ACC 2011

NEW ORLEANS – The cost of transcatheter aortic valve replacement among patients with inoperable severe aortic stenosis is in line with other accepted cardiovascular procedures, according to an economic analysis of the PARTNER trial.

Index hospitalization costs for transcatheter aortic valve replacement (TAVR) were $78,540 based on an estimated cost of $30,000 for the investigational Edwards SAPIEN valve. TAVR was, however, associated with a projected gain in survival, resulting in overall lifetime cost effectiveness.

"In this extremely high-risk population, an elderly population, the intervention is adding roughly 2 years of life, and that is the return on investment," principal investigator Dr. Matthew Reynolds said during a press briefing at the annual meeting of the American College of Cardiology. "The cost-effectiveness ratio, when you do the math, works out to just over $50,000 per life-year gained."

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, said up-front hospital costs for TAVR will be high because of the need for a hybrid operative/interventional suite, but that as long as the risks and costs are reasonable, patients will opt for the percutaneous approach simply because they don’t want surgery.

During the formal study presentation, invited discussant Dr. Martyn Thomas, director of cardiovascular services at Guy’s and St. Thomas’ Hospitals, London, said clinicians in the United Kingdom were awaiting results of the cost analysis with bated breath to determine if TAVR could get the nod from the National Institute for Health and Clinical Excellence.

"When I plug in our numbers ... I get somewhere around £20,000 [U.S.$32,700] per QALY [quality-adjusted life-year], which for us would be absolutely perfect," Dr. Thomas said.

Anticipation regarding TAVR has been building since efficacy data reported last fall for the same 358 inoperable patients, known as cohort B, demonstrated a 20% survival benefit with TAVR at 1 year, compared with standard medical therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-6070).

The question, however, is whether the novel procedure will be cost effective in an increasingly heated climate of health care cost containment.

In an attempt to tackle the issue, Dr. Reynolds and his colleagues assessed lifetime incremental cost-effectiveness ratios (ICERs) and lifetime incremental costs per QALY using hospital billing data or MEDPAR when bills were unavailable. Costs from the last 6 months for surviving patients were used to project future costs beyond 12 months, while parametric survival models fit to the trial data were used to extrapolate patient-level life expectancy beyond the follow-up period.

The initial $78,540 price tag for TAVR includes $42,806 for procedural costs, $30,756 for nonprocedural expenses, and $4,978 for physician fees, said Dr. Reynolds, director of the Economics and Quality of Life Research Center at the Harvard Clinical Research Institute, Boston. Patients spent an average of 10 days in the hospital, including 4 days in the intensive care unit.

Twelve-month follow-up costs were $23,372 higher for patients treated with standard medical therapy. This was a result of significantly more hospitalizations in the control group than in the TAVR group (2.15 vs. 1.02), mainly due to cardiovascular causes (1.7 vs. 0.50), he said.

The estimated life expectancy was 3.1 years for patients treated with TAVR and 1.2 years for those treated with medical therapy, or a difference of 1.9 years.

The lifetime incremental cost per patient was $79,837, and the lifetime incremental gain in life expectancy was 1.59 years. This translated into an ICER of $50,212 per life-year gained and $61,889 per QALY, he said.

Additional analysis showed that if the price of the device were to drop to $20,000, the ICER would be $43,642 per life-year gained. In Europe, both the SAPIEN valve (Edwards Lifesciences) and the CoreValve (Medtronic) are already on the market.

On the basis of the data, TAVR in this older inoperable cohort falls very close to published cost-effectiveness estimates for implantable defibrillators and atrial fibrillation ablation, and is actually lower than current estimates for hemodialysis or percutaneous coronary intervention for stable coronary artery disease, Dr. Reynolds said.

"For patients with severe aortic stenosis who are unsuitable for surgical aortic valve replacement, TAVR significantly increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies," he said.

When asked what the budget impact would be of adoption of TAVR, Dr. Reynolds said they have not performed such an analysis, but that an estimated 30% of patients with severe aortic stenosis do not undergo conventional open surgery.

Efficacy data presented at the same session by Dr. Craig Smith on cohort A of the PARTNER trial, revealed that all-cause mortality in 699 high-risk patients with severe aortic stenosis was the same at 1 year, at 24% with TAVR vs. 27% with conventional open surgery, but that the incidence of stroke was increased at 8.3% vs. 4.3%. Cost comparisons of TAVR vs. conventional surgery are not yet available.

Edwards Lifesciences provided grant support for the analysis.

NEW ORLEANS – The cost of transcatheter aortic valve replacement among patients with inoperable severe aortic stenosis is in line with other accepted cardiovascular procedures, according to an economic analysis of the PARTNER trial.

Index hospitalization costs for transcatheter aortic valve replacement (TAVR) were $78,540 based on an estimated cost of $30,000 for the investigational Edwards SAPIEN valve. TAVR was, however, associated with a projected gain in survival, resulting in overall lifetime cost effectiveness.

"In this extremely high-risk population, an elderly population, the intervention is adding roughly 2 years of life, and that is the return on investment," principal investigator Dr. Matthew Reynolds said during a press briefing at the annual meeting of the American College of Cardiology. "The cost-effectiveness ratio, when you do the math, works out to just over $50,000 per life-year gained."

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, said up-front hospital costs for TAVR will be high because of the need for a hybrid operative/interventional suite, but that as long as the risks and costs are reasonable, patients will opt for the percutaneous approach simply because they don’t want surgery.

During the formal study presentation, invited discussant Dr. Martyn Thomas, director of cardiovascular services at Guy’s and St. Thomas’ Hospitals, London, said clinicians in the United Kingdom were awaiting results of the cost analysis with bated breath to determine if TAVR could get the nod from the National Institute for Health and Clinical Excellence.

"When I plug in our numbers ... I get somewhere around £20,000 [U.S.$32,700] per QALY [quality-adjusted life-year], which for us would be absolutely perfect," Dr. Thomas said.

Anticipation regarding TAVR has been building since efficacy data reported last fall for the same 358 inoperable patients, known as cohort B, demonstrated a 20% survival benefit with TAVR at 1 year, compared with standard medical therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-6070).

The question, however, is whether the novel procedure will be cost effective in an increasingly heated climate of health care cost containment.

In an attempt to tackle the issue, Dr. Reynolds and his colleagues assessed lifetime incremental cost-effectiveness ratios (ICERs) and lifetime incremental costs per QALY using hospital billing data or MEDPAR when bills were unavailable. Costs from the last 6 months for surviving patients were used to project future costs beyond 12 months, while parametric survival models fit to the trial data were used to extrapolate patient-level life expectancy beyond the follow-up period.

The initial $78,540 price tag for TAVR includes $42,806 for procedural costs, $30,756 for nonprocedural expenses, and $4,978 for physician fees, said Dr. Reynolds, director of the Economics and Quality of Life Research Center at the Harvard Clinical Research Institute, Boston. Patients spent an average of 10 days in the hospital, including 4 days in the intensive care unit.

Twelve-month follow-up costs were $23,372 higher for patients treated with standard medical therapy. This was a result of significantly more hospitalizations in the control group than in the TAVR group (2.15 vs. 1.02), mainly due to cardiovascular causes (1.7 vs. 0.50), he said.

The estimated life expectancy was 3.1 years for patients treated with TAVR and 1.2 years for those treated with medical therapy, or a difference of 1.9 years.

The lifetime incremental cost per patient was $79,837, and the lifetime incremental gain in life expectancy was 1.59 years. This translated into an ICER of $50,212 per life-year gained and $61,889 per QALY, he said.

Additional analysis showed that if the price of the device were to drop to $20,000, the ICER would be $43,642 per life-year gained. In Europe, both the SAPIEN valve (Edwards Lifesciences) and the CoreValve (Medtronic) are already on the market.

On the basis of the data, TAVR in this older inoperable cohort falls very close to published cost-effectiveness estimates for implantable defibrillators and atrial fibrillation ablation, and is actually lower than current estimates for hemodialysis or percutaneous coronary intervention for stable coronary artery disease, Dr. Reynolds said.

"For patients with severe aortic stenosis who are unsuitable for surgical aortic valve replacement, TAVR significantly increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies," he said.

When asked what the budget impact would be of adoption of TAVR, Dr. Reynolds said they have not performed such an analysis, but that an estimated 30% of patients with severe aortic stenosis do not undergo conventional open surgery.

Efficacy data presented at the same session by Dr. Craig Smith on cohort A of the PARTNER trial, revealed that all-cause mortality in 699 high-risk patients with severe aortic stenosis was the same at 1 year, at 24% with TAVR vs. 27% with conventional open surgery, but that the incidence of stroke was increased at 8.3% vs. 4.3%. Cost comparisons of TAVR vs. conventional surgery are not yet available.

Edwards Lifesciences provided grant support for the analysis.

NEW ORLEANS – The cost of transcatheter aortic valve replacement among patients with inoperable severe aortic stenosis is in line with other accepted cardiovascular procedures, according to an economic analysis of the PARTNER trial.

Index hospitalization costs for transcatheter aortic valve replacement (TAVR) were $78,540 based on an estimated cost of $30,000 for the investigational Edwards SAPIEN valve. TAVR was, however, associated with a projected gain in survival, resulting in overall lifetime cost effectiveness.

"In this extremely high-risk population, an elderly population, the intervention is adding roughly 2 years of life, and that is the return on investment," principal investigator Dr. Matthew Reynolds said during a press briefing at the annual meeting of the American College of Cardiology. "The cost-effectiveness ratio, when you do the math, works out to just over $50,000 per life-year gained."

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, said up-front hospital costs for TAVR will be high because of the need for a hybrid operative/interventional suite, but that as long as the risks and costs are reasonable, patients will opt for the percutaneous approach simply because they don’t want surgery.

During the formal study presentation, invited discussant Dr. Martyn Thomas, director of cardiovascular services at Guy’s and St. Thomas’ Hospitals, London, said clinicians in the United Kingdom were awaiting results of the cost analysis with bated breath to determine if TAVR could get the nod from the National Institute for Health and Clinical Excellence.

"When I plug in our numbers ... I get somewhere around £20,000 [U.S.$32,700] per QALY [quality-adjusted life-year], which for us would be absolutely perfect," Dr. Thomas said.

Anticipation regarding TAVR has been building since efficacy data reported last fall for the same 358 inoperable patients, known as cohort B, demonstrated a 20% survival benefit with TAVR at 1 year, compared with standard medical therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-6070).

The question, however, is whether the novel procedure will be cost effective in an increasingly heated climate of health care cost containment.

In an attempt to tackle the issue, Dr. Reynolds and his colleagues assessed lifetime incremental cost-effectiveness ratios (ICERs) and lifetime incremental costs per QALY using hospital billing data or MEDPAR when bills were unavailable. Costs from the last 6 months for surviving patients were used to project future costs beyond 12 months, while parametric survival models fit to the trial data were used to extrapolate patient-level life expectancy beyond the follow-up period.

The initial $78,540 price tag for TAVR includes $42,806 for procedural costs, $30,756 for nonprocedural expenses, and $4,978 for physician fees, said Dr. Reynolds, director of the Economics and Quality of Life Research Center at the Harvard Clinical Research Institute, Boston. Patients spent an average of 10 days in the hospital, including 4 days in the intensive care unit.

Twelve-month follow-up costs were $23,372 higher for patients treated with standard medical therapy. This was a result of significantly more hospitalizations in the control group than in the TAVR group (2.15 vs. 1.02), mainly due to cardiovascular causes (1.7 vs. 0.50), he said.

The estimated life expectancy was 3.1 years for patients treated with TAVR and 1.2 years for those treated with medical therapy, or a difference of 1.9 years.

The lifetime incremental cost per patient was $79,837, and the lifetime incremental gain in life expectancy was 1.59 years. This translated into an ICER of $50,212 per life-year gained and $61,889 per QALY, he said.

Additional analysis showed that if the price of the device were to drop to $20,000, the ICER would be $43,642 per life-year gained. In Europe, both the SAPIEN valve (Edwards Lifesciences) and the CoreValve (Medtronic) are already on the market.

On the basis of the data, TAVR in this older inoperable cohort falls very close to published cost-effectiveness estimates for implantable defibrillators and atrial fibrillation ablation, and is actually lower than current estimates for hemodialysis or percutaneous coronary intervention for stable coronary artery disease, Dr. Reynolds said.

"For patients with severe aortic stenosis who are unsuitable for surgical aortic valve replacement, TAVR significantly increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies," he said.

When asked what the budget impact would be of adoption of TAVR, Dr. Reynolds said they have not performed such an analysis, but that an estimated 30% of patients with severe aortic stenosis do not undergo conventional open surgery.

Efficacy data presented at the same session by Dr. Craig Smith on cohort A of the PARTNER trial, revealed that all-cause mortality in 699 high-risk patients with severe aortic stenosis was the same at 1 year, at 24% with TAVR vs. 27% with conventional open surgery, but that the incidence of stroke was increased at 8.3% vs. 4.3%. Cost comparisons of TAVR vs. conventional surgery are not yet available.

Edwards Lifesciences provided grant support for the analysis.

NEW ORLEANS – The cost of transcatheter aortic valve replacement among patients with inoperable severe aortic stenosis is in line with other accepted cardiovascular procedures, according to an economic analysis of the PARTNER trial.

Index hospitalization costs for transcatheter aortic valve replacement (TAVR) were $78,540 based on an estimated cost of $30,000 for the investigational Edwards SAPIEN valve. TAVR was, however, associated with a projected gain in survival, resulting in overall lifetime cost effectiveness.

"In this extremely high-risk population, an elderly population, the intervention is adding roughly 2 years of life, and that is the return on investment," principal investigator Dr. Matthew Reynolds said during a press briefing at the annual meeting of the American College of Cardiology. "The cost-effectiveness ratio, when you do the math, works out to just over $50,000 per life-year gained."

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, said up-front hospital costs for TAVR will be high because of the need for a hybrid operative/interventional suite, but that as long as the risks and costs are reasonable, patients will opt for the percutaneous approach simply because they don’t want surgery.

During the formal study presentation, invited discussant Dr. Martyn Thomas, director of cardiovascular services at Guy’s and St. Thomas’ Hospitals, London, said clinicians in the United Kingdom were awaiting results of the cost analysis with bated breath to determine if TAVR could get the nod from the National Institute for Health and Clinical Excellence.

"When I plug in our numbers ... I get somewhere around £20,000 [U.S.$32,700] per QALY [quality-adjusted life-year], which for us would be absolutely perfect," Dr. Thomas said.

Anticipation regarding TAVR has been building since efficacy data reported last fall for the same 358 inoperable patients, known as cohort B, demonstrated a 20% survival benefit with TAVR at 1 year, compared with standard medical therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-6070).

The question, however, is whether the novel procedure will be cost effective in an increasingly heated climate of health care cost containment.

In an attempt to tackle the issue, Dr. Reynolds and his colleagues assessed lifetime incremental cost-effectiveness ratios (ICERs) and lifetime incremental costs per QALY using hospital billing data or MEDPAR when bills were unavailable. Costs from the last 6 months for surviving patients were used to project future costs beyond 12 months, while parametric survival models fit to the trial data were used to extrapolate patient-level life expectancy beyond the follow-up period.

The initial $78,540 price tag for TAVR includes $42,806 for procedural costs, $30,756 for nonprocedural expenses, and $4,978 for physician fees, said Dr. Reynolds, director of the Economics and Quality of Life Research Center at the Harvard Clinical Research Institute, Boston. Patients spent an average of 10 days in the hospital, including 4 days in the intensive care unit.

Twelve-month follow-up costs were $23,372 higher for patients treated with standard medical therapy. This was a result of significantly more hospitalizations in the control group than in the TAVR group (2.15 vs. 1.02), mainly due to cardiovascular causes (1.7 vs. 0.50), he said.

The estimated life expectancy was 3.1 years for patients treated with TAVR and 1.2 years for those treated with medical therapy, or a difference of 1.9 years.

The lifetime incremental cost per patient was $79,837, and the lifetime incremental gain in life expectancy was 1.59 years. This translated into an ICER of $50,212 per life-year gained and $61,889 per QALY, he said.

Additional analysis showed that if the price of the device were to drop to $20,000, the ICER would be $43,642 per life-year gained. In Europe, both the SAPIEN valve (Edwards Lifesciences) and the CoreValve (Medtronic) are already on the market.

On the basis of the data, TAVR in this older inoperable cohort falls very close to published cost-effectiveness estimates for implantable defibrillators and atrial fibrillation ablation, and is actually lower than current estimates for hemodialysis or percutaneous coronary intervention for stable coronary artery disease, Dr. Reynolds said.

"For patients with severe aortic stenosis who are unsuitable for surgical aortic valve replacement, TAVR significantly increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies," he said.

When asked what the budget impact would be of adoption of TAVR, Dr. Reynolds said they have not performed such an analysis, but that an estimated 30% of patients with severe aortic stenosis do not undergo conventional open surgery.

Efficacy data presented at the same session by Dr. Craig Smith on cohort A of the PARTNER trial, revealed that all-cause mortality in 699 high-risk patients with severe aortic stenosis was the same at 1 year, at 24% with TAVR vs. 27% with conventional open surgery, but that the incidence of stroke was increased at 8.3% vs. 4.3%. Cost comparisons of TAVR vs. conventional surgery are not yet available.

Edwards Lifesciences provided grant support for the analysis.

NEW ORLEANS – The cost of transcatheter aortic valve replacement among patients with inoperable severe aortic stenosis is in line with other accepted cardiovascular procedures, according to an economic analysis of the PARTNER trial.

Index hospitalization costs for transcatheter aortic valve replacement (TAVR) were $78,540 based on an estimated cost of $30,000 for the investigational Edwards SAPIEN valve. TAVR was, however, associated with a projected gain in survival, resulting in overall lifetime cost effectiveness.

"In this extremely high-risk population, an elderly population, the intervention is adding roughly 2 years of life, and that is the return on investment," principal investigator Dr. Matthew Reynolds said during a press briefing at the annual meeting of the American College of Cardiology. "The cost-effectiveness ratio, when you do the math, works out to just over $50,000 per life-year gained."

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, said up-front hospital costs for TAVR will be high because of the need for a hybrid operative/interventional suite, but that as long as the risks and costs are reasonable, patients will opt for the percutaneous approach simply because they don’t want surgery.

During the formal study presentation, invited discussant Dr. Martyn Thomas, director of cardiovascular services at Guy’s and St. Thomas’ Hospitals, London, said clinicians in the United Kingdom were awaiting results of the cost analysis with bated breath to determine if TAVR could get the nod from the National Institute for Health and Clinical Excellence.

"When I plug in our numbers ... I get somewhere around £20,000 [U.S.$32,700] per QALY [quality-adjusted life-year], which for us would be absolutely perfect," Dr. Thomas said.

Anticipation regarding TAVR has been building since efficacy data reported last fall for the same 358 inoperable patients, known as cohort B, demonstrated a 20% survival benefit with TAVR at 1 year, compared with standard medical therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-6070).

The question, however, is whether the novel procedure will be cost effective in an increasingly heated climate of health care cost containment.

In an attempt to tackle the issue, Dr. Reynolds and his colleagues assessed lifetime incremental cost-effectiveness ratios (ICERs) and lifetime incremental costs per QALY using hospital billing data or MEDPAR when bills were unavailable. Costs from the last 6 months for surviving patients were used to project future costs beyond 12 months, while parametric survival models fit to the trial data were used to extrapolate patient-level life expectancy beyond the follow-up period.

The initial $78,540 price tag for TAVR includes $42,806 for procedural costs, $30,756 for nonprocedural expenses, and $4,978 for physician fees, said Dr. Reynolds, director of the Economics and Quality of Life Research Center at the Harvard Clinical Research Institute, Boston. Patients spent an average of 10 days in the hospital, including 4 days in the intensive care unit.

Twelve-month follow-up costs were $23,372 higher for patients treated with standard medical therapy. This was a result of significantly more hospitalizations in the control group than in the TAVR group (2.15 vs. 1.02), mainly due to cardiovascular causes (1.7 vs. 0.50), he said.

The estimated life expectancy was 3.1 years for patients treated with TAVR and 1.2 years for those treated with medical therapy, or a difference of 1.9 years.

The lifetime incremental cost per patient was $79,837, and the lifetime incremental gain in life expectancy was 1.59 years. This translated into an ICER of $50,212 per life-year gained and $61,889 per QALY, he said.

Additional analysis showed that if the price of the device were to drop to $20,000, the ICER would be $43,642 per life-year gained. In Europe, both the SAPIEN valve (Edwards Lifesciences) and the CoreValve (Medtronic) are already on the market.

On the basis of the data, TAVR in this older inoperable cohort falls very close to published cost-effectiveness estimates for implantable defibrillators and atrial fibrillation ablation, and is actually lower than current estimates for hemodialysis or percutaneous coronary intervention for stable coronary artery disease, Dr. Reynolds said.

"For patients with severe aortic stenosis who are unsuitable for surgical aortic valve replacement, TAVR significantly increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies," he said.

When asked what the budget impact would be of adoption of TAVR, Dr. Reynolds said they have not performed such an analysis, but that an estimated 30% of patients with severe aortic stenosis do not undergo conventional open surgery.

Efficacy data presented at the same session by Dr. Craig Smith on cohort A of the PARTNER trial, revealed that all-cause mortality in 699 high-risk patients with severe aortic stenosis was the same at 1 year, at 24% with TAVR vs. 27% with conventional open surgery, but that the incidence of stroke was increased at 8.3% vs. 4.3%. Cost comparisons of TAVR vs. conventional surgery are not yet available.

Edwards Lifesciences provided grant support for the analysis.

NEW ORLEANS – The cost of transcatheter aortic valve replacement among patients with inoperable severe aortic stenosis is in line with other accepted cardiovascular procedures, according to an economic analysis of the PARTNER trial.

Index hospitalization costs for transcatheter aortic valve replacement (TAVR) were $78,540 based on an estimated cost of $30,000 for the investigational Edwards SAPIEN valve. TAVR was, however, associated with a projected gain in survival, resulting in overall lifetime cost effectiveness.

"In this extremely high-risk population, an elderly population, the intervention is adding roughly 2 years of life, and that is the return on investment," principal investigator Dr. Matthew Reynolds said during a press briefing at the annual meeting of the American College of Cardiology. "The cost-effectiveness ratio, when you do the math, works out to just over $50,000 per life-year gained."

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, said up-front hospital costs for TAVR will be high because of the need for a hybrid operative/interventional suite, but that as long as the risks and costs are reasonable, patients will opt for the percutaneous approach simply because they don’t want surgery.

During the formal study presentation, invited discussant Dr. Martyn Thomas, director of cardiovascular services at Guy’s and St. Thomas’ Hospitals, London, said clinicians in the United Kingdom were awaiting results of the cost analysis with bated breath to determine if TAVR could get the nod from the National Institute for Health and Clinical Excellence.

"When I plug in our numbers ... I get somewhere around £20,000 [U.S.$32,700] per QALY [quality-adjusted life-year], which for us would be absolutely perfect," Dr. Thomas said.

Anticipation regarding TAVR has been building since efficacy data reported last fall for the same 358 inoperable patients, known as cohort B, demonstrated a 20% survival benefit with TAVR at 1 year, compared with standard medical therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-6070).

The question, however, is whether the novel procedure will be cost effective in an increasingly heated climate of health care cost containment.

In an attempt to tackle the issue, Dr. Reynolds and his colleagues assessed lifetime incremental cost-effectiveness ratios (ICERs) and lifetime incremental costs per QALY using hospital billing data or MEDPAR when bills were unavailable. Costs from the last 6 months for surviving patients were used to project future costs beyond 12 months, while parametric survival models fit to the trial data were used to extrapolate patient-level life expectancy beyond the follow-up period.

The initial $78,540 price tag for TAVR includes $42,806 for procedural costs, $30,756 for nonprocedural expenses, and $4,978 for physician fees, said Dr. Reynolds, director of the Economics and Quality of Life Research Center at the Harvard Clinical Research Institute, Boston. Patients spent an average of 10 days in the hospital, including 4 days in the intensive care unit.

Twelve-month follow-up costs were $23,372 higher for patients treated with standard medical therapy. This was a result of significantly more hospitalizations in the control group than in the TAVR group (2.15 vs. 1.02), mainly due to cardiovascular causes (1.7 vs. 0.50), he said.

The estimated life expectancy was 3.1 years for patients treated with TAVR and 1.2 years for those treated with medical therapy, or a difference of 1.9 years.

The lifetime incremental cost per patient was $79,837, and the lifetime incremental gain in life expectancy was 1.59 years. This translated into an ICER of $50,212 per life-year gained and $61,889 per QALY, he said.

Additional analysis showed that if the price of the device were to drop to $20,000, the ICER would be $43,642 per life-year gained. In Europe, both the SAPIEN valve (Edwards Lifesciences) and the CoreValve (Medtronic) are already on the market.

On the basis of the data, TAVR in this older inoperable cohort falls very close to published cost-effectiveness estimates for implantable defibrillators and atrial fibrillation ablation, and is actually lower than current estimates for hemodialysis or percutaneous coronary intervention for stable coronary artery disease, Dr. Reynolds said.

"For patients with severe aortic stenosis who are unsuitable for surgical aortic valve replacement, TAVR significantly increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies," he said.

When asked what the budget impact would be of adoption of TAVR, Dr. Reynolds said they have not performed such an analysis, but that an estimated 30% of patients with severe aortic stenosis do not undergo conventional open surgery.

Efficacy data presented at the same session by Dr. Craig Smith on cohort A of the PARTNER trial, revealed that all-cause mortality in 699 high-risk patients with severe aortic stenosis was the same at 1 year, at 24% with TAVR vs. 27% with conventional open surgery, but that the incidence of stroke was increased at 8.3% vs. 4.3%. Cost comparisons of TAVR vs. conventional surgery are not yet available.

Edwards Lifesciences provided grant support for the analysis.

NEW ORLEANS – The cost of transcatheter aortic valve replacement among patients with inoperable severe aortic stenosis is in line with other accepted cardiovascular procedures, according to an economic analysis of the PARTNER trial.

Index hospitalization costs for transcatheter aortic valve replacement (TAVR) were $78,540 based on an estimated cost of $30,000 for the investigational Edwards SAPIEN valve. TAVR was, however, associated with a projected gain in survival, resulting in overall lifetime cost effectiveness.

"In this extremely high-risk population, an elderly population, the intervention is adding roughly 2 years of life, and that is the return on investment," principal investigator Dr. Matthew Reynolds said during a press briefing at the annual meeting of the American College of Cardiology. "The cost-effectiveness ratio, when you do the math, works out to just over $50,000 per life-year gained."

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, said up-front hospital costs for TAVR will be high because of the need for a hybrid operative/interventional suite, but that as long as the risks and costs are reasonable, patients will opt for the percutaneous approach simply because they don’t want surgery.

During the formal study presentation, invited discussant Dr. Martyn Thomas, director of cardiovascular services at Guy’s and St. Thomas’ Hospitals, London, said clinicians in the United Kingdom were awaiting results of the cost analysis with bated breath to determine if TAVR could get the nod from the National Institute for Health and Clinical Excellence.

"When I plug in our numbers ... I get somewhere around £20,000 [U.S.$32,700] per QALY [quality-adjusted life-year], which for us would be absolutely perfect," Dr. Thomas said.

Anticipation regarding TAVR has been building since efficacy data reported last fall for the same 358 inoperable patients, known as cohort B, demonstrated a 20% survival benefit with TAVR at 1 year, compared with standard medical therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-6070).

The question, however, is whether the novel procedure will be cost effective in an increasingly heated climate of health care cost containment.

In an attempt to tackle the issue, Dr. Reynolds and his colleagues assessed lifetime incremental cost-effectiveness ratios (ICERs) and lifetime incremental costs per QALY using hospital billing data or MEDPAR when bills were unavailable. Costs from the last 6 months for surviving patients were used to project future costs beyond 12 months, while parametric survival models fit to the trial data were used to extrapolate patient-level life expectancy beyond the follow-up period.

The initial $78,540 price tag for TAVR includes $42,806 for procedural costs, $30,756 for nonprocedural expenses, and $4,978 for physician fees, said Dr. Reynolds, director of the Economics and Quality of Life Research Center at the Harvard Clinical Research Institute, Boston. Patients spent an average of 10 days in the hospital, including 4 days in the intensive care unit.

Twelve-month follow-up costs were $23,372 higher for patients treated with standard medical therapy. This was a result of significantly more hospitalizations in the control group than in the TAVR group (2.15 vs. 1.02), mainly due to cardiovascular causes (1.7 vs. 0.50), he said.

The estimated life expectancy was 3.1 years for patients treated with TAVR and 1.2 years for those treated with medical therapy, or a difference of 1.9 years.

The lifetime incremental cost per patient was $79,837, and the lifetime incremental gain in life expectancy was 1.59 years. This translated into an ICER of $50,212 per life-year gained and $61,889 per QALY, he said.

Additional analysis showed that if the price of the device were to drop to $20,000, the ICER would be $43,642 per life-year gained. In Europe, both the SAPIEN valve (Edwards Lifesciences) and the CoreValve (Medtronic) are already on the market.

On the basis of the data, TAVR in this older inoperable cohort falls very close to published cost-effectiveness estimates for implantable defibrillators and atrial fibrillation ablation, and is actually lower than current estimates for hemodialysis or percutaneous coronary intervention for stable coronary artery disease, Dr. Reynolds said.

"For patients with severe aortic stenosis who are unsuitable for surgical aortic valve replacement, TAVR significantly increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies," he said.

When asked what the budget impact would be of adoption of TAVR, Dr. Reynolds said they have not performed such an analysis, but that an estimated 30% of patients with severe aortic stenosis do not undergo conventional open surgery.

Efficacy data presented at the same session by Dr. Craig Smith on cohort A of the PARTNER trial, revealed that all-cause mortality in 699 high-risk patients with severe aortic stenosis was the same at 1 year, at 24% with TAVR vs. 27% with conventional open surgery, but that the incidence of stroke was increased at 8.3% vs. 4.3%. Cost comparisons of TAVR vs. conventional surgery are not yet available.

Edwards Lifesciences provided grant support for the analysis.

NEW ORLEANS – The cost of transcatheter aortic valve replacement among patients with inoperable severe aortic stenosis is in line with other accepted cardiovascular procedures, according to an economic analysis of the PARTNER trial.

Index hospitalization costs for transcatheter aortic valve replacement (TAVR) were $78,540 based on an estimated cost of $30,000 for the investigational Edwards SAPIEN valve. TAVR was, however, associated with a projected gain in survival, resulting in overall lifetime cost effectiveness.

"In this extremely high-risk population, an elderly population, the intervention is adding roughly 2 years of life, and that is the return on investment," principal investigator Dr. Matthew Reynolds said during a press briefing at the annual meeting of the American College of Cardiology. "The cost-effectiveness ratio, when you do the math, works out to just over $50,000 per life-year gained."

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, said up-front hospital costs for TAVR will be high because of the need for a hybrid operative/interventional suite, but that as long as the risks and costs are reasonable, patients will opt for the percutaneous approach simply because they don’t want surgery.

During the formal study presentation, invited discussant Dr. Martyn Thomas, director of cardiovascular services at Guy’s and St. Thomas’ Hospitals, London, said clinicians in the United Kingdom were awaiting results of the cost analysis with bated breath to determine if TAVR could get the nod from the National Institute for Health and Clinical Excellence.

"When I plug in our numbers ... I get somewhere around £20,000 [U.S.$32,700] per QALY [quality-adjusted life-year], which for us would be absolutely perfect," Dr. Thomas said.

Anticipation regarding TAVR has been building since efficacy data reported last fall for the same 358 inoperable patients, known as cohort B, demonstrated a 20% survival benefit with TAVR at 1 year, compared with standard medical therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-6070).

The question, however, is whether the novel procedure will be cost effective in an increasingly heated climate of health care cost containment.

In an attempt to tackle the issue, Dr. Reynolds and his colleagues assessed lifetime incremental cost-effectiveness ratios (ICERs) and lifetime incremental costs per QALY using hospital billing data or MEDPAR when bills were unavailable. Costs from the last 6 months for surviving patients were used to project future costs beyond 12 months, while parametric survival models fit to the trial data were used to extrapolate patient-level life expectancy beyond the follow-up period.

The initial $78,540 price tag for TAVR includes $42,806 for procedural costs, $30,756 for nonprocedural expenses, and $4,978 for physician fees, said Dr. Reynolds, director of the Economics and Quality of Life Research Center at the Harvard Clinical Research Institute, Boston. Patients spent an average of 10 days in the hospital, including 4 days in the intensive care unit.

Twelve-month follow-up costs were $23,372 higher for patients treated with standard medical therapy. This was a result of significantly more hospitalizations in the control group than in the TAVR group (2.15 vs. 1.02), mainly due to cardiovascular causes (1.7 vs. 0.50), he said.

The estimated life expectancy was 3.1 years for patients treated with TAVR and 1.2 years for those treated with medical therapy, or a difference of 1.9 years.

The lifetime incremental cost per patient was $79,837, and the lifetime incremental gain in life expectancy was 1.59 years. This translated into an ICER of $50,212 per life-year gained and $61,889 per QALY, he said.

Additional analysis showed that if the price of the device were to drop to $20,000, the ICER would be $43,642 per life-year gained. In Europe, both the SAPIEN valve (Edwards Lifesciences) and the CoreValve (Medtronic) are already on the market.

On the basis of the data, TAVR in this older inoperable cohort falls very close to published cost-effectiveness estimates for implantable defibrillators and atrial fibrillation ablation, and is actually lower than current estimates for hemodialysis or percutaneous coronary intervention for stable coronary artery disease, Dr. Reynolds said.

"For patients with severe aortic stenosis who are unsuitable for surgical aortic valve replacement, TAVR significantly increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies," he said.

When asked what the budget impact would be of adoption of TAVR, Dr. Reynolds said they have not performed such an analysis, but that an estimated 30% of patients with severe aortic stenosis do not undergo conventional open surgery.

Efficacy data presented at the same session by Dr. Craig Smith on cohort A of the PARTNER trial, revealed that all-cause mortality in 699 high-risk patients with severe aortic stenosis was the same at 1 year, at 24% with TAVR vs. 27% with conventional open surgery, but that the incidence of stroke was increased at 8.3% vs. 4.3%. Cost comparisons of TAVR vs. conventional surgery are not yet available.

Edwards Lifesciences provided grant support for the analysis.

NEW ORLEANS – The cost of transcatheter aortic valve replacement among patients with inoperable severe aortic stenosis is in line with other accepted cardiovascular procedures, according to an economic analysis of the PARTNER trial.

Index hospitalization costs for transcatheter aortic valve replacement (TAVR) were $78,540 based on an estimated cost of $30,000 for the investigational Edwards SAPIEN valve. TAVR was, however, associated with a projected gain in survival, resulting in overall lifetime cost effectiveness.

"In this extremely high-risk population, an elderly population, the intervention is adding roughly 2 years of life, and that is the return on investment," principal investigator Dr. Matthew Reynolds said during a press briefing at the annual meeting of the American College of Cardiology. "The cost-effectiveness ratio, when you do the math, works out to just over $50,000 per life-year gained."

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, said up-front hospital costs for TAVR will be high because of the need for a hybrid operative/interventional suite, but that as long as the risks and costs are reasonable, patients will opt for the percutaneous approach simply because they don’t want surgery.

During the formal study presentation, invited discussant Dr. Martyn Thomas, director of cardiovascular services at Guy’s and St. Thomas’ Hospitals, London, said clinicians in the United Kingdom were awaiting results of the cost analysis with bated breath to determine if TAVR could get the nod from the National Institute for Health and Clinical Excellence.

"When I plug in our numbers ... I get somewhere around £20,000 [U.S.$32,700] per QALY [quality-adjusted life-year], which for us would be absolutely perfect," Dr. Thomas said.

Anticipation regarding TAVR has been building since efficacy data reported last fall for the same 358 inoperable patients, known as cohort B, demonstrated a 20% survival benefit with TAVR at 1 year, compared with standard medical therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-6070).

The question, however, is whether the novel procedure will be cost effective in an increasingly heated climate of health care cost containment.

In an attempt to tackle the issue, Dr. Reynolds and his colleagues assessed lifetime incremental cost-effectiveness ratios (ICERs) and lifetime incremental costs per QALY using hospital billing data or MEDPAR when bills were unavailable. Costs from the last 6 months for surviving patients were used to project future costs beyond 12 months, while parametric survival models fit to the trial data were used to extrapolate patient-level life expectancy beyond the follow-up period.

The initial $78,540 price tag for TAVR includes $42,806 for procedural costs, $30,756 for nonprocedural expenses, and $4,978 for physician fees, said Dr. Reynolds, director of the Economics and Quality of Life Research Center at the Harvard Clinical Research Institute, Boston. Patients spent an average of 10 days in the hospital, including 4 days in the intensive care unit.

Twelve-month follow-up costs were $23,372 higher for patients treated with standard medical therapy. This was a result of significantly more hospitalizations in the control group than in the TAVR group (2.15 vs. 1.02), mainly due to cardiovascular causes (1.7 vs. 0.50), he said.

The estimated life expectancy was 3.1 years for patients treated with TAVR and 1.2 years for those treated with medical therapy, or a difference of 1.9 years.

The lifetime incremental cost per patient was $79,837, and the lifetime incremental gain in life expectancy was 1.59 years. This translated into an ICER of $50,212 per life-year gained and $61,889 per QALY, he said.

Additional analysis showed that if the price of the device were to drop to $20,000, the ICER would be $43,642 per life-year gained. In Europe, both the SAPIEN valve (Edwards Lifesciences) and the CoreValve (Medtronic) are already on the market.

On the basis of the data, TAVR in this older inoperable cohort falls very close to published cost-effectiveness estimates for implantable defibrillators and atrial fibrillation ablation, and is actually lower than current estimates for hemodialysis or percutaneous coronary intervention for stable coronary artery disease, Dr. Reynolds said.

"For patients with severe aortic stenosis who are unsuitable for surgical aortic valve replacement, TAVR significantly increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies," he said.

When asked what the budget impact would be of adoption of TAVR, Dr. Reynolds said they have not performed such an analysis, but that an estimated 30% of patients with severe aortic stenosis do not undergo conventional open surgery.

Efficacy data presented at the same session by Dr. Craig Smith on cohort A of the PARTNER trial, revealed that all-cause mortality in 699 high-risk patients with severe aortic stenosis was the same at 1 year, at 24% with TAVR vs. 27% with conventional open surgery, but that the incidence of stroke was increased at 8.3% vs. 4.3%. Cost comparisons of TAVR vs. conventional surgery are not yet available.

Edwards Lifesciences provided grant support for the analysis.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – Prevention of major cardiovascular events was similar in a comparison of valsartan and amlodipine in patients with hypertension and diabetes or glucose intolerance, according to a Japanese study presented April 5 at the annual meeting of the American College of Cardiology.

The Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment (NAGOYA-HEART) Study is the first randomized trial to compare the effects of an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) on cardiovascular outcomes in this patient population. No significant differences were found between the two classes, reported Dr. Toyoaki Murohara of Nagoya (Japan) University.

"Our study showed no difference in the efficacies between the ARB and the CCB in terms of prevention of major cardiovascular events, [however] the ARB was superior to the CCB in preventing heart failure, especially in diabetic patients," Dr. Murohara said.

All-cause mortality also was similar. Hospital admission for heart failure was the only outcome measure in which there was a statistically significant difference between the two agents.

In previous nonrandomized analyses comparing ARBs with CCBs, results have been conflicting and, therefore, the preferred first-line class of agents is not well established, Dr. Murohara said. Guidelines mainly recommend ARBs and ACE inhibitors for first-line treatment and reserve CCBs as alternatives or second-line agents, he added.

The NAGOYA-HEART Study is an investigator-initiated trial applying a prospective, randomized open-label, blinded-endpoint (PROBE) method in which allocated treatment was open label but outcomes were adjudicated in a blinded manner as for drug assignment.

The Japanese research team enrolled 1,150 hypertensive patients with either type 2 diabetes (82%) or impaired glucose tolerance (18%) at 46 facilities across the country between 2004 and 2010. Mean glycosylated hemoglobin was 7.0% on the valsartan arm and 6.9% on the amlodipine arm and fasting plasma glucose levels were 8.2 mmol/L and 7.9 mmol/L, respectively. Mean blood pressure was 144/82 mm Hg in each arm.

Patients were randomized to receive either valsartan or amlodipine as their first-line antihypertensive agent. After a run-in phase, patients received valsartan 80 mg/day, titrating to 160 mg/day after 1 week of treatment, or amlodipine 5 mg/day, titrating to 10 mg/day. Both arms could receive other antihypertensives as needed, excluding ACE inhibitors, other ARBs, or CCBs.

The treatment goal was to reduce blood pressure to below 130/80 mm Hg. The primary outcome was a composite of cardiovascular events (acute myocardial infarction, stroke, coronary revascularization, admission due to heart failure, and sudden cardiac death); all-cause mortality was a secondary outcome.

The efficacy and safety analyses included 575 in both the valsartan and amlodipine arms. Patients were followed a median of 3.2 years.

Blood pressure lowering and glucose control were similar between the treatment arms. Blood pressure levels achieved were 131/73 mm Hg with valsartan and 132/74 mm Hg with amlodipine. Final hemoglobin A1C was 6.7% in each arm, Dr. Murohara reported.

There was no difference between the agents in the primary composite cardiovascular outcome. At 3.2 years, cardiovascular events were observed in 54 (9.4%) patients in the valsartan group and 56 (9.7%) in the amlodipine group. "The time-to-event curves showed no difference between the two groups," he said.

Among the components of the composite, only heart failure was affected by treatment, noted in 3 (0.5%) patients on valsartan, compared with 15 (2.6%) on amlodipine, a significant difference. Valsartan use was associated with an 80% relative risk reduction in heart failure admissions.

Safety outcomes were similar, with at least one adverse event reported by 106 patients in the valsartan arm and 112 in the amlodipine arm.

"Our results highlight the safety and efficacy of an ARB, especially in preventing heart failure," he noted, "and support the current recommendations for diabetic hypertensive patients."

Session panelist Dr. Sara Sirna of Temple University, Philadelphia, commented that the NAGOYA-HEART Study is "an excellent study on two drugs we commonly use for patients with diabetes and hypertension, which we see every day in our practices."

She questioned whether there may be a subgroup that would fare better with one versus the other agent. "The ejection fraction was about 40%, mildly reduced, yet those patients seemed to do better on valsartan," she observed.

Dr. Murohara responded that the study did not recruit patients with overt heart failure, but he noted that since the renin-angiotensin system is activated in the setting of heart failure, it makes sense that new-onset heart failure may be prevented better with the ARB.

The study was funded and supported by Nagoya University. Dr. Murohara reported receiving lecturer’s fees from Daiichi-Sankyo, Novartis, Pfizer, and Takeda. Dr. Sirna reported no relevant disclosures.

[Want more news from the ACC's annual scientific session? Check out our complete coverage of the meeting.]

NEW ORLEANS – Prevention of major cardiovascular events was similar in a comparison of valsartan and amlodipine in patients with hypertension and diabetes or glucose intolerance, according to a Japanese study presented April 5 at the annual meeting of the American College of Cardiology.

The Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment (NAGOYA-HEART) Study is the first randomized trial to compare the effects of an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) on cardiovascular outcomes in this patient population. No significant differences were found between the two classes, reported Dr. Toyoaki Murohara of Nagoya (Japan) University.

"Our study showed no difference in the efficacies between the ARB and the CCB in terms of prevention of major cardiovascular events, [however] the ARB was superior to the CCB in preventing heart failure, especially in diabetic patients," Dr. Murohara said.

All-cause mortality also was similar. Hospital admission for heart failure was the only outcome measure in which there was a statistically significant difference between the two agents.

In previous nonrandomized analyses comparing ARBs with CCBs, results have been conflicting and, therefore, the preferred first-line class of agents is not well established, Dr. Murohara said. Guidelines mainly recommend ARBs and ACE inhibitors for first-line treatment and reserve CCBs as alternatives or second-line agents, he added.

The NAGOYA-HEART Study is an investigator-initiated trial applying a prospective, randomized open-label, blinded-endpoint (PROBE) method in which allocated treatment was open label but outcomes were adjudicated in a blinded manner as for drug assignment.

The Japanese research team enrolled 1,150 hypertensive patients with either type 2 diabetes (82%) or impaired glucose tolerance (18%) at 46 facilities across the country between 2004 and 2010. Mean glycosylated hemoglobin was 7.0% on the valsartan arm and 6.9% on the amlodipine arm and fasting plasma glucose levels were 8.2 mmol/L and 7.9 mmol/L, respectively. Mean blood pressure was 144/82 mm Hg in each arm.

Patients were randomized to receive either valsartan or amlodipine as their first-line antihypertensive agent. After a run-in phase, patients received valsartan 80 mg/day, titrating to 160 mg/day after 1 week of treatment, or amlodipine 5 mg/day, titrating to 10 mg/day. Both arms could receive other antihypertensives as needed, excluding ACE inhibitors, other ARBs, or CCBs.

The treatment goal was to reduce blood pressure to below 130/80 mm Hg. The primary outcome was a composite of cardiovascular events (acute myocardial infarction, stroke, coronary revascularization, admission due to heart failure, and sudden cardiac death); all-cause mortality was a secondary outcome.

The efficacy and safety analyses included 575 in both the valsartan and amlodipine arms. Patients were followed a median of 3.2 years.

Blood pressure lowering and glucose control were similar between the treatment arms. Blood pressure levels achieved were 131/73 mm Hg with valsartan and 132/74 mm Hg with amlodipine. Final hemoglobin A1C was 6.7% in each arm, Dr. Murohara reported.

There was no difference between the agents in the primary composite cardiovascular outcome. At 3.2 years, cardiovascular events were observed in 54 (9.4%) patients in the valsartan group and 56 (9.7%) in the amlodipine group. "The time-to-event curves showed no difference between the two groups," he said.

Among the components of the composite, only heart failure was affected by treatment, noted in 3 (0.5%) patients on valsartan, compared with 15 (2.6%) on amlodipine, a significant difference. Valsartan use was associated with an 80% relative risk reduction in heart failure admissions.

Safety outcomes were similar, with at least one adverse event reported by 106 patients in the valsartan arm and 112 in the amlodipine arm.

"Our results highlight the safety and efficacy of an ARB, especially in preventing heart failure," he noted, "and support the current recommendations for diabetic hypertensive patients."

Session panelist Dr. Sara Sirna of Temple University, Philadelphia, commented that the NAGOYA-HEART Study is "an excellent study on two drugs we commonly use for patients with diabetes and hypertension, which we see every day in our practices."

She questioned whether there may be a subgroup that would fare better with one versus the other agent. "The ejection fraction was about 40%, mildly reduced, yet those patients seemed to do better on valsartan," she observed.

Dr. Murohara responded that the study did not recruit patients with overt heart failure, but he noted that since the renin-angiotensin system is activated in the setting of heart failure, it makes sense that new-onset heart failure may be prevented better with the ARB.

The study was funded and supported by Nagoya University. Dr. Murohara reported receiving lecturer’s fees from Daiichi-Sankyo, Novartis, Pfizer, and Takeda. Dr. Sirna reported no relevant disclosures.

[Want more news from the ACC's annual scientific session? Check out our complete coverage of the meeting.]

NEW ORLEANS – Prevention of major cardiovascular events was similar in a comparison of valsartan and amlodipine in patients with hypertension and diabetes or glucose intolerance, according to a Japanese study presented April 5 at the annual meeting of the American College of Cardiology.

The Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment (NAGOYA-HEART) Study is the first randomized trial to compare the effects of an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) on cardiovascular outcomes in this patient population. No significant differences were found between the two classes, reported Dr. Toyoaki Murohara of Nagoya (Japan) University.

"Our study showed no difference in the efficacies between the ARB and the CCB in terms of prevention of major cardiovascular events, [however] the ARB was superior to the CCB in preventing heart failure, especially in diabetic patients," Dr. Murohara said.

All-cause mortality also was similar. Hospital admission for heart failure was the only outcome measure in which there was a statistically significant difference between the two agents.

In previous nonrandomized analyses comparing ARBs with CCBs, results have been conflicting and, therefore, the preferred first-line class of agents is not well established, Dr. Murohara said. Guidelines mainly recommend ARBs and ACE inhibitors for first-line treatment and reserve CCBs as alternatives or second-line agents, he added.

The NAGOYA-HEART Study is an investigator-initiated trial applying a prospective, randomized open-label, blinded-endpoint (PROBE) method in which allocated treatment was open label but outcomes were adjudicated in a blinded manner as for drug assignment.

The Japanese research team enrolled 1,150 hypertensive patients with either type 2 diabetes (82%) or impaired glucose tolerance (18%) at 46 facilities across the country between 2004 and 2010. Mean glycosylated hemoglobin was 7.0% on the valsartan arm and 6.9% on the amlodipine arm and fasting plasma glucose levels were 8.2 mmol/L and 7.9 mmol/L, respectively. Mean blood pressure was 144/82 mm Hg in each arm.

Patients were randomized to receive either valsartan or amlodipine as their first-line antihypertensive agent. After a run-in phase, patients received valsartan 80 mg/day, titrating to 160 mg/day after 1 week of treatment, or amlodipine 5 mg/day, titrating to 10 mg/day. Both arms could receive other antihypertensives as needed, excluding ACE inhibitors, other ARBs, or CCBs.

The treatment goal was to reduce blood pressure to below 130/80 mm Hg. The primary outcome was a composite of cardiovascular events (acute myocardial infarction, stroke, coronary revascularization, admission due to heart failure, and sudden cardiac death); all-cause mortality was a secondary outcome.

The efficacy and safety analyses included 575 in both the valsartan and amlodipine arms. Patients were followed a median of 3.2 years.

Blood pressure lowering and glucose control were similar between the treatment arms. Blood pressure levels achieved were 131/73 mm Hg with valsartan and 132/74 mm Hg with amlodipine. Final hemoglobin A1C was 6.7% in each arm, Dr. Murohara reported.

There was no difference between the agents in the primary composite cardiovascular outcome. At 3.2 years, cardiovascular events were observed in 54 (9.4%) patients in the valsartan group and 56 (9.7%) in the amlodipine group. "The time-to-event curves showed no difference between the two groups," he said.

Among the components of the composite, only heart failure was affected by treatment, noted in 3 (0.5%) patients on valsartan, compared with 15 (2.6%) on amlodipine, a significant difference. Valsartan use was associated with an 80% relative risk reduction in heart failure admissions.

Safety outcomes were similar, with at least one adverse event reported by 106 patients in the valsartan arm and 112 in the amlodipine arm.

"Our results highlight the safety and efficacy of an ARB, especially in preventing heart failure," he noted, "and support the current recommendations for diabetic hypertensive patients."

Session panelist Dr. Sara Sirna of Temple University, Philadelphia, commented that the NAGOYA-HEART Study is "an excellent study on two drugs we commonly use for patients with diabetes and hypertension, which we see every day in our practices."

She questioned whether there may be a subgroup that would fare better with one versus the other agent. "The ejection fraction was about 40%, mildly reduced, yet those patients seemed to do better on valsartan," she observed.

Dr. Murohara responded that the study did not recruit patients with overt heart failure, but he noted that since the renin-angiotensin system is activated in the setting of heart failure, it makes sense that new-onset heart failure may be prevented better with the ARB.

The study was funded and supported by Nagoya University. Dr. Murohara reported receiving lecturer’s fees from Daiichi-Sankyo, Novartis, Pfizer, and Takeda. Dr. Sirna reported no relevant disclosures.

[Want more news from the ACC's annual scientific session? Check out our complete coverage of the meeting.]

NEW ORLEANS – Prevention of major cardiovascular events was similar in a comparison of valsartan and amlodipine in patients with hypertension and diabetes or glucose intolerance, according to a Japanese study presented April 5 at the annual meeting of the American College of Cardiology.

The Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment (NAGOYA-HEART) Study is the first randomized trial to compare the effects of an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) on cardiovascular outcomes in this patient population. No significant differences were found between the two classes, reported Dr. Toyoaki Murohara of Nagoya (Japan) University.

"Our study showed no difference in the efficacies between the ARB and the CCB in terms of prevention of major cardiovascular events, [however] the ARB was superior to the CCB in preventing heart failure, especially in diabetic patients," Dr. Murohara said.

All-cause mortality also was similar. Hospital admission for heart failure was the only outcome measure in which there was a statistically significant difference between the two agents.

In previous nonrandomized analyses comparing ARBs with CCBs, results have been conflicting and, therefore, the preferred first-line class of agents is not well established, Dr. Murohara said. Guidelines mainly recommend ARBs and ACE inhibitors for first-line treatment and reserve CCBs as alternatives or second-line agents, he added.

The NAGOYA-HEART Study is an investigator-initiated trial applying a prospective, randomized open-label, blinded-endpoint (PROBE) method in which allocated treatment was open label but outcomes were adjudicated in a blinded manner as for drug assignment.

The Japanese research team enrolled 1,150 hypertensive patients with either type 2 diabetes (82%) or impaired glucose tolerance (18%) at 46 facilities across the country between 2004 and 2010. Mean glycosylated hemoglobin was 7.0% on the valsartan arm and 6.9% on the amlodipine arm and fasting plasma glucose levels were 8.2 mmol/L and 7.9 mmol/L, respectively. Mean blood pressure was 144/82 mm Hg in each arm.

Patients were randomized to receive either valsartan or amlodipine as their first-line antihypertensive agent. After a run-in phase, patients received valsartan 80 mg/day, titrating to 160 mg/day after 1 week of treatment, or amlodipine 5 mg/day, titrating to 10 mg/day. Both arms could receive other antihypertensives as needed, excluding ACE inhibitors, other ARBs, or CCBs.

The treatment goal was to reduce blood pressure to below 130/80 mm Hg. The primary outcome was a composite of cardiovascular events (acute myocardial infarction, stroke, coronary revascularization, admission due to heart failure, and sudden cardiac death); all-cause mortality was a secondary outcome.

The efficacy and safety analyses included 575 in both the valsartan and amlodipine arms. Patients were followed a median of 3.2 years.

Blood pressure lowering and glucose control were similar between the treatment arms. Blood pressure levels achieved were 131/73 mm Hg with valsartan and 132/74 mm Hg with amlodipine. Final hemoglobin A1C was 6.7% in each arm, Dr. Murohara reported.

There was no difference between the agents in the primary composite cardiovascular outcome. At 3.2 years, cardiovascular events were observed in 54 (9.4%) patients in the valsartan group and 56 (9.7%) in the amlodipine group. "The time-to-event curves showed no difference between the two groups," he said.

Among the components of the composite, only heart failure was affected by treatment, noted in 3 (0.5%) patients on valsartan, compared with 15 (2.6%) on amlodipine, a significant difference. Valsartan use was associated with an 80% relative risk reduction in heart failure admissions.

Safety outcomes were similar, with at least one adverse event reported by 106 patients in the valsartan arm and 112 in the amlodipine arm.

"Our results highlight the safety and efficacy of an ARB, especially in preventing heart failure," he noted, "and support the current recommendations for diabetic hypertensive patients."

Session panelist Dr. Sara Sirna of Temple University, Philadelphia, commented that the NAGOYA-HEART Study is "an excellent study on two drugs we commonly use for patients with diabetes and hypertension, which we see every day in our practices."

She questioned whether there may be a subgroup that would fare better with one versus the other agent. "The ejection fraction was about 40%, mildly reduced, yet those patients seemed to do better on valsartan," she observed.

Dr. Murohara responded that the study did not recruit patients with overt heart failure, but he noted that since the renin-angiotensin system is activated in the setting of heart failure, it makes sense that new-onset heart failure may be prevented better with the ARB.

The study was funded and supported by Nagoya University. Dr. Murohara reported receiving lecturer’s fees from Daiichi-Sankyo, Novartis, Pfizer, and Takeda. Dr. Sirna reported no relevant disclosures.

NEW ORLEANS – Prevention of major cardiovascular events was similar in a comparison of valsartan and amlodipine in patients with hypertension and diabetes or glucose intolerance, according to a Japanese study presented April 5 at the annual meeting of the American College of Cardiology.

The Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment (NAGOYA-HEART) Study is the first randomized trial to compare the effects of an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) on cardiovascular outcomes in this patient population. No significant differences were found between the two classes, reported Dr. Toyoaki Murohara of Nagoya (Japan) University.

"Our study showed no difference in the efficacies between the ARB and the CCB in terms of prevention of major cardiovascular events, [however] the ARB was superior to the CCB in preventing heart failure, especially in diabetic patients," Dr. Murohara said.

All-cause mortality also was similar. Hospital admission for heart failure was the only outcome measure in which there was a statistically significant difference between the two agents.

In previous nonrandomized analyses comparing ARBs with CCBs, results have been conflicting and, therefore, the preferred first-line class of agents is not well established, Dr. Murohara said. Guidelines mainly recommend ARBs and ACE inhibitors for first-line treatment and reserve CCBs as alternatives or second-line agents, he added.

The NAGOYA-HEART Study is an investigator-initiated trial applying a prospective, randomized open-label, blinded-endpoint (PROBE) method in which allocated treatment was open label but outcomes were adjudicated in a blinded manner as for drug assignment.

The Japanese research team enrolled 1,150 hypertensive patients with either type 2 diabetes (82%) or impaired glucose tolerance (18%) at 46 facilities across the country between 2004 and 2010. Mean glycosylated hemoglobin was 7.0% on the valsartan arm and 6.9% on the amlodipine arm and fasting plasma glucose levels were 8.2 mmol/L and 7.9 mmol/L, respectively. Mean blood pressure was 144/82 mm Hg in each arm.

Patients were randomized to receive either valsartan or amlodipine as their first-line antihypertensive agent. After a run-in phase, patients received valsartan 80 mg/day, titrating to 160 mg/day after 1 week of treatment, or amlodipine 5 mg/day, titrating to 10 mg/day. Both arms could receive other antihypertensives as needed, excluding ACE inhibitors, other ARBs, or CCBs.

The treatment goal was to reduce blood pressure to below 130/80 mm Hg. The primary outcome was a composite of cardiovascular events (acute myocardial infarction, stroke, coronary revascularization, admission due to heart failure, and sudden cardiac death); all-cause mortality was a secondary outcome.

The efficacy and safety analyses included 575 in both the valsartan and amlodipine arms. Patients were followed a median of 3.2 years.

Blood pressure lowering and glucose control were similar between the treatment arms. Blood pressure levels achieved were 131/73 mm Hg with valsartan and 132/74 mm Hg with amlodipine. Final hemoglobin A1C was 6.7% in each arm, Dr. Murohara reported.

There was no difference between the agents in the primary composite cardiovascular outcome. At 3.2 years, cardiovascular events were observed in 54 (9.4%) patients in the valsartan group and 56 (9.7%) in the amlodipine group. "The time-to-event curves showed no difference between the two groups," he said.

Among the components of the composite, only heart failure was affected by treatment, noted in 3 (0.5%) patients on valsartan, compared with 15 (2.6%) on amlodipine, a significant difference. Valsartan use was associated with an 80% relative risk reduction in heart failure admissions.

Safety outcomes were similar, with at least one adverse event reported by 106 patients in the valsartan arm and 112 in the amlodipine arm.

"Our results highlight the safety and efficacy of an ARB, especially in preventing heart failure," he noted, "and support the current recommendations for diabetic hypertensive patients."

Session panelist Dr. Sara Sirna of Temple University, Philadelphia, commented that the NAGOYA-HEART Study is "an excellent study on two drugs we commonly use for patients with diabetes and hypertension, which we see every day in our practices."

She questioned whether there may be a subgroup that would fare better with one versus the other agent. "The ejection fraction was about 40%, mildly reduced, yet those patients seemed to do better on valsartan," she observed.

Dr. Murohara responded that the study did not recruit patients with overt heart failure, but he noted that since the renin-angiotensin system is activated in the setting of heart failure, it makes sense that new-onset heart failure may be prevented better with the ARB.

The study was funded and supported by Nagoya University. Dr. Murohara reported receiving lecturer’s fees from Daiichi-Sankyo, Novartis, Pfizer, and Takeda. Dr. Sirna reported no relevant disclosures.

NEW ORLEANS – Prevention of major cardiovascular events was similar in a comparison of valsartan and amlodipine in patients with hypertension and diabetes or glucose intolerance, according to a Japanese study presented April 5 at the annual meeting of the American College of Cardiology.

The Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment (NAGOYA-HEART) Study is the first randomized trial to compare the effects of an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) on cardiovascular outcomes in this patient population. No significant differences were found between the two classes, reported Dr. Toyoaki Murohara of Nagoya (Japan) University.

"Our study showed no difference in the efficacies between the ARB and the CCB in terms of prevention of major cardiovascular events, [however] the ARB was superior to the CCB in preventing heart failure, especially in diabetic patients," Dr. Murohara said.

All-cause mortality also was similar. Hospital admission for heart failure was the only outcome measure in which there was a statistically significant difference between the two agents.

In previous nonrandomized analyses comparing ARBs with CCBs, results have been conflicting and, therefore, the preferred first-line class of agents is not well established, Dr. Murohara said. Guidelines mainly recommend ARBs and ACE inhibitors for first-line treatment and reserve CCBs as alternatives or second-line agents, he added.

The NAGOYA-HEART Study is an investigator-initiated trial applying a prospective, randomized open-label, blinded-endpoint (PROBE) method in which allocated treatment was open label but outcomes were adjudicated in a blinded manner as for drug assignment.

The Japanese research team enrolled 1,150 hypertensive patients with either type 2 diabetes (82%) or impaired glucose tolerance (18%) at 46 facilities across the country between 2004 and 2010. Mean glycosylated hemoglobin was 7.0% on the valsartan arm and 6.9% on the amlodipine arm and fasting plasma glucose levels were 8.2 mmol/L and 7.9 mmol/L, respectively. Mean blood pressure was 144/82 mm Hg in each arm.

Patients were randomized to receive either valsartan or amlodipine as their first-line antihypertensive agent. After a run-in phase, patients received valsartan 80 mg/day, titrating to 160 mg/day after 1 week of treatment, or amlodipine 5 mg/day, titrating to 10 mg/day. Both arms could receive other antihypertensives as needed, excluding ACE inhibitors, other ARBs, or CCBs.

The treatment goal was to reduce blood pressure to below 130/80 mm Hg. The primary outcome was a composite of cardiovascular events (acute myocardial infarction, stroke, coronary revascularization, admission due to heart failure, and sudden cardiac death); all-cause mortality was a secondary outcome.

The efficacy and safety analyses included 575 in both the valsartan and amlodipine arms. Patients were followed a median of 3.2 years.

Blood pressure lowering and glucose control were similar between the treatment arms. Blood pressure levels achieved were 131/73 mm Hg with valsartan and 132/74 mm Hg with amlodipine. Final hemoglobin A1C was 6.7% in each arm, Dr. Murohara reported.

There was no difference between the agents in the primary composite cardiovascular outcome. At 3.2 years, cardiovascular events were observed in 54 (9.4%) patients in the valsartan group and 56 (9.7%) in the amlodipine group. "The time-to-event curves showed no difference between the two groups," he said.

Among the components of the composite, only heart failure was affected by treatment, noted in 3 (0.5%) patients on valsartan, compared with 15 (2.6%) on amlodipine, a significant difference. Valsartan use was associated with an 80% relative risk reduction in heart failure admissions.

Safety outcomes were similar, with at least one adverse event reported by 106 patients in the valsartan arm and 112 in the amlodipine arm.

"Our results highlight the safety and efficacy of an ARB, especially in preventing heart failure," he noted, "and support the current recommendations for diabetic hypertensive patients."

Session panelist Dr. Sara Sirna of Temple University, Philadelphia, commented that the NAGOYA-HEART Study is "an excellent study on two drugs we commonly use for patients with diabetes and hypertension, which we see every day in our practices."

She questioned whether there may be a subgroup that would fare better with one versus the other agent. "The ejection fraction was about 40%, mildly reduced, yet those patients seemed to do better on valsartan," she observed.

Dr. Murohara responded that the study did not recruit patients with overt heart failure, but he noted that since the renin-angiotensin system is activated in the setting of heart failure, it makes sense that new-onset heart failure may be prevented better with the ARB.

The study was funded and supported by Nagoya University. Dr. Murohara reported receiving lecturer’s fees from Daiichi-Sankyo, Novartis, Pfizer, and Takeda. Dr. Sirna reported no relevant disclosures.

NEW ORLEANS – Prevention of major cardiovascular events was similar in a comparison of valsartan and amlodipine in patients with hypertension and diabetes or glucose intolerance, according to a Japanese study presented April 5 at the annual meeting of the American College of Cardiology.

The Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment (NAGOYA-HEART) Study is the first randomized trial to compare the effects of an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) on cardiovascular outcomes in this patient population. No significant differences were found between the two classes, reported Dr. Toyoaki Murohara of Nagoya (Japan) University.

"Our study showed no difference in the efficacies between the ARB and the CCB in terms of prevention of major cardiovascular events, [however] the ARB was superior to the CCB in preventing heart failure, especially in diabetic patients," Dr. Murohara said.

All-cause mortality also was similar. Hospital admission for heart failure was the only outcome measure in which there was a statistically significant difference between the two agents.

In previous nonrandomized analyses comparing ARBs with CCBs, results have been conflicting and, therefore, the preferred first-line class of agents is not well established, Dr. Murohara said. Guidelines mainly recommend ARBs and ACE inhibitors for first-line treatment and reserve CCBs as alternatives or second-line agents, he added.

The NAGOYA-HEART Study is an investigator-initiated trial applying a prospective, randomized open-label, blinded-endpoint (PROBE) method in which allocated treatment was open label but outcomes were adjudicated in a blinded manner as for drug assignment.

The Japanese research team enrolled 1,150 hypertensive patients with either type 2 diabetes (82%) or impaired glucose tolerance (18%) at 46 facilities across the country between 2004 and 2010. Mean glycosylated hemoglobin was 7.0% on the valsartan arm and 6.9% on the amlodipine arm and fasting plasma glucose levels were 8.2 mmol/L and 7.9 mmol/L, respectively. Mean blood pressure was 144/82 mm Hg in each arm.

Patients were randomized to receive either valsartan or amlodipine as their first-line antihypertensive agent. After a run-in phase, patients received valsartan 80 mg/day, titrating to 160 mg/day after 1 week of treatment, or amlodipine 5 mg/day, titrating to 10 mg/day. Both arms could receive other antihypertensives as needed, excluding ACE inhibitors, other ARBs, or CCBs.

The treatment goal was to reduce blood pressure to below 130/80 mm Hg. The primary outcome was a composite of cardiovascular events (acute myocardial infarction, stroke, coronary revascularization, admission due to heart failure, and sudden cardiac death); all-cause mortality was a secondary outcome.

The efficacy and safety analyses included 575 in both the valsartan and amlodipine arms. Patients were followed a median of 3.2 years.

Blood pressure lowering and glucose control were similar between the treatment arms. Blood pressure levels achieved were 131/73 mm Hg with valsartan and 132/74 mm Hg with amlodipine. Final hemoglobin A1C was 6.7% in each arm, Dr. Murohara reported.

There was no difference between the agents in the primary composite cardiovascular outcome. At 3.2 years, cardiovascular events were observed in 54 (9.4%) patients in the valsartan group and 56 (9.7%) in the amlodipine group. "The time-to-event curves showed no difference between the two groups," he said.

Among the components of the composite, only heart failure was affected by treatment, noted in 3 (0.5%) patients on valsartan, compared with 15 (2.6%) on amlodipine, a significant difference. Valsartan use was associated with an 80% relative risk reduction in heart failure admissions.

Safety outcomes were similar, with at least one adverse event reported by 106 patients in the valsartan arm and 112 in the amlodipine arm.

"Our results highlight the safety and efficacy of an ARB, especially in preventing heart failure," he noted, "and support the current recommendations for diabetic hypertensive patients."

Session panelist Dr. Sara Sirna of Temple University, Philadelphia, commented that the NAGOYA-HEART Study is "an excellent study on two drugs we commonly use for patients with diabetes and hypertension, which we see every day in our practices."

She questioned whether there may be a subgroup that would fare better with one versus the other agent. "The ejection fraction was about 40%, mildly reduced, yet those patients seemed to do better on valsartan," she observed.

Dr. Murohara responded that the study did not recruit patients with overt heart failure, but he noted that since the renin-angiotensin system is activated in the setting of heart failure, it makes sense that new-onset heart failure may be prevented better with the ARB.

The study was funded and supported by Nagoya University. Dr. Murohara reported receiving lecturer’s fees from Daiichi-Sankyo, Novartis, Pfizer, and Takeda. Dr. Sirna reported no relevant disclosures.

[Want more news from the ACC's annual scientific session? Check out our complete coverage of the meeting.]

NEW ORLEANS – Prevention of major cardiovascular events was similar in a comparison of valsartan and amlodipine in patients with hypertension and diabetes or glucose intolerance, according to a Japanese study presented April 5 at the annual meeting of the American College of Cardiology.

The Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment (NAGOYA-HEART) Study is the first randomized trial to compare the effects of an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) on cardiovascular outcomes in this patient population. No significant differences were found between the two classes, reported Dr. Toyoaki Murohara of Nagoya (Japan) University.

"Our study showed no difference in the efficacies between the ARB and the CCB in terms of prevention of major cardiovascular events, [however] the ARB was superior to the CCB in preventing heart failure, especially in diabetic patients," Dr. Murohara said.

All-cause mortality also was similar. Hospital admission for heart failure was the only outcome measure in which there was a statistically significant difference between the two agents.

In previous nonrandomized analyses comparing ARBs with CCBs, results have been conflicting and, therefore, the preferred first-line class of agents is not well established, Dr. Murohara said. Guidelines mainly recommend ARBs and ACE inhibitors for first-line treatment and reserve CCBs as alternatives or second-line agents, he added.

The NAGOYA-HEART Study is an investigator-initiated trial applying a prospective, randomized open-label, blinded-endpoint (PROBE) method in which allocated treatment was open label but outcomes were adjudicated in a blinded manner as for drug assignment.

The Japanese research team enrolled 1,150 hypertensive patients with either type 2 diabetes (82%) or impaired glucose tolerance (18%) at 46 facilities across the country between 2004 and 2010. Mean glycosylated hemoglobin was 7.0% on the valsartan arm and 6.9% on the amlodipine arm and fasting plasma glucose levels were 8.2 mmol/L and 7.9 mmol/L, respectively. Mean blood pressure was 144/82 mm Hg in each arm.

Patients were randomized to receive either valsartan or amlodipine as their first-line antihypertensive agent. After a run-in phase, patients received valsartan 80 mg/day, titrating to 160 mg/day after 1 week of treatment, or amlodipine 5 mg/day, titrating to 10 mg/day. Both arms could receive other antihypertensives as needed, excluding ACE inhibitors, other ARBs, or CCBs.

The treatment goal was to reduce blood pressure to below 130/80 mm Hg. The primary outcome was a composite of cardiovascular events (acute myocardial infarction, stroke, coronary revascularization, admission due to heart failure, and sudden cardiac death); all-cause mortality was a secondary outcome.

The efficacy and safety analyses included 575 in both the valsartan and amlodipine arms. Patients were followed a median of 3.2 years.

Blood pressure lowering and glucose control were similar between the treatment arms. Blood pressure levels achieved were 131/73 mm Hg with valsartan and 132/74 mm Hg with amlodipine. Final hemoglobin A1C was 6.7% in each arm, Dr. Murohara reported.

There was no difference between the agents in the primary composite cardiovascular outcome. At 3.2 years, cardiovascular events were observed in 54 (9.4%) patients in the valsartan group and 56 (9.7%) in the amlodipine group. "The time-to-event curves showed no difference between the two groups," he said.

Among the components of the composite, only heart failure was affected by treatment, noted in 3 (0.5%) patients on valsartan, compared with 15 (2.6%) on amlodipine, a significant difference. Valsartan use was associated with an 80% relative risk reduction in heart failure admissions.

Safety outcomes were similar, with at least one adverse event reported by 106 patients in the valsartan arm and 112 in the amlodipine arm.

"Our results highlight the safety and efficacy of an ARB, especially in preventing heart failure," he noted, "and support the current recommendations for diabetic hypertensive patients."

Session panelist Dr. Sara Sirna of Temple University, Philadelphia, commented that the NAGOYA-HEART Study is "an excellent study on two drugs we commonly use for patients with diabetes and hypertension, which we see every day in our practices."

She questioned whether there may be a subgroup that would fare better with one versus the other agent. "The ejection fraction was about 40%, mildly reduced, yet those patients seemed to do better on valsartan," she observed.

Dr. Murohara responded that the study did not recruit patients with overt heart failure, but he noted that since the renin-angiotensin system is activated in the setting of heart failure, it makes sense that new-onset heart failure may be prevented better with the ARB.

The study was funded and supported by Nagoya University. Dr. Murohara reported receiving lecturer’s fees from Daiichi-Sankyo, Novartis, Pfizer, and Takeda. Dr. Sirna reported no relevant disclosures.

[Want more news from the ACC's annual scientific session? Check out our complete coverage of the meeting.]

NEW ORLEANS – Prevention of major cardiovascular events was similar in a comparison of valsartan and amlodipine in patients with hypertension and diabetes or glucose intolerance, according to a Japanese study presented April 5 at the annual meeting of the American College of Cardiology.

The Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment (NAGOYA-HEART) Study is the first randomized trial to compare the effects of an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) on cardiovascular outcomes in this patient population. No significant differences were found between the two classes, reported Dr. Toyoaki Murohara of Nagoya (Japan) University.

"Our study showed no difference in the efficacies between the ARB and the CCB in terms of prevention of major cardiovascular events, [however] the ARB was superior to the CCB in preventing heart failure, especially in diabetic patients," Dr. Murohara said.

All-cause mortality also was similar. Hospital admission for heart failure was the only outcome measure in which there was a statistically significant difference between the two agents.

In previous nonrandomized analyses comparing ARBs with CCBs, results have been conflicting and, therefore, the preferred first-line class of agents is not well established, Dr. Murohara said. Guidelines mainly recommend ARBs and ACE inhibitors for first-line treatment and reserve CCBs as alternatives or second-line agents, he added.

The NAGOYA-HEART Study is an investigator-initiated trial applying a prospective, randomized open-label, blinded-endpoint (PROBE) method in which allocated treatment was open label but outcomes were adjudicated in a blinded manner as for drug assignment.

The Japanese research team enrolled 1,150 hypertensive patients with either type 2 diabetes (82%) or impaired glucose tolerance (18%) at 46 facilities across the country between 2004 and 2010. Mean glycosylated hemoglobin was 7.0% on the valsartan arm and 6.9% on the amlodipine arm and fasting plasma glucose levels were 8.2 mmol/L and 7.9 mmol/L, respectively. Mean blood pressure was 144/82 mm Hg in each arm.

Patients were randomized to receive either valsartan or amlodipine as their first-line antihypertensive agent. After a run-in phase, patients received valsartan 80 mg/day, titrating to 160 mg/day after 1 week of treatment, or amlodipine 5 mg/day, titrating to 10 mg/day. Both arms could receive other antihypertensives as needed, excluding ACE inhibitors, other ARBs, or CCBs.

The treatment goal was to reduce blood pressure to below 130/80 mm Hg. The primary outcome was a composite of cardiovascular events (acute myocardial infarction, stroke, coronary revascularization, admission due to heart failure, and sudden cardiac death); all-cause mortality was a secondary outcome.

The efficacy and safety analyses included 575 in both the valsartan and amlodipine arms. Patients were followed a median of 3.2 years.

Blood pressure lowering and glucose control were similar between the treatment arms. Blood pressure levels achieved were 131/73 mm Hg with valsartan and 132/74 mm Hg with amlodipine. Final hemoglobin A1C was 6.7% in each arm, Dr. Murohara reported.

There was no difference between the agents in the primary composite cardiovascular outcome. At 3.2 years, cardiovascular events were observed in 54 (9.4%) patients in the valsartan group and 56 (9.7%) in the amlodipine group. "The time-to-event curves showed no difference between the two groups," he said.

Among the components of the composite, only heart failure was affected by treatment, noted in 3 (0.5%) patients on valsartan, compared with 15 (2.6%) on amlodipine, a significant difference. Valsartan use was associated with an 80% relative risk reduction in heart failure admissions.

Safety outcomes were similar, with at least one adverse event reported by 106 patients in the valsartan arm and 112 in the amlodipine arm.

"Our results highlight the safety and efficacy of an ARB, especially in preventing heart failure," he noted, "and support the current recommendations for diabetic hypertensive patients."

Session panelist Dr. Sara Sirna of Temple University, Philadelphia, commented that the NAGOYA-HEART Study is "an excellent study on two drugs we commonly use for patients with diabetes and hypertension, which we see every day in our practices."

She questioned whether there may be a subgroup that would fare better with one versus the other agent. "The ejection fraction was about 40%, mildly reduced, yet those patients seemed to do better on valsartan," she observed.

Dr. Murohara responded that the study did not recruit patients with overt heart failure, but he noted that since the renin-angiotensin system is activated in the setting of heart failure, it makes sense that new-onset heart failure may be prevented better with the ARB.

The study was funded and supported by Nagoya University. Dr. Murohara reported receiving lecturer’s fees from Daiichi-Sankyo, Novartis, Pfizer, and Takeda. Dr. Sirna reported no relevant disclosures.

[Want more news from the ACC's annual scientific session? Check out our complete coverage of the meeting.]

NEW ORLEANS – The investigational oral anticoagulant rivaroxaban was as effective as injection enoxaparin in preventing venous thromboembolism at 10 days and superior at 35 days among critically ill hospitalized patients in the phase III MAGELLAN study.

Overall bleeding rates were low, at about 1%, but were significantly higher in patients receiving rivaroxaban across the entire study period, lead author Dr. Alexander T. Cohen said April 5 at the annual meeting of the American College of Cardiology.

"MAGELLAN confirms that there is a continued risk of VTE [venous thromboembolism] beyond the initial period of hospitalization, and I believe this is an important finding because the benchmark data said we should get a figure of 4%, and we got a figure of 5.7% at day 45," he said.

The study randomly assigned 8,101 patients hospitalized for an acute medical illness including heart failure, acute infectious disease, and acute respiratory insufficiency to oral rivaroxaban 10 mg daily for 35 days or subcutaneous enoxaparin 40 mg daily for 10 days plus placebo.

At day 10, the primary composite efficacy end point, defined as the cumulative incidence of asymptomatic proximal deep venous thromboembolism (DVT) detected by ultrasonography, symptomatic DVT, symptomatic nonfatal pulmonary embolism (PE), and VTE-related death, occurred in 2.7% of patients in both arms, reaching the prespecified noninferiority benchmark for day 10.

At 35 days, significantly fewer rivaroxaban patients experienced the primary efficacy end point, at 4.4% vs. 5.7% of patients in the enoxaparin arm, reaching the superiority end point for day 35. The absolute risk reduction was 1.3% and the relative risk reduction was 23%, said Dr. Cohen, who is with King’s College in London.

Clinically relevant bleeding occurred significantly more often in the rivaroxaban group than in the enoxaparin group from day 1 to 10 (2.8% vs. 1.2%), from day 1 to 35 (4.1% vs. 1.7%), and from day 11 to 35 (1.4% vs. 0.5%).

Among major bleeding events, a drop in hemoglobin of 2 g/dL or more was observed in 31 rivaroxaban patients and 10 enoxaparin patients, 2 or more units of blood were transfused in 34 and 8 patients, respectively, and critical site bleeds occurred in 9 and 4 patients, respectively.

Notably, seven rivaroxaban patients died of fatal bleeds, compared with only one enoxaparin patient. Overall, about 5% of patients in the trial died of all causes.

The net clinical benefit was 9.4% for rivaroxaban and 7.8% for enoxaparin. Based on the prespecified net clinical benefit analysis, Dr. Cohen acknowledged that a consistently positive benefit-risk balance was not seen among the cohort, but that they plan to conduct subgroup analyses to determine factors related to bleeding and to identify patients who might derive greater benefit from thromboprophylaxis with rivaroxaban.

He stressed that the study used a highly sensitive analysis of bleeding, such as a drop in hemoglobin of just 2 g/dL, and that even nosebleeds and bruising were counted in the risk-benefit analysis. When asked whether removal of these lesser bleeding events would result in a positive clinical benefit for rivaroxaban, Dr. Cohen said he was hesitant to speculate outside the trial’s prespecified outcome measures. When pressed further, he replied, "If we looked at a traditional risk-benefit analysis of major bleeds, then the picture swings back the other way. ... It would start to look more favorable toward rivaroxaban, but I have to stick to the study protocol."

When asked whether he had a theory as to why fatal bleeds occurred, Dr. Cohen pointed out that while there were 7 bleeding deaths with rivaroxaban and only 1 with enoxaparin, there were 30 PE-related deaths with enoxaparin and 19 with rivaroxaban.

"So we saved 11 lives from blood clots, if you want to [make that sort of analysis], and lost 6 lives through bleeding," he said.

In a separate interview, Dr. A. Michael Lincoff, director of the Cleveland Clinic Coordinating Center for Clinical Research, said numerous studies have shown that the risk of DVT persists beyond the acute hospitalization period and that the ability to give rivaroxaban after patients are discharged is valuable.

"It’s a much more practical drug to send patients home on," he said in an interview. "Yes, you can train patients to inject themselves with enoxaparin, but it’s not well accepted in many cases."

Dr. Cohen reported financial ties with more than a dozen pharmaceutical companies, including Bayer (maker of rivaroxaban). Dr. Lincoff had no relevant disclosures.

NEW ORLEANS – The investigational oral anticoagulant rivaroxaban was as effective as injection enoxaparin in preventing venous thromboembolism at 10 days and superior at 35 days among critically ill hospitalized patients in the phase III MAGELLAN study.

Overall bleeding rates were low, at about 1%, but were significantly higher in patients receiving rivaroxaban across the entire study period, lead author Dr. Alexander T. Cohen said April 5 at the annual meeting of the American College of Cardiology.

"MAGELLAN confirms that there is a continued risk of VTE [venous thromboembolism] beyond the initial period of hospitalization, and I believe this is an important finding because the benchmark data said we should get a figure of 4%, and we got a figure of 5.7% at day 45," he said.

The study randomly assigned 8,101 patients hospitalized for an acute medical illness including heart failure, acute infectious disease, and acute respiratory insufficiency to oral rivaroxaban 10 mg daily for 35 days or subcutaneous enoxaparin 40 mg daily for 10 days plus placebo.

At day 10, the primary composite efficacy end point, defined as the cumulative incidence of asymptomatic proximal deep venous thromboembolism (DVT) detected by ultrasonography, symptomatic DVT, symptomatic nonfatal pulmonary embolism (PE), and VTE-related death, occurred in 2.7% of patients in both arms, reaching the prespecified noninferiority benchmark for day 10.

At 35 days, significantly fewer rivaroxaban patients experienced the primary efficacy end point, at 4.4% vs. 5.7% of patients in the enoxaparin arm, reaching the superiority end point for day 35. The absolute risk reduction was 1.3% and the relative risk reduction was 23%, said Dr. Cohen, who is with King’s College in London.

Clinically relevant bleeding occurred significantly more often in the rivaroxaban group than in the enoxaparin group from day 1 to 10 (2.8% vs. 1.2%), from day 1 to 35 (4.1% vs. 1.7%), and from day 11 to 35 (1.4% vs. 0.5%).

Among major bleeding events, a drop in hemoglobin of 2 g/dL or more was observed in 31 rivaroxaban patients and 10 enoxaparin patients, 2 or more units of blood were transfused in 34 and 8 patients, respectively, and critical site bleeds occurred in 9 and 4 patients, respectively.

Notably, seven rivaroxaban patients died of fatal bleeds, compared with only one enoxaparin patient. Overall, about 5% of patients in the trial died of all causes.

The net clinical benefit was 9.4% for rivaroxaban and 7.8% for enoxaparin. Based on the prespecified net clinical benefit analysis, Dr. Cohen acknowledged that a consistently positive benefit-risk balance was not seen among the cohort, but that they plan to conduct subgroup analyses to determine factors related to bleeding and to identify patients who might derive greater benefit from thromboprophylaxis with rivaroxaban.

He stressed that the study used a highly sensitive analysis of bleeding, such as a drop in hemoglobin of just 2 g/dL, and that even nosebleeds and bruising were counted in the risk-benefit analysis. When asked whether removal of these lesser bleeding events would result in a positive clinical benefit for rivaroxaban, Dr. Cohen said he was hesitant to speculate outside the trial’s prespecified outcome measures. When pressed further, he replied, "If we looked at a traditional risk-benefit analysis of major bleeds, then the picture swings back the other way. ... It would start to look more favorable toward rivaroxaban, but I have to stick to the study protocol."

When asked whether he had a theory as to why fatal bleeds occurred, Dr. Cohen pointed out that while there were 7 bleeding deaths with rivaroxaban and only 1 with enoxaparin, there were 30 PE-related deaths with enoxaparin and 19 with rivaroxaban.

"So we saved 11 lives from blood clots, if you want to [make that sort of analysis], and lost 6 lives through bleeding," he said.

In a separate interview, Dr. A. Michael Lincoff, director of the Cleveland Clinic Coordinating Center for Clinical Research, said numerous studies have shown that the risk of DVT persists beyond the acute hospitalization period and that the ability to give rivaroxaban after patients are discharged is valuable.

"It’s a much more practical drug to send patients home on," he said in an interview. "Yes, you can train patients to inject themselves with enoxaparin, but it’s not well accepted in many cases."

Dr. Cohen reported financial ties with more than a dozen pharmaceutical companies, including Bayer (maker of rivaroxaban). Dr. Lincoff had no relevant disclosures.

NEW ORLEANS – The investigational oral anticoagulant rivaroxaban was as effective as injection enoxaparin in preventing venous thromboembolism at 10 days and superior at 35 days among critically ill hospitalized patients in the phase III MAGELLAN study.

Overall bleeding rates were low, at about 1%, but were significantly higher in patients receiving rivaroxaban across the entire study period, lead author Dr. Alexander T. Cohen said April 5 at the annual meeting of the American College of Cardiology.

"MAGELLAN confirms that there is a continued risk of VTE [venous thromboembolism] beyond the initial period of hospitalization, and I believe this is an important finding because the benchmark data said we should get a figure of 4%, and we got a figure of 5.7% at day 45," he said.

The study randomly assigned 8,101 patients hospitalized for an acute medical illness including heart failure, acute infectious disease, and acute respiratory insufficiency to oral rivaroxaban 10 mg daily for 35 days or subcutaneous enoxaparin 40 mg daily for 10 days plus placebo.

At day 10, the primary composite efficacy end point, defined as the cumulative incidence of asymptomatic proximal deep venous thromboembolism (DVT) detected by ultrasonography, symptomatic DVT, symptomatic nonfatal pulmonary embolism (PE), and VTE-related death, occurred in 2.7% of patients in both arms, reaching the prespecified noninferiority benchmark for day 10.

At 35 days, significantly fewer rivaroxaban patients experienced the primary efficacy end point, at 4.4% vs. 5.7% of patients in the enoxaparin arm, reaching the superiority end point for day 35. The absolute risk reduction was 1.3% and the relative risk reduction was 23%, said Dr. Cohen, who is with King’s College in London.

Clinically relevant bleeding occurred significantly more often in the rivaroxaban group than in the enoxaparin group from day 1 to 10 (2.8% vs. 1.2%), from day 1 to 35 (4.1% vs. 1.7%), and from day 11 to 35 (1.4% vs. 0.5%).

Among major bleeding events, a drop in hemoglobin of 2 g/dL or more was observed in 31 rivaroxaban patients and 10 enoxaparin patients, 2 or more units of blood were transfused in 34 and 8 patients, respectively, and critical site bleeds occurred in 9 and 4 patients, respectively.

Notably, seven rivaroxaban patients died of fatal bleeds, compared with only one enoxaparin patient. Overall, about 5% of patients in the trial died of all causes.

The net clinical benefit was 9.4% for rivaroxaban and 7.8% for enoxaparin. Based on the prespecified net clinical benefit analysis, Dr. Cohen acknowledged that a consistently positive benefit-risk balance was not seen among the cohort, but that they plan to conduct subgroup analyses to determine factors related to bleeding and to identify patients who might derive greater benefit from thromboprophylaxis with rivaroxaban.

He stressed that the study used a highly sensitive analysis of bleeding, such as a drop in hemoglobin of just 2 g/dL, and that even nosebleeds and bruising were counted in the risk-benefit analysis. When asked whether removal of these lesser bleeding events would result in a positive clinical benefit for rivaroxaban, Dr. Cohen said he was hesitant to speculate outside the trial’s prespecified outcome measures. When pressed further, he replied, "If we looked at a traditional risk-benefit analysis of major bleeds, then the picture swings back the other way. ... It would start to look more favorable toward rivaroxaban, but I have to stick to the study protocol."

When asked whether he had a theory as to why fatal bleeds occurred, Dr. Cohen pointed out that while there were 7 bleeding deaths with rivaroxaban and only 1 with enoxaparin, there were 30 PE-related deaths with enoxaparin and 19 with rivaroxaban.

"So we saved 11 lives from blood clots, if you want to [make that sort of analysis], and lost 6 lives through bleeding," he said.

In a separate interview, Dr. A. Michael Lincoff, director of the Cleveland Clinic Coordinating Center for Clinical Research, said numerous studies have shown that the risk of DVT persists beyond the acute hospitalization period and that the ability to give rivaroxaban after patients are discharged is valuable.

"It’s a much more practical drug to send patients home on," he said in an interview. "Yes, you can train patients to inject themselves with enoxaparin, but it’s not well accepted in many cases."

Dr. Cohen reported financial ties with more than a dozen pharmaceutical companies, including Bayer (maker of rivaroxaban). Dr. Lincoff had no relevant disclosures.