeed undergo measurement of both FFR and instant Wave-Free Ratio (iFR) while on the table immediately before and after their real or sham PCI. The mean stenosis severity was 0.69 by FFR and 0.76 by iFR, readings indicative of significantly impaired flow. However, the operators were blinded as to those results. The rationale for withholding that information was that, even though it has been shown to be clinically useful, studies show that 80% of angioplasties are done based upon angiography alone, and the ORBITA investigators wanted the study to reflect routine clinical practice, Dr. Al-Lamee explained.
“I think one of the many lessons coming out of this trial is to see the discrepancy between the angiogram and functional testing. We cannot guide our therapy solely by the angiogram. We have to get physiologic data and consider that together with symptoms in the patient’s clinical context,” said panelist Allen Jeremias, MD, director of interventional cardiology research at St. Francis Hospital in Rosyln, N.Y.
Commentary goes too far
The “last-nail-in-the-coffin” Lancet commentary (2017 Nov 2. doi: 10.1016/S0140-6736[17]32757-5) penned by David L. Brown, MD, of Washington University in St. Louis and Rita F. Redberg, MD, of the University of California, San Francisco, emphatically declared that the ORBITA results mean all cardiology guidelines should be revised to downgrade the recommendation for PCI in patients with angina despite medical therapy. Dr. Al-Lamee was one of many at TCT 2017 who took strong exception to that.
“This is the first trial of its kind. I think it would be very easy to take the results of this trial and overextrapolate. To downgrade the guideline recommendations based on this study would be an incredibly large overreach,” she said.
Ajay J. Kirtane, MD, who chaired a press conference in which Dr. Al-Lamee presented the ORBITA results, had a further criticism of the editorial.
“Some of the risks of PCI as described in the editorial are just factually inaccurate. An MI rate of 15%, an acute kidney injury rate of 13% – those are simply factually incorrect,” said Dr. Kirtane, director of the cardiac catheterization laboratories at New York-Presbyterian/Columbia University Medical Center.
The ORBITA trial was sponsored by Imperial College London and funded by grants from the National Institute of Health Research Imperial Biomedical Research Center and charity organizations. Dr. Al-Lamee reported serving as a paid consultant to Philips Volcano, which supplied the coronary pressure wires for physiologic testing.
DENVER – The first-ever blinded, sham-controlled randomized trial of percutaneous coronary intervention for stable angina failed to show a significant improvement in exercise time for PCI, compared with placebo PCI, Rasha Al-Lamee, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
The blockbuster results of the ORBITA trial, published online in the Lancet simultaneously with Dr. Al-Lamee’s presentation in Denver, quickly went viral, with a story splashed across the front page of the New York Times under the headline “‘Unbelievable’: Heart Stents Fail to Ease Chest Pain.” Interventional cardiology thought leaders at TCT said the newspaper piece, and a Lancet editorial commentary entitled “Last nail in the coffin for PCI in stable angina?” that accompanied publication of ORBITA, failed to convey the study’s major limitations, drawbacks that Dr. Al-Lamee readily acknowledged.
What ORBITA did
ORBITA (Objective Randomized Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina) included 200 patients referred to five U.K. cardiac catheterization labs for diagnostic angiography. Participants had to have stable angina, single-vessel disease, and at least one 70% or greater stenosis; in fact, their stenotic severity averaged 84.4% by quantitative coronary angiography.
The patients received 6 weeks of intensive medical therapy during which they were uptitrated to an average of three antianginal medications. They then underwent either real or sham PCI followed by 6 weeks of recovery, during which both the patients and care team remained blinded. Then the same assessments done before randomization were repeated, including exercise treadmill testing, the Seattle Angina Questionnaire, and dobutamine stress echocardiography, explained Dr. Al-Lamee of Imperial College London.
The primary outcome was achievement of at least a 30-second greater improvement in total exercise time following PCI, compared with sham PCI, an effect size chosen based on placebo-controlled studies of antianginal drugs. The PCI group improved by a mean of 28.4 seconds, the controls by 11.8 seconds, and the resultant 16.6-second difference made for a negative result (Lancet. 2017 Nov 2;doi: 10.1016/S0140-6736[17]32714-9).
PCI did, however, result in significant improvement in the secondary endpoint of ischemia reduction as assessed by blinded evaluation of dobutamine stress echocardiography results. The PCI group’s mean peak stress wall motion index score improved from 1.11 prerandomization to 1.03 – that is, normal – at follow-up 6 weeks post procedure while remaining unchanged in the sham PCI group, Dr. Al-Lamee noted at the meeting, sponsored by the Cardiovascular Research Foundation.
What the results mean
Dr. Al-Lamee said the ORBITA results should enable cardiologists to sit with patients similar to those in the trial and have a more informed, patient-centered discussion in which intensive medical management can be offered as an initial first-line option with an understanding that it will likely improve their symptoms to the same degree as angioplasty.
“There will be those patients who would rather avoid having to take high doses of antianginal medications with the side effects they involve, who may well prefer to have an upfront procedure with a small risk in order to reduce their pill count, and who also would rather have improved blood flow to the heart, which may have prognostic implications,” Dr. Al-Lamee said.
Carl L. Tommaso, MD, part of the panel of discussants at the late-breaking clinical trials session in which Dr. Al-Lamee presented the ORBITA findings, applauded the investigators for their ingenious study design, which included elaborate blinding techniques involving music played through headphones throughout the procedure, heavy sedation, separate angioplasty and clinical care teams, the same postprocedural instructions and discharge letter, and dual-antiplatelet therapy in both study arms.
“This is a great study. I don’t think any of us could get this study past an institutional review board in the United States,” commented Dr. Tommaso, director of the cardiac catheterization laboratory at Skokie (Ill.) Hospital.
He added, however, that he wouldn’t have performed PCI on the basis of angiographic findings alone in stable angina patients with a 9-minute treadmill exercise time.
Where OPTIMA fell short
Angiography vs. functional testing
“Twenty-nine percent of patients, we’d all agree, should not have had angioplasty because they had no ischemia,” said Dr. Stone, professor of medicine at Columbia University, New York, and director of the TCT conference.
All subjects in ORBITA did indeed undergo measurement of both FFR and instant Wave-Free Ratio (iFR) while on the table immediately before and after their real or sham PCI. The mean stenosis severity was 0.69 by FFR and 0.76 by iFR, readings indicative of significantly impaired flow. However, the operators were blinded as to those results. The rationale for withholding that information was that, even though it has been shown to be clinically useful, studies show that 80% of angioplasties are done based upon angiography alone, and the ORBITA investigators wanted the study to reflect routine clinical practice, Dr. Al-Lamee explained.
“I think one of the many lessons coming out of this trial is to see the discrepancy between the angiogram and functional testing. We cannot guide our therapy solely by the angiogram. We have to get physiologic data and consider that together with symptoms in the patient’s clinical context,” said panelist Allen Jeremias, MD, director of interventional cardiology research at St. Francis Hospital in Rosyln, N.Y.
Commentary goes too far
The “last-nail-in-the-coffin” Lancet commentary (2017 Nov 2. doi: 10.1016/S0140-6736[17]32757-5) penned by David L. Brown, MD, of Washington University in St. Louis and Rita F. Redberg, MD, of the University of California, San Francisco, emphatically declared that the ORBITA results mean all cardiology guidelines should be revised to downgrade the recommendation for PCI in patients with angina despite medical therapy. Dr. Al-Lamee was one of many at TCT 2017 who took strong exception to that.
“This is the first trial of its kind. I think it would be very easy to take the results of this trial and overextrapolate. To downgrade the guideline recommendations based on this study would be an incredibly large overreach,” she said.
Ajay J. Kirtane, MD, who chaired a press conference in which Dr. Al-Lamee presented the ORBITA results, had a further criticism of the editorial.
“Some of the risks of PCI as described in the editorial are just factually inaccurate. An MI rate of 15%, an acute kidney injury rate of 13% – those are simply factually incorrect,” said Dr. Kirtane, director of the cardiac catheterization laboratories at New York-Presbyterian/Columbia University Medical Center.
The ORBITA trial was sponsored by Imperial College London and funded by grants from the National Institute of Health Research Imperial Biomedical Research Center and charity organizations. Dr. Al-Lamee reported serving as a paid consultant to Philips Volcano, which supplied the coronary pressure wires for physiologic testing.
DENVER – The first-ever blinded, sham-controlled randomized trial of percutaneous coronary intervention for stable angina failed to show a significant improvement in exercise time for PCI, compared with placebo PCI, Rasha Al-Lamee, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
The blockbuster results of the ORBITA trial, published online in the Lancet simultaneously with Dr. Al-Lamee’s presentation in Denver, quickly went viral, with a story splashed across the front page of the New York Times under the headline “‘Unbelievable’: Heart Stents Fail to Ease Chest Pain.” Interventional cardiology thought leaders at TCT said the newspaper piece, and a Lancet editorial commentary entitled “Last nail in the coffin for PCI in stable angina?” that accompanied publication of ORBITA, failed to convey the study’s major limitations, drawbacks that Dr. Al-Lamee readily acknowledged.
What ORBITA did
ORBITA (Objective Randomized Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina) included 200 patients referred to five U.K. cardiac catheterization labs for diagnostic angiography. Participants had to have stable angina, single-vessel disease, and at least one 70% or greater stenosis; in fact, their stenotic severity averaged 84.4% by quantitative coronary angiography.
The patients received 6 weeks of intensive medical therapy during which they were uptitrated to an average of three antianginal medications. They then underwent either real or sham PCI followed by 6 weeks of recovery, during which both the patients and care team remained blinded. Then the same assessments done before randomization were repeated, including exercise treadmill testing, the Seattle Angina Questionnaire, and dobutamine stress echocardiography, explained Dr. Al-Lamee of Imperial College London.
The primary outcome was achievement of at least a 30-second greater improvement in total exercise time following PCI, compared with sham PCI, an effect size chosen based on placebo-controlled studies of antianginal drugs. The PCI group improved by a mean of 28.4 seconds, the controls by 11.8 seconds, and the resultant 16.6-second difference made for a negative result (Lancet. 2017 Nov 2;doi: 10.1016/S0140-6736[17]32714-9).
PCI did, however, result in significant improvement in the secondary endpoint of ischemia reduction as assessed by blinded evaluation of dobutamine stress echocardiography results. The PCI group’s mean peak stress wall motion index score improved from 1.11 prerandomization to 1.03 – that is, normal – at follow-up 6 weeks post procedure while remaining unchanged in the sham PCI group, Dr. Al-Lamee noted at the meeting, sponsored by the Cardiovascular Research Foundation.
What the results mean
Dr. Al-Lamee said the ORBITA results should enable cardiologists to sit with patients similar to those in the trial and have a more informed, patient-centered discussion in which intensive medical management can be offered as an initial first-line option with an understanding that it will likely improve their symptoms to the same degree as angioplasty.
“There will be those patients who would rather avoid having to take high doses of antianginal medications with the side effects they involve, who may well prefer to have an upfront procedure with a small risk in order to reduce their pill count, and who also would rather have improved blood flow to the heart, which may have prognostic implications,” Dr. Al-Lamee said.
Carl L. Tommaso, MD, part of the panel of discussants at the late-breaking clinical trials session in which Dr. Al-Lamee presented the ORBITA findings, applauded the investigators for their ingenious study design, which included elaborate blinding techniques involving music played through headphones throughout the procedure, heavy sedation, separate angioplasty and clinical care teams, the same postprocedural instructions and discharge letter, and dual-antiplatelet therapy in both study arms.
“This is a great study. I don’t think any of us could get this study past an institutional review board in the United States,” commented Dr. Tommaso, director of the cardiac catheterization laboratory at Skokie (Ill.) Hospital.
He added, however, that he wouldn’t have performed PCI on the basis of angiographic findings alone in stable angina patients with a 9-minute treadmill exercise time.
Where OPTIMA fell short
Angiography vs. functional testing
“Twenty-nine percent of patients, we’d all agree, should not have had angioplasty because they had no ischemia,” said Dr. Stone, professor of medicine at Columbia University, New York, and director of the TCT conference.
All subjects in ORBITA did indeed undergo measurement of both FFR and instant Wave-Free Ratio (iFR) while on the table immediately before and after their real or sham PCI. The mean stenosis severity was 0.69 by FFR and 0.76 by iFR, readings indicative of significantly impaired flow. However, the operators were blinded as to those results. The rationale for withholding that information was that, even though it has been shown to be clinically useful, studies show that 80% of angioplasties are done based upon angiography alone, and the ORBITA investigators wanted the study to reflect routine clinical practice, Dr. Al-Lamee explained.
“I think one of the many lessons coming out of this trial is to see the discrepancy between the angiogram and functional testing. We cannot guide our therapy solely by the angiogram. We have to get physiologic data and consider that together with symptoms in the patient’s clinical context,” said panelist Allen Jeremias, MD, director of interventional cardiology research at St. Francis Hospital in Rosyln, N.Y.
Commentary goes too far
The “last-nail-in-the-coffin” Lancet commentary (2017 Nov 2. doi: 10.1016/S0140-6736[17]32757-5) penned by David L. Brown, MD, of Washington University in St. Louis and Rita F. Redberg, MD, of the University of California, San Francisco, emphatically declared that the ORBITA results mean all cardiology guidelines should be revised to downgrade the recommendation for PCI in patients with angina despite medical therapy. Dr. Al-Lamee was one of many at TCT 2017 who took strong exception to that.
“This is the first trial of its kind. I think it would be very easy to take the results of this trial and overextrapolate. To downgrade the guideline recommendations based on this study would be an incredibly large overreach,” she said.
Ajay J. Kirtane, MD, who chaired a press conference in which Dr. Al-Lamee presented the ORBITA results, had a further criticism of the editorial.
“Some of the risks of PCI as described in the editorial are just factually inaccurate. An MI rate of 15%, an acute kidney injury rate of 13% – those are simply factually incorrect,” said Dr. Kirtane, director of the cardiac catheterization laboratories at New York-Presbyterian/Columbia University Medical Center.
The ORBITA trial was sponsored by Imperial College London and funded by grants from the National Institute of Health Research Imperial Biomedical Research Center and charity organizations. Dr. Al-Lamee reported serving as a paid consultant to Philips Volcano, which supplied the coronary pressure wires for physiologic testing.
AT TCT 2017
Key clinical point:
Major finding: PCI on top of intensive antianginal medications was not significantly more effective at improving exercise tolerance than sham PCI.
Data source: ORBITA, a randomized, multicenter, blinded, sham-controlled study of 200 patients with mild angina and single-vessel CAD.
Disclosures: ORBITA was sponsored by Imperial College London and funded by grants from the National Institute of Health Research Imperial Biomedical Research Center and charity organizations. The presenter reported serving as a paid consultant to Philips Volcano, which supplied the coronary pressure wires for physiologic testing.
TAVR wallops SAVR in cost-effectiveness for intermediate-risk patients
DENVER – A formal cost-effectiveness analysis indicates that transcatheter aortic valve replacement (TAVR) is substantially more cost effective than surgical valve replacement in patients at intermediate surgical risk similar to those enrolled in the landmark PARTNER 2 trial.
The analysis demonstrated that over a 1- and 2-year follow-up period, as well as with projected lifetime follow-up, TAVR entails both lower long-term costs and greater quality-adjusted life expectancy, David J. Cohen, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
His two-part, patient-level economic analysis examined data from nearly 2,000 participants in the PARTNER 2A randomized trial comparing TAVR, using the Sapien XT valve, with surgical aortic valve replacement (SAVR), as well as the experience with the current-generation Sapien 3 TAVR valve in 1,077 intermediate–surgical risk TAVR patients in the S3i registry. The analysis utilized Medicare claims data on the costs of the index hospitalization and follow-up care.
In PARTNER 2A, the average total cost of the index hospitalization for valve replacement was $61,433 with TAVR. That was just $2,888 more than the SAVR hospitalization, despite the far higher acquisition cost of the Sapien 3 valve, which was roughly $32,500, compared with $5,000 for the surgical valve. Most of this additional cost of the TAVR valve was counterbalanced by TAVR’s 2-hour shorter procedural duration, the 6.4-day average length of stay, compared with 10.9 days for SAVR, and the fact that TAVR patients spent only 2.4 days in intensive care while SAVR patients averaged 4.6 days, Dr. Cohen explained at the meeting sponsored by the Cardiovascular Research Foundation.
During 24 months of postdischarge follow-up in the PARTNER 2A trial, SAVR patients racked up an average of $9,303 more in costs than TAVR patients. This was mainly because of their much higher rates of rehospitalization and time spent in skilled nursing facilities and rehabilitation centers, mainly during months 2-6 post discharge. The result was that 2-year total costs including the index hospitalization averaged $107,716 per TAVR patient and $114,132 per SAVR patient.
“One of the really remarkable findings of this study was what happened during follow-up,” the cardiologist observed.
Extrapolating to projected remaining lifetime years, TAVR using the Sapien XT valve resulted in a cost savings of $7,949 per patient and a 0.15-year increase in quality-adjusted life expectancy compared with SAVR.
But since the time of PARTNER 2A, the Sapien XT valve has been replaced by the updated Sapien 3 valve. The analysis of the S3i registry showed that the economic dominance of TAVR over SAVR was even greater owing to improved valve technology and contemporary care patterns. For this analysis, because there has been no randomized trial of TAVR with the Sapien 3 valve versus SAVR, patients in the SAVR of arm of PARTNER 2A served as the comparison group.
The cost of the index hospitalization was more than $4,000 less with TAVR in the S3i registry than with SAVR. The total cost of TAVR through 1 year of follow-up averaged $80,977, which was $15,511 less than the $96,489 for SAVR. The cost post discharge out to 1 year was more than $11,000 less per TAVR patient, driven by sharply lower rates of both cardiovascular and noncardiovascular hospitalizations as well as a greater than 50% reduction in days spent in rehab centers and skilled nursing facilities, compared with SAVR patients.
Projected over estimated remaining years of life, TAVR with the Sapien 3 valve yielded a cost savings of $9,692 per patient compared with SAVR, as well as a 0.27-year gain in quality-adjusted life-years.
Eighty-eight percent of patients in the S3i registry received their Sapien 3 valve via a transfemoral approach. When Dr. Cohen and his coinvestigators compared their costs and clinical outcomes to the subset of PARTNER 2A TAVR patients who got the Sapien XT valve transfemorally, the outcomes were “virtually identical,” he said.
“These findings are reassuring with regard to the S3i results and also suggest that the primary mechanism of benefit of the Sapien 3 valve over the XT valve is its lower profile, which allows roughly 90% of patients to be treated via a transfemoral approach,” according to Dr. Cohen.
He predicted the new cost-effectiveness findings will not substantially increase patient demand for TAVR, which is already high.
“By far what’s driving patients to TAVR today are the quality of life advantages. They love the idea of recovering quickly,” he said.
Michael Mack, MD, commented that this analysis probably underestimates the true cost advantage of TAVR by a fair amount, since the average hospital length of stay for TAVR patients in PARTNER 2A was 6.4 days.
“We now know that half of U.S. TAVR patients in many centers go home the day after the procedure, so you would expect that TAVR would look even more favorable based on current practice,” said Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and chairman of the Heart Hospital Baylor Plano (Tex.) Research Center.
Session moderator Patrick W. Serruys, MD, of Imperial College, London, observed that the cost differential between TAVR and SAVR will grow even larger once the sky-high cost of TAVR valves comes down. He predicted that’s likely to happen as a result of increased competition once a third valve receives marketing approval, just as occurred after a third drug-eluting stent hit the market.
Several physicians grumbled about the unfairness of current reimbursement for TAVR, which in effect penalizes hospitals. Dr. Cohen said that situation will change.
“I think the future of health care financing in the U.S. is bundled payment and accountable care organizations. In the setting of bundled payment for a 6-month period or even for 90 days, TAVR would look fantastic to a hospital or an health maintenance organization due to avoidance of rehospitalizations and rehabilitation and skilled nursing facility stays,” the cardiologist said.
The PARTNER 2A trial, the S3i registry, and the cost-effectiveness analysis were funded by Edwards Lifesciences. Dr. Cohen reported receiving research funding from and serving as a consultant to Edwards Lifesciences and other device companies.
DENVER – A formal cost-effectiveness analysis indicates that transcatheter aortic valve replacement (TAVR) is substantially more cost effective than surgical valve replacement in patients at intermediate surgical risk similar to those enrolled in the landmark PARTNER 2 trial.
The analysis demonstrated that over a 1- and 2-year follow-up period, as well as with projected lifetime follow-up, TAVR entails both lower long-term costs and greater quality-adjusted life expectancy, David J. Cohen, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
His two-part, patient-level economic analysis examined data from nearly 2,000 participants in the PARTNER 2A randomized trial comparing TAVR, using the Sapien XT valve, with surgical aortic valve replacement (SAVR), as well as the experience with the current-generation Sapien 3 TAVR valve in 1,077 intermediate–surgical risk TAVR patients in the S3i registry. The analysis utilized Medicare claims data on the costs of the index hospitalization and follow-up care.
In PARTNER 2A, the average total cost of the index hospitalization for valve replacement was $61,433 with TAVR. That was just $2,888 more than the SAVR hospitalization, despite the far higher acquisition cost of the Sapien 3 valve, which was roughly $32,500, compared with $5,000 for the surgical valve. Most of this additional cost of the TAVR valve was counterbalanced by TAVR’s 2-hour shorter procedural duration, the 6.4-day average length of stay, compared with 10.9 days for SAVR, and the fact that TAVR patients spent only 2.4 days in intensive care while SAVR patients averaged 4.6 days, Dr. Cohen explained at the meeting sponsored by the Cardiovascular Research Foundation.
During 24 months of postdischarge follow-up in the PARTNER 2A trial, SAVR patients racked up an average of $9,303 more in costs than TAVR patients. This was mainly because of their much higher rates of rehospitalization and time spent in skilled nursing facilities and rehabilitation centers, mainly during months 2-6 post discharge. The result was that 2-year total costs including the index hospitalization averaged $107,716 per TAVR patient and $114,132 per SAVR patient.
“One of the really remarkable findings of this study was what happened during follow-up,” the cardiologist observed.
Extrapolating to projected remaining lifetime years, TAVR using the Sapien XT valve resulted in a cost savings of $7,949 per patient and a 0.15-year increase in quality-adjusted life expectancy compared with SAVR.
But since the time of PARTNER 2A, the Sapien XT valve has been replaced by the updated Sapien 3 valve. The analysis of the S3i registry showed that the economic dominance of TAVR over SAVR was even greater owing to improved valve technology and contemporary care patterns. For this analysis, because there has been no randomized trial of TAVR with the Sapien 3 valve versus SAVR, patients in the SAVR of arm of PARTNER 2A served as the comparison group.
The cost of the index hospitalization was more than $4,000 less with TAVR in the S3i registry than with SAVR. The total cost of TAVR through 1 year of follow-up averaged $80,977, which was $15,511 less than the $96,489 for SAVR. The cost post discharge out to 1 year was more than $11,000 less per TAVR patient, driven by sharply lower rates of both cardiovascular and noncardiovascular hospitalizations as well as a greater than 50% reduction in days spent in rehab centers and skilled nursing facilities, compared with SAVR patients.
Projected over estimated remaining years of life, TAVR with the Sapien 3 valve yielded a cost savings of $9,692 per patient compared with SAVR, as well as a 0.27-year gain in quality-adjusted life-years.
Eighty-eight percent of patients in the S3i registry received their Sapien 3 valve via a transfemoral approach. When Dr. Cohen and his coinvestigators compared their costs and clinical outcomes to the subset of PARTNER 2A TAVR patients who got the Sapien XT valve transfemorally, the outcomes were “virtually identical,” he said.
“These findings are reassuring with regard to the S3i results and also suggest that the primary mechanism of benefit of the Sapien 3 valve over the XT valve is its lower profile, which allows roughly 90% of patients to be treated via a transfemoral approach,” according to Dr. Cohen.
He predicted the new cost-effectiveness findings will not substantially increase patient demand for TAVR, which is already high.
“By far what’s driving patients to TAVR today are the quality of life advantages. They love the idea of recovering quickly,” he said.
Michael Mack, MD, commented that this analysis probably underestimates the true cost advantage of TAVR by a fair amount, since the average hospital length of stay for TAVR patients in PARTNER 2A was 6.4 days.
“We now know that half of U.S. TAVR patients in many centers go home the day after the procedure, so you would expect that TAVR would look even more favorable based on current practice,” said Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and chairman of the Heart Hospital Baylor Plano (Tex.) Research Center.
Session moderator Patrick W. Serruys, MD, of Imperial College, London, observed that the cost differential between TAVR and SAVR will grow even larger once the sky-high cost of TAVR valves comes down. He predicted that’s likely to happen as a result of increased competition once a third valve receives marketing approval, just as occurred after a third drug-eluting stent hit the market.
Several physicians grumbled about the unfairness of current reimbursement for TAVR, which in effect penalizes hospitals. Dr. Cohen said that situation will change.
“I think the future of health care financing in the U.S. is bundled payment and accountable care organizations. In the setting of bundled payment for a 6-month period or even for 90 days, TAVR would look fantastic to a hospital or an health maintenance organization due to avoidance of rehospitalizations and rehabilitation and skilled nursing facility stays,” the cardiologist said.
The PARTNER 2A trial, the S3i registry, and the cost-effectiveness analysis were funded by Edwards Lifesciences. Dr. Cohen reported receiving research funding from and serving as a consultant to Edwards Lifesciences and other device companies.
DENVER – A formal cost-effectiveness analysis indicates that transcatheter aortic valve replacement (TAVR) is substantially more cost effective than surgical valve replacement in patients at intermediate surgical risk similar to those enrolled in the landmark PARTNER 2 trial.
The analysis demonstrated that over a 1- and 2-year follow-up period, as well as with projected lifetime follow-up, TAVR entails both lower long-term costs and greater quality-adjusted life expectancy, David J. Cohen, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
His two-part, patient-level economic analysis examined data from nearly 2,000 participants in the PARTNER 2A randomized trial comparing TAVR, using the Sapien XT valve, with surgical aortic valve replacement (SAVR), as well as the experience with the current-generation Sapien 3 TAVR valve in 1,077 intermediate–surgical risk TAVR patients in the S3i registry. The analysis utilized Medicare claims data on the costs of the index hospitalization and follow-up care.
In PARTNER 2A, the average total cost of the index hospitalization for valve replacement was $61,433 with TAVR. That was just $2,888 more than the SAVR hospitalization, despite the far higher acquisition cost of the Sapien 3 valve, which was roughly $32,500, compared with $5,000 for the surgical valve. Most of this additional cost of the TAVR valve was counterbalanced by TAVR’s 2-hour shorter procedural duration, the 6.4-day average length of stay, compared with 10.9 days for SAVR, and the fact that TAVR patients spent only 2.4 days in intensive care while SAVR patients averaged 4.6 days, Dr. Cohen explained at the meeting sponsored by the Cardiovascular Research Foundation.
During 24 months of postdischarge follow-up in the PARTNER 2A trial, SAVR patients racked up an average of $9,303 more in costs than TAVR patients. This was mainly because of their much higher rates of rehospitalization and time spent in skilled nursing facilities and rehabilitation centers, mainly during months 2-6 post discharge. The result was that 2-year total costs including the index hospitalization averaged $107,716 per TAVR patient and $114,132 per SAVR patient.
“One of the really remarkable findings of this study was what happened during follow-up,” the cardiologist observed.
Extrapolating to projected remaining lifetime years, TAVR using the Sapien XT valve resulted in a cost savings of $7,949 per patient and a 0.15-year increase in quality-adjusted life expectancy compared with SAVR.
But since the time of PARTNER 2A, the Sapien XT valve has been replaced by the updated Sapien 3 valve. The analysis of the S3i registry showed that the economic dominance of TAVR over SAVR was even greater owing to improved valve technology and contemporary care patterns. For this analysis, because there has been no randomized trial of TAVR with the Sapien 3 valve versus SAVR, patients in the SAVR of arm of PARTNER 2A served as the comparison group.
The cost of the index hospitalization was more than $4,000 less with TAVR in the S3i registry than with SAVR. The total cost of TAVR through 1 year of follow-up averaged $80,977, which was $15,511 less than the $96,489 for SAVR. The cost post discharge out to 1 year was more than $11,000 less per TAVR patient, driven by sharply lower rates of both cardiovascular and noncardiovascular hospitalizations as well as a greater than 50% reduction in days spent in rehab centers and skilled nursing facilities, compared with SAVR patients.
Projected over estimated remaining years of life, TAVR with the Sapien 3 valve yielded a cost savings of $9,692 per patient compared with SAVR, as well as a 0.27-year gain in quality-adjusted life-years.
Eighty-eight percent of patients in the S3i registry received their Sapien 3 valve via a transfemoral approach. When Dr. Cohen and his coinvestigators compared their costs and clinical outcomes to the subset of PARTNER 2A TAVR patients who got the Sapien XT valve transfemorally, the outcomes were “virtually identical,” he said.
“These findings are reassuring with regard to the S3i results and also suggest that the primary mechanism of benefit of the Sapien 3 valve over the XT valve is its lower profile, which allows roughly 90% of patients to be treated via a transfemoral approach,” according to Dr. Cohen.
He predicted the new cost-effectiveness findings will not substantially increase patient demand for TAVR, which is already high.
“By far what’s driving patients to TAVR today are the quality of life advantages. They love the idea of recovering quickly,” he said.
Michael Mack, MD, commented that this analysis probably underestimates the true cost advantage of TAVR by a fair amount, since the average hospital length of stay for TAVR patients in PARTNER 2A was 6.4 days.
“We now know that half of U.S. TAVR patients in many centers go home the day after the procedure, so you would expect that TAVR would look even more favorable based on current practice,” said Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and chairman of the Heart Hospital Baylor Plano (Tex.) Research Center.
Session moderator Patrick W. Serruys, MD, of Imperial College, London, observed that the cost differential between TAVR and SAVR will grow even larger once the sky-high cost of TAVR valves comes down. He predicted that’s likely to happen as a result of increased competition once a third valve receives marketing approval, just as occurred after a third drug-eluting stent hit the market.
Several physicians grumbled about the unfairness of current reimbursement for TAVR, which in effect penalizes hospitals. Dr. Cohen said that situation will change.
“I think the future of health care financing in the U.S. is bundled payment and accountable care organizations. In the setting of bundled payment for a 6-month period or even for 90 days, TAVR would look fantastic to a hospital or an health maintenance organization due to avoidance of rehospitalizations and rehabilitation and skilled nursing facility stays,” the cardiologist said.
The PARTNER 2A trial, the S3i registry, and the cost-effectiveness analysis were funded by Edwards Lifesciences. Dr. Cohen reported receiving research funding from and serving as a consultant to Edwards Lifesciences and other device companies.
AT TCT 2017
Key clinical point:
Major finding: The total cost of TAVR with the Sapien 3 valve in intermediate-risk patients, including the index hospitalization and costs incurred during the first year after, averaged $80,977, compared with $96,489 per SAVR patient.
Data source: This patient-level formal cost-effectiveness analysis included nearly 2,000 patients in the PARTNER 2A trial and more than 1,700 in a registry of recipients of the Sapien 3 TAVR valve.
Disclosures: The cost-effectiveness analysis was funded by Edwards Lifesciences. The presenter reported receiving research funding from and serving as a consultant to Edwards Lifesciences and other device companies.
HOPE-3 wades into fray regarding optimal blood pressure targets
BARCELONA – How low to go in treating hypertension is a topic of considerable recent controversy. Now the HOPE-3 trial investigators have weighed in, reporting that optimal outcomes in their landmark randomized trial were seen with an achieved, on-treatment systolic blood pressure of 130-140 mm Hg and a diastolic blood pressure of 75-80 mm Hg, Eva M. Lonn, MD, reported at the annual congress of the European Society of Cardiology.
Those results stand in glaring contrast to the findings of the much-discussed SPRINT trial, in which hypertensive patients fared best with an on-treatment SBP driven below 120 mm Hg (N Engl J Med. 2015 Nov 26; 373:2103-16).
“Please note that lower blood pressures, both systolic and diastolic, weren’t associated with lower risk, whereas higher blood pressures considerably increased the risk for major vascular events,” she added.
HOPE-3 (the Third Heart Outcomes Prevention Evaluation) included 12,705 patients in 21 countries who did not have cardiovascular disease and were at intermediate risk, with an average age of 65 years at enrollment and a Framinhgam Risk Score of about 10%. They were randomized double-blind in a 2x2 factorial design to rosuvastatin at 10 mg per day or placebo and/or candesartan at 16 mg plus hydrochlorothiazide at 12.5 mg per day or placebo and prospectively followed for a median of 5.6 years.
The primary outcomes of HOPE-3 have been published (N Engl J Med. 2016 May 26;374[21]:2009-20 and 2021-31). This was a practice-changing trial that opened the door to broader use of statin therapy for primary prevention.
At the ESC congress in Barcelona, Dr. Lonn presented a secondary post-hoc analysis that focused on the impact of antihypertensive therapy in HOPE-3. The results shed new light on the optimal blood pressure levels for triggering initation of antihypertensive therapy, as well as defining the achieved blood pressures that resulted in the greatest reductions in major vascular events.
As this was essentially an all-comers trial of intermediate-risk patients, participants presented with a range of blood pressures at baseline. But more than 4,700 subjects had a baseline SBP of 140-159.9 mm Hg, and 833 had an SBP of 160 mm Hg or more.
The candesartan/hydrochlorothiazide regimen resulted in what Dr. Lonn termed a “moderate” net placebo-subtracted blood pressure reduction of 6/3 mm Hg. The higher the baseline blood pressure, the bigger the reduction.
In the one-third of subjects with a baseline SBP greater than 143.5 mm Hg, antihypertensive therapy resulted in a significant 27% reduction in the composite endpoint of cardiovascular death, MI, or stroke compared with placebo. Those with a baseline SBP of 150 mm Hg or more showed even greater benefit from antihypertensive therapy, with a composite event rate of 4.8% compared with 7.2% for placebo, representing a 34% relative risk reduction in which the event curves began separating at about 2 years.
In contrast, antihypertensive therapy brought no significant reduction in events in patients in the lower two tertiles of baseline SBP. And there was no association at all between baseline DBP and major cardiovascular events across the range of DBP values evaluated in HOPE-3.
But wait: Things get more interesting, according to the cardiac electrophysiologist.
“I find the association between mean in-trial blood pressure as recorded in many measurements and vascular outcomes to be the most interesting analysis. This may be a better look at the association between blood pressure and outcomes than a measurement obtained just once or twice at baseline,” she explained.
Of note, among the 6,356 subjects on candesartan/hydrochlorothiazide, those with a mean on-treatment SBP of 160 mm Hg or more had a 2.61% per year rate of the composite of cardiovascular death, MI, stroke, rescue from cardiac arrest, heart failure, or revascularization. This was more than three-fold higher than the 0.75% per year rate in patients with an on-treatment SBP of 120-139.9 mm Hg. The composite event rate was also significantly higher in those with a mean on-treatment SBP of 140-159.9 mm Hg, at 1.4% per year. The event rate in patients with an on-treatment SBP below 120 mm Hg was identical to that of patients with a value of 120-139.9 mm Hg.
Only among patients with an on-treatment DBP of 90 mm Hg or more was the composite event rate significantly greater than in those with a DBP of 70-79.9 mm Hg, who had the lowest event rate by a margin of 1.89% versus 0.75% per year.
An Australian cardiologist in the audience who has been involved in revamping hypertension treatment guidelines Down Under expressed frustration. He only recently succeeded in wrangling his fellow panelists into incorporating the SPRINT results into the draft guidelines; now HOPE-3 is sending a very different message. What gives? Could the disparate findings simply be due to play of chance? he asked.
Highly unlikely, Dr. Lonn replied.
“There were substantial differences between our trials,” she explained. “First of all, the SPRINT population was at substantially higher risk. They either had to have established cardiovascular disease – we eliminated those people – or significant renal disease – we eliminated those people, too – or age greater than 75, or a Framingham Risk Score above 15%.”
Also, the SPRINT protocol controversially called for unattended blood pressure measurement.
“This is a very pure way ot eliminating white coat hypertension, but it is different from other studies, so it is very difficult to compare SPRINT to older studies or to HOPE-3. Some other investigators have suggested that the difference between attended and unattended blood pressure is close to 10 mm Hg. So our SBP of 130 mm Hg, which had the best outcomes in HOPE-3, may be the same as about 120 mm Hg in SPRINT,” according to Dr. Lonn.
HOPE-3 was funded by the Canadian Institutes of Health Research and AstraZeneca. Dr. Lonn reported serving as a consultant to and receiving research grants from AstraZeneca, Amgen, Bayer, and Novartis.
BARCELONA – How low to go in treating hypertension is a topic of considerable recent controversy. Now the HOPE-3 trial investigators have weighed in, reporting that optimal outcomes in their landmark randomized trial were seen with an achieved, on-treatment systolic blood pressure of 130-140 mm Hg and a diastolic blood pressure of 75-80 mm Hg, Eva M. Lonn, MD, reported at the annual congress of the European Society of Cardiology.
Those results stand in glaring contrast to the findings of the much-discussed SPRINT trial, in which hypertensive patients fared best with an on-treatment SBP driven below 120 mm Hg (N Engl J Med. 2015 Nov 26; 373:2103-16).
“Please note that lower blood pressures, both systolic and diastolic, weren’t associated with lower risk, whereas higher blood pressures considerably increased the risk for major vascular events,” she added.
HOPE-3 (the Third Heart Outcomes Prevention Evaluation) included 12,705 patients in 21 countries who did not have cardiovascular disease and were at intermediate risk, with an average age of 65 years at enrollment and a Framinhgam Risk Score of about 10%. They were randomized double-blind in a 2x2 factorial design to rosuvastatin at 10 mg per day or placebo and/or candesartan at 16 mg plus hydrochlorothiazide at 12.5 mg per day or placebo and prospectively followed for a median of 5.6 years.
The primary outcomes of HOPE-3 have been published (N Engl J Med. 2016 May 26;374[21]:2009-20 and 2021-31). This was a practice-changing trial that opened the door to broader use of statin therapy for primary prevention.
At the ESC congress in Barcelona, Dr. Lonn presented a secondary post-hoc analysis that focused on the impact of antihypertensive therapy in HOPE-3. The results shed new light on the optimal blood pressure levels for triggering initation of antihypertensive therapy, as well as defining the achieved blood pressures that resulted in the greatest reductions in major vascular events.
As this was essentially an all-comers trial of intermediate-risk patients, participants presented with a range of blood pressures at baseline. But more than 4,700 subjects had a baseline SBP of 140-159.9 mm Hg, and 833 had an SBP of 160 mm Hg or more.
The candesartan/hydrochlorothiazide regimen resulted in what Dr. Lonn termed a “moderate” net placebo-subtracted blood pressure reduction of 6/3 mm Hg. The higher the baseline blood pressure, the bigger the reduction.
In the one-third of subjects with a baseline SBP greater than 143.5 mm Hg, antihypertensive therapy resulted in a significant 27% reduction in the composite endpoint of cardiovascular death, MI, or stroke compared with placebo. Those with a baseline SBP of 150 mm Hg or more showed even greater benefit from antihypertensive therapy, with a composite event rate of 4.8% compared with 7.2% for placebo, representing a 34% relative risk reduction in which the event curves began separating at about 2 years.
In contrast, antihypertensive therapy brought no significant reduction in events in patients in the lower two tertiles of baseline SBP. And there was no association at all between baseline DBP and major cardiovascular events across the range of DBP values evaluated in HOPE-3.
But wait: Things get more interesting, according to the cardiac electrophysiologist.
“I find the association between mean in-trial blood pressure as recorded in many measurements and vascular outcomes to be the most interesting analysis. This may be a better look at the association between blood pressure and outcomes than a measurement obtained just once or twice at baseline,” she explained.
Of note, among the 6,356 subjects on candesartan/hydrochlorothiazide, those with a mean on-treatment SBP of 160 mm Hg or more had a 2.61% per year rate of the composite of cardiovascular death, MI, stroke, rescue from cardiac arrest, heart failure, or revascularization. This was more than three-fold higher than the 0.75% per year rate in patients with an on-treatment SBP of 120-139.9 mm Hg. The composite event rate was also significantly higher in those with a mean on-treatment SBP of 140-159.9 mm Hg, at 1.4% per year. The event rate in patients with an on-treatment SBP below 120 mm Hg was identical to that of patients with a value of 120-139.9 mm Hg.
Only among patients with an on-treatment DBP of 90 mm Hg or more was the composite event rate significantly greater than in those with a DBP of 70-79.9 mm Hg, who had the lowest event rate by a margin of 1.89% versus 0.75% per year.
An Australian cardiologist in the audience who has been involved in revamping hypertension treatment guidelines Down Under expressed frustration. He only recently succeeded in wrangling his fellow panelists into incorporating the SPRINT results into the draft guidelines; now HOPE-3 is sending a very different message. What gives? Could the disparate findings simply be due to play of chance? he asked.
Highly unlikely, Dr. Lonn replied.
“There were substantial differences between our trials,” she explained. “First of all, the SPRINT population was at substantially higher risk. They either had to have established cardiovascular disease – we eliminated those people – or significant renal disease – we eliminated those people, too – or age greater than 75, or a Framingham Risk Score above 15%.”
Also, the SPRINT protocol controversially called for unattended blood pressure measurement.
“This is a very pure way ot eliminating white coat hypertension, but it is different from other studies, so it is very difficult to compare SPRINT to older studies or to HOPE-3. Some other investigators have suggested that the difference between attended and unattended blood pressure is close to 10 mm Hg. So our SBP of 130 mm Hg, which had the best outcomes in HOPE-3, may be the same as about 120 mm Hg in SPRINT,” according to Dr. Lonn.
HOPE-3 was funded by the Canadian Institutes of Health Research and AstraZeneca. Dr. Lonn reported serving as a consultant to and receiving research grants from AstraZeneca, Amgen, Bayer, and Novartis.
BARCELONA – How low to go in treating hypertension is a topic of considerable recent controversy. Now the HOPE-3 trial investigators have weighed in, reporting that optimal outcomes in their landmark randomized trial were seen with an achieved, on-treatment systolic blood pressure of 130-140 mm Hg and a diastolic blood pressure of 75-80 mm Hg, Eva M. Lonn, MD, reported at the annual congress of the European Society of Cardiology.
Those results stand in glaring contrast to the findings of the much-discussed SPRINT trial, in which hypertensive patients fared best with an on-treatment SBP driven below 120 mm Hg (N Engl J Med. 2015 Nov 26; 373:2103-16).
“Please note that lower blood pressures, both systolic and diastolic, weren’t associated with lower risk, whereas higher blood pressures considerably increased the risk for major vascular events,” she added.
HOPE-3 (the Third Heart Outcomes Prevention Evaluation) included 12,705 patients in 21 countries who did not have cardiovascular disease and were at intermediate risk, with an average age of 65 years at enrollment and a Framinhgam Risk Score of about 10%. They were randomized double-blind in a 2x2 factorial design to rosuvastatin at 10 mg per day or placebo and/or candesartan at 16 mg plus hydrochlorothiazide at 12.5 mg per day or placebo and prospectively followed for a median of 5.6 years.
The primary outcomes of HOPE-3 have been published (N Engl J Med. 2016 May 26;374[21]:2009-20 and 2021-31). This was a practice-changing trial that opened the door to broader use of statin therapy for primary prevention.
At the ESC congress in Barcelona, Dr. Lonn presented a secondary post-hoc analysis that focused on the impact of antihypertensive therapy in HOPE-3. The results shed new light on the optimal blood pressure levels for triggering initation of antihypertensive therapy, as well as defining the achieved blood pressures that resulted in the greatest reductions in major vascular events.
As this was essentially an all-comers trial of intermediate-risk patients, participants presented with a range of blood pressures at baseline. But more than 4,700 subjects had a baseline SBP of 140-159.9 mm Hg, and 833 had an SBP of 160 mm Hg or more.
The candesartan/hydrochlorothiazide regimen resulted in what Dr. Lonn termed a “moderate” net placebo-subtracted blood pressure reduction of 6/3 mm Hg. The higher the baseline blood pressure, the bigger the reduction.
In the one-third of subjects with a baseline SBP greater than 143.5 mm Hg, antihypertensive therapy resulted in a significant 27% reduction in the composite endpoint of cardiovascular death, MI, or stroke compared with placebo. Those with a baseline SBP of 150 mm Hg or more showed even greater benefit from antihypertensive therapy, with a composite event rate of 4.8% compared with 7.2% for placebo, representing a 34% relative risk reduction in which the event curves began separating at about 2 years.
In contrast, antihypertensive therapy brought no significant reduction in events in patients in the lower two tertiles of baseline SBP. And there was no association at all between baseline DBP and major cardiovascular events across the range of DBP values evaluated in HOPE-3.
But wait: Things get more interesting, according to the cardiac electrophysiologist.
“I find the association between mean in-trial blood pressure as recorded in many measurements and vascular outcomes to be the most interesting analysis. This may be a better look at the association between blood pressure and outcomes than a measurement obtained just once or twice at baseline,” she explained.
Of note, among the 6,356 subjects on candesartan/hydrochlorothiazide, those with a mean on-treatment SBP of 160 mm Hg or more had a 2.61% per year rate of the composite of cardiovascular death, MI, stroke, rescue from cardiac arrest, heart failure, or revascularization. This was more than three-fold higher than the 0.75% per year rate in patients with an on-treatment SBP of 120-139.9 mm Hg. The composite event rate was also significantly higher in those with a mean on-treatment SBP of 140-159.9 mm Hg, at 1.4% per year. The event rate in patients with an on-treatment SBP below 120 mm Hg was identical to that of patients with a value of 120-139.9 mm Hg.
Only among patients with an on-treatment DBP of 90 mm Hg or more was the composite event rate significantly greater than in those with a DBP of 70-79.9 mm Hg, who had the lowest event rate by a margin of 1.89% versus 0.75% per year.
An Australian cardiologist in the audience who has been involved in revamping hypertension treatment guidelines Down Under expressed frustration. He only recently succeeded in wrangling his fellow panelists into incorporating the SPRINT results into the draft guidelines; now HOPE-3 is sending a very different message. What gives? Could the disparate findings simply be due to play of chance? he asked.
Highly unlikely, Dr. Lonn replied.
“There were substantial differences between our trials,” she explained. “First of all, the SPRINT population was at substantially higher risk. They either had to have established cardiovascular disease – we eliminated those people – or significant renal disease – we eliminated those people, too – or age greater than 75, or a Framingham Risk Score above 15%.”
Also, the SPRINT protocol controversially called for unattended blood pressure measurement.
“This is a very pure way ot eliminating white coat hypertension, but it is different from other studies, so it is very difficult to compare SPRINT to older studies or to HOPE-3. Some other investigators have suggested that the difference between attended and unattended blood pressure is close to 10 mm Hg. So our SBP of 130 mm Hg, which had the best outcomes in HOPE-3, may be the same as about 120 mm Hg in SPRINT,” according to Dr. Lonn.
HOPE-3 was funded by the Canadian Institutes of Health Research and AstraZeneca. Dr. Lonn reported serving as a consultant to and receiving research grants from AstraZeneca, Amgen, Bayer, and Novartis.
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: The on-treatment systolic blood pressure target associated with the greatest reduction in vascular events in the HOPE-3 trial was 130-140 mm Hg.
Data source: The HOPE-3 trial was a randomized, double-blind, placebo-controlled study of 12,705 intermediate-cardiovascular-risk patients in 21 countries who were prospectively followed for a median 5.6 years.
Disclosures: HOPE-3 was funded by the Canadian Institutes of Health Research and AstraZeneca. The presenter reported serving as a consultant to and receiving research grants from AstraZeneca, Amgen, Bayer, and Novartis.
Obesity paradox slings its weight around in atrial fibrillation
BARCELONA – The obesity paradox is alive and well in the rapidly growing population with atrial fibrillation, Samuel Z. Goldhaber, MD, reported at the annual congress of the European Society of Cardiology.
In an analysis of 22,541 participants in the international registry known as GARFIELD-AF (Global Anticoagulation Registry in the Field-Atrial Fibrillation) – the largest ongoing prospective AF registry in the world – all-cause mortality during the first 2 years after diagnosis of the arrhythmia paradoxically decreased as body mass index increased all the way up to a ceiling of 40 kg/m2, according to Dr. Goldhaber, professor of medicine at Harvard Medical School and section head of vascular medicine and director of the thrombosis research group at Brigham and Women’s Hospital, Boston.
“It’s pretty impressive. This degree of mortality reduction with overweight and obesity is of about the same magnitude you might get with thrombolytic therapy for an acute MI, or with beta blocker therapy or statins post-MI,” the cardiologist said in an interview.
This newly described obesity paradox in AF is all the more baffling in light of the heavy cardiovascular risk factor burden that accompanied increased BMI. For example, the prevalence of type 2 diabetes rose from 14.1% among normal-weight individuals with AF, to 19.7% in the overweight, 27.5% in the obese, 34.6% in those with a BMI of 35 to less than 40 kg/m2, and 41.6% in patients with a BMI of 40 kg/m2 or more.
“It’s perplexing,” Dr. Goldhaber confessed. “I think there’s some hidden message here that we haven’t decoded yet.”
Patients with AF who were at the low extreme of the BMI spectrum -- the 3.3% who were underweight, with a BMI below 20 kg/m2 – fared particularly poorly. Their 2-year all-cause mortality rate of 8.71 per 100 person-years was by far the highest of any BMI class in the study. But that’s relatively straightforward to understand, as it’s likely that many underweight patients with AF were frail and/or had cancer. Indeed, only 49% of deaths in the underweight group were due to cardiovascular disease, in contrast to 64% of deaths in persons whose BMI was 40 kg/m2 or more.
Interestingly, only 5%-6% of all deaths in GARFIELD-AF were due to stroke; deaths from heart failure were far more common.
Overall, 71% of patients who presented with newly diagnosed AF in GARFIELD-AF were overweight or obese. The only contributory factor to the obesity paradox that Dr. Goldhaber could spot was that the heavier patients were younger at diagnosis of AF. But this age disparity seems unlikely to overcome their massive burden of multiple other cardiovascular risk factors. So he solicited theories from his audience. One physician argued that morbidly obese individuals are sedentary, so they don’t leave the house as much as leaner AF patients.
“You stay at home because you cannot move. You don’t get into fatal car accidents. You don’t get into conflicts and get murdered,” the physician postulated.
Dr. Goldhaber wasn’t convinced.
“When I go out to bars or dancing, I look around at people, and I estimate that a lot of them have a BMI of 35,” he commented.
Another proposed theory was that overweight and obese AF patients exercise less, so they inhale less of the airborne toxic fine particulates present in the urban environment. The adverse health impact of air pollution is a particularly hot topic of late among European cardiologists, but the notion that obese AF patients fare better because they don’t exercise runs contrary to a wealth of data supporting the health benefits of working out.
The GARFIELD-AF registry is funded by Bayer AG. Dr. Goldhaber reported receiving research grants and/or serving as a consultant to Bayer and numerous other entities, including the National Heart, Lung and Blood Institute.
BARCELONA – The obesity paradox is alive and well in the rapidly growing population with atrial fibrillation, Samuel Z. Goldhaber, MD, reported at the annual congress of the European Society of Cardiology.
In an analysis of 22,541 participants in the international registry known as GARFIELD-AF (Global Anticoagulation Registry in the Field-Atrial Fibrillation) – the largest ongoing prospective AF registry in the world – all-cause mortality during the first 2 years after diagnosis of the arrhythmia paradoxically decreased as body mass index increased all the way up to a ceiling of 40 kg/m2, according to Dr. Goldhaber, professor of medicine at Harvard Medical School and section head of vascular medicine and director of the thrombosis research group at Brigham and Women’s Hospital, Boston.
“It’s pretty impressive. This degree of mortality reduction with overweight and obesity is of about the same magnitude you might get with thrombolytic therapy for an acute MI, or with beta blocker therapy or statins post-MI,” the cardiologist said in an interview.
This newly described obesity paradox in AF is all the more baffling in light of the heavy cardiovascular risk factor burden that accompanied increased BMI. For example, the prevalence of type 2 diabetes rose from 14.1% among normal-weight individuals with AF, to 19.7% in the overweight, 27.5% in the obese, 34.6% in those with a BMI of 35 to less than 40 kg/m2, and 41.6% in patients with a BMI of 40 kg/m2 or more.
“It’s perplexing,” Dr. Goldhaber confessed. “I think there’s some hidden message here that we haven’t decoded yet.”
Patients with AF who were at the low extreme of the BMI spectrum -- the 3.3% who were underweight, with a BMI below 20 kg/m2 – fared particularly poorly. Their 2-year all-cause mortality rate of 8.71 per 100 person-years was by far the highest of any BMI class in the study. But that’s relatively straightforward to understand, as it’s likely that many underweight patients with AF were frail and/or had cancer. Indeed, only 49% of deaths in the underweight group were due to cardiovascular disease, in contrast to 64% of deaths in persons whose BMI was 40 kg/m2 or more.
Interestingly, only 5%-6% of all deaths in GARFIELD-AF were due to stroke; deaths from heart failure were far more common.
Overall, 71% of patients who presented with newly diagnosed AF in GARFIELD-AF were overweight or obese. The only contributory factor to the obesity paradox that Dr. Goldhaber could spot was that the heavier patients were younger at diagnosis of AF. But this age disparity seems unlikely to overcome their massive burden of multiple other cardiovascular risk factors. So he solicited theories from his audience. One physician argued that morbidly obese individuals are sedentary, so they don’t leave the house as much as leaner AF patients.
“You stay at home because you cannot move. You don’t get into fatal car accidents. You don’t get into conflicts and get murdered,” the physician postulated.
Dr. Goldhaber wasn’t convinced.
“When I go out to bars or dancing, I look around at people, and I estimate that a lot of them have a BMI of 35,” he commented.
Another proposed theory was that overweight and obese AF patients exercise less, so they inhale less of the airborne toxic fine particulates present in the urban environment. The adverse health impact of air pollution is a particularly hot topic of late among European cardiologists, but the notion that obese AF patients fare better because they don’t exercise runs contrary to a wealth of data supporting the health benefits of working out.
The GARFIELD-AF registry is funded by Bayer AG. Dr. Goldhaber reported receiving research grants and/or serving as a consultant to Bayer and numerous other entities, including the National Heart, Lung and Blood Institute.
BARCELONA – The obesity paradox is alive and well in the rapidly growing population with atrial fibrillation, Samuel Z. Goldhaber, MD, reported at the annual congress of the European Society of Cardiology.
In an analysis of 22,541 participants in the international registry known as GARFIELD-AF (Global Anticoagulation Registry in the Field-Atrial Fibrillation) – the largest ongoing prospective AF registry in the world – all-cause mortality during the first 2 years after diagnosis of the arrhythmia paradoxically decreased as body mass index increased all the way up to a ceiling of 40 kg/m2, according to Dr. Goldhaber, professor of medicine at Harvard Medical School and section head of vascular medicine and director of the thrombosis research group at Brigham and Women’s Hospital, Boston.
“It’s pretty impressive. This degree of mortality reduction with overweight and obesity is of about the same magnitude you might get with thrombolytic therapy for an acute MI, or with beta blocker therapy or statins post-MI,” the cardiologist said in an interview.
This newly described obesity paradox in AF is all the more baffling in light of the heavy cardiovascular risk factor burden that accompanied increased BMI. For example, the prevalence of type 2 diabetes rose from 14.1% among normal-weight individuals with AF, to 19.7% in the overweight, 27.5% in the obese, 34.6% in those with a BMI of 35 to less than 40 kg/m2, and 41.6% in patients with a BMI of 40 kg/m2 or more.
“It’s perplexing,” Dr. Goldhaber confessed. “I think there’s some hidden message here that we haven’t decoded yet.”
Patients with AF who were at the low extreme of the BMI spectrum -- the 3.3% who were underweight, with a BMI below 20 kg/m2 – fared particularly poorly. Their 2-year all-cause mortality rate of 8.71 per 100 person-years was by far the highest of any BMI class in the study. But that’s relatively straightforward to understand, as it’s likely that many underweight patients with AF were frail and/or had cancer. Indeed, only 49% of deaths in the underweight group were due to cardiovascular disease, in contrast to 64% of deaths in persons whose BMI was 40 kg/m2 or more.
Interestingly, only 5%-6% of all deaths in GARFIELD-AF were due to stroke; deaths from heart failure were far more common.
Overall, 71% of patients who presented with newly diagnosed AF in GARFIELD-AF were overweight or obese. The only contributory factor to the obesity paradox that Dr. Goldhaber could spot was that the heavier patients were younger at diagnosis of AF. But this age disparity seems unlikely to overcome their massive burden of multiple other cardiovascular risk factors. So he solicited theories from his audience. One physician argued that morbidly obese individuals are sedentary, so they don’t leave the house as much as leaner AF patients.
“You stay at home because you cannot move. You don’t get into fatal car accidents. You don’t get into conflicts and get murdered,” the physician postulated.
Dr. Goldhaber wasn’t convinced.
“When I go out to bars or dancing, I look around at people, and I estimate that a lot of them have a BMI of 35,” he commented.
Another proposed theory was that overweight and obese AF patients exercise less, so they inhale less of the airborne toxic fine particulates present in the urban environment. The adverse health impact of air pollution is a particularly hot topic of late among European cardiologists, but the notion that obese AF patients fare better because they don’t exercise runs contrary to a wealth of data supporting the health benefits of working out.
The GARFIELD-AF registry is funded by Bayer AG. Dr. Goldhaber reported receiving research grants and/or serving as a consultant to Bayer and numerous other entities, including the National Heart, Lung and Blood Institute.
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: Two-year all-cause mortality following diagnosis of atrial fibrillation fell substantially in stepwise fashion with increasing body mass index, for reasons unknown.
Data source: GARFIELD-AF is an ongoing enormous international prospective registry of patients newly diagnosed with atrial fibrillation.
Disclosures: The GARFIELD-AF registry is funded by Bayer AG. The presenter reported receiving research grants and/or consultant fees from that company and numerous others.
LDL levels below 10 mg/dL shown safe, effective
BARCELONA – The maxim that lower is better for LDL cholesterol continues to hold true, even at jaw-droppingly low levels of less than 10 mg/dL in a new analysis of data from the FOURIER trial.
The Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial was the pivotal efficacy and safety study for the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab (Repatha) and enrolled patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of at least 70 mg/dL (N Engl J Med. 2017 May 4;376[18]:1713-22).
After a median follow-up of 26 months, the incidence of the study’s primary endpoint (cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary revascularization) dropped by a statistically significant 15% in patients with an achieved LDL cholesterol of 20-49 mg/dL, compared with patients whose 4-week LDL cholesterol was at or above 100 mg/dL (primarily patients randomized to the study’s control arm), by 24% in all patients with LDL cholesterol less than 20 mg/dL, and by 31% in the 2% of patients whose LDL cholesterol levels fell below 10 mg/dL.
These strikingly improved event rates at the lowest levels of LDL cholesterol occurred with no signal of excess adverse events, Robert P. Giugliano, MD, said at the annual congress of the European Society of Cardiology.
In contrast, the 13% of patents whose achieved LDL cholesterol was 50-69 mg/dL had an event rate just 6% below the referent group of 100 mg/dL or more, a nonsignificant difference. Existing cholesterol management guidelines that set LDL cholesterol targets for secondary prevention have used a level below 70 mg/dL as the target, such as the European Society of Cardiology’s 2016 guidelines (Eur Heart J. 2016 Oct 14;37[39]:2999-3058).
“The data suggest that we should target considerably lower LDL cholesterol than is currently recommended for our patients with atherosclerotic cardiovascular disease,” said Dr. Giugliano, a cardiologist at Brigham and Women’s Hospital in Boston.
“Lowest is best with LDL. You don’t need a lot of LDL in the serum for normal human function,” he noted during the discussion of his report.
While FOURIER’s event curve continued to drop as LDL cholesterol fell below 10 mg/dL, the study’s wide-ranging safety assessment showed no signal of harm at the lowest levels. This “gives us some reassurance it’s safe,” he said in an interview. “We saw benefit that continued down to the lowest LDL levels, so it’s hard to pick a LDL target. I no longer feel comfortable treating my patients to just less than 70 mg/dL. I’m not sure what is the optimal LDL target, but I think it needs to be lower than that.”
To achieve such ultralow LDL levels, most patients need treatment with a PCSK9 inhibitor plus at least one and perhaps two additional cholesterol-lowering drugs, a statin and ezetimibe, he noted.
The FOURIER analyses Dr. Giugliano reported included data on the incidence during the study of 10 specific types of adverse events: noncardiovascular death, serious adverse events, adverse events leading to study discontinuation, and new onset of diabetes, cancer, cataract, neurocognitive deficit, significant liver enzyme increase, significant creatine kinase increase, and hemorrhagic stroke. The incidence of each of these was similar among the patients in five study subgroups based on achieved levels of LDL cholesterol: less than 20 mg/dL, 20-49 mg/dL, 50-69 mg/dL, 70-99 mg/dL, and 100 mg/dL or higher. In addition, the rates of both serious adverse events and adverse events leading to study discontinuation was roughly the same in the subgroup of patients with an achieved LDL cholesterol of less than 10 mg/dL as in those with an achieved LDL of at least 100 mg/dL.
Concurrently with Dr. Giugliano’s report, the results also appeared in an online article (Lancet. 2017 Aug 28. doi: 10.1016/S0140-6736[17]32290-0).
FOURIER was funded by Amgen, the company that markets evolocumab (Repatha). Dr. Giugliano has been a consultant to and has received research funding from Amgen, and he has also been a consultant to Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Merck, and Pfizer.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
BARCELONA – The maxim that lower is better for LDL cholesterol continues to hold true, even at jaw-droppingly low levels of less than 10 mg/dL in a new analysis of data from the FOURIER trial.
The Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial was the pivotal efficacy and safety study for the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab (Repatha) and enrolled patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of at least 70 mg/dL (N Engl J Med. 2017 May 4;376[18]:1713-22).
After a median follow-up of 26 months, the incidence of the study’s primary endpoint (cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary revascularization) dropped by a statistically significant 15% in patients with an achieved LDL cholesterol of 20-49 mg/dL, compared with patients whose 4-week LDL cholesterol was at or above 100 mg/dL (primarily patients randomized to the study’s control arm), by 24% in all patients with LDL cholesterol less than 20 mg/dL, and by 31% in the 2% of patients whose LDL cholesterol levels fell below 10 mg/dL.
These strikingly improved event rates at the lowest levels of LDL cholesterol occurred with no signal of excess adverse events, Robert P. Giugliano, MD, said at the annual congress of the European Society of Cardiology.
In contrast, the 13% of patents whose achieved LDL cholesterol was 50-69 mg/dL had an event rate just 6% below the referent group of 100 mg/dL or more, a nonsignificant difference. Existing cholesterol management guidelines that set LDL cholesterol targets for secondary prevention have used a level below 70 mg/dL as the target, such as the European Society of Cardiology’s 2016 guidelines (Eur Heart J. 2016 Oct 14;37[39]:2999-3058).
“The data suggest that we should target considerably lower LDL cholesterol than is currently recommended for our patients with atherosclerotic cardiovascular disease,” said Dr. Giugliano, a cardiologist at Brigham and Women’s Hospital in Boston.
“Lowest is best with LDL. You don’t need a lot of LDL in the serum for normal human function,” he noted during the discussion of his report.
While FOURIER’s event curve continued to drop as LDL cholesterol fell below 10 mg/dL, the study’s wide-ranging safety assessment showed no signal of harm at the lowest levels. This “gives us some reassurance it’s safe,” he said in an interview. “We saw benefit that continued down to the lowest LDL levels, so it’s hard to pick a LDL target. I no longer feel comfortable treating my patients to just less than 70 mg/dL. I’m not sure what is the optimal LDL target, but I think it needs to be lower than that.”
To achieve such ultralow LDL levels, most patients need treatment with a PCSK9 inhibitor plus at least one and perhaps two additional cholesterol-lowering drugs, a statin and ezetimibe, he noted.
The FOURIER analyses Dr. Giugliano reported included data on the incidence during the study of 10 specific types of adverse events: noncardiovascular death, serious adverse events, adverse events leading to study discontinuation, and new onset of diabetes, cancer, cataract, neurocognitive deficit, significant liver enzyme increase, significant creatine kinase increase, and hemorrhagic stroke. The incidence of each of these was similar among the patients in five study subgroups based on achieved levels of LDL cholesterol: less than 20 mg/dL, 20-49 mg/dL, 50-69 mg/dL, 70-99 mg/dL, and 100 mg/dL or higher. In addition, the rates of both serious adverse events and adverse events leading to study discontinuation was roughly the same in the subgroup of patients with an achieved LDL cholesterol of less than 10 mg/dL as in those with an achieved LDL of at least 100 mg/dL.
Concurrently with Dr. Giugliano’s report, the results also appeared in an online article (Lancet. 2017 Aug 28. doi: 10.1016/S0140-6736[17]32290-0).
FOURIER was funded by Amgen, the company that markets evolocumab (Repatha). Dr. Giugliano has been a consultant to and has received research funding from Amgen, and he has also been a consultant to Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Merck, and Pfizer.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
BARCELONA – The maxim that lower is better for LDL cholesterol continues to hold true, even at jaw-droppingly low levels of less than 10 mg/dL in a new analysis of data from the FOURIER trial.
The Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial was the pivotal efficacy and safety study for the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab (Repatha) and enrolled patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of at least 70 mg/dL (N Engl J Med. 2017 May 4;376[18]:1713-22).
After a median follow-up of 26 months, the incidence of the study’s primary endpoint (cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary revascularization) dropped by a statistically significant 15% in patients with an achieved LDL cholesterol of 20-49 mg/dL, compared with patients whose 4-week LDL cholesterol was at or above 100 mg/dL (primarily patients randomized to the study’s control arm), by 24% in all patients with LDL cholesterol less than 20 mg/dL, and by 31% in the 2% of patients whose LDL cholesterol levels fell below 10 mg/dL.
These strikingly improved event rates at the lowest levels of LDL cholesterol occurred with no signal of excess adverse events, Robert P. Giugliano, MD, said at the annual congress of the European Society of Cardiology.
In contrast, the 13% of patents whose achieved LDL cholesterol was 50-69 mg/dL had an event rate just 6% below the referent group of 100 mg/dL or more, a nonsignificant difference. Existing cholesterol management guidelines that set LDL cholesterol targets for secondary prevention have used a level below 70 mg/dL as the target, such as the European Society of Cardiology’s 2016 guidelines (Eur Heart J. 2016 Oct 14;37[39]:2999-3058).
“The data suggest that we should target considerably lower LDL cholesterol than is currently recommended for our patients with atherosclerotic cardiovascular disease,” said Dr. Giugliano, a cardiologist at Brigham and Women’s Hospital in Boston.
“Lowest is best with LDL. You don’t need a lot of LDL in the serum for normal human function,” he noted during the discussion of his report.
While FOURIER’s event curve continued to drop as LDL cholesterol fell below 10 mg/dL, the study’s wide-ranging safety assessment showed no signal of harm at the lowest levels. This “gives us some reassurance it’s safe,” he said in an interview. “We saw benefit that continued down to the lowest LDL levels, so it’s hard to pick a LDL target. I no longer feel comfortable treating my patients to just less than 70 mg/dL. I’m not sure what is the optimal LDL target, but I think it needs to be lower than that.”
To achieve such ultralow LDL levels, most patients need treatment with a PCSK9 inhibitor plus at least one and perhaps two additional cholesterol-lowering drugs, a statin and ezetimibe, he noted.
The FOURIER analyses Dr. Giugliano reported included data on the incidence during the study of 10 specific types of adverse events: noncardiovascular death, serious adverse events, adverse events leading to study discontinuation, and new onset of diabetes, cancer, cataract, neurocognitive deficit, significant liver enzyme increase, significant creatine kinase increase, and hemorrhagic stroke. The incidence of each of these was similar among the patients in five study subgroups based on achieved levels of LDL cholesterol: less than 20 mg/dL, 20-49 mg/dL, 50-69 mg/dL, 70-99 mg/dL, and 100 mg/dL or higher. In addition, the rates of both serious adverse events and adverse events leading to study discontinuation was roughly the same in the subgroup of patients with an achieved LDL cholesterol of less than 10 mg/dL as in those with an achieved LDL of at least 100 mg/dL.
Concurrently with Dr. Giugliano’s report, the results also appeared in an online article (Lancet. 2017 Aug 28. doi: 10.1016/S0140-6736[17]32290-0).
FOURIER was funded by Amgen, the company that markets evolocumab (Repatha). Dr. Giugliano has been a consultant to and has received research funding from Amgen, and he has also been a consultant to Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Merck, and Pfizer.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: Patients with an achieved LDL of less than 10 mg/dL had an event rate 31% below patients with an LDL at or above 100 mg/dL.
Data source: FOURIER, an international multicenter trial with 27,564 patients.
Disclosures: FOURIER was funded by Amgen, the company that markets evolocumab (Repatha). Dr. Giugliano has been a consultant to and has received research funding from Amgen, and he has also been a consultant to Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Merck, and Pfizer.
How to apply SPRINT findings to elderly patients
SAN FRANCISCO – The benefit of lowering blood pressure exceeded the potential for harm, even among the most frail elderly, in SPRINT, but it’s important to remember who was excluded from the trial when using the findings in the clinic, according to Mark Supiano, MD.
SPRINT (Systolic Blood Pressure Intervention Trial) excluded people with histories of stroke, diabetes, heart failure, and chronic kidney disease with a markedly reduced glomerular filtration rate. People living in nursing homes, assisted living centers, and those with prevalent dementia were also excluded, as were individuals with a standing systolic pressure below 110 mm Hg (N Engl J Med. 2015 Nov 26;373:2103-16).
Even with those exclusions, however, the 2,636 patients in SPRINT who were 75 years and older “were not a super healthy group of older people,” Dr. Supiano said at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
They were at high risk for cardiovascular disease (CVD), with a median 10-year Framingham risk score of almost 25%. More than a quarter had gait speeds below 0.8 m/sec, and almost a third were classified as frail. Many had mild cognitive impairment at baseline.
In the United States, Dr. Supiano and his colleagues estimate that there are almost 6 million similar people 75 years or older with hypertension who would likely achieve the same benefits from hypertension control as elderly subjects in the trial. “As a geriatrician, there are very few things that I can offer patients 75 years and older that will have a profound improvement in their overall mortality.” Blood pressure control is one of them, said Dr. Supiano, chief of geriatrics at the University of Utah, Salt Lake City, and a SPRINT investigator.
In SPRINT, intensive treatment to systolic pressure below 120 mm Hg showed greater benefit for patients 75 years and older than it did for younger patients, even among the frail, with a 34% reduction in fatal and nonfatal CVD events versus patients treated to below 140 mm Hg, and a 33% lower rate of death from any cause.
It should be no surprise that older patients had greater benefit from tighter control, because elderly patients have “a greater CVD risk. There’s more bang for the buck” with blood pressure lowering in an older population. “Overall, benefits exceed the potential for harm, even among the frailest older patients,” Dr. Supiano said.
“A systemic target of less than 140 mm Hg is, I believe, appropriate for most healthy people age 60 and older. A benefit-based systemic target of less than 120 mm Hg may be appropriate for those at higher CVD risk.” Among patients 60-75 years old, that would include those with a Framingham score above 15%. Among patients older than age 75 with an elevated CVD risk, treatment to below 120 mm Hg makes sense if it aligns with patient’s goals of care, Dr. Supiano said.
The 120–mm Hg target in SPRINT was associated with a greater incidence of some transient side effects in the elderly, including hypotension, syncope, acute kidney injury, and electrolyte imbalance, but not a higher risk of serious adverse events or injurious falls.
There were concerns raised at the joint sessions about the effect of blood pressure lowering on the cognitive function of older people. Dr. Supiano noted that the cognitive outcomes in SPRINT, as well as outcomes in patients with chronic kidney disease, have not yet been released, but are expected soon.
Dr. Supiano had no relevant disclosures.
SAN FRANCISCO – The benefit of lowering blood pressure exceeded the potential for harm, even among the most frail elderly, in SPRINT, but it’s important to remember who was excluded from the trial when using the findings in the clinic, according to Mark Supiano, MD.
SPRINT (Systolic Blood Pressure Intervention Trial) excluded people with histories of stroke, diabetes, heart failure, and chronic kidney disease with a markedly reduced glomerular filtration rate. People living in nursing homes, assisted living centers, and those with prevalent dementia were also excluded, as were individuals with a standing systolic pressure below 110 mm Hg (N Engl J Med. 2015 Nov 26;373:2103-16).
Even with those exclusions, however, the 2,636 patients in SPRINT who were 75 years and older “were not a super healthy group of older people,” Dr. Supiano said at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
They were at high risk for cardiovascular disease (CVD), with a median 10-year Framingham risk score of almost 25%. More than a quarter had gait speeds below 0.8 m/sec, and almost a third were classified as frail. Many had mild cognitive impairment at baseline.
In the United States, Dr. Supiano and his colleagues estimate that there are almost 6 million similar people 75 years or older with hypertension who would likely achieve the same benefits from hypertension control as elderly subjects in the trial. “As a geriatrician, there are very few things that I can offer patients 75 years and older that will have a profound improvement in their overall mortality.” Blood pressure control is one of them, said Dr. Supiano, chief of geriatrics at the University of Utah, Salt Lake City, and a SPRINT investigator.
In SPRINT, intensive treatment to systolic pressure below 120 mm Hg showed greater benefit for patients 75 years and older than it did for younger patients, even among the frail, with a 34% reduction in fatal and nonfatal CVD events versus patients treated to below 140 mm Hg, and a 33% lower rate of death from any cause.
It should be no surprise that older patients had greater benefit from tighter control, because elderly patients have “a greater CVD risk. There’s more bang for the buck” with blood pressure lowering in an older population. “Overall, benefits exceed the potential for harm, even among the frailest older patients,” Dr. Supiano said.
“A systemic target of less than 140 mm Hg is, I believe, appropriate for most healthy people age 60 and older. A benefit-based systemic target of less than 120 mm Hg may be appropriate for those at higher CVD risk.” Among patients 60-75 years old, that would include those with a Framingham score above 15%. Among patients older than age 75 with an elevated CVD risk, treatment to below 120 mm Hg makes sense if it aligns with patient’s goals of care, Dr. Supiano said.
The 120–mm Hg target in SPRINT was associated with a greater incidence of some transient side effects in the elderly, including hypotension, syncope, acute kidney injury, and electrolyte imbalance, but not a higher risk of serious adverse events or injurious falls.
There were concerns raised at the joint sessions about the effect of blood pressure lowering on the cognitive function of older people. Dr. Supiano noted that the cognitive outcomes in SPRINT, as well as outcomes in patients with chronic kidney disease, have not yet been released, but are expected soon.
Dr. Supiano had no relevant disclosures.
SAN FRANCISCO – The benefit of lowering blood pressure exceeded the potential for harm, even among the most frail elderly, in SPRINT, but it’s important to remember who was excluded from the trial when using the findings in the clinic, according to Mark Supiano, MD.
SPRINT (Systolic Blood Pressure Intervention Trial) excluded people with histories of stroke, diabetes, heart failure, and chronic kidney disease with a markedly reduced glomerular filtration rate. People living in nursing homes, assisted living centers, and those with prevalent dementia were also excluded, as were individuals with a standing systolic pressure below 110 mm Hg (N Engl J Med. 2015 Nov 26;373:2103-16).
Even with those exclusions, however, the 2,636 patients in SPRINT who were 75 years and older “were not a super healthy group of older people,” Dr. Supiano said at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
They were at high risk for cardiovascular disease (CVD), with a median 10-year Framingham risk score of almost 25%. More than a quarter had gait speeds below 0.8 m/sec, and almost a third were classified as frail. Many had mild cognitive impairment at baseline.
In the United States, Dr. Supiano and his colleagues estimate that there are almost 6 million similar people 75 years or older with hypertension who would likely achieve the same benefits from hypertension control as elderly subjects in the trial. “As a geriatrician, there are very few things that I can offer patients 75 years and older that will have a profound improvement in their overall mortality.” Blood pressure control is one of them, said Dr. Supiano, chief of geriatrics at the University of Utah, Salt Lake City, and a SPRINT investigator.
In SPRINT, intensive treatment to systolic pressure below 120 mm Hg showed greater benefit for patients 75 years and older than it did for younger patients, even among the frail, with a 34% reduction in fatal and nonfatal CVD events versus patients treated to below 140 mm Hg, and a 33% lower rate of death from any cause.
It should be no surprise that older patients had greater benefit from tighter control, because elderly patients have “a greater CVD risk. There’s more bang for the buck” with blood pressure lowering in an older population. “Overall, benefits exceed the potential for harm, even among the frailest older patients,” Dr. Supiano said.
“A systemic target of less than 140 mm Hg is, I believe, appropriate for most healthy people age 60 and older. A benefit-based systemic target of less than 120 mm Hg may be appropriate for those at higher CVD risk.” Among patients 60-75 years old, that would include those with a Framingham score above 15%. Among patients older than age 75 with an elevated CVD risk, treatment to below 120 mm Hg makes sense if it aligns with patient’s goals of care, Dr. Supiano said.
The 120–mm Hg target in SPRINT was associated with a greater incidence of some transient side effects in the elderly, including hypotension, syncope, acute kidney injury, and electrolyte imbalance, but not a higher risk of serious adverse events or injurious falls.
There were concerns raised at the joint sessions about the effect of blood pressure lowering on the cognitive function of older people. Dr. Supiano noted that the cognitive outcomes in SPRINT, as well as outcomes in patients with chronic kidney disease, have not yet been released, but are expected soon.
Dr. Supiano had no relevant disclosures.
EXPERT ANALYSIS FROM JOINT HYPERTENSION 2017
Rheumatoid arthritis characteristics make large contribution to cardiovascular risk
Nearly one-third of cardiovascular events in patients with rheumatoid arthritis can be attributed to their rheumatoid arthritis characteristics, such as Disease Activity Score and rheumatoid factor or anticitrullinated protein antibody positivity, research suggests.
A prospective, international cohort study published in Annals of the Rheumatic Diseases followed 5,638 patients with rheumatoid arthritis (RA) and no history of cardiovascular disease for a mean of 5.8 years to look at their risk of myocardial infarction, angina, revascularization, stroke, peripheral vascular disease, and death from cardiovascular disease.
Overall, the 10-year cumulative incidence of cardiovascular events was 20.9% in men and 11.1% in women.
Smoking and hypertension were the strongest predictors of cardiovascular disease in both men and women and had the highest population attributable risk (PAR), even after adjustment for other cardiovascular risk factors.
The PAR for triglycerides was 11.5% overall, but it was 12.6% for Disease Activity Score in 28 joints (DAS28) and 12.2% for rheumatoid factor (RF)/anticitrullinated protein antibody (ACPA) positivity. Other RA-related factors, such as erythrocyte sedimentation rate (ESR) and C-reactive protein, did not have a significant effect on cardiovascular event risk.
When combined, cardiovascular risk factors such as blood pressure, cholesterol levels, smoking, body mass index, diabetes, and family history accounted for 49% of the PAR of cardiovascular events in people with RA, and the RA characteristics explained 30.3% of the risk.
Together, the cardiovascular and RA risk factors accounted for 69.6% of the risk of cardiovascular events, and the remaining 30.4% could not be explained.
While the PAR associated with the combined cardiovascular risk factors was higher in men than in women, the contribution of all the RA characteristics combined proved to be greater in women than in men. However, neither sex difference was statistically significant.
“While the prevalence of RF/ACPA positivity and DAS28 levels was similar between the sexes, the effect sizes of RA characteristics appeared to be larger among women than men, despite lack of statistical significance,” the authors wrote.
“Moreover, higher levels of ESR in women than men may partially explain this apparent difference in PAR [and] RA disease duration was longer among women, and more women than men were receiving biological [disease-modifying antirheumatic drugs] at baseline.”
Eli Lilly, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Norwegian South East Health Authority supported the study. Two authors declared honoraria, fees, and grants from the pharmaceutical industry, including Eli Lilly. No other conflicts of interest were declared.
Nearly one-third of cardiovascular events in patients with rheumatoid arthritis can be attributed to their rheumatoid arthritis characteristics, such as Disease Activity Score and rheumatoid factor or anticitrullinated protein antibody positivity, research suggests.
A prospective, international cohort study published in Annals of the Rheumatic Diseases followed 5,638 patients with rheumatoid arthritis (RA) and no history of cardiovascular disease for a mean of 5.8 years to look at their risk of myocardial infarction, angina, revascularization, stroke, peripheral vascular disease, and death from cardiovascular disease.
Overall, the 10-year cumulative incidence of cardiovascular events was 20.9% in men and 11.1% in women.
Smoking and hypertension were the strongest predictors of cardiovascular disease in both men and women and had the highest population attributable risk (PAR), even after adjustment for other cardiovascular risk factors.
The PAR for triglycerides was 11.5% overall, but it was 12.6% for Disease Activity Score in 28 joints (DAS28) and 12.2% for rheumatoid factor (RF)/anticitrullinated protein antibody (ACPA) positivity. Other RA-related factors, such as erythrocyte sedimentation rate (ESR) and C-reactive protein, did not have a significant effect on cardiovascular event risk.
When combined, cardiovascular risk factors such as blood pressure, cholesterol levels, smoking, body mass index, diabetes, and family history accounted for 49% of the PAR of cardiovascular events in people with RA, and the RA characteristics explained 30.3% of the risk.
Together, the cardiovascular and RA risk factors accounted for 69.6% of the risk of cardiovascular events, and the remaining 30.4% could not be explained.
While the PAR associated with the combined cardiovascular risk factors was higher in men than in women, the contribution of all the RA characteristics combined proved to be greater in women than in men. However, neither sex difference was statistically significant.
“While the prevalence of RF/ACPA positivity and DAS28 levels was similar between the sexes, the effect sizes of RA characteristics appeared to be larger among women than men, despite lack of statistical significance,” the authors wrote.
“Moreover, higher levels of ESR in women than men may partially explain this apparent difference in PAR [and] RA disease duration was longer among women, and more women than men were receiving biological [disease-modifying antirheumatic drugs] at baseline.”
Eli Lilly, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Norwegian South East Health Authority supported the study. Two authors declared honoraria, fees, and grants from the pharmaceutical industry, including Eli Lilly. No other conflicts of interest were declared.
Nearly one-third of cardiovascular events in patients with rheumatoid arthritis can be attributed to their rheumatoid arthritis characteristics, such as Disease Activity Score and rheumatoid factor or anticitrullinated protein antibody positivity, research suggests.
A prospective, international cohort study published in Annals of the Rheumatic Diseases followed 5,638 patients with rheumatoid arthritis (RA) and no history of cardiovascular disease for a mean of 5.8 years to look at their risk of myocardial infarction, angina, revascularization, stroke, peripheral vascular disease, and death from cardiovascular disease.
Overall, the 10-year cumulative incidence of cardiovascular events was 20.9% in men and 11.1% in women.
Smoking and hypertension were the strongest predictors of cardiovascular disease in both men and women and had the highest population attributable risk (PAR), even after adjustment for other cardiovascular risk factors.
The PAR for triglycerides was 11.5% overall, but it was 12.6% for Disease Activity Score in 28 joints (DAS28) and 12.2% for rheumatoid factor (RF)/anticitrullinated protein antibody (ACPA) positivity. Other RA-related factors, such as erythrocyte sedimentation rate (ESR) and C-reactive protein, did not have a significant effect on cardiovascular event risk.
When combined, cardiovascular risk factors such as blood pressure, cholesterol levels, smoking, body mass index, diabetes, and family history accounted for 49% of the PAR of cardiovascular events in people with RA, and the RA characteristics explained 30.3% of the risk.
Together, the cardiovascular and RA risk factors accounted for 69.6% of the risk of cardiovascular events, and the remaining 30.4% could not be explained.
While the PAR associated with the combined cardiovascular risk factors was higher in men than in women, the contribution of all the RA characteristics combined proved to be greater in women than in men. However, neither sex difference was statistically significant.
“While the prevalence of RF/ACPA positivity and DAS28 levels was similar between the sexes, the effect sizes of RA characteristics appeared to be larger among women than men, despite lack of statistical significance,” the authors wrote.
“Moreover, higher levels of ESR in women than men may partially explain this apparent difference in PAR [and] RA disease duration was longer among women, and more women than men were receiving biological [disease-modifying antirheumatic drugs] at baseline.”
Eli Lilly, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Norwegian South East Health Authority supported the study. Two authors declared honoraria, fees, and grants from the pharmaceutical industry, including Eli Lilly. No other conflicts of interest were declared.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point:
Major finding: Rheumatoid arthritis characteristics explained 30.3% of the risk of cardiovascular events in individuals with RA.
Data source: A prospective, international cohort study of 5,638 patients with RA.
Disclosures: Eli Lilly, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Norwegian South East Health Authority supported the study. Two authors declared honoraria, fees, and grants from the pharmaceutical industry, including Eli Lilly. No other conflicts of interest were declared.
ANCA-associated vasculitis appears to increase risk of stroke, death
MADRID – Small-vessel vasculitis associated with antineutrophil cytoplasmic autoantibodies (ANCAs) appears to increase the risk of stroke and overall mortality, results of a French retrospective study suggest.
Patients with ANCA-associated vasculitis (AAV) were twice as likely as those without to experience a stroke over 7.5 years, Grégory Pugnet, MD, reported at the European Congress of Rheumatology. Their all-cause mortality was also significantly higher, with 30% of the deaths attributed to cardiovascular causes, said Dr. Pugnet of the Internal Medicine Service at Purpan Hospital in Toulouse, France.
“We think this [shows that it] is very important to monitor [these patients] and to be vigilant in our search for cardiovascular complications and cardiovascular risk factors in this population,” he said.
Dr. Pugnet and his colleagues conducted a retrospective study of 125 patients with AAV who were diagnosed in a teaching hospital between 1981 and 2015. He compared cardiovascular outcomes and mortality between this cohort and two French regional registries: the Midi-Pyrénées County Mortality and Acute Myocardial Infarction Registry and the Dijon Stroke Registry. Outcomes were the date of first acute myocardial infarction, date of first stroke, and date of death; the mean follow-up was about 90 months.
Of the 125 patients with AAV, 99 had granulomatosis with polyangiitis, and 26 had microscopic polyangiitis. Preexisting cardiovascular disease was present in 23. Patients were a mean of 61 years old. Hypertension, peripheral artery disease, and coronary artery disease were all more common among those with cardiovascular disease. These patients were also more likely to smoke.
Over the follow-up period, there were 10 acute myocardial infarctions for an incidence of 8.5 per 1,000 person-years. The MI incidence in the Midi-Pyrénées registry was 2.2 per 1,000 person-years, which was a significant difference in an unadjusted analysis. But after adjusting for age, AAV patients were not significantly more likely to experience a heart attack than were those in the registry.
There were nine strokes during the follow-up period for an incidence of 10.2 per 1,000 person-years. After adjusting for age, this was more than three times higher than the rate of 1.9 per 1,000 person-year in the Dijon Stroke Registry – a significant difference.
A total of 22 AAV patients died during the follow-up period, translating to a mortality of 22.5 per 1,000 person-years. Mortality in the stroke registry was 1.9 per 1,000 person-years. An age-adjusted analysis found that AAV patients were about 1.6 times more likely to die than were those in the Midi-Pyrénées registry.
A multivariate regression analysis identified some factors that were independently associated with the outcomes. Smoking almost quadrupled the risk of having any cardiovascular event (hazard ratio, 3.7), and having had a plasma exchange tripled it (HR, 2.9). Smoking and a history of coronary artery disease were significant risk factors for myocardial infarction (HRs of 8.8 and 10.3, respectively). Dr. Pugnet and his associates didn’t find any significant independent risk factors for stroke. Age was not independently associated with any of the outcomes.
Dr. Pugnet reported receiving travel support from AbbVie and Actelion, fees for serving on an advisory board from Grifols, and lecture fees from AbbVie.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
MADRID – Small-vessel vasculitis associated with antineutrophil cytoplasmic autoantibodies (ANCAs) appears to increase the risk of stroke and overall mortality, results of a French retrospective study suggest.
Patients with ANCA-associated vasculitis (AAV) were twice as likely as those without to experience a stroke over 7.5 years, Grégory Pugnet, MD, reported at the European Congress of Rheumatology. Their all-cause mortality was also significantly higher, with 30% of the deaths attributed to cardiovascular causes, said Dr. Pugnet of the Internal Medicine Service at Purpan Hospital in Toulouse, France.
“We think this [shows that it] is very important to monitor [these patients] and to be vigilant in our search for cardiovascular complications and cardiovascular risk factors in this population,” he said.
Dr. Pugnet and his colleagues conducted a retrospective study of 125 patients with AAV who were diagnosed in a teaching hospital between 1981 and 2015. He compared cardiovascular outcomes and mortality between this cohort and two French regional registries: the Midi-Pyrénées County Mortality and Acute Myocardial Infarction Registry and the Dijon Stroke Registry. Outcomes were the date of first acute myocardial infarction, date of first stroke, and date of death; the mean follow-up was about 90 months.
Of the 125 patients with AAV, 99 had granulomatosis with polyangiitis, and 26 had microscopic polyangiitis. Preexisting cardiovascular disease was present in 23. Patients were a mean of 61 years old. Hypertension, peripheral artery disease, and coronary artery disease were all more common among those with cardiovascular disease. These patients were also more likely to smoke.
Over the follow-up period, there were 10 acute myocardial infarctions for an incidence of 8.5 per 1,000 person-years. The MI incidence in the Midi-Pyrénées registry was 2.2 per 1,000 person-years, which was a significant difference in an unadjusted analysis. But after adjusting for age, AAV patients were not significantly more likely to experience a heart attack than were those in the registry.
There were nine strokes during the follow-up period for an incidence of 10.2 per 1,000 person-years. After adjusting for age, this was more than three times higher than the rate of 1.9 per 1,000 person-year in the Dijon Stroke Registry – a significant difference.
A total of 22 AAV patients died during the follow-up period, translating to a mortality of 22.5 per 1,000 person-years. Mortality in the stroke registry was 1.9 per 1,000 person-years. An age-adjusted analysis found that AAV patients were about 1.6 times more likely to die than were those in the Midi-Pyrénées registry.
A multivariate regression analysis identified some factors that were independently associated with the outcomes. Smoking almost quadrupled the risk of having any cardiovascular event (hazard ratio, 3.7), and having had a plasma exchange tripled it (HR, 2.9). Smoking and a history of coronary artery disease were significant risk factors for myocardial infarction (HRs of 8.8 and 10.3, respectively). Dr. Pugnet and his associates didn’t find any significant independent risk factors for stroke. Age was not independently associated with any of the outcomes.
Dr. Pugnet reported receiving travel support from AbbVie and Actelion, fees for serving on an advisory board from Grifols, and lecture fees from AbbVie.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
MADRID – Small-vessel vasculitis associated with antineutrophil cytoplasmic autoantibodies (ANCAs) appears to increase the risk of stroke and overall mortality, results of a French retrospective study suggest.
Patients with ANCA-associated vasculitis (AAV) were twice as likely as those without to experience a stroke over 7.5 years, Grégory Pugnet, MD, reported at the European Congress of Rheumatology. Their all-cause mortality was also significantly higher, with 30% of the deaths attributed to cardiovascular causes, said Dr. Pugnet of the Internal Medicine Service at Purpan Hospital in Toulouse, France.
“We think this [shows that it] is very important to monitor [these patients] and to be vigilant in our search for cardiovascular complications and cardiovascular risk factors in this population,” he said.
Dr. Pugnet and his colleagues conducted a retrospective study of 125 patients with AAV who were diagnosed in a teaching hospital between 1981 and 2015. He compared cardiovascular outcomes and mortality between this cohort and two French regional registries: the Midi-Pyrénées County Mortality and Acute Myocardial Infarction Registry and the Dijon Stroke Registry. Outcomes were the date of first acute myocardial infarction, date of first stroke, and date of death; the mean follow-up was about 90 months.
Of the 125 patients with AAV, 99 had granulomatosis with polyangiitis, and 26 had microscopic polyangiitis. Preexisting cardiovascular disease was present in 23. Patients were a mean of 61 years old. Hypertension, peripheral artery disease, and coronary artery disease were all more common among those with cardiovascular disease. These patients were also more likely to smoke.
Over the follow-up period, there were 10 acute myocardial infarctions for an incidence of 8.5 per 1,000 person-years. The MI incidence in the Midi-Pyrénées registry was 2.2 per 1,000 person-years, which was a significant difference in an unadjusted analysis. But after adjusting for age, AAV patients were not significantly more likely to experience a heart attack than were those in the registry.
There were nine strokes during the follow-up period for an incidence of 10.2 per 1,000 person-years. After adjusting for age, this was more than three times higher than the rate of 1.9 per 1,000 person-year in the Dijon Stroke Registry – a significant difference.
A total of 22 AAV patients died during the follow-up period, translating to a mortality of 22.5 per 1,000 person-years. Mortality in the stroke registry was 1.9 per 1,000 person-years. An age-adjusted analysis found that AAV patients were about 1.6 times more likely to die than were those in the Midi-Pyrénées registry.
A multivariate regression analysis identified some factors that were independently associated with the outcomes. Smoking almost quadrupled the risk of having any cardiovascular event (hazard ratio, 3.7), and having had a plasma exchange tripled it (HR, 2.9). Smoking and a history of coronary artery disease were significant risk factors for myocardial infarction (HRs of 8.8 and 10.3, respectively). Dr. Pugnet and his associates didn’t find any significant independent risk factors for stroke. Age was not independently associated with any of the outcomes.
Dr. Pugnet reported receiving travel support from AbbVie and Actelion, fees for serving on an advisory board from Grifols, and lecture fees from AbbVie.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: AAV patients were twice as likely as those without the vasculitis to experience a stroke over 7.5 years.
Data source: A retrospective comparison of 125 AAV patients and patients from two French regional registries: the Midi-Pyrénées County Mortality and Acute Myocardial Infarction Registry and the Dijon Stroke Registry.
Disclosures: Dr. Pugnet reported receiving travel support from AbbVie and Actelion, fees for serving on an advisory board from Grifols, and lecture fees from AbbVie.
Very-low-volume vascular surgery practice linked to worse outcomes
The very-low-volume practice of surgeons performing no more than one open abdominal aortic aneurysm repair (OAR) or carotid endarterectomy (CEA) per year has persisted in New York State and was associated with worse postoperative outcomes and longer lengths of stay in a cohort study of statewide hospital data.
The study examined inpatient data on elective OARs and CEAs performed from 2000 to 2014 in every hospital in the state.
While the numbers and proportions of very-low-volume surgeons decreased (44.6%-23% for OAR and 35.2%-18.1% for CEA) and the number of procedures performed by these surgeons also decreased (QAR, 346-47; CEA, 395-90), the data are “concerning” and elucidate the “persistence” of very-low-volume practice in open vascular surgery, said Jialin Mao, MD, of Cornell University, New York, and associates (JAMA Surg. doi: 10:1001/jamasurg.2017.1100).
Very-low-volume surgeons were significantly less likely to be vascular surgeons, compared with higher-volume surgeons for both OAR (23.9% vs. 63.9%) and CEA (14.6% vs. 51.7%), they reported.
Compared with patients treated by higher-volume surgeons, those whose OAR was performed by very-low-volume surgeons had a twofold higher risk of postoperative death (6.7% vs. 3.5%) after adjusting for patient risk factors, surgeon specialty, and facility characteristics. Patients of very-low-volume surgeons also had significantly higher odds of sepsis or shock (odds ratio, 1.45), prolonged length of stay (OR, 1.37) and 30-day readmission (OR, 1.19), although the latter was not significant.
Similarly, patients whose CEA was performed by very-low-volume surgeons had a significant 1.8-fold higher odds of experiencing postoperative acute myocardial infarction (1.5% vs. 0.5%) and stroke (3.5% vs. 2.1%). They also were significantly more likely to have 30-day readmission (OR, 1.30).
With both procedures, patients treated by very-low-volume surgeons tended to be younger and healthier (less likely to have two or more comorbidities). They also were more likely to be nonwhite or insured by Medicaid.
“It is reasonable to speculate,” the researchers wrote, “that those treated by very-low-volume surgeons were more likely to be socioeconomically disadvantaged.”
Notably, 30% of the very-low-volume practice occurred in New York City, “where accessibility to high-volume practitioners should generally be higher,” they said.
The findings “indicate the need to eliminate this type of practice, to restrict the practice of these very-low-volume surgeons or to force referrals to higher-volume and specialized surgeons, and to improve disparity in access to high-quality care for all patients,” they said.
The study was funded in part by the U.S. Food and Drug Administration. The researchers reported having no relevant conflicts of interest.
The delineation of a threshold number of cases of OAR and CEA below which surgeons should not be credentialed remains unclear, despite much discussion of the volume-outcome relationship in vascular surgery.
In the current endovascular era, OAR in particular has become increasingly less frequent, with a dramatic effect on trainee experiences. It is often proposed that these cases be limited to high-volume surgeons. Some are concerned, however, that this action will leave rural surgeons unprepared to deal with ruptured abdominal aortic aneurysm and will force patients to travel long distances.
Sarah E. Deery, MD, and Marc L. Schermerhorn, MD, are in the division of vascular and endovascular surgery at Beth Israel Deaconess Medical Center in Boston. These remarks are adapted from an editorial accompanying the study. They reported having no disclosures.
The delineation of a threshold number of cases of OAR and CEA below which surgeons should not be credentialed remains unclear, despite much discussion of the volume-outcome relationship in vascular surgery.
In the current endovascular era, OAR in particular has become increasingly less frequent, with a dramatic effect on trainee experiences. It is often proposed that these cases be limited to high-volume surgeons. Some are concerned, however, that this action will leave rural surgeons unprepared to deal with ruptured abdominal aortic aneurysm and will force patients to travel long distances.
Sarah E. Deery, MD, and Marc L. Schermerhorn, MD, are in the division of vascular and endovascular surgery at Beth Israel Deaconess Medical Center in Boston. These remarks are adapted from an editorial accompanying the study. They reported having no disclosures.
The delineation of a threshold number of cases of OAR and CEA below which surgeons should not be credentialed remains unclear, despite much discussion of the volume-outcome relationship in vascular surgery.
In the current endovascular era, OAR in particular has become increasingly less frequent, with a dramatic effect on trainee experiences. It is often proposed that these cases be limited to high-volume surgeons. Some are concerned, however, that this action will leave rural surgeons unprepared to deal with ruptured abdominal aortic aneurysm and will force patients to travel long distances.
Sarah E. Deery, MD, and Marc L. Schermerhorn, MD, are in the division of vascular and endovascular surgery at Beth Israel Deaconess Medical Center in Boston. These remarks are adapted from an editorial accompanying the study. They reported having no disclosures.
The very-low-volume practice of surgeons performing no more than one open abdominal aortic aneurysm repair (OAR) or carotid endarterectomy (CEA) per year has persisted in New York State and was associated with worse postoperative outcomes and longer lengths of stay in a cohort study of statewide hospital data.
The study examined inpatient data on elective OARs and CEAs performed from 2000 to 2014 in every hospital in the state.
While the numbers and proportions of very-low-volume surgeons decreased (44.6%-23% for OAR and 35.2%-18.1% for CEA) and the number of procedures performed by these surgeons also decreased (QAR, 346-47; CEA, 395-90), the data are “concerning” and elucidate the “persistence” of very-low-volume practice in open vascular surgery, said Jialin Mao, MD, of Cornell University, New York, and associates (JAMA Surg. doi: 10:1001/jamasurg.2017.1100).
Very-low-volume surgeons were significantly less likely to be vascular surgeons, compared with higher-volume surgeons for both OAR (23.9% vs. 63.9%) and CEA (14.6% vs. 51.7%), they reported.
Compared with patients treated by higher-volume surgeons, those whose OAR was performed by very-low-volume surgeons had a twofold higher risk of postoperative death (6.7% vs. 3.5%) after adjusting for patient risk factors, surgeon specialty, and facility characteristics. Patients of very-low-volume surgeons also had significantly higher odds of sepsis or shock (odds ratio, 1.45), prolonged length of stay (OR, 1.37) and 30-day readmission (OR, 1.19), although the latter was not significant.
Similarly, patients whose CEA was performed by very-low-volume surgeons had a significant 1.8-fold higher odds of experiencing postoperative acute myocardial infarction (1.5% vs. 0.5%) and stroke (3.5% vs. 2.1%). They also were significantly more likely to have 30-day readmission (OR, 1.30).
With both procedures, patients treated by very-low-volume surgeons tended to be younger and healthier (less likely to have two or more comorbidities). They also were more likely to be nonwhite or insured by Medicaid.
“It is reasonable to speculate,” the researchers wrote, “that those treated by very-low-volume surgeons were more likely to be socioeconomically disadvantaged.”
Notably, 30% of the very-low-volume practice occurred in New York City, “where accessibility to high-volume practitioners should generally be higher,” they said.
The findings “indicate the need to eliminate this type of practice, to restrict the practice of these very-low-volume surgeons or to force referrals to higher-volume and specialized surgeons, and to improve disparity in access to high-quality care for all patients,” they said.
The study was funded in part by the U.S. Food and Drug Administration. The researchers reported having no relevant conflicts of interest.
The very-low-volume practice of surgeons performing no more than one open abdominal aortic aneurysm repair (OAR) or carotid endarterectomy (CEA) per year has persisted in New York State and was associated with worse postoperative outcomes and longer lengths of stay in a cohort study of statewide hospital data.
The study examined inpatient data on elective OARs and CEAs performed from 2000 to 2014 in every hospital in the state.
While the numbers and proportions of very-low-volume surgeons decreased (44.6%-23% for OAR and 35.2%-18.1% for CEA) and the number of procedures performed by these surgeons also decreased (QAR, 346-47; CEA, 395-90), the data are “concerning” and elucidate the “persistence” of very-low-volume practice in open vascular surgery, said Jialin Mao, MD, of Cornell University, New York, and associates (JAMA Surg. doi: 10:1001/jamasurg.2017.1100).
Very-low-volume surgeons were significantly less likely to be vascular surgeons, compared with higher-volume surgeons for both OAR (23.9% vs. 63.9%) and CEA (14.6% vs. 51.7%), they reported.
Compared with patients treated by higher-volume surgeons, those whose OAR was performed by very-low-volume surgeons had a twofold higher risk of postoperative death (6.7% vs. 3.5%) after adjusting for patient risk factors, surgeon specialty, and facility characteristics. Patients of very-low-volume surgeons also had significantly higher odds of sepsis or shock (odds ratio, 1.45), prolonged length of stay (OR, 1.37) and 30-day readmission (OR, 1.19), although the latter was not significant.
Similarly, patients whose CEA was performed by very-low-volume surgeons had a significant 1.8-fold higher odds of experiencing postoperative acute myocardial infarction (1.5% vs. 0.5%) and stroke (3.5% vs. 2.1%). They also were significantly more likely to have 30-day readmission (OR, 1.30).
With both procedures, patients treated by very-low-volume surgeons tended to be younger and healthier (less likely to have two or more comorbidities). They also were more likely to be nonwhite or insured by Medicaid.
“It is reasonable to speculate,” the researchers wrote, “that those treated by very-low-volume surgeons were more likely to be socioeconomically disadvantaged.”
Notably, 30% of the very-low-volume practice occurred in New York City, “where accessibility to high-volume practitioners should generally be higher,” they said.
The findings “indicate the need to eliminate this type of practice, to restrict the practice of these very-low-volume surgeons or to force referrals to higher-volume and specialized surgeons, and to improve disparity in access to high-quality care for all patients,” they said.
The study was funded in part by the U.S. Food and Drug Administration. The researchers reported having no relevant conflicts of interest.
FROM JAMA SURGERY
Key clinical point: The very-low-volume practice of open abdominal aortic aneurysm repair and carotid endarterectomy (one or fewer annual procedures) is associated with worse postoperative outcomes and greater length of stay.
Major finding: Patients whose procedure was performed by very-low-volume surgeons had a twofold higher risk of postoperative death after OAR or 1.8-fold higher odds of experiencing postoperative acute myocardial infarction or stroke after CEA.
Data source: The study was funded in part by the U.S. Food and Drug Administration.
Disclosures: The researchers reported having no relevant conflicts of interest.
Transradial PCI in acute coronary syndrome causes less kidney damage
PARIS – Transradial-access percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS) results in a significantly lower risk of acute kidney injury (AKI), compared with the transfemoral approach, according to a new analysis from the large randomized MATRIX trial.
The results of this prespecified secondary subgroup analysis of MATRIX suggest it’s time to update the classic “five golden rules” for reduction of contrast medium–induced AKI by adding a sixth. “Use a transradial approach,” Bernardo Cortese, MD, said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He reported on 8,210 participants in the MATRIX trial (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) who were randomized to transradial- or transfemoral-access PCI for non–ST-elevation MI or ST-elevation MI.
The primary results of the 78-site, four-country European study, previously published, showed that transradial PCI reduced the composite risk of death, MI, stroke, or major bleeding by 17%, compared with transfemoral PCI, a benefit mainly driven by a marked reduction in clinically important bleeding (Lancet. 2015 Jun 20;385[9986]:2465-76).
Left unanswered by the primary analysis was the question of whether transradial PCI in ACS patients also reduced AKI risk, as had previously been suggested by a meta-analysis of observational studies (Int J Cardiol. 2015 Jan 20;179:309-11). In designing the MATRIX trial, Dr. Cortese and the other investigators decided to address that issue separately in a prespecified secondary analysis known as AKI-MATRIX. For this purpose, AKI was defined as either a post-PCI in-hospital increase in serum creatinine level of more than 25%, compared with the preangiography baseline, or an absolute increase in serum creatinine of greater than 0.5 mg/dL.
AKI occurred in 15.4% of ACS patients who underwent PCI with transradial access and 17.3% of those randomized to transfemoral access, for a significant 13% relative risk reduction. This was accomplished without any increase in the volume of contrast media required. The average was 200 mL in both study groups.
The reduction in AKI achieved with transradial-access PCI was seen in all patient subgroups, including those at increased AKI risk because of an estimated glomerular filtration rate below 60 mL/min, age 75 or older, Killup class III or IV, or a Mehran score greater than 10.
Dr. Cortese proposed several possible mechanisms for the observed reduction in AKI seen with transradial-access PCI. The major factor in his view is that the transradial approach entails less bleeding, as earlier demonstrated in the primary analysis – and bleeding has been associated with impaired renal perfusion in several prior studies. Also, it’s plausible that the passage of the catheter across the renal arteries during the transfemoral approach dislodges atherosclerotic debris, which then travels down the renal vessels.
The five golden rules for preventing contrast media–induced AKI, he noted, are
1. Discontinue nephrotoxic drugs before the procedure.
2. Identify high-risk patients.
3. Hydrate them.
4. Choose an ideal contrast medium.
5. Adapt the dose of contrast medium to the patient’s specific situation.
Discussant Jacek Legutko, MD, PhD, of Jagiellonian University in Krakow, Poland, said the primary results of the MATRIX trial published in 2015 have had a major impact on Polish interventional cardiology, where transradial PCI is now used in 80% of PCIs. The AKI study results will reinforce this trend, he added.
“You have shown something opposite to what we’ve thought in the past, that maybe, with a radial approach, we would use more contrast medium, which is a risk factor for AKI. In your study – at least in ACS with very experienced transradial operators – there was no increase in contrast volume, and the risk of AKI decreased,” Dr. Legutko said.
Asked about the possibility that transradial PCI might be associated with an increased risk of embolization to the brain, much as the transfemoral approach might cause embolization to the kidneys, Dr. Cortese said there was no significant difference between the two AKI-MATRIX study arms in rates of transient ischemic attack or stroke.
“I did my first transradial PCI in 2003, and I haven’t seen any increase in these events or later dementia,” he added.
The prespecified secondary analysis of the MATRIX trial was conducted without commercial support. The presenter reported serving as a consultant to Abbott, AstraZeneca, Daiichi Sankyo, Eli Lilly, and Stentys.
Simultaneous with his presentation in Paris, the AKI-MATRIX study was published online at www.sciencedirect.com/science/article/pii/S0735109717368973.
PARIS – Transradial-access percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS) results in a significantly lower risk of acute kidney injury (AKI), compared with the transfemoral approach, according to a new analysis from the large randomized MATRIX trial.
The results of this prespecified secondary subgroup analysis of MATRIX suggest it’s time to update the classic “five golden rules” for reduction of contrast medium–induced AKI by adding a sixth. “Use a transradial approach,” Bernardo Cortese, MD, said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He reported on 8,210 participants in the MATRIX trial (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) who were randomized to transradial- or transfemoral-access PCI for non–ST-elevation MI or ST-elevation MI.
The primary results of the 78-site, four-country European study, previously published, showed that transradial PCI reduced the composite risk of death, MI, stroke, or major bleeding by 17%, compared with transfemoral PCI, a benefit mainly driven by a marked reduction in clinically important bleeding (Lancet. 2015 Jun 20;385[9986]:2465-76).
Left unanswered by the primary analysis was the question of whether transradial PCI in ACS patients also reduced AKI risk, as had previously been suggested by a meta-analysis of observational studies (Int J Cardiol. 2015 Jan 20;179:309-11). In designing the MATRIX trial, Dr. Cortese and the other investigators decided to address that issue separately in a prespecified secondary analysis known as AKI-MATRIX. For this purpose, AKI was defined as either a post-PCI in-hospital increase in serum creatinine level of more than 25%, compared with the preangiography baseline, or an absolute increase in serum creatinine of greater than 0.5 mg/dL.
AKI occurred in 15.4% of ACS patients who underwent PCI with transradial access and 17.3% of those randomized to transfemoral access, for a significant 13% relative risk reduction. This was accomplished without any increase in the volume of contrast media required. The average was 200 mL in both study groups.
The reduction in AKI achieved with transradial-access PCI was seen in all patient subgroups, including those at increased AKI risk because of an estimated glomerular filtration rate below 60 mL/min, age 75 or older, Killup class III or IV, or a Mehran score greater than 10.
Dr. Cortese proposed several possible mechanisms for the observed reduction in AKI seen with transradial-access PCI. The major factor in his view is that the transradial approach entails less bleeding, as earlier demonstrated in the primary analysis – and bleeding has been associated with impaired renal perfusion in several prior studies. Also, it’s plausible that the passage of the catheter across the renal arteries during the transfemoral approach dislodges atherosclerotic debris, which then travels down the renal vessels.
The five golden rules for preventing contrast media–induced AKI, he noted, are
1. Discontinue nephrotoxic drugs before the procedure.
2. Identify high-risk patients.
3. Hydrate them.
4. Choose an ideal contrast medium.
5. Adapt the dose of contrast medium to the patient’s specific situation.
Discussant Jacek Legutko, MD, PhD, of Jagiellonian University in Krakow, Poland, said the primary results of the MATRIX trial published in 2015 have had a major impact on Polish interventional cardiology, where transradial PCI is now used in 80% of PCIs. The AKI study results will reinforce this trend, he added.
“You have shown something opposite to what we’ve thought in the past, that maybe, with a radial approach, we would use more contrast medium, which is a risk factor for AKI. In your study – at least in ACS with very experienced transradial operators – there was no increase in contrast volume, and the risk of AKI decreased,” Dr. Legutko said.
Asked about the possibility that transradial PCI might be associated with an increased risk of embolization to the brain, much as the transfemoral approach might cause embolization to the kidneys, Dr. Cortese said there was no significant difference between the two AKI-MATRIX study arms in rates of transient ischemic attack or stroke.
“I did my first transradial PCI in 2003, and I haven’t seen any increase in these events or later dementia,” he added.
The prespecified secondary analysis of the MATRIX trial was conducted without commercial support. The presenter reported serving as a consultant to Abbott, AstraZeneca, Daiichi Sankyo, Eli Lilly, and Stentys.
Simultaneous with his presentation in Paris, the AKI-MATRIX study was published online at www.sciencedirect.com/science/article/pii/S0735109717368973.
PARIS – Transradial-access percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS) results in a significantly lower risk of acute kidney injury (AKI), compared with the transfemoral approach, according to a new analysis from the large randomized MATRIX trial.
The results of this prespecified secondary subgroup analysis of MATRIX suggest it’s time to update the classic “five golden rules” for reduction of contrast medium–induced AKI by adding a sixth. “Use a transradial approach,” Bernardo Cortese, MD, said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He reported on 8,210 participants in the MATRIX trial (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) who were randomized to transradial- or transfemoral-access PCI for non–ST-elevation MI or ST-elevation MI.
The primary results of the 78-site, four-country European study, previously published, showed that transradial PCI reduced the composite risk of death, MI, stroke, or major bleeding by 17%, compared with transfemoral PCI, a benefit mainly driven by a marked reduction in clinically important bleeding (Lancet. 2015 Jun 20;385[9986]:2465-76).
Left unanswered by the primary analysis was the question of whether transradial PCI in ACS patients also reduced AKI risk, as had previously been suggested by a meta-analysis of observational studies (Int J Cardiol. 2015 Jan 20;179:309-11). In designing the MATRIX trial, Dr. Cortese and the other investigators decided to address that issue separately in a prespecified secondary analysis known as AKI-MATRIX. For this purpose, AKI was defined as either a post-PCI in-hospital increase in serum creatinine level of more than 25%, compared with the preangiography baseline, or an absolute increase in serum creatinine of greater than 0.5 mg/dL.
AKI occurred in 15.4% of ACS patients who underwent PCI with transradial access and 17.3% of those randomized to transfemoral access, for a significant 13% relative risk reduction. This was accomplished without any increase in the volume of contrast media required. The average was 200 mL in both study groups.
The reduction in AKI achieved with transradial-access PCI was seen in all patient subgroups, including those at increased AKI risk because of an estimated glomerular filtration rate below 60 mL/min, age 75 or older, Killup class III or IV, or a Mehran score greater than 10.
Dr. Cortese proposed several possible mechanisms for the observed reduction in AKI seen with transradial-access PCI. The major factor in his view is that the transradial approach entails less bleeding, as earlier demonstrated in the primary analysis – and bleeding has been associated with impaired renal perfusion in several prior studies. Also, it’s plausible that the passage of the catheter across the renal arteries during the transfemoral approach dislodges atherosclerotic debris, which then travels down the renal vessels.
The five golden rules for preventing contrast media–induced AKI, he noted, are
1. Discontinue nephrotoxic drugs before the procedure.
2. Identify high-risk patients.
3. Hydrate them.
4. Choose an ideal contrast medium.
5. Adapt the dose of contrast medium to the patient’s specific situation.
Discussant Jacek Legutko, MD, PhD, of Jagiellonian University in Krakow, Poland, said the primary results of the MATRIX trial published in 2015 have had a major impact on Polish interventional cardiology, where transradial PCI is now used in 80% of PCIs. The AKI study results will reinforce this trend, he added.
“You have shown something opposite to what we’ve thought in the past, that maybe, with a radial approach, we would use more contrast medium, which is a risk factor for AKI. In your study – at least in ACS with very experienced transradial operators – there was no increase in contrast volume, and the risk of AKI decreased,” Dr. Legutko said.
Asked about the possibility that transradial PCI might be associated with an increased risk of embolization to the brain, much as the transfemoral approach might cause embolization to the kidneys, Dr. Cortese said there was no significant difference between the two AKI-MATRIX study arms in rates of transient ischemic attack or stroke.
“I did my first transradial PCI in 2003, and I haven’t seen any increase in these events or later dementia,” he added.
The prespecified secondary analysis of the MATRIX trial was conducted without commercial support. The presenter reported serving as a consultant to Abbott, AstraZeneca, Daiichi Sankyo, Eli Lilly, and Stentys.
Simultaneous with his presentation in Paris, the AKI-MATRIX study was published online at www.sciencedirect.com/science/article/pii/S0735109717368973.
AT EUROPCR
Key clinical point:
Major finding: Transradial-access PCI for ACS resulted in a 13% lower risk of acute kidney injury than the transfemoral approach.
Data source: A four-country European randomized trial of transradial- vs. transfemoral-access PCI in more than 8,200 patients with ACS.
Disclosures: This prespecified secondary analysis of the MATRIX trial was conducted without commercial support. The presenter reported serving as a consultant to Abbott, AstraZeneca, Daiichi Sankyo, Eli Lilly, and Stentys.