TBD Meeting (3309-23)

WASHINGTON – Left atrial appendage closure can be performed safely and effectively in older patients, those with end-stage renal disease, and likely others not included in the pivotal clinical trials, according to a series of new studies, including a late-breaker, presented on the both older and newer Watchman devices at the Cardiovascular Research Technologies conference.

In the case of the late-breaking clinical trial report, which included more than 60,000 patients, the goal was to look at the safety of the Watchman FLX, which is the newest of the devices in real-world practice, according to Samir R. Kapadia, MD, chairman of the department of cardiovascular medicine at the Cleveland Clinic.

Ted Bosworth/MDedge News

In the SURPASS registry, the number of patients discharged on the Watchman FLX climbed from zero in August 2020, when data accrual began, to 66,894 by March 2022. For the current analysis, 45-day follow-up was available for 61,963 patients and 1-year follow-up was available for 18,233.

Based on this number of patients treated by more than 2,300 clinicians at more than 740 sites, the SURPASS registry establishes that Watchman FLX “can be accomplished safely with clinical outcomes similar to pivotal trials at 45 days and 1 year,” Dr. Kapadia reported.
 

No surprises found in real-world outcome

At 7 days or hospital discharge (whichever came last), the rate of all-cause death was 0.18%, the rate of ischemic stroke was 0.13%, and there were no systemic emboli. By 45 days, the rate of all-cause death (0.84%) and stroke of any kind (0.32%) remained less than 1% and there were still no systemic emboli. Major bleeding events, of which about one-third occurred during hospitalization, had reached 3.34% by day 45.

By 1 year, all-cause mortality had risen to 8.3%, the stroke rate was 1.6%, and major bleeding reached 6.7%. The rate of systemic emboli remained very low (0.1%). The rates of death and stroke rose at a slow but steady rate throughout the 1-year follow-up. In contrast, major bleeding events rose steeply in the first 90 days and were followed by a much slower accrual subsequently.

At 1 year, 84.4% of patients had a complete seal. Leaks ≤ 3 mm were observed in 12.1%. The remaining leaks were larger, but just 0.7% had a leak > 5 mm.

Relative to the first-generation Watchman, the Watchman FLX has numerous design changes, including a shorter profile, more struts, and a reduced metal exposure. Most of these changes were performed to make the device easier to deploy.

When the SURPASS data are compared to the pivotal trials with Watchman FLX or to the Ewolution and National Cardiovascular Data (NCD) registries, which were created to monitor efficacy and safety with the earlier generation Watchman, the outcomes are similar or, in many cases, numerically favorable for such outcomes as bleeding and rates of stroke.

In addition to providing reassurance for the real-world safety of Watchman FLX, Dr. Kapadia said that these data establish reasonable benchmarks for centers tracking in-hospital and 1-year outcomes.

Dr. Kapadia also reported that outcomes overall in SURPASS were similar in women and men with the exception of major bleeding, a finding common to other interventional studies.

The late-breaker panelists generally agreed that SURPASS provides a robust set of data by which to be reassured, but David J. Cohen, MD, director of Clinical and Outcomes Research at the Cardiovascular Research Foundation in New York, said that he thinks the rate of bleeding is unnecessarily high.

“You really need to figure out a way to get the rate of bleeding at 45 days down,” Dr. Cohen said. He called for studies of anticoagulation in the post-procedural period that offer a better benefit-to-risk ratio.
 

Elderly patients benefit equally from Watchman

Yet, Watchman devices are generally regarded as a success story, and this has led investigators to evaluate safety in patients not well represented or explicitly excluded from clinical trials, such as the elderly and those with end-stage renal disease (ESRD). New data derived from experience in both of these groups were presented at the conference, which was sponsored by MedStar Heart & Vascular Institute.

To tease out the relative safety of Watchman in octogenarians, Samian Sulaiman, MD, a cardiology fellow at West Virginia University Heart and Vascular Institute, Morgantown, performed a competing risk analysis to study the relative benefit of Watchman devices after controlling for the greater overall risk of complications in the elderly.

In raw data comparisons of those 80 years of age or older to those younger in published trials, the not-surprising result is that overall rates of death and ischemic events are far higher in the elderly, according to Dr. Sulaiman, but it’s an “unfair comparison,” he said.

“It is easy to mistakenly conclude that left atrial appendage closure is associated with worse outcomes, but older patients have far higher rates of these events independent of other factors,” Dr. Sulaiman noted.

In fact, in his comparison of 472 older patients to 1,404 younger patients, the seal rates at 45 days, 6 months, and 12 months are almost identical. Moreover, after the extensive adjustments performed for competing risk analysis, the rates of death, stroke, and bleeding were also almost identical for those 80 years or older whether or not they received a Watchman.

Although he acknowledged the risk for residual confounding, Dr. Sulaiman concluded that elderly patients derive about the same benefits as younger patients from the Watchman. He concluded age alone should not be a factor in selecting candidates for this device.
 

ESRD is not Watchman contraindication

A similar point was made about ESRD based on analysis of 237 patients who received either an earlier generation Watchman or the Watchman FLX. Initiated in Spain, the study was amended to collect data from centers elsewhere in Europe, the United States, and Australia.

Successful implantation was achieved in 99.2% of the patients, reported Armando Perez de Prado, MD, PhD, head of interventional cardiology at the University of Leon, Spain.

Ted Bosworth/MDedge News

WASHINGTON – Left atrial appendage closure can be performed safely and effectively in older patients, those with end-stage renal disease, and likely others not included in the pivotal clinical trials, according to a series of new studies, including a late-breaker, presented on the both older and newer Watchman devices at the Cardiovascular Research Technologies conference.

In the case of the late-breaking clinical trial report, which included more than 60,000 patients, the goal was to look at the safety of the Watchman FLX, which is the newest of the devices in real-world practice, according to Samir R. Kapadia, MD, chairman of the department of cardiovascular medicine at the Cleveland Clinic.

Ted Bosworth/MDedge News

In the SURPASS registry, the number of patients discharged on the Watchman FLX climbed from zero in August 2020, when data accrual began, to 66,894 by March 2022. For the current analysis, 45-day follow-up was available for 61,963 patients and 1-year follow-up was available for 18,233.

Based on this number of patients treated by more than 2,300 clinicians at more than 740 sites, the SURPASS registry establishes that Watchman FLX “can be accomplished safely with clinical outcomes similar to pivotal trials at 45 days and 1 year,” Dr. Kapadia reported.
 

No surprises found in real-world outcome

At 7 days or hospital discharge (whichever came last), the rate of all-cause death was 0.18%, the rate of ischemic stroke was 0.13%, and there were no systemic emboli. By 45 days, the rate of all-cause death (0.84%) and stroke of any kind (0.32%) remained less than 1% and there were still no systemic emboli. Major bleeding events, of which about one-third occurred during hospitalization, had reached 3.34% by day 45.

By 1 year, all-cause mortality had risen to 8.3%, the stroke rate was 1.6%, and major bleeding reached 6.7%. The rate of systemic emboli remained very low (0.1%). The rates of death and stroke rose at a slow but steady rate throughout the 1-year follow-up. In contrast, major bleeding events rose steeply in the first 90 days and were followed by a much slower accrual subsequently.

At 1 year, 84.4% of patients had a complete seal. Leaks ≤ 3 mm were observed in 12.1%. The remaining leaks were larger, but just 0.7% had a leak > 5 mm.

Relative to the first-generation Watchman, the Watchman FLX has numerous design changes, including a shorter profile, more struts, and a reduced metal exposure. Most of these changes were performed to make the device easier to deploy.

When the SURPASS data are compared to the pivotal trials with Watchman FLX or to the Ewolution and National Cardiovascular Data (NCD) registries, which were created to monitor efficacy and safety with the earlier generation Watchman, the outcomes are similar or, in many cases, numerically favorable for such outcomes as bleeding and rates of stroke.

In addition to providing reassurance for the real-world safety of Watchman FLX, Dr. Kapadia said that these data establish reasonable benchmarks for centers tracking in-hospital and 1-year outcomes.

Dr. Kapadia also reported that outcomes overall in SURPASS were similar in women and men with the exception of major bleeding, a finding common to other interventional studies.

The late-breaker panelists generally agreed that SURPASS provides a robust set of data by which to be reassured, but David J. Cohen, MD, director of Clinical and Outcomes Research at the Cardiovascular Research Foundation in New York, said that he thinks the rate of bleeding is unnecessarily high.

“You really need to figure out a way to get the rate of bleeding at 45 days down,” Dr. Cohen said. He called for studies of anticoagulation in the post-procedural period that offer a better benefit-to-risk ratio.
 

Elderly patients benefit equally from Watchman

Yet, Watchman devices are generally regarded as a success story, and this has led investigators to evaluate safety in patients not well represented or explicitly excluded from clinical trials, such as the elderly and those with end-stage renal disease (ESRD). New data derived from experience in both of these groups were presented at the conference, which was sponsored by MedStar Heart & Vascular Institute.

To tease out the relative safety of Watchman in octogenarians, Samian Sulaiman, MD, a cardiology fellow at West Virginia University Heart and Vascular Institute, Morgantown, performed a competing risk analysis to study the relative benefit of Watchman devices after controlling for the greater overall risk of complications in the elderly.

In raw data comparisons of those 80 years of age or older to those younger in published trials, the not-surprising result is that overall rates of death and ischemic events are far higher in the elderly, according to Dr. Sulaiman, but it’s an “unfair comparison,” he said.

“It is easy to mistakenly conclude that left atrial appendage closure is associated with worse outcomes, but older patients have far higher rates of these events independent of other factors,” Dr. Sulaiman noted.

In fact, in his comparison of 472 older patients to 1,404 younger patients, the seal rates at 45 days, 6 months, and 12 months are almost identical. Moreover, after the extensive adjustments performed for competing risk analysis, the rates of death, stroke, and bleeding were also almost identical for those 80 years or older whether or not they received a Watchman.

Although he acknowledged the risk for residual confounding, Dr. Sulaiman concluded that elderly patients derive about the same benefits as younger patients from the Watchman. He concluded age alone should not be a factor in selecting candidates for this device.
 

ESRD is not Watchman contraindication

A similar point was made about ESRD based on analysis of 237 patients who received either an earlier generation Watchman or the Watchman FLX. Initiated in Spain, the study was amended to collect data from centers elsewhere in Europe, the United States, and Australia.

Successful implantation was achieved in 99.2% of the patients, reported Armando Perez de Prado, MD, PhD, head of interventional cardiology at the University of Leon, Spain.

Ted Bosworth/MDedge News

WASHINGTON – Left atrial appendage closure can be performed safely and effectively in older patients, those with end-stage renal disease, and likely others not included in the pivotal clinical trials, according to a series of new studies, including a late-breaker, presented on the both older and newer Watchman devices at the Cardiovascular Research Technologies conference.

In the case of the late-breaking clinical trial report, which included more than 60,000 patients, the goal was to look at the safety of the Watchman FLX, which is the newest of the devices in real-world practice, according to Samir R. Kapadia, MD, chairman of the department of cardiovascular medicine at the Cleveland Clinic.

Ted Bosworth/MDedge News

In the SURPASS registry, the number of patients discharged on the Watchman FLX climbed from zero in August 2020, when data accrual began, to 66,894 by March 2022. For the current analysis, 45-day follow-up was available for 61,963 patients and 1-year follow-up was available for 18,233.

Based on this number of patients treated by more than 2,300 clinicians at more than 740 sites, the SURPASS registry establishes that Watchman FLX “can be accomplished safely with clinical outcomes similar to pivotal trials at 45 days and 1 year,” Dr. Kapadia reported.
 

No surprises found in real-world outcome

At 7 days or hospital discharge (whichever came last), the rate of all-cause death was 0.18%, the rate of ischemic stroke was 0.13%, and there were no systemic emboli. By 45 days, the rate of all-cause death (0.84%) and stroke of any kind (0.32%) remained less than 1% and there were still no systemic emboli. Major bleeding events, of which about one-third occurred during hospitalization, had reached 3.34% by day 45.

By 1 year, all-cause mortality had risen to 8.3%, the stroke rate was 1.6%, and major bleeding reached 6.7%. The rate of systemic emboli remained very low (0.1%). The rates of death and stroke rose at a slow but steady rate throughout the 1-year follow-up. In contrast, major bleeding events rose steeply in the first 90 days and were followed by a much slower accrual subsequently.

At 1 year, 84.4% of patients had a complete seal. Leaks ≤ 3 mm were observed in 12.1%. The remaining leaks were larger, but just 0.7% had a leak > 5 mm.

Relative to the first-generation Watchman, the Watchman FLX has numerous design changes, including a shorter profile, more struts, and a reduced metal exposure. Most of these changes were performed to make the device easier to deploy.

When the SURPASS data are compared to the pivotal trials with Watchman FLX or to the Ewolution and National Cardiovascular Data (NCD) registries, which were created to monitor efficacy and safety with the earlier generation Watchman, the outcomes are similar or, in many cases, numerically favorable for such outcomes as bleeding and rates of stroke.

In addition to providing reassurance for the real-world safety of Watchman FLX, Dr. Kapadia said that these data establish reasonable benchmarks for centers tracking in-hospital and 1-year outcomes.

Dr. Kapadia also reported that outcomes overall in SURPASS were similar in women and men with the exception of major bleeding, a finding common to other interventional studies.

The late-breaker panelists generally agreed that SURPASS provides a robust set of data by which to be reassured, but David J. Cohen, MD, director of Clinical and Outcomes Research at the Cardiovascular Research Foundation in New York, said that he thinks the rate of bleeding is unnecessarily high.

“You really need to figure out a way to get the rate of bleeding at 45 days down,” Dr. Cohen said. He called for studies of anticoagulation in the post-procedural period that offer a better benefit-to-risk ratio.
 

Elderly patients benefit equally from Watchman

Yet, Watchman devices are generally regarded as a success story, and this has led investigators to evaluate safety in patients not well represented or explicitly excluded from clinical trials, such as the elderly and those with end-stage renal disease (ESRD). New data derived from experience in both of these groups were presented at the conference, which was sponsored by MedStar Heart & Vascular Institute.

To tease out the relative safety of Watchman in octogenarians, Samian Sulaiman, MD, a cardiology fellow at West Virginia University Heart and Vascular Institute, Morgantown, performed a competing risk analysis to study the relative benefit of Watchman devices after controlling for the greater overall risk of complications in the elderly.

In raw data comparisons of those 80 years of age or older to those younger in published trials, the not-surprising result is that overall rates of death and ischemic events are far higher in the elderly, according to Dr. Sulaiman, but it’s an “unfair comparison,” he said.

“It is easy to mistakenly conclude that left atrial appendage closure is associated with worse outcomes, but older patients have far higher rates of these events independent of other factors,” Dr. Sulaiman noted.

In fact, in his comparison of 472 older patients to 1,404 younger patients, the seal rates at 45 days, 6 months, and 12 months are almost identical. Moreover, after the extensive adjustments performed for competing risk analysis, the rates of death, stroke, and bleeding were also almost identical for those 80 years or older whether or not they received a Watchman.

Although he acknowledged the risk for residual confounding, Dr. Sulaiman concluded that elderly patients derive about the same benefits as younger patients from the Watchman. He concluded age alone should not be a factor in selecting candidates for this device.
 

ESRD is not Watchman contraindication

A similar point was made about ESRD based on analysis of 237 patients who received either an earlier generation Watchman or the Watchman FLX. Initiated in Spain, the study was amended to collect data from centers elsewhere in Europe, the United States, and Australia.

Successful implantation was achieved in 99.2% of the patients, reported Armando Perez de Prado, MD, PhD, head of interventional cardiology at the University of Leon, Spain.

Ted Bosworth/MDedge News

At 6 months follow-up, a new-generation resorbable stent with a magnesium scaffold appears to perform at a level comparable to nonabsorbable drug-eluting stents (DES), according to first-in-man results presented as a late-breaker at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

“IVUS [intravascular ultrasound] assessment demonstrated preservation of the scaffold area from post procedure up to 6 months with a low mean neointimal area,” reported Michael Haude, MD, PhD, director of the Heart & Vascular Center, Neuss, Germany.

Neointimal formation and late lumen loss (LLL) have been the Achilles’ heel of previous efforts to develop a viable fully absorbable stent, making these 6-month data highly encouraging.

Ted Bosworth/MDedge Cardiology

The tested device is the most recent iteration of the DREAMS (drug-eluting resorbable magnesium scaffold) technology. Relative to DREAMS 2G, the DREAMS 3G device has several design changes, including a higher radial force and reduced strut thickness.

The goal was to build on the promise of DREAMS 2G while avoiding its limitations.

“The problem with DREAMS 2G was that it showed low–target lesion failure and scaffold thrombosis rates in multiple trials, but in-scaffold LLL was not comparable to LLL values observed with historical PLLA [poly-L-lactic acid]–based scaffolds or contemporary DES,” Dr. Haude said.

The 6-month data with DREAMS 3G were drawn from the BIOMAG-I study. Patients with stable or unstable angina were enrolled if they had no angiographic evidence of thrombus at the target lesion. Patients were also required to have no more than two single de novo lesions requiring revascularization.

Of 116 patients enrolled, 115 were available for evaluation at 6 months. The study was not controlled, but outcomes were compared at 6 months to those observed with the DREAMS 2G device in the BIOSOLVE-II trial, published several years ago in the Lancet.

For the primary outcome of in-scaffold LLL at 6 months, the mean LLL from baseline at 6 months was more than 50% lower with the DREAMS 3G device in BIOMAG-I than DREAMS 2G in BIOSOLVE-II (0.21 vs. 0.44 mm). In a post hoc superiority analysis employing a weighted mean, a superiority analysis supported a highly significant difference in favor of the newer device (P < .0001).

More importantly, the low LLL in BIOMAG-I was not just favorable relative to previously evaluated bioabsorbable stents, but it appears to compete with nonabsorbable options at least after this length of follow-up.

In terms of LLL at 6 months, “these data suggested that DREAMS 3G “is now on the level of contemporary DES,” Dr. Haude said.

The relative difference in favor of DREAMS 3G was even greater at 6 months for the secondary endpoint of in-segment LLL (0.05 vs. 0.27 mm) with similar significance for the superiority margin in a post hoc analysis (P < .0001).

Serial optical coherence tomography (OCT) was conducted post procedure, and indicated that the struts “were well embedded in the vessel wall,” according to Dr. Haude. Only 4.4% of struts on average were malapposed. The total incomplete strut apposition area was on average 0.08 mm. At 6 months, most struts were no long discernible on OCT, documenting device resorption.

Clinical results at 6 months were supportive. There were no cases of definite or probable scaffold thrombosis, and there were no target vessel myocardial infarctions or cardiac deaths. There was one clinically driven target lesion revascularization.

DREAMS 3G has other features designed to make it easier to deploy, Dr. Haude said. For example, radiopaque markers are now situated on both ends of the stent, making it easier to see on imaging. There are also plans to make these stents available in 15 sizes to accommodate a broad range of anatomy.

The data were impressive for many of the panelists invited to discuss the results.

“For the first time, we are seeing a bioabsorbable device showing excellent healing and very little late lumen loss,” said Michael H. Joner, MD, professor of early clinical trials at the German Center for Cardiovascular Research, Munich. “The next step is some sort of direct comparison with a drug-eluting stent.”

Describing himself as “a little more skeptical,” Aoke V Finn, MD, medical director and chief scientific officer, CVPath Institute, University of Maryland, Baltimore, said he wants to know more about the speed of device degradation and to see more long-term results in terms of clinical events. Although he considers the data promising so far, he considers it too early to embark on a randomized trial.

Longer-term data are coming, according to Dr. Haude. In addition to the 12-month follow-up that will include OCT and IVUS evaluations, there are annual clinical follow-up analyses planned to 5 years.

Dr. Haude reports financial relationships with Biotronik, Cardiac Dimensions, OrbusNeich, and Philips. Dr. Joner reports no potential conflicts of interest. Dr. Finn reports financial relationships with 19 pharmaceutical companies including those that manufacture cardiovascular stents.

At 6 months follow-up, a new-generation resorbable stent with a magnesium scaffold appears to perform at a level comparable to nonabsorbable drug-eluting stents (DES), according to first-in-man results presented as a late-breaker at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

“IVUS [intravascular ultrasound] assessment demonstrated preservation of the scaffold area from post procedure up to 6 months with a low mean neointimal area,” reported Michael Haude, MD, PhD, director of the Heart & Vascular Center, Neuss, Germany.

Neointimal formation and late lumen loss (LLL) have been the Achilles’ heel of previous efforts to develop a viable fully absorbable stent, making these 6-month data highly encouraging.

Ted Bosworth/MDedge Cardiology

The tested device is the most recent iteration of the DREAMS (drug-eluting resorbable magnesium scaffold) technology. Relative to DREAMS 2G, the DREAMS 3G device has several design changes, including a higher radial force and reduced strut thickness.

The goal was to build on the promise of DREAMS 2G while avoiding its limitations.

“The problem with DREAMS 2G was that it showed low–target lesion failure and scaffold thrombosis rates in multiple trials, but in-scaffold LLL was not comparable to LLL values observed with historical PLLA [poly-L-lactic acid]–based scaffolds or contemporary DES,” Dr. Haude said.

The 6-month data with DREAMS 3G were drawn from the BIOMAG-I study. Patients with stable or unstable angina were enrolled if they had no angiographic evidence of thrombus at the target lesion. Patients were also required to have no more than two single de novo lesions requiring revascularization.

Of 116 patients enrolled, 115 were available for evaluation at 6 months. The study was not controlled, but outcomes were compared at 6 months to those observed with the DREAMS 2G device in the BIOSOLVE-II trial, published several years ago in the Lancet.

For the primary outcome of in-scaffold LLL at 6 months, the mean LLL from baseline at 6 months was more than 50% lower with the DREAMS 3G device in BIOMAG-I than DREAMS 2G in BIOSOLVE-II (0.21 vs. 0.44 mm). In a post hoc superiority analysis employing a weighted mean, a superiority analysis supported a highly significant difference in favor of the newer device (P < .0001).

More importantly, the low LLL in BIOMAG-I was not just favorable relative to previously evaluated bioabsorbable stents, but it appears to compete with nonabsorbable options at least after this length of follow-up.

In terms of LLL at 6 months, “these data suggested that DREAMS 3G “is now on the level of contemporary DES,” Dr. Haude said.

The relative difference in favor of DREAMS 3G was even greater at 6 months for the secondary endpoint of in-segment LLL (0.05 vs. 0.27 mm) with similar significance for the superiority margin in a post hoc analysis (P < .0001).

Serial optical coherence tomography (OCT) was conducted post procedure, and indicated that the struts “were well embedded in the vessel wall,” according to Dr. Haude. Only 4.4% of struts on average were malapposed. The total incomplete strut apposition area was on average 0.08 mm. At 6 months, most struts were no long discernible on OCT, documenting device resorption.

Clinical results at 6 months were supportive. There were no cases of definite or probable scaffold thrombosis, and there were no target vessel myocardial infarctions or cardiac deaths. There was one clinically driven target lesion revascularization.

DREAMS 3G has other features designed to make it easier to deploy, Dr. Haude said. For example, radiopaque markers are now situated on both ends of the stent, making it easier to see on imaging. There are also plans to make these stents available in 15 sizes to accommodate a broad range of anatomy.

The data were impressive for many of the panelists invited to discuss the results.

“For the first time, we are seeing a bioabsorbable device showing excellent healing and very little late lumen loss,” said Michael H. Joner, MD, professor of early clinical trials at the German Center for Cardiovascular Research, Munich. “The next step is some sort of direct comparison with a drug-eluting stent.”

Describing himself as “a little more skeptical,” Aoke V Finn, MD, medical director and chief scientific officer, CVPath Institute, University of Maryland, Baltimore, said he wants to know more about the speed of device degradation and to see more long-term results in terms of clinical events. Although he considers the data promising so far, he considers it too early to embark on a randomized trial.

Longer-term data are coming, according to Dr. Haude. In addition to the 12-month follow-up that will include OCT and IVUS evaluations, there are annual clinical follow-up analyses planned to 5 years.

Dr. Haude reports financial relationships with Biotronik, Cardiac Dimensions, OrbusNeich, and Philips. Dr. Joner reports no potential conflicts of interest. Dr. Finn reports financial relationships with 19 pharmaceutical companies including those that manufacture cardiovascular stents.

At 6 months follow-up, a new-generation resorbable stent with a magnesium scaffold appears to perform at a level comparable to nonabsorbable drug-eluting stents (DES), according to first-in-man results presented as a late-breaker at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

“IVUS [intravascular ultrasound] assessment demonstrated preservation of the scaffold area from post procedure up to 6 months with a low mean neointimal area,” reported Michael Haude, MD, PhD, director of the Heart & Vascular Center, Neuss, Germany.

Neointimal formation and late lumen loss (LLL) have been the Achilles’ heel of previous efforts to develop a viable fully absorbable stent, making these 6-month data highly encouraging.

Ted Bosworth/MDedge Cardiology

The tested device is the most recent iteration of the DREAMS (drug-eluting resorbable magnesium scaffold) technology. Relative to DREAMS 2G, the DREAMS 3G device has several design changes, including a higher radial force and reduced strut thickness.

The goal was to build on the promise of DREAMS 2G while avoiding its limitations.

“The problem with DREAMS 2G was that it showed low–target lesion failure and scaffold thrombosis rates in multiple trials, but in-scaffold LLL was not comparable to LLL values observed with historical PLLA [poly-L-lactic acid]–based scaffolds or contemporary DES,” Dr. Haude said.

The 6-month data with DREAMS 3G were drawn from the BIOMAG-I study. Patients with stable or unstable angina were enrolled if they had no angiographic evidence of thrombus at the target lesion. Patients were also required to have no more than two single de novo lesions requiring revascularization.

Of 116 patients enrolled, 115 were available for evaluation at 6 months. The study was not controlled, but outcomes were compared at 6 months to those observed with the DREAMS 2G device in the BIOSOLVE-II trial, published several years ago in the Lancet.

For the primary outcome of in-scaffold LLL at 6 months, the mean LLL from baseline at 6 months was more than 50% lower with the DREAMS 3G device in BIOMAG-I than DREAMS 2G in BIOSOLVE-II (0.21 vs. 0.44 mm). In a post hoc superiority analysis employing a weighted mean, a superiority analysis supported a highly significant difference in favor of the newer device (P < .0001).

More importantly, the low LLL in BIOMAG-I was not just favorable relative to previously evaluated bioabsorbable stents, but it appears to compete with nonabsorbable options at least after this length of follow-up.

In terms of LLL at 6 months, “these data suggested that DREAMS 3G “is now on the level of contemporary DES,” Dr. Haude said.

The relative difference in favor of DREAMS 3G was even greater at 6 months for the secondary endpoint of in-segment LLL (0.05 vs. 0.27 mm) with similar significance for the superiority margin in a post hoc analysis (P < .0001).

Serial optical coherence tomography (OCT) was conducted post procedure, and indicated that the struts “were well embedded in the vessel wall,” according to Dr. Haude. Only 4.4% of struts on average were malapposed. The total incomplete strut apposition area was on average 0.08 mm. At 6 months, most struts were no long discernible on OCT, documenting device resorption.

Clinical results at 6 months were supportive. There were no cases of definite or probable scaffold thrombosis, and there were no target vessel myocardial infarctions or cardiac deaths. There was one clinically driven target lesion revascularization.

DREAMS 3G has other features designed to make it easier to deploy, Dr. Haude said. For example, radiopaque markers are now situated on both ends of the stent, making it easier to see on imaging. There are also plans to make these stents available in 15 sizes to accommodate a broad range of anatomy.

The data were impressive for many of the panelists invited to discuss the results.

“For the first time, we are seeing a bioabsorbable device showing excellent healing and very little late lumen loss,” said Michael H. Joner, MD, professor of early clinical trials at the German Center for Cardiovascular Research, Munich. “The next step is some sort of direct comparison with a drug-eluting stent.”

Describing himself as “a little more skeptical,” Aoke V Finn, MD, medical director and chief scientific officer, CVPath Institute, University of Maryland, Baltimore, said he wants to know more about the speed of device degradation and to see more long-term results in terms of clinical events. Although he considers the data promising so far, he considers it too early to embark on a randomized trial.

Longer-term data are coming, according to Dr. Haude. In addition to the 12-month follow-up that will include OCT and IVUS evaluations, there are annual clinical follow-up analyses planned to 5 years.

Dr. Haude reports financial relationships with Biotronik, Cardiac Dimensions, OrbusNeich, and Philips. Dr. Joner reports no potential conflicts of interest. Dr. Finn reports financial relationships with 19 pharmaceutical companies including those that manufacture cardiovascular stents.

WASHINGTON – On the heels the recently published final report from the SYMPLICITY HTN-3 renal denervation trial, a new analysis showed that Black patients, like non-Blacks, had sustained blood pressure control.

Contrary to a signal from earlier results, “there is nothing race specific about renal denervation,” said presenter Deepak L. Bhatt, MD, at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

This did not prove to be the case during the 6-month controlled phase of the trial. When patients randomized to renal denervation or the sham procedure were stratified by race, the primary endpoint of reduction in office systolic blood pressure (SBP) reached significance in the experimental arm among non-Black patients (–6.63 mm Hg; P = .01), but not among Black patients (–2.25 mm Hg; P = .09).
 

Blacks comprised 26% of SYMPLICITY HTN-3 trial

In the initial controlled analysis, published in the New England Journal of Medicine, the lack of benefit in the substantial Black enrollment – representing 26% of the study total – weighed against the ability of the trial to demonstrate a benefit, but Dr. Bhatt pointed out that BP reductions were unexpectedly high in the sham group regardless of race. Patients randomized to the sham group were encouraged to adhere to antihypertensive therapy, and based on response, this was particularly effective in the Black sham subgroup.

In SYMPLICITY HTN-3, patients with treatment-resistant hypertension were randomized to renal denervation or a sham procedure in a 2:1 ratio. While the controlled phase lasted just 6 months, the follow-up after the study was unblinded has continued out to 3 years. Safety and efficacy were assessed at 12, 24, and 36 months.

Unlike the disappointing results at 6 months, renal denervation has been consistently associated with significantly lower BP over long-term follow-up, even though those randomized to the sham procedure were permitted to cross over. About two-thirds of the sham group did so.

In the recently published final report of SYMPLICITY, the overall median change in office SBP at 3 years regardless of race was –26.4 mm Hg in the group initially randomized to renal denervation versus –5.7 mm Hg (P < .0001) among those randomized to the sham procedure.

In the subgroup analysis presented by Dr. Bhatt, the relative control of office SBP, as well as other measures of blood pressure, were similarly and significantly reduced in both Black and non-Black patients. In general, the relative control offered by being randomized initially to renal denervation increased over time in both groups.

For example, the relative reduction in office SBP favoring renal denervation climbed from –12.0 mm Hg at 12 months (P = .0066) to –21.0 at 18 months (P = .0002) and then to –24.9 mm Hg (P < .0001) at 36 months in the Black subgroup. In non-Blacks, the same type of relative reductions were seen at each time point, climbing from –13.5 (P < .0001) to –20.5 (P < .0001) and then to –21.0 (P < .0001).

The comparisons for other measures of BP control, including office diastolic BP, 24-hour SBP, and BP control during morning, day, and night periods were also statistically and similarly improved for those initially randomized to renal denervation rather than a sham procedure among both Blacks and non-Blacks.

Renal denervation safe in Black and non-Black patients

Renal denervation was well tolerated in both Black and non-Black participants with no signal of long-term risks over 36 months in either group. Among Blacks, rates of death at 36 months (3% vs. 11%) and stroke (7% vs. 11%) were lower among those randomized to renal denervation relative to sham patients who never crossed over, but Dr. Bhatt said the numbers are too small to draw any conclusions about outcomes.

While this subgroup analysis, along with the final SYMPLICITY report, supports the efficacy of renal denervation over the long term, these data are also consistent with the recently published analysis of SPYRAL ON-MED . Together, these data have led many experts, including Dr. Bhatt, to conclude that renal denervation is effective and deserves regulatory approval.

“In out-of-control blood pressure, when patients have maxed out on medications and lifestyle, I think renal denervation is efficacious, and it is equally efficacious in Blacks and non-Blacks,” Dr. Bhatt said.

This subgroup analysis is important because of the need for options in treatment-resistant hypertension among Black as well as non-Black patients, pointed out Sripal Bangalore, MBBS, director of complex coronary intervention at New York University.

“I am glad that we did not conclude too soon that it does not work in Blacks,” Dr. Bangalore said. If renal denervation is approved, he expects this procedure to be a valuable tool in this racial group.

Dr. Bhatt reported financial relationship with more than 20 pharmaceutical and device companies, including Medtronic, which provided funding for the SYMPLICITY HTN-3 trial. Dr. Bangalore has financial relationships with Abbott Vascular, Amgen, Biotronik, Inari, Pfizer, Reata, and Truvic.

WASHINGTON – On the heels the recently published final report from the SYMPLICITY HTN-3 renal denervation trial, a new analysis showed that Black patients, like non-Blacks, had sustained blood pressure control.

Contrary to a signal from earlier results, “there is nothing race specific about renal denervation,” said presenter Deepak L. Bhatt, MD, at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

This did not prove to be the case during the 6-month controlled phase of the trial. When patients randomized to renal denervation or the sham procedure were stratified by race, the primary endpoint of reduction in office systolic blood pressure (SBP) reached significance in the experimental arm among non-Black patients (–6.63 mm Hg; P = .01), but not among Black patients (–2.25 mm Hg; P = .09).
 

Blacks comprised 26% of SYMPLICITY HTN-3 trial

In the initial controlled analysis, published in the New England Journal of Medicine, the lack of benefit in the substantial Black enrollment – representing 26% of the study total – weighed against the ability of the trial to demonstrate a benefit, but Dr. Bhatt pointed out that BP reductions were unexpectedly high in the sham group regardless of race. Patients randomized to the sham group were encouraged to adhere to antihypertensive therapy, and based on response, this was particularly effective in the Black sham subgroup.

In SYMPLICITY HTN-3, patients with treatment-resistant hypertension were randomized to renal denervation or a sham procedure in a 2:1 ratio. While the controlled phase lasted just 6 months, the follow-up after the study was unblinded has continued out to 3 years. Safety and efficacy were assessed at 12, 24, and 36 months.

Unlike the disappointing results at 6 months, renal denervation has been consistently associated with significantly lower BP over long-term follow-up, even though those randomized to the sham procedure were permitted to cross over. About two-thirds of the sham group did so.

In the recently published final report of SYMPLICITY, the overall median change in office SBP at 3 years regardless of race was –26.4 mm Hg in the group initially randomized to renal denervation versus –5.7 mm Hg (P < .0001) among those randomized to the sham procedure.

In the subgroup analysis presented by Dr. Bhatt, the relative control of office SBP, as well as other measures of blood pressure, were similarly and significantly reduced in both Black and non-Black patients. In general, the relative control offered by being randomized initially to renal denervation increased over time in both groups.

For example, the relative reduction in office SBP favoring renal denervation climbed from –12.0 mm Hg at 12 months (P = .0066) to –21.0 at 18 months (P = .0002) and then to –24.9 mm Hg (P < .0001) at 36 months in the Black subgroup. In non-Blacks, the same type of relative reductions were seen at each time point, climbing from –13.5 (P < .0001) to –20.5 (P < .0001) and then to –21.0 (P < .0001).

The comparisons for other measures of BP control, including office diastolic BP, 24-hour SBP, and BP control during morning, day, and night periods were also statistically and similarly improved for those initially randomized to renal denervation rather than a sham procedure among both Blacks and non-Blacks.

Renal denervation safe in Black and non-Black patients

Renal denervation was well tolerated in both Black and non-Black participants with no signal of long-term risks over 36 months in either group. Among Blacks, rates of death at 36 months (3% vs. 11%) and stroke (7% vs. 11%) were lower among those randomized to renal denervation relative to sham patients who never crossed over, but Dr. Bhatt said the numbers are too small to draw any conclusions about outcomes.

While this subgroup analysis, along with the final SYMPLICITY report, supports the efficacy of renal denervation over the long term, these data are also consistent with the recently published analysis of SPYRAL ON-MED . Together, these data have led many experts, including Dr. Bhatt, to conclude that renal denervation is effective and deserves regulatory approval.

“In out-of-control blood pressure, when patients have maxed out on medications and lifestyle, I think renal denervation is efficacious, and it is equally efficacious in Blacks and non-Blacks,” Dr. Bhatt said.

This subgroup analysis is important because of the need for options in treatment-resistant hypertension among Black as well as non-Black patients, pointed out Sripal Bangalore, MBBS, director of complex coronary intervention at New York University.

“I am glad that we did not conclude too soon that it does not work in Blacks,” Dr. Bangalore said. If renal denervation is approved, he expects this procedure to be a valuable tool in this racial group.

Dr. Bhatt reported financial relationship with more than 20 pharmaceutical and device companies, including Medtronic, which provided funding for the SYMPLICITY HTN-3 trial. Dr. Bangalore has financial relationships with Abbott Vascular, Amgen, Biotronik, Inari, Pfizer, Reata, and Truvic.

WASHINGTON – On the heels the recently published final report from the SYMPLICITY HTN-3 renal denervation trial, a new analysis showed that Black patients, like non-Blacks, had sustained blood pressure control.

Contrary to a signal from earlier results, “there is nothing race specific about renal denervation,” said presenter Deepak L. Bhatt, MD, at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

This did not prove to be the case during the 6-month controlled phase of the trial. When patients randomized to renal denervation or the sham procedure were stratified by race, the primary endpoint of reduction in office systolic blood pressure (SBP) reached significance in the experimental arm among non-Black patients (–6.63 mm Hg; P = .01), but not among Black patients (–2.25 mm Hg; P = .09).
 

Blacks comprised 26% of SYMPLICITY HTN-3 trial

In the initial controlled analysis, published in the New England Journal of Medicine, the lack of benefit in the substantial Black enrollment – representing 26% of the study total – weighed against the ability of the trial to demonstrate a benefit, but Dr. Bhatt pointed out that BP reductions were unexpectedly high in the sham group regardless of race. Patients randomized to the sham group were encouraged to adhere to antihypertensive therapy, and based on response, this was particularly effective in the Black sham subgroup.

In SYMPLICITY HTN-3, patients with treatment-resistant hypertension were randomized to renal denervation or a sham procedure in a 2:1 ratio. While the controlled phase lasted just 6 months, the follow-up after the study was unblinded has continued out to 3 years. Safety and efficacy were assessed at 12, 24, and 36 months.

Unlike the disappointing results at 6 months, renal denervation has been consistently associated with significantly lower BP over long-term follow-up, even though those randomized to the sham procedure were permitted to cross over. About two-thirds of the sham group did so.

In the recently published final report of SYMPLICITY, the overall median change in office SBP at 3 years regardless of race was –26.4 mm Hg in the group initially randomized to renal denervation versus –5.7 mm Hg (P < .0001) among those randomized to the sham procedure.

In the subgroup analysis presented by Dr. Bhatt, the relative control of office SBP, as well as other measures of blood pressure, were similarly and significantly reduced in both Black and non-Black patients. In general, the relative control offered by being randomized initially to renal denervation increased over time in both groups.

For example, the relative reduction in office SBP favoring renal denervation climbed from –12.0 mm Hg at 12 months (P = .0066) to –21.0 at 18 months (P = .0002) and then to –24.9 mm Hg (P < .0001) at 36 months in the Black subgroup. In non-Blacks, the same type of relative reductions were seen at each time point, climbing from –13.5 (P < .0001) to –20.5 (P < .0001) and then to –21.0 (P < .0001).

The comparisons for other measures of BP control, including office diastolic BP, 24-hour SBP, and BP control during morning, day, and night periods were also statistically and similarly improved for those initially randomized to renal denervation rather than a sham procedure among both Blacks and non-Blacks.

Renal denervation safe in Black and non-Black patients

Renal denervation was well tolerated in both Black and non-Black participants with no signal of long-term risks over 36 months in either group. Among Blacks, rates of death at 36 months (3% vs. 11%) and stroke (7% vs. 11%) were lower among those randomized to renal denervation relative to sham patients who never crossed over, but Dr. Bhatt said the numbers are too small to draw any conclusions about outcomes.

While this subgroup analysis, along with the final SYMPLICITY report, supports the efficacy of renal denervation over the long term, these data are also consistent with the recently published analysis of SPYRAL ON-MED . Together, these data have led many experts, including Dr. Bhatt, to conclude that renal denervation is effective and deserves regulatory approval.

“In out-of-control blood pressure, when patients have maxed out on medications and lifestyle, I think renal denervation is efficacious, and it is equally efficacious in Blacks and non-Blacks,” Dr. Bhatt said.

This subgroup analysis is important because of the need for options in treatment-resistant hypertension among Black as well as non-Black patients, pointed out Sripal Bangalore, MBBS, director of complex coronary intervention at New York University.

“I am glad that we did not conclude too soon that it does not work in Blacks,” Dr. Bangalore said. If renal denervation is approved, he expects this procedure to be a valuable tool in this racial group.

Dr. Bhatt reported financial relationship with more than 20 pharmaceutical and device companies, including Medtronic, which provided funding for the SYMPLICITY HTN-3 trial. Dr. Bangalore has financial relationships with Abbott Vascular, Amgen, Biotronik, Inari, Pfizer, Reata, and Truvic.

In a pooled analysis from two randomized trials, transcatheter aortic valve implantation (TAVI) was associated with significantly less bioprosthetic valve dysfunction (BVD) than a surgical prosthetic implantation, according to data presented as a late-breaker at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

“The difference in valve performance was driven by a twofold lower SVD [structural valve deterioration] and a 3-fold lower severe PPM [prothesis-patient mismatch] for TAVI versus surgery,” reported Steven J. Yakubov, MD.

Ted Bosworth/MDedge News

The data were pooled from the CoreValve U.S. Pivotal and SURTAVI randomized trials. Of patients participating in these two trials, 5-year follow-up data were available for 1,128 randomized to the CoreValve/Evolut TAVI and 971 randomized to surgical prosthetic valve replacement.

The major focus of the study was on the cumulative incidence of BVD, but the study also included separate analyses on the relationship between BVD and clinical outcomes. Preprocedural indicators for BVD at 5 years were also analyzed.

SVD was defined as a mean gradient increase of at least 10 mm Hg from discharge to 30 days, along with at least 20 mm Hg at last echo or new-onset aortic regurgitation. Nonstructural valve deterioration (NSVD) was defined as severe PPM at discharge or 30 days or severe paravalvular regurgitation through 5 years. In addition to these two components, the BVD endpoint also included thrombosis and endocarditis.
 

Surgical valve deterioration high at 5 years

On the basis of these definitions, the rate of BVD at 5 years was 14.2% in the surgery group and 7.8% in the TAVI group, translating into a 50% risk reduction in favor of TAVI (hazard ratio, 0.50; P < .001).

Thrombosis or endocarditis occurred in low rates in both groups, but every other component of BVD favored TAVI significantly, not just numerically. This included SVD (2.2% vs. 4.4%; P = .004), and the two components of NSVD, PPM (3.7% vs. 11.8%; P < .001) and severe paravalvular regurgitation (0.2% vs. 1.2%; P = .02).

When stratified by annular diameter, the relative advantage of TAVI over surgery was greatest in those valves with diameters of up to 23 mm. In this group, the lower relative rate in the TAVI group (8.6% vs. 19.7%) represented a nearly 70% reduction in risk of valve deterioration at 5 years (HR, 0.31; P < .001).

However, the advantage at 5 years also remained substantial and significant in larger valves (8.1% vs. 12.6%), translating into a 40% risk reduction in favor of TAVI (HR, 0.60; P = .002).

Independent of type of valve replacement, BVD at 5 years was associated with worse outcomes, including significantly increased risks for all-cause mortality (HR, 1.46; P = .004), cardiovascular mortality (1.84; P < .001), and hospitalization for valve disease or worsening heart failure (HR, 1.67; P = .001).

The baseline characteristics that were statistically associated with BVD at 5 years on multivariate analysis in pooled data from both the TAVI and surgical groups included age (P = .02), a creatinine clearance less than 30 mL/min per 1.73 m² (P = .006), and a low relative baseline left ventricular ejection fraction (P < .001).
 

BVD criteria validated for outcome prediction

The four components of valve performance employed in this analysis (SVD, NSVD, thrombosis, and endocarditis) were drawn from consensus documents issued by the Valve Academic Research Consortium and the European Association of Percutaneous Cardiovascular Interventions, but the relative importance of these components for predicting valve survival was previously unknown, according to Dr. Yakubov.

“This is the first analysis to validate clinical criteria for valve performance and its association with clinical outcomes,” said Dr. Yakubov, medical director of cardiovascular studies, OhioHealth Research Institute at Riverside Methodist Hospital, Columbus.

This is also the first study to employ randomized data to prove an advantage of TAVI over surgery in long-term follow-up.

A 10-year follow-up is planned for the patients who participated in these two trials, but the lower rate of BVD in the TAVI arm at 5 years is already a threat to surgical repairs, acknowledged several surgeons who served as panelists in the session where these results were presented.

“I think that these data are a reflection of the fact that we [surgeons] are not being as aggressive as we should be,” said Gregory P. Fontana, MD, who is national director, cardiothoracic surgery, HCA Healthcare, and is affiliated with Los Robles Health System, Thousand Oaks, Calif. “We need to be employing larger prostheses.”

Ted Bosworth/MDedge News

A very similar comment was made by Michael J. Reardon, MD, a professor of cardiothoracic surgery at Houston Methodist Hospital. Pointing to the higher rate of PVL as an example of a common postsurgical complication, he agreed that surgeons should be moving to bigger valve sizes.

While adjustments in valve size might address the steeper rise in NSVD subtypes of BVD observed in the surgical group, but Dr. Reardon and others pointed out that late BVD events also rose at a greater pace in the surgical group. These suggest other improvements in technique might also be needed to keep surgical valve repairs competitive.

Dr. Yakubov reported financial relationships with Medtronic and Boston Scientific, both of which provided funding for this study. Dr. Fontana reported financial relationships with Abbott and Medtronic. Dr. Reardon reported financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical.

In a pooled analysis from two randomized trials, transcatheter aortic valve implantation (TAVI) was associated with significantly less bioprosthetic valve dysfunction (BVD) than a surgical prosthetic implantation, according to data presented as a late-breaker at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

“The difference in valve performance was driven by a twofold lower SVD [structural valve deterioration] and a 3-fold lower severe PPM [prothesis-patient mismatch] for TAVI versus surgery,” reported Steven J. Yakubov, MD.

Ted Bosworth/MDedge News

The data were pooled from the CoreValve U.S. Pivotal and SURTAVI randomized trials. Of patients participating in these two trials, 5-year follow-up data were available for 1,128 randomized to the CoreValve/Evolut TAVI and 971 randomized to surgical prosthetic valve replacement.

The major focus of the study was on the cumulative incidence of BVD, but the study also included separate analyses on the relationship between BVD and clinical outcomes. Preprocedural indicators for BVD at 5 years were also analyzed.

SVD was defined as a mean gradient increase of at least 10 mm Hg from discharge to 30 days, along with at least 20 mm Hg at last echo or new-onset aortic regurgitation. Nonstructural valve deterioration (NSVD) was defined as severe PPM at discharge or 30 days or severe paravalvular regurgitation through 5 years. In addition to these two components, the BVD endpoint also included thrombosis and endocarditis.
 

Surgical valve deterioration high at 5 years

On the basis of these definitions, the rate of BVD at 5 years was 14.2% in the surgery group and 7.8% in the TAVI group, translating into a 50% risk reduction in favor of TAVI (hazard ratio, 0.50; P < .001).

Thrombosis or endocarditis occurred in low rates in both groups, but every other component of BVD favored TAVI significantly, not just numerically. This included SVD (2.2% vs. 4.4%; P = .004), and the two components of NSVD, PPM (3.7% vs. 11.8%; P < .001) and severe paravalvular regurgitation (0.2% vs. 1.2%; P = .02).

When stratified by annular diameter, the relative advantage of TAVI over surgery was greatest in those valves with diameters of up to 23 mm. In this group, the lower relative rate in the TAVI group (8.6% vs. 19.7%) represented a nearly 70% reduction in risk of valve deterioration at 5 years (HR, 0.31; P < .001).

However, the advantage at 5 years also remained substantial and significant in larger valves (8.1% vs. 12.6%), translating into a 40% risk reduction in favor of TAVI (HR, 0.60; P = .002).

Independent of type of valve replacement, BVD at 5 years was associated with worse outcomes, including significantly increased risks for all-cause mortality (HR, 1.46; P = .004), cardiovascular mortality (1.84; P < .001), and hospitalization for valve disease or worsening heart failure (HR, 1.67; P = .001).

The baseline characteristics that were statistically associated with BVD at 5 years on multivariate analysis in pooled data from both the TAVI and surgical groups included age (P = .02), a creatinine clearance less than 30 mL/min per 1.73 m² (P = .006), and a low relative baseline left ventricular ejection fraction (P < .001).
 

BVD criteria validated for outcome prediction

The four components of valve performance employed in this analysis (SVD, NSVD, thrombosis, and endocarditis) were drawn from consensus documents issued by the Valve Academic Research Consortium and the European Association of Percutaneous Cardiovascular Interventions, but the relative importance of these components for predicting valve survival was previously unknown, according to Dr. Yakubov.

“This is the first analysis to validate clinical criteria for valve performance and its association with clinical outcomes,” said Dr. Yakubov, medical director of cardiovascular studies, OhioHealth Research Institute at Riverside Methodist Hospital, Columbus.

This is also the first study to employ randomized data to prove an advantage of TAVI over surgery in long-term follow-up.

A 10-year follow-up is planned for the patients who participated in these two trials, but the lower rate of BVD in the TAVI arm at 5 years is already a threat to surgical repairs, acknowledged several surgeons who served as panelists in the session where these results were presented.

“I think that these data are a reflection of the fact that we [surgeons] are not being as aggressive as we should be,” said Gregory P. Fontana, MD, who is national director, cardiothoracic surgery, HCA Healthcare, and is affiliated with Los Robles Health System, Thousand Oaks, Calif. “We need to be employing larger prostheses.”

Ted Bosworth/MDedge News

A very similar comment was made by Michael J. Reardon, MD, a professor of cardiothoracic surgery at Houston Methodist Hospital. Pointing to the higher rate of PVL as an example of a common postsurgical complication, he agreed that surgeons should be moving to bigger valve sizes.

While adjustments in valve size might address the steeper rise in NSVD subtypes of BVD observed in the surgical group, but Dr. Reardon and others pointed out that late BVD events also rose at a greater pace in the surgical group. These suggest other improvements in technique might also be needed to keep surgical valve repairs competitive.

Dr. Yakubov reported financial relationships with Medtronic and Boston Scientific, both of which provided funding for this study. Dr. Fontana reported financial relationships with Abbott and Medtronic. Dr. Reardon reported financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical.

In a pooled analysis from two randomized trials, transcatheter aortic valve implantation (TAVI) was associated with significantly less bioprosthetic valve dysfunction (BVD) than a surgical prosthetic implantation, according to data presented as a late-breaker at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

“The difference in valve performance was driven by a twofold lower SVD [structural valve deterioration] and a 3-fold lower severe PPM [prothesis-patient mismatch] for TAVI versus surgery,” reported Steven J. Yakubov, MD.

Ted Bosworth/MDedge News

The data were pooled from the CoreValve U.S. Pivotal and SURTAVI randomized trials. Of patients participating in these two trials, 5-year follow-up data were available for 1,128 randomized to the CoreValve/Evolut TAVI and 971 randomized to surgical prosthetic valve replacement.

The major focus of the study was on the cumulative incidence of BVD, but the study also included separate analyses on the relationship between BVD and clinical outcomes. Preprocedural indicators for BVD at 5 years were also analyzed.

SVD was defined as a mean gradient increase of at least 10 mm Hg from discharge to 30 days, along with at least 20 mm Hg at last echo or new-onset aortic regurgitation. Nonstructural valve deterioration (NSVD) was defined as severe PPM at discharge or 30 days or severe paravalvular regurgitation through 5 years. In addition to these two components, the BVD endpoint also included thrombosis and endocarditis.
 

Surgical valve deterioration high at 5 years

On the basis of these definitions, the rate of BVD at 5 years was 14.2% in the surgery group and 7.8% in the TAVI group, translating into a 50% risk reduction in favor of TAVI (hazard ratio, 0.50; P < .001).

Thrombosis or endocarditis occurred in low rates in both groups, but every other component of BVD favored TAVI significantly, not just numerically. This included SVD (2.2% vs. 4.4%; P = .004), and the two components of NSVD, PPM (3.7% vs. 11.8%; P < .001) and severe paravalvular regurgitation (0.2% vs. 1.2%; P = .02).

When stratified by annular diameter, the relative advantage of TAVI over surgery was greatest in those valves with diameters of up to 23 mm. In this group, the lower relative rate in the TAVI group (8.6% vs. 19.7%) represented a nearly 70% reduction in risk of valve deterioration at 5 years (HR, 0.31; P < .001).

However, the advantage at 5 years also remained substantial and significant in larger valves (8.1% vs. 12.6%), translating into a 40% risk reduction in favor of TAVI (HR, 0.60; P = .002).

Independent of type of valve replacement, BVD at 5 years was associated with worse outcomes, including significantly increased risks for all-cause mortality (HR, 1.46; P = .004), cardiovascular mortality (1.84; P < .001), and hospitalization for valve disease or worsening heart failure (HR, 1.67; P = .001).

The baseline characteristics that were statistically associated with BVD at 5 years on multivariate analysis in pooled data from both the TAVI and surgical groups included age (P = .02), a creatinine clearance less than 30 mL/min per 1.73 m² (P = .006), and a low relative baseline left ventricular ejection fraction (P < .001).
 

BVD criteria validated for outcome prediction

The four components of valve performance employed in this analysis (SVD, NSVD, thrombosis, and endocarditis) were drawn from consensus documents issued by the Valve Academic Research Consortium and the European Association of Percutaneous Cardiovascular Interventions, but the relative importance of these components for predicting valve survival was previously unknown, according to Dr. Yakubov.

“This is the first analysis to validate clinical criteria for valve performance and its association with clinical outcomes,” said Dr. Yakubov, medical director of cardiovascular studies, OhioHealth Research Institute at Riverside Methodist Hospital, Columbus.

This is also the first study to employ randomized data to prove an advantage of TAVI over surgery in long-term follow-up.

A 10-year follow-up is planned for the patients who participated in these two trials, but the lower rate of BVD in the TAVI arm at 5 years is already a threat to surgical repairs, acknowledged several surgeons who served as panelists in the session where these results were presented.

“I think that these data are a reflection of the fact that we [surgeons] are not being as aggressive as we should be,” said Gregory P. Fontana, MD, who is national director, cardiothoracic surgery, HCA Healthcare, and is affiliated with Los Robles Health System, Thousand Oaks, Calif. “We need to be employing larger prostheses.”

Ted Bosworth/MDedge News

A very similar comment was made by Michael J. Reardon, MD, a professor of cardiothoracic surgery at Houston Methodist Hospital. Pointing to the higher rate of PVL as an example of a common postsurgical complication, he agreed that surgeons should be moving to bigger valve sizes.

While adjustments in valve size might address the steeper rise in NSVD subtypes of BVD observed in the surgical group, but Dr. Reardon and others pointed out that late BVD events also rose at a greater pace in the surgical group. These suggest other improvements in technique might also be needed to keep surgical valve repairs competitive.

Dr. Yakubov reported financial relationships with Medtronic and Boston Scientific, both of which provided funding for this study. Dr. Fontana reported financial relationships with Abbott and Medtronic. Dr. Reardon reported financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical.

Infections of coronary stents appear to be uncommon, but it is not clear if they are often missed, underreported, or truly rare, according to a new analysis.

In a search of multiple databases, 79 cases of coronary stent infections (CSI) were found in 65 published reports, according to Venkatakrishnan Ramakumar, MBBS, MD, department of cardiology, All India Institute of Medical Sciences, New Delhi.

Ted Bosworth/MDedge News

Over the period of evaluation, which had no defined starting point but stretched to November 2021, the 79 infections reported worldwide occurred when millions of percutaneous coronary intervention (PCI) procedures were performed. In the United States alone, the current estimated annual number of PCIs is 600,000, according to an article published in the Journal of the American Heart Association.

If the number of reported CSI cases represented even a modest fraction of those that occurred, the risk would still be almost negligible. Yet, Dr. Ramakumar insisted that there has been little attention paid to the potential for CSI, creating a situation in which many or almost all cases are simply being missed.

“We do not know how many infections have gone unrecognized,” Dr. Ramakumar said in presenting his results at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute. And even if they are identified and promptly treated, there “is the potential for a publication bias,” he added, referring to the reluctance of investigators to submit and publishers to accept manuscripts with negative results.

Regardless of the frequency with which they occur, CSI is associated with bad outcomes, according to the data evaluated by Dr. Ramakumar. On the basis of in-hospital mortality, the primary endpoint of this analysis, the rate of death in patients developing CSI was 30.3%.
 

Successful treatment varied by hospital type

This risk was not uniform. Rather, rates of in-hospital mortality and proportion of patients treated successfully varied substantially by type of hospital. At private teaching hospitals for example, successful treatment – whether medical alone or followed by bailout surgery – was 80%. The rates fell to 40% at public teaching hospitals and then to 25% at private nonteaching hospitals.

The full-text articles included in this analysis were evaluated and selected by two reviewers working independently. A CSI diagnosis made clinically or with imaging and treatment outcomes were among criteria for the case studies to be included. Dr. Ramakumar said the study, which he claimed is the largest systematic review of CSI ever conducted, has been registered with PROSPERO, an international prospective registry of systematic reviews.

The presenting symptom was fever in 72% of cases and chest pain in the others, although there was one asymptomatic CSI reported. On angiography, 62% had a concomitant mycotic aneurysm. Intramyocardial abscess (13.9%), rupture (11.3%), and coronary fistula (7.5%) were also common findings, but no angiographic abnormalities could be identified in 53% of patients.

Following PCI, most CSI developed within 8 days (43%) or the first month (23%), but CSI was reported more than 6 months after the procedure in 19%. Complex PCI accounted for 51% of cases. Of stent types, 56% were drug eluting and 13% were bare metal.

When comparing characteristics of those who survived CSI with those who did not, most (89%) of those with a non–ST-segment elevated acute coronary syndrome ultimately survived, while survival from CSI in those with structural heart disease was only 17%.

Microbiological findings were not a criterion for study inclusion, but Staphylococcus species accounted for 65% of the infections for which positive cultures were reported. Pseudomonas accounted for 13%. Less than 4% (3.8%) tested positive for multiple pathogens. A small proportion of patients had unusual infectious organisms.

As part of this analysis, the investigators developed an artificial intelligence model to predict CSI based on patient characteristics and other variables. However, the specificity of only around 70% led Dr. Ramakumar to conclude that it does not yet have practical value.

However, he believes that better methodology to detect CSI is needed, and he proposed a diagnostic algorithm that he believes would both improve detection rates and accelerate the time to diagnosis.
 

Algorithm proposed for detection of CSI

In this algorithm, the first step in symptomatic patients with a positive blood culture suspected of CSI is imaging, such as transthoracic echocardiography, to identify features of infective endocarditis or endarteritis. If the imaging is positive, further imaging, such as PET, that supports the diagnosis, should be adequate to support a diagnosis and treatment.

If initial imaging is negative, alternative diagnoses should be considered, but Dr. Ramakumar advised repeat imaging after 48 hours if symptoms persist and no other causes are found.

Dr. Ramakumar acknowledged the many limitations of this analysis, including the small sample size and the challenges of assembling coherent data from case reports with variable types of information submitted during different eras of PCI evolution. However, reiterating that CSI might be frequently missed, he emphasized that this problem might be bigger than currently understood.

It is difficult to rule out any possibility that CSI is frequently missed, but Andrew Sharp, MD, PhD, a consultant interventional cardiologist at the University Hospital of Wales, Cardiff, is skeptical.

“One might think this is a potential problem, but I cannot think of one patient in whom this has occurred,” Dr. Sharp said in an interview. He is fairly confident that they are extremely rare.

“When there is infection associated with a foreign body, such as a pacemaker, they do not typically resolve by themselves,” he explained. “Often the device has to be removed. If this was true for CSI, then I think we would be aware of these complications.”

However, he praised the investigators for taking a look at CSI in a systematic approach. An invited panelist during the CRT featured research, which is where these data were presented, Dr. Sharp was more interested in understanding why they do not occur now that data are available to suggest they are rare.

“Is there something in the coronary environment, such as the consistent blood flow, that protects against infection?” he asked. CSI is a valid area of further research, according to Dr. Sharp, but he does not consider infected stents to be a common threat based on his own sizable case series.

Dr. Ramakumar and Dr. Sharp reported no potential conflicts of interest.

Infections of coronary stents appear to be uncommon, but it is not clear if they are often missed, underreported, or truly rare, according to a new analysis.

In a search of multiple databases, 79 cases of coronary stent infections (CSI) were found in 65 published reports, according to Venkatakrishnan Ramakumar, MBBS, MD, department of cardiology, All India Institute of Medical Sciences, New Delhi.

Ted Bosworth/MDedge News

Over the period of evaluation, which had no defined starting point but stretched to November 2021, the 79 infections reported worldwide occurred when millions of percutaneous coronary intervention (PCI) procedures were performed. In the United States alone, the current estimated annual number of PCIs is 600,000, according to an article published in the Journal of the American Heart Association.

If the number of reported CSI cases represented even a modest fraction of those that occurred, the risk would still be almost negligible. Yet, Dr. Ramakumar insisted that there has been little attention paid to the potential for CSI, creating a situation in which many or almost all cases are simply being missed.

“We do not know how many infections have gone unrecognized,” Dr. Ramakumar said in presenting his results at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute. And even if they are identified and promptly treated, there “is the potential for a publication bias,” he added, referring to the reluctance of investigators to submit and publishers to accept manuscripts with negative results.

Regardless of the frequency with which they occur, CSI is associated with bad outcomes, according to the data evaluated by Dr. Ramakumar. On the basis of in-hospital mortality, the primary endpoint of this analysis, the rate of death in patients developing CSI was 30.3%.
 

Successful treatment varied by hospital type

This risk was not uniform. Rather, rates of in-hospital mortality and proportion of patients treated successfully varied substantially by type of hospital. At private teaching hospitals for example, successful treatment – whether medical alone or followed by bailout surgery – was 80%. The rates fell to 40% at public teaching hospitals and then to 25% at private nonteaching hospitals.

The full-text articles included in this analysis were evaluated and selected by two reviewers working independently. A CSI diagnosis made clinically or with imaging and treatment outcomes were among criteria for the case studies to be included. Dr. Ramakumar said the study, which he claimed is the largest systematic review of CSI ever conducted, has been registered with PROSPERO, an international prospective registry of systematic reviews.

The presenting symptom was fever in 72% of cases and chest pain in the others, although there was one asymptomatic CSI reported. On angiography, 62% had a concomitant mycotic aneurysm. Intramyocardial abscess (13.9%), rupture (11.3%), and coronary fistula (7.5%) were also common findings, but no angiographic abnormalities could be identified in 53% of patients.

Following PCI, most CSI developed within 8 days (43%) or the first month (23%), but CSI was reported more than 6 months after the procedure in 19%. Complex PCI accounted for 51% of cases. Of stent types, 56% were drug eluting and 13% were bare metal.

When comparing characteristics of those who survived CSI with those who did not, most (89%) of those with a non–ST-segment elevated acute coronary syndrome ultimately survived, while survival from CSI in those with structural heart disease was only 17%.

Microbiological findings were not a criterion for study inclusion, but Staphylococcus species accounted for 65% of the infections for which positive cultures were reported. Pseudomonas accounted for 13%. Less than 4% (3.8%) tested positive for multiple pathogens. A small proportion of patients had unusual infectious organisms.

As part of this analysis, the investigators developed an artificial intelligence model to predict CSI based on patient characteristics and other variables. However, the specificity of only around 70% led Dr. Ramakumar to conclude that it does not yet have practical value.

However, he believes that better methodology to detect CSI is needed, and he proposed a diagnostic algorithm that he believes would both improve detection rates and accelerate the time to diagnosis.
 

Algorithm proposed for detection of CSI

In this algorithm, the first step in symptomatic patients with a positive blood culture suspected of CSI is imaging, such as transthoracic echocardiography, to identify features of infective endocarditis or endarteritis. If the imaging is positive, further imaging, such as PET, that supports the diagnosis, should be adequate to support a diagnosis and treatment.

If initial imaging is negative, alternative diagnoses should be considered, but Dr. Ramakumar advised repeat imaging after 48 hours if symptoms persist and no other causes are found.

Dr. Ramakumar acknowledged the many limitations of this analysis, including the small sample size and the challenges of assembling coherent data from case reports with variable types of information submitted during different eras of PCI evolution. However, reiterating that CSI might be frequently missed, he emphasized that this problem might be bigger than currently understood.

It is difficult to rule out any possibility that CSI is frequently missed, but Andrew Sharp, MD, PhD, a consultant interventional cardiologist at the University Hospital of Wales, Cardiff, is skeptical.

“One might think this is a potential problem, but I cannot think of one patient in whom this has occurred,” Dr. Sharp said in an interview. He is fairly confident that they are extremely rare.

“When there is infection associated with a foreign body, such as a pacemaker, they do not typically resolve by themselves,” he explained. “Often the device has to be removed. If this was true for CSI, then I think we would be aware of these complications.”

However, he praised the investigators for taking a look at CSI in a systematic approach. An invited panelist during the CRT featured research, which is where these data were presented, Dr. Sharp was more interested in understanding why they do not occur now that data are available to suggest they are rare.

“Is there something in the coronary environment, such as the consistent blood flow, that protects against infection?” he asked. CSI is a valid area of further research, according to Dr. Sharp, but he does not consider infected stents to be a common threat based on his own sizable case series.

Dr. Ramakumar and Dr. Sharp reported no potential conflicts of interest.

Infections of coronary stents appear to be uncommon, but it is not clear if they are often missed, underreported, or truly rare, according to a new analysis.

In a search of multiple databases, 79 cases of coronary stent infections (CSI) were found in 65 published reports, according to Venkatakrishnan Ramakumar, MBBS, MD, department of cardiology, All India Institute of Medical Sciences, New Delhi.

Ted Bosworth/MDedge News

Over the period of evaluation, which had no defined starting point but stretched to November 2021, the 79 infections reported worldwide occurred when millions of percutaneous coronary intervention (PCI) procedures were performed. In the United States alone, the current estimated annual number of PCIs is 600,000, according to an article published in the Journal of the American Heart Association.

If the number of reported CSI cases represented even a modest fraction of those that occurred, the risk would still be almost negligible. Yet, Dr. Ramakumar insisted that there has been little attention paid to the potential for CSI, creating a situation in which many or almost all cases are simply being missed.

“We do not know how many infections have gone unrecognized,” Dr. Ramakumar said in presenting his results at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute. And even if they are identified and promptly treated, there “is the potential for a publication bias,” he added, referring to the reluctance of investigators to submit and publishers to accept manuscripts with negative results.

Regardless of the frequency with which they occur, CSI is associated with bad outcomes, according to the data evaluated by Dr. Ramakumar. On the basis of in-hospital mortality, the primary endpoint of this analysis, the rate of death in patients developing CSI was 30.3%.
 

Successful treatment varied by hospital type

This risk was not uniform. Rather, rates of in-hospital mortality and proportion of patients treated successfully varied substantially by type of hospital. At private teaching hospitals for example, successful treatment – whether medical alone or followed by bailout surgery – was 80%. The rates fell to 40% at public teaching hospitals and then to 25% at private nonteaching hospitals.

The full-text articles included in this analysis were evaluated and selected by two reviewers working independently. A CSI diagnosis made clinically or with imaging and treatment outcomes were among criteria for the case studies to be included. Dr. Ramakumar said the study, which he claimed is the largest systematic review of CSI ever conducted, has been registered with PROSPERO, an international prospective registry of systematic reviews.

The presenting symptom was fever in 72% of cases and chest pain in the others, although there was one asymptomatic CSI reported. On angiography, 62% had a concomitant mycotic aneurysm. Intramyocardial abscess (13.9%), rupture (11.3%), and coronary fistula (7.5%) were also common findings, but no angiographic abnormalities could be identified in 53% of patients.

Following PCI, most CSI developed within 8 days (43%) or the first month (23%), but CSI was reported more than 6 months after the procedure in 19%. Complex PCI accounted for 51% of cases. Of stent types, 56% were drug eluting and 13% were bare metal.

When comparing characteristics of those who survived CSI with those who did not, most (89%) of those with a non–ST-segment elevated acute coronary syndrome ultimately survived, while survival from CSI in those with structural heart disease was only 17%.

Microbiological findings were not a criterion for study inclusion, but Staphylococcus species accounted for 65% of the infections for which positive cultures were reported. Pseudomonas accounted for 13%. Less than 4% (3.8%) tested positive for multiple pathogens. A small proportion of patients had unusual infectious organisms.

As part of this analysis, the investigators developed an artificial intelligence model to predict CSI based on patient characteristics and other variables. However, the specificity of only around 70% led Dr. Ramakumar to conclude that it does not yet have practical value.

However, he believes that better methodology to detect CSI is needed, and he proposed a diagnostic algorithm that he believes would both improve detection rates and accelerate the time to diagnosis.
 

Algorithm proposed for detection of CSI

In this algorithm, the first step in symptomatic patients with a positive blood culture suspected of CSI is imaging, such as transthoracic echocardiography, to identify features of infective endocarditis or endarteritis. If the imaging is positive, further imaging, such as PET, that supports the diagnosis, should be adequate to support a diagnosis and treatment.

If initial imaging is negative, alternative diagnoses should be considered, but Dr. Ramakumar advised repeat imaging after 48 hours if symptoms persist and no other causes are found.

Dr. Ramakumar acknowledged the many limitations of this analysis, including the small sample size and the challenges of assembling coherent data from case reports with variable types of information submitted during different eras of PCI evolution. However, reiterating that CSI might be frequently missed, he emphasized that this problem might be bigger than currently understood.

It is difficult to rule out any possibility that CSI is frequently missed, but Andrew Sharp, MD, PhD, a consultant interventional cardiologist at the University Hospital of Wales, Cardiff, is skeptical.

“One might think this is a potential problem, but I cannot think of one patient in whom this has occurred,” Dr. Sharp said in an interview. He is fairly confident that they are extremely rare.

“When there is infection associated with a foreign body, such as a pacemaker, they do not typically resolve by themselves,” he explained. “Often the device has to be removed. If this was true for CSI, then I think we would be aware of these complications.”

However, he praised the investigators for taking a look at CSI in a systematic approach. An invited panelist during the CRT featured research, which is where these data were presented, Dr. Sharp was more interested in understanding why they do not occur now that data are available to suggest they are rare.

“Is there something in the coronary environment, such as the consistent blood flow, that protects against infection?” he asked. CSI is a valid area of further research, according to Dr. Sharp, but he does not consider infected stents to be a common threat based on his own sizable case series.

Dr. Ramakumar and Dr. Sharp reported no potential conflicts of interest.

WASHINGTON – For patients with diabetes, there are trade-offs for selecting a percutaneous intervention (PCI) over coronary artery bypass grafting (CABG) for left main artery disease when either can be considered, according to a hypothesis-generating pooled analysis.

The pooled data from four trials indicate that either method of revascularization is “reasonable,” but risk of myocardial infarction and revascularization is higher and risk of stroke is lower in patients with diabetes following PCI relative to CABG, Prakriti Gaba, MD, said in presenting the analysis at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

Ted Bosworth/MDedge News

Despite decades of advances in both PCI and CABG, the findings are remarkably similar to those of Emory Angioplasty Versus Surgery Trial (EAST), the first major study to compare PCI to CABG, which were published almost 30 years ago. In the new analysis, like in EAST, PCI and CABG were comparable for a primary composite endpoint overall, but patients with diabetes were the exception. In those, outcomes were modestly better after CABG, said Dr. Gaba, a cardiology fellow at Brigham and Women’s Hospital, Harvard Medical School, both in Boston.

“More and more I am hearing from practitioners that diabetes does not matter, but what I get from your data is that diabetes still matters,” said Spencer B. King, MD, a pioneer of PCI affiliated with Emory University, Atlanta.

Dr. King, the first author of the 1994 paper and a panelist in the late-breaking trial session where the new data were presented, pointed out that a relatively limited proportion of patients with diabetes are equally suitable for PCI and CABG because of other considerations. However, he said an updated look once again suggesting that PCI and CABG are not equivalent for left main lesions in patients with diabetes “is helpful to see.”
 

CABG traditionally preferred for left main revascularization

The issue was revisited because CABG has been preferred traditionally for left main disease, but there was increasing evidence that PCI is associated with similar survival, according to Dr. Gaba. These new data support that contention, even if it shows that outcomes are not the same in those with diabetes relative to those without.

In this pooled analysis, data were drawn from four trials. Each compared PCI with drug-eluting stents with CABG in patients that were considered suitable for either. From the four trials, the numbers in this analysis included 705 patients from SYNTAX, 600 patients from PRECOMBAT, 1,184 patients from NOBLE, and 1,905 patients from EXCEL.

The focus was on the 1,104 patients with diabetes relative to the 3,289 without. The primary endpoint was all-cause death at 5 years. The multiple secondary endpoints included cardiovascular (CV) death, MI, stroke, and revascularization.

Overall, the 5-year mortality, independent of revascularization procedure, was 14.8% for those with diabetes and 9.3% for those without (P < .001). For this endpoint, the rates were numerically lower but not statistically different for CABG whether patients had diabetes (14.1% vs. 15.3%) or no diabetes (8.9% vs. 9.7%).

However, the rate of spontaneous MI was twice as great with PCI than with CABG for those with diabetes (8.9% vs. 4.4%), which doubled the hazard ratio within significant confidence intervals (HR, 2.01; 95% CI, 1.21-3.35). The rates of revascularization were also about twice as great with PCI than with CABG (24.5% vs. 12.4%), again producing a twofold increase in risk (HR, 2.12; 95% CI, 1.56-2.87).

For stroke in patients with diabetes, there was no difference in events at 5 years for PCI relative to CABG (2.1% in both groups). However, in those without diabetes, a trend approaching significance favored CABG over PCI (1.2% vs. 2.1%; HR, 0.177; 95% CI, 0.99-1.77). This difference was concentrated in the first year, when stroke rates among those treated with CABG were more than double the rates among those treated with PCI. Over time, this difference dissipated so that the difference was reduced to a trend at the end of follow-up.
 

Data considered hypothesis generating

Although patients with diabetes were prespecified as a subgroup of interest in these studies, Dr. Gaba said that the data can only be considered hypothesis generating and pointed out several limitations, including the fact that these studies preceded some therapies, such as sodium-glucose cotransporter 2 inhibitors, that are known to affect CV outcomes.

However, Dr. King was not alone in suggesting that these data once again show that diabetes matters. Several panelists agreed, including the moderator of the session, Robert A Byrne, MBBcH, PhD, director of cardiology, Mater Private Hospital, Dublin.

“Of course, there has been a lot of discussion over the last 4 or 5 years about this issue since the long-term EXCEL data were presented,” Dr. Byrne said. He added that the team of investigators who put this together “have done a great service to the community” by providing a detailed combined analysis to explore the interaction between diabetes and outcomes relative to method of revascularization. Although PCI and CABG are not always equivalent choices for reasons other than diabetes, he echoed the sentiment that diabetes likely remains a variable to consider when considering revascularization of left main artery disease.

Dr. Gabi, Dr. Spencer, and Dr. Byrne report no potential conflicts of interest.

WASHINGTON – For patients with diabetes, there are trade-offs for selecting a percutaneous intervention (PCI) over coronary artery bypass grafting (CABG) for left main artery disease when either can be considered, according to a hypothesis-generating pooled analysis.

The pooled data from four trials indicate that either method of revascularization is “reasonable,” but risk of myocardial infarction and revascularization is higher and risk of stroke is lower in patients with diabetes following PCI relative to CABG, Prakriti Gaba, MD, said in presenting the analysis at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

Ted Bosworth/MDedge News

Despite decades of advances in both PCI and CABG, the findings are remarkably similar to those of Emory Angioplasty Versus Surgery Trial (EAST), the first major study to compare PCI to CABG, which were published almost 30 years ago. In the new analysis, like in EAST, PCI and CABG were comparable for a primary composite endpoint overall, but patients with diabetes were the exception. In those, outcomes were modestly better after CABG, said Dr. Gaba, a cardiology fellow at Brigham and Women’s Hospital, Harvard Medical School, both in Boston.

“More and more I am hearing from practitioners that diabetes does not matter, but what I get from your data is that diabetes still matters,” said Spencer B. King, MD, a pioneer of PCI affiliated with Emory University, Atlanta.

Dr. King, the first author of the 1994 paper and a panelist in the late-breaking trial session where the new data were presented, pointed out that a relatively limited proportion of patients with diabetes are equally suitable for PCI and CABG because of other considerations. However, he said an updated look once again suggesting that PCI and CABG are not equivalent for left main lesions in patients with diabetes “is helpful to see.”
 

CABG traditionally preferred for left main revascularization

The issue was revisited because CABG has been preferred traditionally for left main disease, but there was increasing evidence that PCI is associated with similar survival, according to Dr. Gaba. These new data support that contention, even if it shows that outcomes are not the same in those with diabetes relative to those without.

In this pooled analysis, data were drawn from four trials. Each compared PCI with drug-eluting stents with CABG in patients that were considered suitable for either. From the four trials, the numbers in this analysis included 705 patients from SYNTAX, 600 patients from PRECOMBAT, 1,184 patients from NOBLE, and 1,905 patients from EXCEL.

The focus was on the 1,104 patients with diabetes relative to the 3,289 without. The primary endpoint was all-cause death at 5 years. The multiple secondary endpoints included cardiovascular (CV) death, MI, stroke, and revascularization.

Overall, the 5-year mortality, independent of revascularization procedure, was 14.8% for those with diabetes and 9.3% for those without (P < .001). For this endpoint, the rates were numerically lower but not statistically different for CABG whether patients had diabetes (14.1% vs. 15.3%) or no diabetes (8.9% vs. 9.7%).

However, the rate of spontaneous MI was twice as great with PCI than with CABG for those with diabetes (8.9% vs. 4.4%), which doubled the hazard ratio within significant confidence intervals (HR, 2.01; 95% CI, 1.21-3.35). The rates of revascularization were also about twice as great with PCI than with CABG (24.5% vs. 12.4%), again producing a twofold increase in risk (HR, 2.12; 95% CI, 1.56-2.87).

For stroke in patients with diabetes, there was no difference in events at 5 years for PCI relative to CABG (2.1% in both groups). However, in those without diabetes, a trend approaching significance favored CABG over PCI (1.2% vs. 2.1%; HR, 0.177; 95% CI, 0.99-1.77). This difference was concentrated in the first year, when stroke rates among those treated with CABG were more than double the rates among those treated with PCI. Over time, this difference dissipated so that the difference was reduced to a trend at the end of follow-up.
 

Data considered hypothesis generating

Although patients with diabetes were prespecified as a subgroup of interest in these studies, Dr. Gaba said that the data can only be considered hypothesis generating and pointed out several limitations, including the fact that these studies preceded some therapies, such as sodium-glucose cotransporter 2 inhibitors, that are known to affect CV outcomes.

However, Dr. King was not alone in suggesting that these data once again show that diabetes matters. Several panelists agreed, including the moderator of the session, Robert A Byrne, MBBcH, PhD, director of cardiology, Mater Private Hospital, Dublin.

“Of course, there has been a lot of discussion over the last 4 or 5 years about this issue since the long-term EXCEL data were presented,” Dr. Byrne said. He added that the team of investigators who put this together “have done a great service to the community” by providing a detailed combined analysis to explore the interaction between diabetes and outcomes relative to method of revascularization. Although PCI and CABG are not always equivalent choices for reasons other than diabetes, he echoed the sentiment that diabetes likely remains a variable to consider when considering revascularization of left main artery disease.

Dr. Gabi, Dr. Spencer, and Dr. Byrne report no potential conflicts of interest.

WASHINGTON – For patients with diabetes, there are trade-offs for selecting a percutaneous intervention (PCI) over coronary artery bypass grafting (CABG) for left main artery disease when either can be considered, according to a hypothesis-generating pooled analysis.

The pooled data from four trials indicate that either method of revascularization is “reasonable,” but risk of myocardial infarction and revascularization is higher and risk of stroke is lower in patients with diabetes following PCI relative to CABG, Prakriti Gaba, MD, said in presenting the analysis at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

Ted Bosworth/MDedge News

Despite decades of advances in both PCI and CABG, the findings are remarkably similar to those of Emory Angioplasty Versus Surgery Trial (EAST), the first major study to compare PCI to CABG, which were published almost 30 years ago. In the new analysis, like in EAST, PCI and CABG were comparable for a primary composite endpoint overall, but patients with diabetes were the exception. In those, outcomes were modestly better after CABG, said Dr. Gaba, a cardiology fellow at Brigham and Women’s Hospital, Harvard Medical School, both in Boston.

“More and more I am hearing from practitioners that diabetes does not matter, but what I get from your data is that diabetes still matters,” said Spencer B. King, MD, a pioneer of PCI affiliated with Emory University, Atlanta.

Dr. King, the first author of the 1994 paper and a panelist in the late-breaking trial session where the new data were presented, pointed out that a relatively limited proportion of patients with diabetes are equally suitable for PCI and CABG because of other considerations. However, he said an updated look once again suggesting that PCI and CABG are not equivalent for left main lesions in patients with diabetes “is helpful to see.”
 

CABG traditionally preferred for left main revascularization

The issue was revisited because CABG has been preferred traditionally for left main disease, but there was increasing evidence that PCI is associated with similar survival, according to Dr. Gaba. These new data support that contention, even if it shows that outcomes are not the same in those with diabetes relative to those without.

In this pooled analysis, data were drawn from four trials. Each compared PCI with drug-eluting stents with CABG in patients that were considered suitable for either. From the four trials, the numbers in this analysis included 705 patients from SYNTAX, 600 patients from PRECOMBAT, 1,184 patients from NOBLE, and 1,905 patients from EXCEL.

The focus was on the 1,104 patients with diabetes relative to the 3,289 without. The primary endpoint was all-cause death at 5 years. The multiple secondary endpoints included cardiovascular (CV) death, MI, stroke, and revascularization.

Overall, the 5-year mortality, independent of revascularization procedure, was 14.8% for those with diabetes and 9.3% for those without (P < .001). For this endpoint, the rates were numerically lower but not statistically different for CABG whether patients had diabetes (14.1% vs. 15.3%) or no diabetes (8.9% vs. 9.7%).

However, the rate of spontaneous MI was twice as great with PCI than with CABG for those with diabetes (8.9% vs. 4.4%), which doubled the hazard ratio within significant confidence intervals (HR, 2.01; 95% CI, 1.21-3.35). The rates of revascularization were also about twice as great with PCI than with CABG (24.5% vs. 12.4%), again producing a twofold increase in risk (HR, 2.12; 95% CI, 1.56-2.87).

For stroke in patients with diabetes, there was no difference in events at 5 years for PCI relative to CABG (2.1% in both groups). However, in those without diabetes, a trend approaching significance favored CABG over PCI (1.2% vs. 2.1%; HR, 0.177; 95% CI, 0.99-1.77). This difference was concentrated in the first year, when stroke rates among those treated with CABG were more than double the rates among those treated with PCI. Over time, this difference dissipated so that the difference was reduced to a trend at the end of follow-up.
 

Data considered hypothesis generating

Although patients with diabetes were prespecified as a subgroup of interest in these studies, Dr. Gaba said that the data can only be considered hypothesis generating and pointed out several limitations, including the fact that these studies preceded some therapies, such as sodium-glucose cotransporter 2 inhibitors, that are known to affect CV outcomes.

However, Dr. King was not alone in suggesting that these data once again show that diabetes matters. Several panelists agreed, including the moderator of the session, Robert A Byrne, MBBcH, PhD, director of cardiology, Mater Private Hospital, Dublin.

“Of course, there has been a lot of discussion over the last 4 or 5 years about this issue since the long-term EXCEL data were presented,” Dr. Byrne said. He added that the team of investigators who put this together “have done a great service to the community” by providing a detailed combined analysis to explore the interaction between diabetes and outcomes relative to method of revascularization. Although PCI and CABG are not always equivalent choices for reasons other than diabetes, he echoed the sentiment that diabetes likely remains a variable to consider when considering revascularization of left main artery disease.

Dr. Gabi, Dr. Spencer, and Dr. Byrne report no potential conflicts of interest.

WASHINGTON – Late lumen loss (LLL) after percutaneous interventions (PCI) can be reduced significantly by a daily glass of beet juice, according to a phase 2 randomized trial.

The protection against LLL, attributed to the nitrate contained in beet juice, was accompanied by a trend for a reduced risk of major adverse cardiovascular events (MACE), according to Krishnaraj Rathod, MBBS, BMedSci, PhD, who presented results at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

The study grew out of relatively recent evidence that ingestion of nitrate-rich foods, such as beets, can trigger noncanonical pathways for nitric oxide generation, sometimes referred to as the nitrate-nitrite-nitric oxide sequence. Dr. Rathod cited experimental evidence associating this pathway with the traditional benefits of NO generation, such as anti-inflammatory and antithrombotic effects.

Ted Bosworth/MDedge News

In this study, 300 patients scheduled for PCI to treat stable angina were randomized to the experimental arm of nitrate-rich beetroot juice or the control arm of nitrate-depleted beetroot juice. Each had a 70-mL glass of juice once daily. Dr. Rathod, a senior interventional cardiology registrar, Barts Heart Centre, London, described this as the equivalent of about four beets.

The primary endpoint of the study was in-stent LLL assessed by quantitative coronary angiography (QCA) at 6 months.

MACE, defined as death, MI, need for revascularization, and in-stent thrombosis, was assessed at 3, 9, 12, and 24 months. In addition, markers of NO activation, platelet reactivity, and inflammation were monitored.

Lumen loss reduced less than 50%

On OCA, the median stent LLL at 6 months was 0.244 mm in the nitrate-depleted beet juice group and 0.117 mm (P = .0165) in the group that received natural beet juice. The mean segment LLL similarly favored the natural beet juice (0.269 vs. 0.050 mm; P = .0011).

The same effect was reflected in the measurement of mean change in minimum lumen diameter at 6 months. From baseline, this in-stent measure was reduced at 6 months by 0.244 mm in the control group, but by only 0.117 mm in the group receiving the dietary nitrate (P = .0154 for two-way analysis of variance).

Over 24 months of follow-up, there were 18 MACE events in the control arm versus 9 in the arm randomized to dietary nitrate (P = .0718). There were no in-stent thromboses observed in either group, but death (two vs. five), MI (one vs. six), and target-vessel revascularization (six vs. seven) were all numerically lower in the group receiving dietary nitrate.

“Once-a-day oral dietary nitrate for 6 months was well tolerated and safe,” Dr. Rathod reported at the meeting.

Asked specifically about the taste of the daily glass of beet juice, Dr. Rathod acknowledged that some patients were not enamored, but many had no objections or even liked the taste.

The patients were reasonably representative of a PCI population. The mean age in both groups was 61 years. There were no significant differences in body mass index (approximately 29 kg/m²) or proportion with diabetes (22%), hypertension, or hypercholesterolemia (about 70% in both groups) and other comorbidities.

More PCI was performed in the left anterior descending artery (36.7% vs. 44.0%) in the control group, while less PCI was performed in the right coronary (27.3% vs. 30.7%). Neither difference was significant. The vast majority (~90%) of patients received drug-eluting stents with a mean of 1.4 implanted. Procedural success was 100% in both groups.

Discharge medications, including antiplatelet and antithrombotic therapies, were similar in the two groups.

Results characterized as highly positive

Based on the 53% reduction in LLL at 6 months and the trend for a MACE reduction, Dr. Rathod concluded that the results were highly positive.

“These results suggest that dietary nitrate may have a therapeutic role in reducing restenosis following PCI for stable angina,” he said.

In the discussion, several panelists pointed out that nearly one-third of patients were not available for evaluation at 6 months (41 of 150 in the experimental group and 51 of 150 in the control group) with further attrition at 1 and 2 years of follow-up. Of these about half were lost to follow-up and the other half withdrew.

The lack of follow-up on such a high proportion of participants is one weakness of this study,” acknowledged Hector M. Garcia-Garcia, MD, PhD, a cardiovascular researcher at MedStar Washington Hospital Center. However, he remains enthusiastic about the premise.

“It was encouraging to see every signal moving in the right direction,” said Dr. Garcia, who consulted with Dr. Rathod’s group on the design of the study. He called these data “promising,” and said they provide support for larger trial for a treatment with potential benefits at low cost.

George Dangas, MD, PhD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York, was among panelists who seemed surprised by such positive findings from a simple but novel concept. However, he remains open to further evaluations.

“As with any surprising result, further confirmation in a large and multicenter trial should be anticipated,” he said in an interview. If, as this study suggests, dietary changes are capable of providing therapeutic NO at the vascular level, he suggested studies to demonstrate anti-inflammatory effects or other mechanistic benefits would be helpful.

“Other sources of oral nitrate would also be a worthwhile investigation,” he said.

Dr. Rathod reports no potential conflicts of interest. Dr. Garcia-Garcia reports ties to Abbott, Biotronik, Boston Scientific, CorFlow, Medtronic, Neovasc, Phillips, and Shockwave. Dr. Dangas reports financial relationships with Abbott Vascular, AstraZeneca, Boston Scientific, Daiichi-Sankyo, and Medtronic.

WASHINGTON – Late lumen loss (LLL) after percutaneous interventions (PCI) can be reduced significantly by a daily glass of beet juice, according to a phase 2 randomized trial.

The protection against LLL, attributed to the nitrate contained in beet juice, was accompanied by a trend for a reduced risk of major adverse cardiovascular events (MACE), according to Krishnaraj Rathod, MBBS, BMedSci, PhD, who presented results at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

The study grew out of relatively recent evidence that ingestion of nitrate-rich foods, such as beets, can trigger noncanonical pathways for nitric oxide generation, sometimes referred to as the nitrate-nitrite-nitric oxide sequence. Dr. Rathod cited experimental evidence associating this pathway with the traditional benefits of NO generation, such as anti-inflammatory and antithrombotic effects.

Ted Bosworth/MDedge News

In this study, 300 patients scheduled for PCI to treat stable angina were randomized to the experimental arm of nitrate-rich beetroot juice or the control arm of nitrate-depleted beetroot juice. Each had a 70-mL glass of juice once daily. Dr. Rathod, a senior interventional cardiology registrar, Barts Heart Centre, London, described this as the equivalent of about four beets.

The primary endpoint of the study was in-stent LLL assessed by quantitative coronary angiography (QCA) at 6 months.

MACE, defined as death, MI, need for revascularization, and in-stent thrombosis, was assessed at 3, 9, 12, and 24 months. In addition, markers of NO activation, platelet reactivity, and inflammation were monitored.

Lumen loss reduced less than 50%

On OCA, the median stent LLL at 6 months was 0.244 mm in the nitrate-depleted beet juice group and 0.117 mm (P = .0165) in the group that received natural beet juice. The mean segment LLL similarly favored the natural beet juice (0.269 vs. 0.050 mm; P = .0011).

The same effect was reflected in the measurement of mean change in minimum lumen diameter at 6 months. From baseline, this in-stent measure was reduced at 6 months by 0.244 mm in the control group, but by only 0.117 mm in the group receiving the dietary nitrate (P = .0154 for two-way analysis of variance).

Over 24 months of follow-up, there were 18 MACE events in the control arm versus 9 in the arm randomized to dietary nitrate (P = .0718). There were no in-stent thromboses observed in either group, but death (two vs. five), MI (one vs. six), and target-vessel revascularization (six vs. seven) were all numerically lower in the group receiving dietary nitrate.

“Once-a-day oral dietary nitrate for 6 months was well tolerated and safe,” Dr. Rathod reported at the meeting.

Asked specifically about the taste of the daily glass of beet juice, Dr. Rathod acknowledged that some patients were not enamored, but many had no objections or even liked the taste.

The patients were reasonably representative of a PCI population. The mean age in both groups was 61 years. There were no significant differences in body mass index (approximately 29 kg/m²) or proportion with diabetes (22%), hypertension, or hypercholesterolemia (about 70% in both groups) and other comorbidities.

More PCI was performed in the left anterior descending artery (36.7% vs. 44.0%) in the control group, while less PCI was performed in the right coronary (27.3% vs. 30.7%). Neither difference was significant. The vast majority (~90%) of patients received drug-eluting stents with a mean of 1.4 implanted. Procedural success was 100% in both groups.

Discharge medications, including antiplatelet and antithrombotic therapies, were similar in the two groups.

Results characterized as highly positive

Based on the 53% reduction in LLL at 6 months and the trend for a MACE reduction, Dr. Rathod concluded that the results were highly positive.

“These results suggest that dietary nitrate may have a therapeutic role in reducing restenosis following PCI for stable angina,” he said.

In the discussion, several panelists pointed out that nearly one-third of patients were not available for evaluation at 6 months (41 of 150 in the experimental group and 51 of 150 in the control group) with further attrition at 1 and 2 years of follow-up. Of these about half were lost to follow-up and the other half withdrew.

The lack of follow-up on such a high proportion of participants is one weakness of this study,” acknowledged Hector M. Garcia-Garcia, MD, PhD, a cardiovascular researcher at MedStar Washington Hospital Center. However, he remains enthusiastic about the premise.

“It was encouraging to see every signal moving in the right direction,” said Dr. Garcia, who consulted with Dr. Rathod’s group on the design of the study. He called these data “promising,” and said they provide support for larger trial for a treatment with potential benefits at low cost.

George Dangas, MD, PhD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York, was among panelists who seemed surprised by such positive findings from a simple but novel concept. However, he remains open to further evaluations.

“As with any surprising result, further confirmation in a large and multicenter trial should be anticipated,” he said in an interview. If, as this study suggests, dietary changes are capable of providing therapeutic NO at the vascular level, he suggested studies to demonstrate anti-inflammatory effects or other mechanistic benefits would be helpful.

“Other sources of oral nitrate would also be a worthwhile investigation,” he said.

Dr. Rathod reports no potential conflicts of interest. Dr. Garcia-Garcia reports ties to Abbott, Biotronik, Boston Scientific, CorFlow, Medtronic, Neovasc, Phillips, and Shockwave. Dr. Dangas reports financial relationships with Abbott Vascular, AstraZeneca, Boston Scientific, Daiichi-Sankyo, and Medtronic.

WASHINGTON – Late lumen loss (LLL) after percutaneous interventions (PCI) can be reduced significantly by a daily glass of beet juice, according to a phase 2 randomized trial.

The protection against LLL, attributed to the nitrate contained in beet juice, was accompanied by a trend for a reduced risk of major adverse cardiovascular events (MACE), according to Krishnaraj Rathod, MBBS, BMedSci, PhD, who presented results at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

The study grew out of relatively recent evidence that ingestion of nitrate-rich foods, such as beets, can trigger noncanonical pathways for nitric oxide generation, sometimes referred to as the nitrate-nitrite-nitric oxide sequence. Dr. Rathod cited experimental evidence associating this pathway with the traditional benefits of NO generation, such as anti-inflammatory and antithrombotic effects.

Ted Bosworth/MDedge News

In this study, 300 patients scheduled for PCI to treat stable angina were randomized to the experimental arm of nitrate-rich beetroot juice or the control arm of nitrate-depleted beetroot juice. Each had a 70-mL glass of juice once daily. Dr. Rathod, a senior interventional cardiology registrar, Barts Heart Centre, London, described this as the equivalent of about four beets.

The primary endpoint of the study was in-stent LLL assessed by quantitative coronary angiography (QCA) at 6 months.

MACE, defined as death, MI, need for revascularization, and in-stent thrombosis, was assessed at 3, 9, 12, and 24 months. In addition, markers of NO activation, platelet reactivity, and inflammation were monitored.

Lumen loss reduced less than 50%

On OCA, the median stent LLL at 6 months was 0.244 mm in the nitrate-depleted beet juice group and 0.117 mm (P = .0165) in the group that received natural beet juice. The mean segment LLL similarly favored the natural beet juice (0.269 vs. 0.050 mm; P = .0011).

The same effect was reflected in the measurement of mean change in minimum lumen diameter at 6 months. From baseline, this in-stent measure was reduced at 6 months by 0.244 mm in the control group, but by only 0.117 mm in the group receiving the dietary nitrate (P = .0154 for two-way analysis of variance).

Over 24 months of follow-up, there were 18 MACE events in the control arm versus 9 in the arm randomized to dietary nitrate (P = .0718). There were no in-stent thromboses observed in either group, but death (two vs. five), MI (one vs. six), and target-vessel revascularization (six vs. seven) were all numerically lower in the group receiving dietary nitrate.

“Once-a-day oral dietary nitrate for 6 months was well tolerated and safe,” Dr. Rathod reported at the meeting.

Asked specifically about the taste of the daily glass of beet juice, Dr. Rathod acknowledged that some patients were not enamored, but many had no objections or even liked the taste.

The patients were reasonably representative of a PCI population. The mean age in both groups was 61 years. There were no significant differences in body mass index (approximately 29 kg/m²) or proportion with diabetes (22%), hypertension, or hypercholesterolemia (about 70% in both groups) and other comorbidities.

More PCI was performed in the left anterior descending artery (36.7% vs. 44.0%) in the control group, while less PCI was performed in the right coronary (27.3% vs. 30.7%). Neither difference was significant. The vast majority (~90%) of patients received drug-eluting stents with a mean of 1.4 implanted. Procedural success was 100% in both groups.

Discharge medications, including antiplatelet and antithrombotic therapies, were similar in the two groups.

Results characterized as highly positive

Based on the 53% reduction in LLL at 6 months and the trend for a MACE reduction, Dr. Rathod concluded that the results were highly positive.

“These results suggest that dietary nitrate may have a therapeutic role in reducing restenosis following PCI for stable angina,” he said.

In the discussion, several panelists pointed out that nearly one-third of patients were not available for evaluation at 6 months (41 of 150 in the experimental group and 51 of 150 in the control group) with further attrition at 1 and 2 years of follow-up. Of these about half were lost to follow-up and the other half withdrew.

The lack of follow-up on such a high proportion of participants is one weakness of this study,” acknowledged Hector M. Garcia-Garcia, MD, PhD, a cardiovascular researcher at MedStar Washington Hospital Center. However, he remains enthusiastic about the premise.

“It was encouraging to see every signal moving in the right direction,” said Dr. Garcia, who consulted with Dr. Rathod’s group on the design of the study. He called these data “promising,” and said they provide support for larger trial for a treatment with potential benefits at low cost.

George Dangas, MD, PhD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York, was among panelists who seemed surprised by such positive findings from a simple but novel concept. However, he remains open to further evaluations.

“As with any surprising result, further confirmation in a large and multicenter trial should be anticipated,” he said in an interview. If, as this study suggests, dietary changes are capable of providing therapeutic NO at the vascular level, he suggested studies to demonstrate anti-inflammatory effects or other mechanistic benefits would be helpful.

“Other sources of oral nitrate would also be a worthwhile investigation,” he said.

Dr. Rathod reports no potential conflicts of interest. Dr. Garcia-Garcia reports ties to Abbott, Biotronik, Boston Scientific, CorFlow, Medtronic, Neovasc, Phillips, and Shockwave. Dr. Dangas reports financial relationships with Abbott Vascular, AstraZeneca, Boston Scientific, Daiichi-Sankyo, and Medtronic.