MOMENTUM 3 HeartMate 3 LVAD ‘practice changing’

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The HeartMate 3 magnetically levitated left ventricular assist (LVAD) device provided far superior outcomes, compared with the widely used HeartMate II axial-flow pump at 2 years of follow-up in patients with advanced heart failure in the large multicenter MOMENTUM 3 trial, Mandeep R. Mehra, MD, reported at the annual meeting of the American College of Cardiology.

Dr. Mandeep R. Mehra
Bruce Jancin/Frontline Medical News
Dr. Mandeep R. Mehra

HeartMate 3 recipients had a 90% lower risk of undergoing reoperation to replace or remove their device because of malfunction, and a stroke rate half that in the HeartMate II group.

“This was the lowest rate of stroke ever seen in any LVAD trial,” according to Dr. Mehra, medical director of the Brigham and Women’s Hospital Heart and Vascular Center, Boston, and professor of medicine at Harvard Medical School.

“We believe this is a practice-changing result in the field, and that the real implication of our findings is to reassure those who refer or treat patients with advanced heart failure that it is perhaps going to be ignorant not to refer patients for consideration for destination therapy,” he said at a press conference highlighting the MOMENTUM 3 results, also presented in a late-breaking clinical trials session.

The HeartMate 3 is a miniaturized centrifugal-flow device that fits entirely within the chest, whereas the HeartMate II requires creation of a pocket in the abdomen. The HeartMate 3 was designed to prevent pump thrombosis – a common limiting problem with the HeartMate II and other LVADs – by employing three innovations: use of wide blood-flow passages to reduce shear stress and minimize disruption of red blood cells as they pass through the pump; reliance on magnetic levitation technology to create a frictionless pump with no mechanical bearings, which are subject to wear and tear; and incorporation of an artificial fixed pulse that speeds up and slows every 2 seconds in order to minimize blood stasis, which promotes thrombosis, the cardiologist explained in a video interview.

 

 

MOMENTUM 3 is the largest-ever randomized trial of LVAD therapy, involving 1,028 advanced heart failure patients at 69 U.S. centers. The study population is a mix of bridge-to-transplant patients and others who weren’t eligible for heart transplantation and are using their device as lifelong destination therapy. In an earlier report on the first 294 patients to reach 6 months of follow-up post implantation, Dr. Mehra and his coinvestigators showed that the HeartMate 3 group had a significantly lower incidence of the composite endpoint of disabling stroke or reoperation to replace or remove the device (N Engl J Med. 2017 Feb 2;376[5]:440-50).

At ACC 2018, he presented the prespecified 2-year analysis of results in the first 366 patients to reach that benchmark. The rate of survival free of disabling stroke or reoperation for device malfunction was 79.5% in the HeartMate 3 group and 60.2% with the HeartMate II, for a highly significant 54% reduction in the risk of bad outcome. Reoperation for device malfunction occurred in 1.6% of HeartMate 3 patients versus 17% of those with a HeartMate II, for a 92% reduction in risk. Two-year survival was 82.8% in the HeartMate 3 group and 76.2% in HeartMate II recipients.

The overall stroke rate was 10% with the HeartMate 3, compared with 19% with the older, axial-flow LVAD. The incidence of disabling stroke was 3% in the HeartMate 3 group and similar at 2% with the HeartMate II; however, nondisabling stroke occurred in only 3% of HeartMate 3 recipients, compared with 14% of patients with the HeartMate II.

“There has always been this notion that, ‘There are so many complications with this device, so let’s suffer with the disease rather than suffer with the pump.’ Now we’re showing that you don’t suffer with the pump as with the earlier-generation devices. I think this is going to open the gates for more referrals and more opportunities for destination therapy in patients who are deemed ineligible for transplant,” Dr. Mehra predicted.

Dr. James L. Januzzi Jr.
Bruce Jancin/Frontline Medical News
Dr. James L. Januzzi Jr.

Discussant James L. Janzuzzi Jr., called the MOMENTUM 3 results “a very-much-needed step forward.”

 

 

“Perhaps the most dramatic observation in this study is the dramatic reduction in thrombosis events requiring reoperation. In essence, this problem was entirely prevented by the use of this magnetically levitated centrifugal-flow device. Reoperation for thrombosis accounted for two-thirds of the reoperations in the HeartMate II group and the rate was zero in the HeartMate 3 population. Essentially, with this technology we’ve addressed a very important unmet need by reducing the onset of pump thrombosis, which is the precursor to either pump dysfunction or embolic stroke,” commented Dr. Januzzi, professor of medicine at Harvard Medical School, Boston.

Given the 83% survival rate at 2 years in the HeartMate 3 group in the MOMENTUM 3 trial, the on-average 50% survival at 10 years for heart transplant recipients, and the perpetual enormous shortage of donor organs, it’s time to consider a randomized trial of an advanced LVAD such as the HeartMate 3 versus heart transplantation, with quality-of-life outcomes front and center, he asserted.

Dr. Mehra was all for the idea. He noted that within the community of physicians and surgeons who provide care for advanced heart failure patients there is a growing move to replace problematic axial-flow LVADs requiring reoperation with a HeartMate 3 upgrade.

The MOMENTUM 3 trial is funded by Abbott. Dr. Mehra reported receiving research funds from and serving as a consultant to the company.

Simultaneous with his presentation at ACC 2018, the 2-year results of MOMENTUM 3 were published online at NEJM.org (doi: 10.1056/NEJMoa1800866).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

 

 

 

SOURCE: Mehra M et al. ACC 18.

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Dr. Hossein Almassi, FCCP
G. Hossein Almassi, MD, FCCP, comments: The reported 2- year follow-up results of MOMENTUM 3 trial on the new generation HeatMate-III magnetically levitated LVAD gives more hope to patients with end-stage heart failure for a better quality of life and longer survival and opens new doors for potentially becoming an alternative to cardiac transplantation for patients with a long waiting time on the transplant list.

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Dr. Hossein Almassi, FCCP
G. Hossein Almassi, MD, FCCP, comments: The reported 2- year follow-up results of MOMENTUM 3 trial on the new generation HeatMate-III magnetically levitated LVAD gives more hope to patients with end-stage heart failure for a better quality of life and longer survival and opens new doors for potentially becoming an alternative to cardiac transplantation for patients with a long waiting time on the transplant list.

Body

Dr. Hossein Almassi, FCCP
G. Hossein Almassi, MD, FCCP, comments: The reported 2- year follow-up results of MOMENTUM 3 trial on the new generation HeatMate-III magnetically levitated LVAD gives more hope to patients with end-stage heart failure for a better quality of life and longer survival and opens new doors for potentially becoming an alternative to cardiac transplantation for patients with a long waiting time on the transplant list.

 

The HeartMate 3 magnetically levitated left ventricular assist (LVAD) device provided far superior outcomes, compared with the widely used HeartMate II axial-flow pump at 2 years of follow-up in patients with advanced heart failure in the large multicenter MOMENTUM 3 trial, Mandeep R. Mehra, MD, reported at the annual meeting of the American College of Cardiology.

Dr. Mandeep R. Mehra
Bruce Jancin/Frontline Medical News
Dr. Mandeep R. Mehra

HeartMate 3 recipients had a 90% lower risk of undergoing reoperation to replace or remove their device because of malfunction, and a stroke rate half that in the HeartMate II group.

“This was the lowest rate of stroke ever seen in any LVAD trial,” according to Dr. Mehra, medical director of the Brigham and Women’s Hospital Heart and Vascular Center, Boston, and professor of medicine at Harvard Medical School.

“We believe this is a practice-changing result in the field, and that the real implication of our findings is to reassure those who refer or treat patients with advanced heart failure that it is perhaps going to be ignorant not to refer patients for consideration for destination therapy,” he said at a press conference highlighting the MOMENTUM 3 results, also presented in a late-breaking clinical trials session.

The HeartMate 3 is a miniaturized centrifugal-flow device that fits entirely within the chest, whereas the HeartMate II requires creation of a pocket in the abdomen. The HeartMate 3 was designed to prevent pump thrombosis – a common limiting problem with the HeartMate II and other LVADs – by employing three innovations: use of wide blood-flow passages to reduce shear stress and minimize disruption of red blood cells as they pass through the pump; reliance on magnetic levitation technology to create a frictionless pump with no mechanical bearings, which are subject to wear and tear; and incorporation of an artificial fixed pulse that speeds up and slows every 2 seconds in order to minimize blood stasis, which promotes thrombosis, the cardiologist explained in a video interview.

 

 

MOMENTUM 3 is the largest-ever randomized trial of LVAD therapy, involving 1,028 advanced heart failure patients at 69 U.S. centers. The study population is a mix of bridge-to-transplant patients and others who weren’t eligible for heart transplantation and are using their device as lifelong destination therapy. In an earlier report on the first 294 patients to reach 6 months of follow-up post implantation, Dr. Mehra and his coinvestigators showed that the HeartMate 3 group had a significantly lower incidence of the composite endpoint of disabling stroke or reoperation to replace or remove the device (N Engl J Med. 2017 Feb 2;376[5]:440-50).

At ACC 2018, he presented the prespecified 2-year analysis of results in the first 366 patients to reach that benchmark. The rate of survival free of disabling stroke or reoperation for device malfunction was 79.5% in the HeartMate 3 group and 60.2% with the HeartMate II, for a highly significant 54% reduction in the risk of bad outcome. Reoperation for device malfunction occurred in 1.6% of HeartMate 3 patients versus 17% of those with a HeartMate II, for a 92% reduction in risk. Two-year survival was 82.8% in the HeartMate 3 group and 76.2% in HeartMate II recipients.

The overall stroke rate was 10% with the HeartMate 3, compared with 19% with the older, axial-flow LVAD. The incidence of disabling stroke was 3% in the HeartMate 3 group and similar at 2% with the HeartMate II; however, nondisabling stroke occurred in only 3% of HeartMate 3 recipients, compared with 14% of patients with the HeartMate II.

“There has always been this notion that, ‘There are so many complications with this device, so let’s suffer with the disease rather than suffer with the pump.’ Now we’re showing that you don’t suffer with the pump as with the earlier-generation devices. I think this is going to open the gates for more referrals and more opportunities for destination therapy in patients who are deemed ineligible for transplant,” Dr. Mehra predicted.

Dr. James L. Januzzi Jr.
Bruce Jancin/Frontline Medical News
Dr. James L. Januzzi Jr.

Discussant James L. Janzuzzi Jr., called the MOMENTUM 3 results “a very-much-needed step forward.”

 

 

“Perhaps the most dramatic observation in this study is the dramatic reduction in thrombosis events requiring reoperation. In essence, this problem was entirely prevented by the use of this magnetically levitated centrifugal-flow device. Reoperation for thrombosis accounted for two-thirds of the reoperations in the HeartMate II group and the rate was zero in the HeartMate 3 population. Essentially, with this technology we’ve addressed a very important unmet need by reducing the onset of pump thrombosis, which is the precursor to either pump dysfunction or embolic stroke,” commented Dr. Januzzi, professor of medicine at Harvard Medical School, Boston.

Given the 83% survival rate at 2 years in the HeartMate 3 group in the MOMENTUM 3 trial, the on-average 50% survival at 10 years for heart transplant recipients, and the perpetual enormous shortage of donor organs, it’s time to consider a randomized trial of an advanced LVAD such as the HeartMate 3 versus heart transplantation, with quality-of-life outcomes front and center, he asserted.

Dr. Mehra was all for the idea. He noted that within the community of physicians and surgeons who provide care for advanced heart failure patients there is a growing move to replace problematic axial-flow LVADs requiring reoperation with a HeartMate 3 upgrade.

The MOMENTUM 3 trial is funded by Abbott. Dr. Mehra reported receiving research funds from and serving as a consultant to the company.

Simultaneous with his presentation at ACC 2018, the 2-year results of MOMENTUM 3 were published online at NEJM.org (doi: 10.1056/NEJMoa1800866).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

 

 

 

SOURCE: Mehra M et al. ACC 18.

 

The HeartMate 3 magnetically levitated left ventricular assist (LVAD) device provided far superior outcomes, compared with the widely used HeartMate II axial-flow pump at 2 years of follow-up in patients with advanced heart failure in the large multicenter MOMENTUM 3 trial, Mandeep R. Mehra, MD, reported at the annual meeting of the American College of Cardiology.

Dr. Mandeep R. Mehra
Bruce Jancin/Frontline Medical News
Dr. Mandeep R. Mehra

HeartMate 3 recipients had a 90% lower risk of undergoing reoperation to replace or remove their device because of malfunction, and a stroke rate half that in the HeartMate II group.

“This was the lowest rate of stroke ever seen in any LVAD trial,” according to Dr. Mehra, medical director of the Brigham and Women’s Hospital Heart and Vascular Center, Boston, and professor of medicine at Harvard Medical School.

“We believe this is a practice-changing result in the field, and that the real implication of our findings is to reassure those who refer or treat patients with advanced heart failure that it is perhaps going to be ignorant not to refer patients for consideration for destination therapy,” he said at a press conference highlighting the MOMENTUM 3 results, also presented in a late-breaking clinical trials session.

The HeartMate 3 is a miniaturized centrifugal-flow device that fits entirely within the chest, whereas the HeartMate II requires creation of a pocket in the abdomen. The HeartMate 3 was designed to prevent pump thrombosis – a common limiting problem with the HeartMate II and other LVADs – by employing three innovations: use of wide blood-flow passages to reduce shear stress and minimize disruption of red blood cells as they pass through the pump; reliance on magnetic levitation technology to create a frictionless pump with no mechanical bearings, which are subject to wear and tear; and incorporation of an artificial fixed pulse that speeds up and slows every 2 seconds in order to minimize blood stasis, which promotes thrombosis, the cardiologist explained in a video interview.

 

 

MOMENTUM 3 is the largest-ever randomized trial of LVAD therapy, involving 1,028 advanced heart failure patients at 69 U.S. centers. The study population is a mix of bridge-to-transplant patients and others who weren’t eligible for heart transplantation and are using their device as lifelong destination therapy. In an earlier report on the first 294 patients to reach 6 months of follow-up post implantation, Dr. Mehra and his coinvestigators showed that the HeartMate 3 group had a significantly lower incidence of the composite endpoint of disabling stroke or reoperation to replace or remove the device (N Engl J Med. 2017 Feb 2;376[5]:440-50).

At ACC 2018, he presented the prespecified 2-year analysis of results in the first 366 patients to reach that benchmark. The rate of survival free of disabling stroke or reoperation for device malfunction was 79.5% in the HeartMate 3 group and 60.2% with the HeartMate II, for a highly significant 54% reduction in the risk of bad outcome. Reoperation for device malfunction occurred in 1.6% of HeartMate 3 patients versus 17% of those with a HeartMate II, for a 92% reduction in risk. Two-year survival was 82.8% in the HeartMate 3 group and 76.2% in HeartMate II recipients.

The overall stroke rate was 10% with the HeartMate 3, compared with 19% with the older, axial-flow LVAD. The incidence of disabling stroke was 3% in the HeartMate 3 group and similar at 2% with the HeartMate II; however, nondisabling stroke occurred in only 3% of HeartMate 3 recipients, compared with 14% of patients with the HeartMate II.

“There has always been this notion that, ‘There are so many complications with this device, so let’s suffer with the disease rather than suffer with the pump.’ Now we’re showing that you don’t suffer with the pump as with the earlier-generation devices. I think this is going to open the gates for more referrals and more opportunities for destination therapy in patients who are deemed ineligible for transplant,” Dr. Mehra predicted.

Dr. James L. Januzzi Jr.
Bruce Jancin/Frontline Medical News
Dr. James L. Januzzi Jr.

Discussant James L. Janzuzzi Jr., called the MOMENTUM 3 results “a very-much-needed step forward.”

 

 

“Perhaps the most dramatic observation in this study is the dramatic reduction in thrombosis events requiring reoperation. In essence, this problem was entirely prevented by the use of this magnetically levitated centrifugal-flow device. Reoperation for thrombosis accounted for two-thirds of the reoperations in the HeartMate II group and the rate was zero in the HeartMate 3 population. Essentially, with this technology we’ve addressed a very important unmet need by reducing the onset of pump thrombosis, which is the precursor to either pump dysfunction or embolic stroke,” commented Dr. Januzzi, professor of medicine at Harvard Medical School, Boston.

Given the 83% survival rate at 2 years in the HeartMate 3 group in the MOMENTUM 3 trial, the on-average 50% survival at 10 years for heart transplant recipients, and the perpetual enormous shortage of donor organs, it’s time to consider a randomized trial of an advanced LVAD such as the HeartMate 3 versus heart transplantation, with quality-of-life outcomes front and center, he asserted.

Dr. Mehra was all for the idea. He noted that within the community of physicians and surgeons who provide care for advanced heart failure patients there is a growing move to replace problematic axial-flow LVADs requiring reoperation with a HeartMate 3 upgrade.

The MOMENTUM 3 trial is funded by Abbott. Dr. Mehra reported receiving research funds from and serving as a consultant to the company.

Simultaneous with his presentation at ACC 2018, the 2-year results of MOMENTUM 3 were published online at NEJM.org (doi: 10.1056/NEJMoa1800866).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

 

 

 

SOURCE: Mehra M et al. ACC 18.

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Key clinical point: Landmark trial paves way to much wider use of LVADs as destination therapy.

Major finding: The 2-year rate of survival free of disabling stroke or reoperation to replace or remove a malfunctioning LVAD was 79.5% with the novel HeartMate 3 LVAD, compared with 60.2% with the commonly used HeartMate II axial-flow device.

Study details: This was a randomized, unblinded, multicenter study of more than 1,000 patients with advanced heart failure.

Disclosures: The MOMENTUM 3 trial was funded by Abbott. The presenter reported receiving research grants from and serving as a consultant to the company.

Source: Mehra MR et al. ACC 18.

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CECCY: Carvedilol didn’t curb cardiotoxicity in breast cancer patients

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– Anthracycline chemotherapy was associated with a cardiotoxicity incidence of roughly 14% of breast cancer patients regardless of treatment with carvedilol, based on data from a randomized trial of 200 patients.

“Cardio-oncology has been neglected,” Monica Samuel Avila, MD, of Hospital das Clínicas da Faculdade de Medicina da Universidade in São Paulo, Brazil, said in a video interview at the annual meeting of the American College of Cardiology. “We have seen improvement of survival in patients with cancer, but with that comes complications related to treatment. I think that the interactions between cardiologists and oncologists are increasing in a more important way,” she said.

In the Carvedilol for Prevention of Chemotherapy-Induced Cardiotoxicity (CECCY) Trial, Dr. Avila and colleagues evaluated primary prevention of cardiotoxicity in women with normal hearts who were undergoing chemotherapy for breast cancer.

 

 


Patients in the treatment group received a median carvedilol dose of 18.4 mg/day. The primary endpoint of cardiotoxicity, defined as a decrease in left ventricular ejection fraction (LVEF) of at least 10% at 6 months, occurred in 15% of carvedilol patients and 14% placebo patients, a nonsignificant difference. No significant differences occurred in diastolic dysfunction or in B-type natriuretic peptide (BNP) levels at 6 weeks, 12 weeks, or 24 weeks between the groups.

However, carvedilol patients showed significantly reduced troponin 1 levels compared with placebo, which suggests protection against myocardial injury, Dr. Avila said.


“In short follow up, we can see cardiotoxicity appearing, and we know we have to treat it promptly to prevent cardiac events,” she said.

Dr. Avila and colleagues identified 200 women older than 18 years with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction. The patients were undergoing chemotherapy with 240 mg/m2 of anthracycline and were randomized to treatment with carvedilol or a placebo. Baseline characteristics were similar between the two groups.
 

 


Adverse effects were not significantly different between the groups, and the most common events in each group included dizziness, dry mouth, symptomatic hypertension, stomachache, and nausea. Although the results suggest that carvedilol can reduce the risk of myocardial injury, more research is needed to address the question of the increase in troponin without change in the LVEF, Dr. Avila noted. The study is ongoing and the research team intends to follow the low-risk patient population for a total of 2 years. “For high-risk patients, I am already giving carvedilol,” she said. “We believe if we find a difference in LVEF or clinical events, we could encourage cardiologists to give carvedilol in a low-risk population,” she said.

“This study highlights that there is no safe dose of anthracycline,” commented Bonnie Ky, MD of the University of Pennsylvania, Philadelphia, at a press briefing. She emphasized the value of carvedilol for a high-risk population, and stressed the importance of following long-term changes in heart injury markers after 1-2 years for low-risk patients.

Dr. Avila had no financial conflicts to disclose. Dr. Ky disclosed relationships with multiple companies including Bioinvent and Bristol Myers.

The findings were published simultaneously in the Journal of the American College of Cardiology.
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– Anthracycline chemotherapy was associated with a cardiotoxicity incidence of roughly 14% of breast cancer patients regardless of treatment with carvedilol, based on data from a randomized trial of 200 patients.

“Cardio-oncology has been neglected,” Monica Samuel Avila, MD, of Hospital das Clínicas da Faculdade de Medicina da Universidade in São Paulo, Brazil, said in a video interview at the annual meeting of the American College of Cardiology. “We have seen improvement of survival in patients with cancer, but with that comes complications related to treatment. I think that the interactions between cardiologists and oncologists are increasing in a more important way,” she said.

In the Carvedilol for Prevention of Chemotherapy-Induced Cardiotoxicity (CECCY) Trial, Dr. Avila and colleagues evaluated primary prevention of cardiotoxicity in women with normal hearts who were undergoing chemotherapy for breast cancer.

 

 


Patients in the treatment group received a median carvedilol dose of 18.4 mg/day. The primary endpoint of cardiotoxicity, defined as a decrease in left ventricular ejection fraction (LVEF) of at least 10% at 6 months, occurred in 15% of carvedilol patients and 14% placebo patients, a nonsignificant difference. No significant differences occurred in diastolic dysfunction or in B-type natriuretic peptide (BNP) levels at 6 weeks, 12 weeks, or 24 weeks between the groups.

However, carvedilol patients showed significantly reduced troponin 1 levels compared with placebo, which suggests protection against myocardial injury, Dr. Avila said.


“In short follow up, we can see cardiotoxicity appearing, and we know we have to treat it promptly to prevent cardiac events,” she said.

Dr. Avila and colleagues identified 200 women older than 18 years with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction. The patients were undergoing chemotherapy with 240 mg/m2 of anthracycline and were randomized to treatment with carvedilol or a placebo. Baseline characteristics were similar between the two groups.
 

 


Adverse effects were not significantly different between the groups, and the most common events in each group included dizziness, dry mouth, symptomatic hypertension, stomachache, and nausea. Although the results suggest that carvedilol can reduce the risk of myocardial injury, more research is needed to address the question of the increase in troponin without change in the LVEF, Dr. Avila noted. The study is ongoing and the research team intends to follow the low-risk patient population for a total of 2 years. “For high-risk patients, I am already giving carvedilol,” she said. “We believe if we find a difference in LVEF or clinical events, we could encourage cardiologists to give carvedilol in a low-risk population,” she said.

“This study highlights that there is no safe dose of anthracycline,” commented Bonnie Ky, MD of the University of Pennsylvania, Philadelphia, at a press briefing. She emphasized the value of carvedilol for a high-risk population, and stressed the importance of following long-term changes in heart injury markers after 1-2 years for low-risk patients.

Dr. Avila had no financial conflicts to disclose. Dr. Ky disclosed relationships with multiple companies including Bioinvent and Bristol Myers.

The findings were published simultaneously in the Journal of the American College of Cardiology.

– Anthracycline chemotherapy was associated with a cardiotoxicity incidence of roughly 14% of breast cancer patients regardless of treatment with carvedilol, based on data from a randomized trial of 200 patients.

“Cardio-oncology has been neglected,” Monica Samuel Avila, MD, of Hospital das Clínicas da Faculdade de Medicina da Universidade in São Paulo, Brazil, said in a video interview at the annual meeting of the American College of Cardiology. “We have seen improvement of survival in patients with cancer, but with that comes complications related to treatment. I think that the interactions between cardiologists and oncologists are increasing in a more important way,” she said.

In the Carvedilol for Prevention of Chemotherapy-Induced Cardiotoxicity (CECCY) Trial, Dr. Avila and colleagues evaluated primary prevention of cardiotoxicity in women with normal hearts who were undergoing chemotherapy for breast cancer.

 

 


Patients in the treatment group received a median carvedilol dose of 18.4 mg/day. The primary endpoint of cardiotoxicity, defined as a decrease in left ventricular ejection fraction (LVEF) of at least 10% at 6 months, occurred in 15% of carvedilol patients and 14% placebo patients, a nonsignificant difference. No significant differences occurred in diastolic dysfunction or in B-type natriuretic peptide (BNP) levels at 6 weeks, 12 weeks, or 24 weeks between the groups.

However, carvedilol patients showed significantly reduced troponin 1 levels compared with placebo, which suggests protection against myocardial injury, Dr. Avila said.


“In short follow up, we can see cardiotoxicity appearing, and we know we have to treat it promptly to prevent cardiac events,” she said.

Dr. Avila and colleagues identified 200 women older than 18 years with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction. The patients were undergoing chemotherapy with 240 mg/m2 of anthracycline and were randomized to treatment with carvedilol or a placebo. Baseline characteristics were similar between the two groups.
 

 


Adverse effects were not significantly different between the groups, and the most common events in each group included dizziness, dry mouth, symptomatic hypertension, stomachache, and nausea. Although the results suggest that carvedilol can reduce the risk of myocardial injury, more research is needed to address the question of the increase in troponin without change in the LVEF, Dr. Avila noted. The study is ongoing and the research team intends to follow the low-risk patient population for a total of 2 years. “For high-risk patients, I am already giving carvedilol,” she said. “We believe if we find a difference in LVEF or clinical events, we could encourage cardiologists to give carvedilol in a low-risk population,” she said.

“This study highlights that there is no safe dose of anthracycline,” commented Bonnie Ky, MD of the University of Pennsylvania, Philadelphia, at a press briefing. She emphasized the value of carvedilol for a high-risk population, and stressed the importance of following long-term changes in heart injury markers after 1-2 years for low-risk patients.

Dr. Avila had no financial conflicts to disclose. Dr. Ky disclosed relationships with multiple companies including Bioinvent and Bristol Myers.

The findings were published simultaneously in the Journal of the American College of Cardiology.
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Key clinical point: Carvedilol was associated with a significant improvement in troponin 1 levels compared with placebo, but had no impact on left ventricular ejection fraction.

Major finding: Cardiotoxicity was roughly 14% in breast cancer patients treated with anthracycline whether they received carvedilol or placebo.

Study details: CECCY was a randomized, placebo-controlled trial of 200 patients with HER2-negative breast cancer tumor status.

Disclosures: Dr. Avila had no financial conflicts to disclose.

Source: Avila M. ACC 2018.

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ODYSSEY Outcomes results build on FOURIER

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ORLANDOThe ODYSSEY Outcomes trial proves the point that LDL-cholesterol reduction with PCSK9 inhibitors can reduce not only cardiovascular events, but all-cause mortality, Prakash Deedwania, MD, said in an interview at the annual meeting of the American College of Cardiology.

That mortality reduction builds on the FOURIER trial results, which showed last year that evolocumab significantly reduced cardiovascular events in patients with stable atherosclerotic cardiovascular disease who were still at residual risk based on elevated LDL cholesterol levels said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno, who was not involved with ODYSSEY Outcomes.

However, one finding about mortality in ODYSSEY Outcomes was disappointing: LDL levels increase slightly over time in both the treatment and placebo groups.

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ORLANDOThe ODYSSEY Outcomes trial proves the point that LDL-cholesterol reduction with PCSK9 inhibitors can reduce not only cardiovascular events, but all-cause mortality, Prakash Deedwania, MD, said in an interview at the annual meeting of the American College of Cardiology.

That mortality reduction builds on the FOURIER trial results, which showed last year that evolocumab significantly reduced cardiovascular events in patients with stable atherosclerotic cardiovascular disease who were still at residual risk based on elevated LDL cholesterol levels said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno, who was not involved with ODYSSEY Outcomes.

However, one finding about mortality in ODYSSEY Outcomes was disappointing: LDL levels increase slightly over time in both the treatment and placebo groups.

ORLANDOThe ODYSSEY Outcomes trial proves the point that LDL-cholesterol reduction with PCSK9 inhibitors can reduce not only cardiovascular events, but all-cause mortality, Prakash Deedwania, MD, said in an interview at the annual meeting of the American College of Cardiology.

That mortality reduction builds on the FOURIER trial results, which showed last year that evolocumab significantly reduced cardiovascular events in patients with stable atherosclerotic cardiovascular disease who were still at residual risk based on elevated LDL cholesterol levels said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno, who was not involved with ODYSSEY Outcomes.

However, one finding about mortality in ODYSSEY Outcomes was disappointing: LDL levels increase slightly over time in both the treatment and placebo groups.

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VEST: Closer tailoring might boost wearable cardioverter defibrillator’s benefit

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Although the VEST study results showed that a wearable cardioverter defibrillator cut all-cause mortality in at-risk, post-MI patients, the findings failed to show a statistically significant reduction in sudden death or death from ventricular tachycardia. This suggests better targeting of the device is needed, commented Dhanunjaya Lakkireddy, MD, in a video interview at the annual meeting of the American College of Cardiology.

The Vest Prevention of Early Sudden Death Trial (VEST) randomized 2,302 patients within the first 7 days following an acute MI who also had a left ventricular ejection fraction of 35% or less to either 90 days of treatment with a wearable cardioverter defibrillator (WCD) or usual care. After a median of 84 days, the results showed no statistically significant reduction from WCD use in the primary endpoint of sudden death or death from ventricular tachyarrhythmias, but a statistically significant reduction in the secondary endpoint of all-cause death: 3.1% in the patients randomized to WCD use and 4.9% among the control patients, reported Jeffrey Olgin, MD, chief of cardiology at the University of California, San Francisco.

The results suggest that a more robust benefit might occur in post-MI, low ejection fraction patients who undergo additional selection based on having frequent premature ventricular contractions and nonsustained ventricular tachycardia, suggested Dr. Lakkireddy, professor of medicine and director of the Center for Excellence in AF and Complex Arrhythmias at the University of Kansas Medical Center in Kansas City.

VEST was sponsored by Zoll, a company that markets a WCD. Dr. Lakkireddy had no relevant disclosures.
mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

Source: Olgin J and Lakkireddy D ACC 18.

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Although the VEST study results showed that a wearable cardioverter defibrillator cut all-cause mortality in at-risk, post-MI patients, the findings failed to show a statistically significant reduction in sudden death or death from ventricular tachycardia. This suggests better targeting of the device is needed, commented Dhanunjaya Lakkireddy, MD, in a video interview at the annual meeting of the American College of Cardiology.

The Vest Prevention of Early Sudden Death Trial (VEST) randomized 2,302 patients within the first 7 days following an acute MI who also had a left ventricular ejection fraction of 35% or less to either 90 days of treatment with a wearable cardioverter defibrillator (WCD) or usual care. After a median of 84 days, the results showed no statistically significant reduction from WCD use in the primary endpoint of sudden death or death from ventricular tachyarrhythmias, but a statistically significant reduction in the secondary endpoint of all-cause death: 3.1% in the patients randomized to WCD use and 4.9% among the control patients, reported Jeffrey Olgin, MD, chief of cardiology at the University of California, San Francisco.

The results suggest that a more robust benefit might occur in post-MI, low ejection fraction patients who undergo additional selection based on having frequent premature ventricular contractions and nonsustained ventricular tachycardia, suggested Dr. Lakkireddy, professor of medicine and director of the Center for Excellence in AF and Complex Arrhythmias at the University of Kansas Medical Center in Kansas City.

VEST was sponsored by Zoll, a company that markets a WCD. Dr. Lakkireddy had no relevant disclosures.
mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

Source: Olgin J and Lakkireddy D ACC 18.

Although the VEST study results showed that a wearable cardioverter defibrillator cut all-cause mortality in at-risk, post-MI patients, the findings failed to show a statistically significant reduction in sudden death or death from ventricular tachycardia. This suggests better targeting of the device is needed, commented Dhanunjaya Lakkireddy, MD, in a video interview at the annual meeting of the American College of Cardiology.

The Vest Prevention of Early Sudden Death Trial (VEST) randomized 2,302 patients within the first 7 days following an acute MI who also had a left ventricular ejection fraction of 35% or less to either 90 days of treatment with a wearable cardioverter defibrillator (WCD) or usual care. After a median of 84 days, the results showed no statistically significant reduction from WCD use in the primary endpoint of sudden death or death from ventricular tachyarrhythmias, but a statistically significant reduction in the secondary endpoint of all-cause death: 3.1% in the patients randomized to WCD use and 4.9% among the control patients, reported Jeffrey Olgin, MD, chief of cardiology at the University of California, San Francisco.

The results suggest that a more robust benefit might occur in post-MI, low ejection fraction patients who undergo additional selection based on having frequent premature ventricular contractions and nonsustained ventricular tachycardia, suggested Dr. Lakkireddy, professor of medicine and director of the Center for Excellence in AF and Complex Arrhythmias at the University of Kansas Medical Center in Kansas City.

VEST was sponsored by Zoll, a company that markets a WCD. Dr. Lakkireddy had no relevant disclosures.
mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

Source: Olgin J and Lakkireddy D ACC 18.

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Post-ACS death lowered in ODYSSEY Outcomes

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The excellent showing of alirocumab in post–acute coronary syndrome patients in the landmark ODYSSEY Outcomes trial should set the stage for broader use of the PCSK9-inhibitor in certain high-risk patients, Gabriel Steg, MD, said in a video interview at the annual meeting of the American College of Cardiology.

The findings from the 3-year trial are threefold: First, the trial met its primary goal, significantly lower major adverse cardiovascular events and 15% lower mortality in alirocumab-treated patients compared with those on placebo; second, the effect was greater in patients who started with an LDL level above 100 mg/dL; and third, alirocumab was remarkably safe, said Dr. Steg, director of the coronary care unit of Bichat Hospital in Paris.

“We now have good reason to target a lower LDL range of at least less than 50 mg/dL, and possibly even lower, using PCSK9 inhibitors to get the benefits we’re seeing in the trial applied to broader groups of patients,” he added.

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The excellent showing of alirocumab in post–acute coronary syndrome patients in the landmark ODYSSEY Outcomes trial should set the stage for broader use of the PCSK9-inhibitor in certain high-risk patients, Gabriel Steg, MD, said in a video interview at the annual meeting of the American College of Cardiology.

The findings from the 3-year trial are threefold: First, the trial met its primary goal, significantly lower major adverse cardiovascular events and 15% lower mortality in alirocumab-treated patients compared with those on placebo; second, the effect was greater in patients who started with an LDL level above 100 mg/dL; and third, alirocumab was remarkably safe, said Dr. Steg, director of the coronary care unit of Bichat Hospital in Paris.

“We now have good reason to target a lower LDL range of at least less than 50 mg/dL, and possibly even lower, using PCSK9 inhibitors to get the benefits we’re seeing in the trial applied to broader groups of patients,” he added.

The excellent showing of alirocumab in post–acute coronary syndrome patients in the landmark ODYSSEY Outcomes trial should set the stage for broader use of the PCSK9-inhibitor in certain high-risk patients, Gabriel Steg, MD, said in a video interview at the annual meeting of the American College of Cardiology.

The findings from the 3-year trial are threefold: First, the trial met its primary goal, significantly lower major adverse cardiovascular events and 15% lower mortality in alirocumab-treated patients compared with those on placebo; second, the effect was greater in patients who started with an LDL level above 100 mg/dL; and third, alirocumab was remarkably safe, said Dr. Steg, director of the coronary care unit of Bichat Hospital in Paris.

“We now have good reason to target a lower LDL range of at least less than 50 mg/dL, and possibly even lower, using PCSK9 inhibitors to get the benefits we’re seeing in the trial applied to broader groups of patients,” he added.

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Postmenopausal women: Walk farther and faster to reduce heart failure risk

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Sat, 12/08/2018 - 14:50

 

Brisk walking for at least 40 minutes two or three times a week reduced the risk of heart failure by approximately 25% in postmenopausal women, according to data from more that 89,000 participants in the Women’s Health Initiative.

The benefits of walking are well understood, said Somwail Rasla, MD, of Saint Vincent Hospital in Worcester, Mass., but he and his colleagues focused for the first time on how the speed, frequency, and duration of walking affected health in older women who may be less likely to visit a gym or engage in a formal exercise program.

woman walking along a trail
iStock/thinkstockphotos
“The more they walk, the higher the speed, and the longer the duration, the less likely they are to have heart failure,” Dr. Rasla said in a press briefing in advance of the annual meeting of the American College of Cardiology.

The researchers followed the women, aged 50-79 years, for approximately 10 years.

 

 

SOURCE: Rasla S et al. ACC 18, Poster 1315M-03.
 

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Brisk walking for at least 40 minutes two or three times a week reduced the risk of heart failure by approximately 25% in postmenopausal women, according to data from more that 89,000 participants in the Women’s Health Initiative.

The benefits of walking are well understood, said Somwail Rasla, MD, of Saint Vincent Hospital in Worcester, Mass., but he and his colleagues focused for the first time on how the speed, frequency, and duration of walking affected health in older women who may be less likely to visit a gym or engage in a formal exercise program.

woman walking along a trail
iStock/thinkstockphotos
“The more they walk, the higher the speed, and the longer the duration, the less likely they are to have heart failure,” Dr. Rasla said in a press briefing in advance of the annual meeting of the American College of Cardiology.

The researchers followed the women, aged 50-79 years, for approximately 10 years.

 

 

SOURCE: Rasla S et al. ACC 18, Poster 1315M-03.
 

 

Brisk walking for at least 40 minutes two or three times a week reduced the risk of heart failure by approximately 25% in postmenopausal women, according to data from more that 89,000 participants in the Women’s Health Initiative.

The benefits of walking are well understood, said Somwail Rasla, MD, of Saint Vincent Hospital in Worcester, Mass., but he and his colleagues focused for the first time on how the speed, frequency, and duration of walking affected health in older women who may be less likely to visit a gym or engage in a formal exercise program.

woman walking along a trail
iStock/thinkstockphotos
“The more they walk, the higher the speed, and the longer the duration, the less likely they are to have heart failure,” Dr. Rasla said in a press briefing in advance of the annual meeting of the American College of Cardiology.

The researchers followed the women, aged 50-79 years, for approximately 10 years.

 

 

SOURCE: Rasla S et al. ACC 18, Poster 1315M-03.
 

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Key clinical point: Urge older female patients to walk briskly at least twice a week.

Major finding: Patients with a fast pace had a 38% lower risk of heart failure.

Study details: A long-term, national observational study of 89,270 women.

Disclosures: The Women’s Health Initiative is sponsored by the National Institutes of Health. The investigators reported no relevant conflicts of interest.

Source: Rasla S et al. ACC 18, Poster 1315M-03.

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Finding a groove helps patients move

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Fri, 01/18/2019 - 17:27

 

Listening to uptempo music significantly improved patients’ exercise capacity during a stress test, compared with patients who didn’t listen to music, according to data from a randomized trial of 127 patients.

Exercise stress tests are frequently recommended to evaluate patients for heart disease, but many patients don’t work hard enough to reach a useful level of exertion, Waseem Shami, MD, of Texas Tech University in El Paso, said in a web briefing in advance of the annual meeting of the American College of Cardiology.

Musical notes
©Zoonar/hormydesign/Thinkstock
Although many exercisers find motivation in listening to music during workouts, the value of music to improve the quality of treadmill exercise stress testing has not been well studied, said Dr. Shami, who said he was inspired to conduct the study based on his own experience with music providing motivation for his daily runs.

The group of patients that listened to lively music averaged 55 seconds longer exercise time, compared with the no-music control group, Dr. Shami said. The average exercise time was 505.8 seconds in the music group and 455.2 in the control group (P = .045).

Dr. Shami and his colleagues randomized 67 adults scheduled for cardiac stress tests to listen to music during the test and 60 controls to undergo the test without music. The average age of the patients was 53 years, and 61% and 67% of those in the music and control groups, respectively, were women. Demographic characteristics and variables, including resting heart rate and blood pressure, were similar between the music and control groups.

In a clinical setting, the use of music may help reduce unnecessary stress testing, which is deemed unsuccessful if the patient doesn’t exercise hard enough to achieve a target heart rate. “Perhaps this motivational tool can help us make stress testing more valuable,” said Dr. Shami. The results were limited by the relatively small study population and the fact that the researchers, not the patients, chose the music, Dr. Shami said.

More research is needed in a larger trial, and “allowing patients to choose their own music might make an even bigger difference,” he noted. Also, patients’ discomfort with exercising in general and exercising in public may have impacted the results, he said.

Moderator Martha Gulati, MD, of the University of Arizona, Phoenix, noted that an area for future research might be to do a cardiac stress test without and without music on the same person, with the patient serving as his or her own control.

Dr. Shami had no relevant financial conflicts to disclose.

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Listening to uptempo music significantly improved patients’ exercise capacity during a stress test, compared with patients who didn’t listen to music, according to data from a randomized trial of 127 patients.

Exercise stress tests are frequently recommended to evaluate patients for heart disease, but many patients don’t work hard enough to reach a useful level of exertion, Waseem Shami, MD, of Texas Tech University in El Paso, said in a web briefing in advance of the annual meeting of the American College of Cardiology.

Musical notes
©Zoonar/hormydesign/Thinkstock
Although many exercisers find motivation in listening to music during workouts, the value of music to improve the quality of treadmill exercise stress testing has not been well studied, said Dr. Shami, who said he was inspired to conduct the study based on his own experience with music providing motivation for his daily runs.

The group of patients that listened to lively music averaged 55 seconds longer exercise time, compared with the no-music control group, Dr. Shami said. The average exercise time was 505.8 seconds in the music group and 455.2 in the control group (P = .045).

Dr. Shami and his colleagues randomized 67 adults scheduled for cardiac stress tests to listen to music during the test and 60 controls to undergo the test without music. The average age of the patients was 53 years, and 61% and 67% of those in the music and control groups, respectively, were women. Demographic characteristics and variables, including resting heart rate and blood pressure, were similar between the music and control groups.

In a clinical setting, the use of music may help reduce unnecessary stress testing, which is deemed unsuccessful if the patient doesn’t exercise hard enough to achieve a target heart rate. “Perhaps this motivational tool can help us make stress testing more valuable,” said Dr. Shami. The results were limited by the relatively small study population and the fact that the researchers, not the patients, chose the music, Dr. Shami said.

More research is needed in a larger trial, and “allowing patients to choose their own music might make an even bigger difference,” he noted. Also, patients’ discomfort with exercising in general and exercising in public may have impacted the results, he said.

Moderator Martha Gulati, MD, of the University of Arizona, Phoenix, noted that an area for future research might be to do a cardiac stress test without and without music on the same person, with the patient serving as his or her own control.

Dr. Shami had no relevant financial conflicts to disclose.

 

Listening to uptempo music significantly improved patients’ exercise capacity during a stress test, compared with patients who didn’t listen to music, according to data from a randomized trial of 127 patients.

Exercise stress tests are frequently recommended to evaluate patients for heart disease, but many patients don’t work hard enough to reach a useful level of exertion, Waseem Shami, MD, of Texas Tech University in El Paso, said in a web briefing in advance of the annual meeting of the American College of Cardiology.

Musical notes
©Zoonar/hormydesign/Thinkstock
Although many exercisers find motivation in listening to music during workouts, the value of music to improve the quality of treadmill exercise stress testing has not been well studied, said Dr. Shami, who said he was inspired to conduct the study based on his own experience with music providing motivation for his daily runs.

The group of patients that listened to lively music averaged 55 seconds longer exercise time, compared with the no-music control group, Dr. Shami said. The average exercise time was 505.8 seconds in the music group and 455.2 in the control group (P = .045).

Dr. Shami and his colleagues randomized 67 adults scheduled for cardiac stress tests to listen to music during the test and 60 controls to undergo the test without music. The average age of the patients was 53 years, and 61% and 67% of those in the music and control groups, respectively, were women. Demographic characteristics and variables, including resting heart rate and blood pressure, were similar between the music and control groups.

In a clinical setting, the use of music may help reduce unnecessary stress testing, which is deemed unsuccessful if the patient doesn’t exercise hard enough to achieve a target heart rate. “Perhaps this motivational tool can help us make stress testing more valuable,” said Dr. Shami. The results were limited by the relatively small study population and the fact that the researchers, not the patients, chose the music, Dr. Shami said.

More research is needed in a larger trial, and “allowing patients to choose their own music might make an even bigger difference,” he noted. Also, patients’ discomfort with exercising in general and exercising in public may have impacted the results, he said.

Moderator Martha Gulati, MD, of the University of Arizona, Phoenix, noted that an area for future research might be to do a cardiac stress test without and without music on the same person, with the patient serving as his or her own control.

Dr. Shami had no relevant financial conflicts to disclose.

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ACC Day 3: Finishing strong in Late-Breaking Clinical Trial Sessions

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Tue, 12/04/2018 - 11:39

 

On the third and final day of the annual meeting of the American College of Cardiology in Orlando, two very different studies were emphasized by the meeting’s vice chair, Andrew Kates, MD, in a media briefing: Blood Pressure Reductions in Black Barbershops and ANNEXA 4.

Blood Pressure Reductions in Black Barbershops

Dr. Ronald G. Victor, professor of cardiology and chair of cardiology research at Cedars-Sinai Medical Center, Los Angeles
Dr. Ronald G. Victor
Ronald G. Victor, MD, of Cedars-Sinai Medical Center in Los Angeles, has been studying the considerable strength of barbershops in African American communities for years. In the joint ACC/New England Journal of Medicine Late-Breaking Clinical Trial Session, 8:00 a.m.-9:15 a.m. in the Main Tent, Dr. Victor and will present such a study of 330 patients in 53 barbershops.

In the study, barbers in those 53 shops were trained to measure clients’ blood pressure and refer those with high readings to a community pharmacist for confirmation of uncontrolled high blood pressure and development of a hypertension management plan. The primary outcome is a 6-month blood pressure reading of less than 135/85 mm Hg.


“This stood out for highlighting because we’re now realizing the importance of barbershops in the community” in education and perhaps improving treatment. The data may reinforce the use of barbershops to improve hypertension,” said Dr. Kates, professor of medicine, Washington University, St. Louis.

 

 


ANNEXA 4

An interim analysis of ANNEXA 4 will shed light on the safety of andexanet alfa, a novel potential reversal agent for patients on direct oral anticoagulants who are experiencing an acute major bleed.

ANNEXA 4 (Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding) is an ongoing phase 3b/4 trial of the novel agent, a modified form of the human factor Xa molecule. Interim results showed that, at 12 hours after infusion, 37 of 47 patients in the efficacy analysis achieved excellent or good hemostasis.

Dr. Stuart J. Connolly of McMaster University, Hamilton, Ont.
Dr. Stuart J. Connolly
ANNEXA 4 “is an important study because of concerns about prescribing specific factor Xa inhibitors due to the lack of reversal agents,” Dr. Kates said. Its safety results will have the potential to change practice, as well. They may also help clinicians understand the pharmacology of these agents if they’re faced with an acute bleed in a patient on a factor Xa inhibitor, he added.

The Food and Drug Administration is currently reviewing andexanet alfa, and a decision is expected this May.

Stuart J. Connolly, MD, of McMaster University, Hamilton, Ont., will present the report at the Fifth Late-Breaking Clinical Trial Session on Monday, 10:45 a.m.-11:45 a.m., in the Main Tent.

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On the third and final day of the annual meeting of the American College of Cardiology in Orlando, two very different studies were emphasized by the meeting’s vice chair, Andrew Kates, MD, in a media briefing: Blood Pressure Reductions in Black Barbershops and ANNEXA 4.

Blood Pressure Reductions in Black Barbershops

Dr. Ronald G. Victor, professor of cardiology and chair of cardiology research at Cedars-Sinai Medical Center, Los Angeles
Dr. Ronald G. Victor
Ronald G. Victor, MD, of Cedars-Sinai Medical Center in Los Angeles, has been studying the considerable strength of barbershops in African American communities for years. In the joint ACC/New England Journal of Medicine Late-Breaking Clinical Trial Session, 8:00 a.m.-9:15 a.m. in the Main Tent, Dr. Victor and will present such a study of 330 patients in 53 barbershops.

In the study, barbers in those 53 shops were trained to measure clients’ blood pressure and refer those with high readings to a community pharmacist for confirmation of uncontrolled high blood pressure and development of a hypertension management plan. The primary outcome is a 6-month blood pressure reading of less than 135/85 mm Hg.


“This stood out for highlighting because we’re now realizing the importance of barbershops in the community” in education and perhaps improving treatment. The data may reinforce the use of barbershops to improve hypertension,” said Dr. Kates, professor of medicine, Washington University, St. Louis.

 

 


ANNEXA 4

An interim analysis of ANNEXA 4 will shed light on the safety of andexanet alfa, a novel potential reversal agent for patients on direct oral anticoagulants who are experiencing an acute major bleed.

ANNEXA 4 (Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding) is an ongoing phase 3b/4 trial of the novel agent, a modified form of the human factor Xa molecule. Interim results showed that, at 12 hours after infusion, 37 of 47 patients in the efficacy analysis achieved excellent or good hemostasis.

Dr. Stuart J. Connolly of McMaster University, Hamilton, Ont.
Dr. Stuart J. Connolly
ANNEXA 4 “is an important study because of concerns about prescribing specific factor Xa inhibitors due to the lack of reversal agents,” Dr. Kates said. Its safety results will have the potential to change practice, as well. They may also help clinicians understand the pharmacology of these agents if they’re faced with an acute bleed in a patient on a factor Xa inhibitor, he added.

The Food and Drug Administration is currently reviewing andexanet alfa, and a decision is expected this May.

Stuart J. Connolly, MD, of McMaster University, Hamilton, Ont., will present the report at the Fifth Late-Breaking Clinical Trial Session on Monday, 10:45 a.m.-11:45 a.m., in the Main Tent.

 

On the third and final day of the annual meeting of the American College of Cardiology in Orlando, two very different studies were emphasized by the meeting’s vice chair, Andrew Kates, MD, in a media briefing: Blood Pressure Reductions in Black Barbershops and ANNEXA 4.

Blood Pressure Reductions in Black Barbershops

Dr. Ronald G. Victor, professor of cardiology and chair of cardiology research at Cedars-Sinai Medical Center, Los Angeles
Dr. Ronald G. Victor
Ronald G. Victor, MD, of Cedars-Sinai Medical Center in Los Angeles, has been studying the considerable strength of barbershops in African American communities for years. In the joint ACC/New England Journal of Medicine Late-Breaking Clinical Trial Session, 8:00 a.m.-9:15 a.m. in the Main Tent, Dr. Victor and will present such a study of 330 patients in 53 barbershops.

In the study, barbers in those 53 shops were trained to measure clients’ blood pressure and refer those with high readings to a community pharmacist for confirmation of uncontrolled high blood pressure and development of a hypertension management plan. The primary outcome is a 6-month blood pressure reading of less than 135/85 mm Hg.


“This stood out for highlighting because we’re now realizing the importance of barbershops in the community” in education and perhaps improving treatment. The data may reinforce the use of barbershops to improve hypertension,” said Dr. Kates, professor of medicine, Washington University, St. Louis.

 

 


ANNEXA 4

An interim analysis of ANNEXA 4 will shed light on the safety of andexanet alfa, a novel potential reversal agent for patients on direct oral anticoagulants who are experiencing an acute major bleed.

ANNEXA 4 (Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding) is an ongoing phase 3b/4 trial of the novel agent, a modified form of the human factor Xa molecule. Interim results showed that, at 12 hours after infusion, 37 of 47 patients in the efficacy analysis achieved excellent or good hemostasis.

Dr. Stuart J. Connolly of McMaster University, Hamilton, Ont.
Dr. Stuart J. Connolly
ANNEXA 4 “is an important study because of concerns about prescribing specific factor Xa inhibitors due to the lack of reversal agents,” Dr. Kates said. Its safety results will have the potential to change practice, as well. They may also help clinicians understand the pharmacology of these agents if they’re faced with an acute bleed in a patient on a factor Xa inhibitor, he added.

The Food and Drug Administration is currently reviewing andexanet alfa, and a decision is expected this May.

Stuart J. Connolly, MD, of McMaster University, Hamilton, Ont., will present the report at the Fifth Late-Breaking Clinical Trial Session on Monday, 10:45 a.m.-11:45 a.m., in the Main Tent.

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Heart attacks soar in young IBD patients

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Fri, 01/18/2019 - 17:27

 

Inflammatory bowel disease significantly increases the risk of a heart attack in adults, but especially young adults aged 18-24 years, and in women compared with men across all age groups, according to data from about 200,000 IBD patients.

The odds ratio for heart attack in IBD patients vs. controls remained a significant 1.2 after adjustment for traditional cardiovascular risk factors, Muhammad S. Panhwar, MD, said in a media briefing in advance of the annual meeting of the American College of Cardiology.

“Chronic inflammation has been recognized as having an important role in the development of heart disease,” he noted.

Although other chronic inflammatory conditions are associated with increased heart attack risk, the link between heart attacks and IBD has not been well studied, despite its high prevalence in the United States (about 3 million adults, according to the Centers for Disease Control and Prevention), said Dr. Panhwar, an internal medicine resident at Case Western Reserve University in Cleveland. He and his colleagues reviewed a nationwide medical records database of 17.5 million adults aged 18-65 years for diagnoses of IBD between 2013 and 2017. Overall, 1.2% of the patients (211,870) had IBD, and most of the patients in the IBD group were younger, female, and white, Dr. Panhwar noted.

 

 


The relative risk of myocardial infarction was roughly twice as high in IBD patients as that of controls without IBD (5.9% vs. 3.5%), Dr. Panhwar said. That risk was highest in patients aged 20-25 years, with a relative risk of 20.5, occurring mostly in women, and decreased to 1.8 by age 60-64 (both P less than .001).

In addition, IBD patients tended to have a higher prevalence of common cardiovascular risk factors such as high blood pressure, obesity, and smoking.

The IBD patients’ higher prevalence of smoking – 21%, vs. 12% of the controls – is not a surprise, said Martha Gulati, MD, who moderated the briefing. Many people with IBD smoke, particularly those with Crohn’s disease, because it seems to reduce the number of flares, said Dr. Gulati, chief of cardiology at the University of Arizona, Phoenix.

The findings may be affected by the increased inflammation often observed in younger individuals with IBD and younger women with IBD, who may not present with traditional cardiovascular risk factors, the researchers noted.

“Clinicians who care for patients with traditional cardiovascular risk factors who also have IBD should recognize IBD as an independent risk factor as well, and treat appropriately,” Dr. Panhwar said.

Dr. Panhwar had no relevant financial conflicts to disclose.

SOURCE: Panhwar M. ACC 18.

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Inflammatory bowel disease significantly increases the risk of a heart attack in adults, but especially young adults aged 18-24 years, and in women compared with men across all age groups, according to data from about 200,000 IBD patients.

The odds ratio for heart attack in IBD patients vs. controls remained a significant 1.2 after adjustment for traditional cardiovascular risk factors, Muhammad S. Panhwar, MD, said in a media briefing in advance of the annual meeting of the American College of Cardiology.

“Chronic inflammation has been recognized as having an important role in the development of heart disease,” he noted.

Although other chronic inflammatory conditions are associated with increased heart attack risk, the link between heart attacks and IBD has not been well studied, despite its high prevalence in the United States (about 3 million adults, according to the Centers for Disease Control and Prevention), said Dr. Panhwar, an internal medicine resident at Case Western Reserve University in Cleveland. He and his colleagues reviewed a nationwide medical records database of 17.5 million adults aged 18-65 years for diagnoses of IBD between 2013 and 2017. Overall, 1.2% of the patients (211,870) had IBD, and most of the patients in the IBD group were younger, female, and white, Dr. Panhwar noted.

 

 


The relative risk of myocardial infarction was roughly twice as high in IBD patients as that of controls without IBD (5.9% vs. 3.5%), Dr. Panhwar said. That risk was highest in patients aged 20-25 years, with a relative risk of 20.5, occurring mostly in women, and decreased to 1.8 by age 60-64 (both P less than .001).

In addition, IBD patients tended to have a higher prevalence of common cardiovascular risk factors such as high blood pressure, obesity, and smoking.

The IBD patients’ higher prevalence of smoking – 21%, vs. 12% of the controls – is not a surprise, said Martha Gulati, MD, who moderated the briefing. Many people with IBD smoke, particularly those with Crohn’s disease, because it seems to reduce the number of flares, said Dr. Gulati, chief of cardiology at the University of Arizona, Phoenix.

The findings may be affected by the increased inflammation often observed in younger individuals with IBD and younger women with IBD, who may not present with traditional cardiovascular risk factors, the researchers noted.

“Clinicians who care for patients with traditional cardiovascular risk factors who also have IBD should recognize IBD as an independent risk factor as well, and treat appropriately,” Dr. Panhwar said.

Dr. Panhwar had no relevant financial conflicts to disclose.

SOURCE: Panhwar M. ACC 18.

 

Inflammatory bowel disease significantly increases the risk of a heart attack in adults, but especially young adults aged 18-24 years, and in women compared with men across all age groups, according to data from about 200,000 IBD patients.

The odds ratio for heart attack in IBD patients vs. controls remained a significant 1.2 after adjustment for traditional cardiovascular risk factors, Muhammad S. Panhwar, MD, said in a media briefing in advance of the annual meeting of the American College of Cardiology.

“Chronic inflammation has been recognized as having an important role in the development of heart disease,” he noted.

Although other chronic inflammatory conditions are associated with increased heart attack risk, the link between heart attacks and IBD has not been well studied, despite its high prevalence in the United States (about 3 million adults, according to the Centers for Disease Control and Prevention), said Dr. Panhwar, an internal medicine resident at Case Western Reserve University in Cleveland. He and his colleagues reviewed a nationwide medical records database of 17.5 million adults aged 18-65 years for diagnoses of IBD between 2013 and 2017. Overall, 1.2% of the patients (211,870) had IBD, and most of the patients in the IBD group were younger, female, and white, Dr. Panhwar noted.

 

 


The relative risk of myocardial infarction was roughly twice as high in IBD patients as that of controls without IBD (5.9% vs. 3.5%), Dr. Panhwar said. That risk was highest in patients aged 20-25 years, with a relative risk of 20.5, occurring mostly in women, and decreased to 1.8 by age 60-64 (both P less than .001).

In addition, IBD patients tended to have a higher prevalence of common cardiovascular risk factors such as high blood pressure, obesity, and smoking.

The IBD patients’ higher prevalence of smoking – 21%, vs. 12% of the controls – is not a surprise, said Martha Gulati, MD, who moderated the briefing. Many people with IBD smoke, particularly those with Crohn’s disease, because it seems to reduce the number of flares, said Dr. Gulati, chief of cardiology at the University of Arizona, Phoenix.

The findings may be affected by the increased inflammation often observed in younger individuals with IBD and younger women with IBD, who may not present with traditional cardiovascular risk factors, the researchers noted.

“Clinicians who care for patients with traditional cardiovascular risk factors who also have IBD should recognize IBD as an independent risk factor as well, and treat appropriately,” Dr. Panhwar said.

Dr. Panhwar had no relevant financial conflicts to disclose.

SOURCE: Panhwar M. ACC 18.

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Key clinical point: Inflammatory bowel disease raises the risk of MI, particularly in young women.

Major finding: The relative risk of MI was roughly twice as high in IBD patients compared with controls without IBD (5.9% vs. 3.5%).

Study details: Review of a nationwide medical records database of 17.5 million adults aged 18-65 years.

Disclosures: Dr. Panhwar had no relevant financial conflicts to disclose.

Source: Panhwar M. ACC 18.

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ACC Day 2: Late-Breaking Clinical Trial highlights

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Of the late-breaking clinical trials to be presented on Sunday, March 11, at the annual meeting of the American College of Cardiology in Orlando, the meeting’s vice chair, Andrew Kates, MD, highlighted two in a press briefing: ARTEMIS and MOMENTUM 3.

ARTEMIS

The investigators of this unique trial sought to determine whether reducing patients’ cost burden for their medication would improve adherence and, in turn, improve patient outcomes.

Specifically, ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) evaluated whether eliminating copayments for patients after acute MI could optimize antiplatelet therapy selection and long-term adherence, as well as patient outcomes and overall cost of care following acute MI.

Dr. Andrew Kates

Dr. Kates, professor of medicine, Washington University, St. Louis, said ARTEMIS would go far in answering the question, “If costs are lowered, are guidelines followed?”

Tracy Wang, MD, of Duke University, Durham, N.C., will present the results on Sunday in a joint Late-Breaking Clinical Trial session with JAMA, being held at 8 a.m.-9 a.m. in the Main Tent (Hall C).

 

 

MOMENTUM 3

Last year, HeartMate 3, a fully magnetically levitated centrifugal-flow circulatory pump, showed better outcomes at 6 months than did HEARTMATE 2, an axial-flow pump, in the primary results of MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3).

Most impressive was the complete elimination of pump thrombosis in the patients with the smaller HeartMate 3 device. On Sunday, the 2-year results will reveal whether longer-term use of the novel technology will carry similar benefits, Dr. Kates said.

MOMENTUM 3 will be presented at the third Late-Breaking Clinical Trials session, at 10:45-11:45 a.m., in the Main Tent (Hall C) by Mandeep R. Mehra, MD, professor of medicine at Harvard Medical School and medical director of the Heart and Vascular Center of Brigham and Women’s Hospital, both in Boston.

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Of the late-breaking clinical trials to be presented on Sunday, March 11, at the annual meeting of the American College of Cardiology in Orlando, the meeting’s vice chair, Andrew Kates, MD, highlighted two in a press briefing: ARTEMIS and MOMENTUM 3.

ARTEMIS

The investigators of this unique trial sought to determine whether reducing patients’ cost burden for their medication would improve adherence and, in turn, improve patient outcomes.

Specifically, ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) evaluated whether eliminating copayments for patients after acute MI could optimize antiplatelet therapy selection and long-term adherence, as well as patient outcomes and overall cost of care following acute MI.

Dr. Andrew Kates

Dr. Kates, professor of medicine, Washington University, St. Louis, said ARTEMIS would go far in answering the question, “If costs are lowered, are guidelines followed?”

Tracy Wang, MD, of Duke University, Durham, N.C., will present the results on Sunday in a joint Late-Breaking Clinical Trial session with JAMA, being held at 8 a.m.-9 a.m. in the Main Tent (Hall C).

 

 

MOMENTUM 3

Last year, HeartMate 3, a fully magnetically levitated centrifugal-flow circulatory pump, showed better outcomes at 6 months than did HEARTMATE 2, an axial-flow pump, in the primary results of MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3).

Most impressive was the complete elimination of pump thrombosis in the patients with the smaller HeartMate 3 device. On Sunday, the 2-year results will reveal whether longer-term use of the novel technology will carry similar benefits, Dr. Kates said.

MOMENTUM 3 will be presented at the third Late-Breaking Clinical Trials session, at 10:45-11:45 a.m., in the Main Tent (Hall C) by Mandeep R. Mehra, MD, professor of medicine at Harvard Medical School and medical director of the Heart and Vascular Center of Brigham and Women’s Hospital, both in Boston.

 

Of the late-breaking clinical trials to be presented on Sunday, March 11, at the annual meeting of the American College of Cardiology in Orlando, the meeting’s vice chair, Andrew Kates, MD, highlighted two in a press briefing: ARTEMIS and MOMENTUM 3.

ARTEMIS

The investigators of this unique trial sought to determine whether reducing patients’ cost burden for their medication would improve adherence and, in turn, improve patient outcomes.

Specifically, ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) evaluated whether eliminating copayments for patients after acute MI could optimize antiplatelet therapy selection and long-term adherence, as well as patient outcomes and overall cost of care following acute MI.

Dr. Andrew Kates

Dr. Kates, professor of medicine, Washington University, St. Louis, said ARTEMIS would go far in answering the question, “If costs are lowered, are guidelines followed?”

Tracy Wang, MD, of Duke University, Durham, N.C., will present the results on Sunday in a joint Late-Breaking Clinical Trial session with JAMA, being held at 8 a.m.-9 a.m. in the Main Tent (Hall C).

 

 

MOMENTUM 3

Last year, HeartMate 3, a fully magnetically levitated centrifugal-flow circulatory pump, showed better outcomes at 6 months than did HEARTMATE 2, an axial-flow pump, in the primary results of MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3).

Most impressive was the complete elimination of pump thrombosis in the patients with the smaller HeartMate 3 device. On Sunday, the 2-year results will reveal whether longer-term use of the novel technology will carry similar benefits, Dr. Kates said.

MOMENTUM 3 will be presented at the third Late-Breaking Clinical Trials session, at 10:45-11:45 a.m., in the Main Tent (Hall C) by Mandeep R. Mehra, MD, professor of medicine at Harvard Medical School and medical director of the Heart and Vascular Center of Brigham and Women’s Hospital, both in Boston.

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