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Diet drinks linked to CVD in women
Drinking two or more diet drinks a day was associated with a 29% increased risk of an incident cardiovascular event and a 26% increased risk of all-cause death compared with less diet drink consumption in an observational study of nearly 60,000 postmenopausal American women.
Although the pathogenic mechanisms behind this "hypothesis-generating" finding remain unclear, a link between high use of diet drinks and increased cardiovascular events and death is consistent with prior reports that linked diet drink intake with metabolic syndrome and cardiovascular disease events, said Dr. Ankur Vyas, who summarized the results of the study during a webcast held prior to the annual meeting of the American College of Cardiology, where he is presenting the data.
"This study is very interesting and clinically relevant given the vast number of people who drink diet drinks daily," commented Dr. Jeffrey T. Kuvin of the division of cardiology at Tufts Medical Center in Boston. "We know that drinking sweetened beverages is associated with weight gain, diabetes, and coronary heart disease, and diet drinks have been linked with metabolic syndrome. This report is very provocative and may shed some light on a subject we need to know more about."
Dr. Kuvin, who admitted to often drinking two or more diet drinks a day himself, added, "I’m not ready just yet to give it up, but the data are compelling to take a closer look at why this could be."
The analysis by Dr. Vyas and his associates focused on 59,614 postmenopausal women aged 50-79 from the observational arm of the Women\'s Health Initiative who enrolled during 1993-1998This subgroup excluded women with preexisting cardiovascular disease, no data available on diet drink consumption, or other reasons. The study examined deaths and cardiovascular disease events during an average 9 years of follow-up among the 5% of women who drank an average of two or more diet drinks daily compared with women who had fewer of these beverages. Women in the subgroup with the highest diet drink intake were significantly younger and had a significantly higher rate of obesity than women with lower intake levels.
In an analysis that adjusted for several demographic and clinical factors, women who drank two or more drinks had, during follow-up, 29% more cardiovascular events compared with the other women, a statistically significant difference for the study’s primary endpoint that combined myocardial infarctions, ischemic strokes, coronary artery revascularization, peripheral artery disease, heart failure, and cardiovascular death, reported Dr. Vyas, a fellow in cardiology at the University of Iowa, Iowa City. The highest level of diet drink use also linked with a statistically significant increase of 52% for the single endpoint of cardiovascular death and a 26% higher rate of all-cause death.
Dr. Vyas suggested that higher diet drink consumption may disrupt normal feedback mechanisms that control intake of food and other beverages, or it may link with various elements of an unhealthy lifestyle.
Dr. Vyas also said that the finding could be the result of inadequate adjustment for confounding factors. "In any observational study it’s close to impossible to control for everything and rule out every possible confounder. Our study faces the same limitations as any retrospective observational study," he said during a press briefing.
Dr. Vyas and Dr. Kuvin said that they had no relevant financial disclosures.
On Twitter @mitchelzoler
Drinking two or more diet drinks a day was associated with a 29% increased risk of an incident cardiovascular event and a 26% increased risk of all-cause death compared with less diet drink consumption in an observational study of nearly 60,000 postmenopausal American women.
Although the pathogenic mechanisms behind this "hypothesis-generating" finding remain unclear, a link between high use of diet drinks and increased cardiovascular events and death is consistent with prior reports that linked diet drink intake with metabolic syndrome and cardiovascular disease events, said Dr. Ankur Vyas, who summarized the results of the study during a webcast held prior to the annual meeting of the American College of Cardiology, where he is presenting the data.
"This study is very interesting and clinically relevant given the vast number of people who drink diet drinks daily," commented Dr. Jeffrey T. Kuvin of the division of cardiology at Tufts Medical Center in Boston. "We know that drinking sweetened beverages is associated with weight gain, diabetes, and coronary heart disease, and diet drinks have been linked with metabolic syndrome. This report is very provocative and may shed some light on a subject we need to know more about."
Dr. Kuvin, who admitted to often drinking two or more diet drinks a day himself, added, "I’m not ready just yet to give it up, but the data are compelling to take a closer look at why this could be."
The analysis by Dr. Vyas and his associates focused on 59,614 postmenopausal women aged 50-79 from the observational arm of the Women\'s Health Initiative who enrolled during 1993-1998This subgroup excluded women with preexisting cardiovascular disease, no data available on diet drink consumption, or other reasons. The study examined deaths and cardiovascular disease events during an average 9 years of follow-up among the 5% of women who drank an average of two or more diet drinks daily compared with women who had fewer of these beverages. Women in the subgroup with the highest diet drink intake were significantly younger and had a significantly higher rate of obesity than women with lower intake levels.
In an analysis that adjusted for several demographic and clinical factors, women who drank two or more drinks had, during follow-up, 29% more cardiovascular events compared with the other women, a statistically significant difference for the study’s primary endpoint that combined myocardial infarctions, ischemic strokes, coronary artery revascularization, peripheral artery disease, heart failure, and cardiovascular death, reported Dr. Vyas, a fellow in cardiology at the University of Iowa, Iowa City. The highest level of diet drink use also linked with a statistically significant increase of 52% for the single endpoint of cardiovascular death and a 26% higher rate of all-cause death.
Dr. Vyas suggested that higher diet drink consumption may disrupt normal feedback mechanisms that control intake of food and other beverages, or it may link with various elements of an unhealthy lifestyle.
Dr. Vyas also said that the finding could be the result of inadequate adjustment for confounding factors. "In any observational study it’s close to impossible to control for everything and rule out every possible confounder. Our study faces the same limitations as any retrospective observational study," he said during a press briefing.
Dr. Vyas and Dr. Kuvin said that they had no relevant financial disclosures.
On Twitter @mitchelzoler
Drinking two or more diet drinks a day was associated with a 29% increased risk of an incident cardiovascular event and a 26% increased risk of all-cause death compared with less diet drink consumption in an observational study of nearly 60,000 postmenopausal American women.
Although the pathogenic mechanisms behind this "hypothesis-generating" finding remain unclear, a link between high use of diet drinks and increased cardiovascular events and death is consistent with prior reports that linked diet drink intake with metabolic syndrome and cardiovascular disease events, said Dr. Ankur Vyas, who summarized the results of the study during a webcast held prior to the annual meeting of the American College of Cardiology, where he is presenting the data.
"This study is very interesting and clinically relevant given the vast number of people who drink diet drinks daily," commented Dr. Jeffrey T. Kuvin of the division of cardiology at Tufts Medical Center in Boston. "We know that drinking sweetened beverages is associated with weight gain, diabetes, and coronary heart disease, and diet drinks have been linked with metabolic syndrome. This report is very provocative and may shed some light on a subject we need to know more about."
Dr. Kuvin, who admitted to often drinking two or more diet drinks a day himself, added, "I’m not ready just yet to give it up, but the data are compelling to take a closer look at why this could be."
The analysis by Dr. Vyas and his associates focused on 59,614 postmenopausal women aged 50-79 from the observational arm of the Women\'s Health Initiative who enrolled during 1993-1998This subgroup excluded women with preexisting cardiovascular disease, no data available on diet drink consumption, or other reasons. The study examined deaths and cardiovascular disease events during an average 9 years of follow-up among the 5% of women who drank an average of two or more diet drinks daily compared with women who had fewer of these beverages. Women in the subgroup with the highest diet drink intake were significantly younger and had a significantly higher rate of obesity than women with lower intake levels.
In an analysis that adjusted for several demographic and clinical factors, women who drank two or more drinks had, during follow-up, 29% more cardiovascular events compared with the other women, a statistically significant difference for the study’s primary endpoint that combined myocardial infarctions, ischemic strokes, coronary artery revascularization, peripheral artery disease, heart failure, and cardiovascular death, reported Dr. Vyas, a fellow in cardiology at the University of Iowa, Iowa City. The highest level of diet drink use also linked with a statistically significant increase of 52% for the single endpoint of cardiovascular death and a 26% higher rate of all-cause death.
Dr. Vyas suggested that higher diet drink consumption may disrupt normal feedback mechanisms that control intake of food and other beverages, or it may link with various elements of an unhealthy lifestyle.
Dr. Vyas also said that the finding could be the result of inadequate adjustment for confounding factors. "In any observational study it’s close to impossible to control for everything and rule out every possible confounder. Our study faces the same limitations as any retrospective observational study," he said during a press briefing.
Dr. Vyas and Dr. Kuvin said that they had no relevant financial disclosures.
On Twitter @mitchelzoler
FROM ACC 14
Major finding: .Women who drank at least two diet drinks daily had 29% more cardiovascular events than women having fewer diet drinks.
Data source: A retrospective analysis of data collected from 59,614 postmenopausal American women enrolled in the Women’s Health Initiative.
Disclosures: Dr. Vyas and Dr. Kuvin said that they had no relevant financial disclosures.
Meta-analysis shows statins help erectile function
Men with erectile dysfunction had a better than threefold improvement in erectile function after receiving statin treatment compared with men randomized to placebo in a meta-analysis of 11 controlled studies with a total of more than 600 patients.
Although the result suggests that statin treatment helps men with erectile dysfunction (ED), the evidence is not strong enough to warrant starting statin treatment when the patient has no established indication for the drug, said Dr. John B. Kostis, who summarized the results of the study during a webcast held prior to the annual meeting of the American College of Cardiology, where he is presenting the data.
He called for a multifactorial trial that could assess the roles for statin, treatment, a phosphodiesterase type 5 inhibitor,and testosterone treatment both individually and in combinations.
"Erectile dysfunction is the canary in the coal mine. It can be the first sign of cardiovascular disease," said Dr. Kostis, John G. Detwiler professor of cardiology, professor of medicine and pharmacology, and director of the Cardiovascular Institute at the Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J. "When a man has erectile dysfunction and no explanation like prostatectomy, he should be evaluated for his cardiovascular risk and treated with a statin if that’s justified," he said during the webcast.
"Over the years it’s become apparent that erectile dysfunction is an indication of reduced vascular health in men, and it is considered by many to be a significant cardiovascular disease risk factor," commented Dr. Jeffrey T. Kuvin of the division of cardiology at Tufts Medical Center in Boston. "The results of this meta-analysis strongly show that statin treatment improves erectile dysfunction after only a short duration of treatment. Whether erectile dysfunction improves because of reduced levels of low-density lipoprotein cholesterol or other pleiotropic effects of statins remains unclear," said Dr. Kuvin.
Dr. Kostis and his associate reviewed 11 randomized controlled trials that compared the effect of statin treatment on erectile function with placebo as a primary or secondary endpoint. The 11 studies involved a total of 647 men with ED and an average age of 58 years. The average duration of treatment was 4 months. On statin treatment the average level of LDL cholesterol fell from 138 mg/dL at baseline to 91 mg/dL, while men on placebo had no meaningful change in their LDL cholesterol level.
The meta-analysis showed that after treatment with a statin for an average of 4 months, the level of erectile function increased 3.4-fold compared with patients in the placebo group. "This benefit is clinically relevant. It’s about a third of what’s achieved with a phosphodiesterase type 5 inhibitor, and perhaps slightly more than what is achieved with nondrug treatments," Dr. Kostis said. The analyses he and his associate ran did not examine the impact of individual statin types or dosages, and he said that even though the study combined results from 11 studies, the overall number of patients remained relatively small.
Dr. Kostis noted that three actions of statins may contribute to the effect seen. Improved erectile function could result from the cholesterol-lowering effect and from their pleiotropic effects, such as boosting blood levels of nitric oxide, acting as antioxidants, and in general improving vascular function. "Erectile dysfunction is also endothelial dysfunction," Dr. Kostis said. Statin treatment may also worsen erectile function by reducing testosterone production as a consequence of reduced cholesterol. The net effect of statins likely results from all three of these pathways.
Dr. Kostis said that he had no relevant financial disclosures. Dr. Kuvin had no financial disclosures.
On Twitter @mitchelzoler
Men with erectile dysfunction had a better than threefold improvement in erectile function after receiving statin treatment compared with men randomized to placebo in a meta-analysis of 11 controlled studies with a total of more than 600 patients.
Although the result suggests that statin treatment helps men with erectile dysfunction (ED), the evidence is not strong enough to warrant starting statin treatment when the patient has no established indication for the drug, said Dr. John B. Kostis, who summarized the results of the study during a webcast held prior to the annual meeting of the American College of Cardiology, where he is presenting the data.
He called for a multifactorial trial that could assess the roles for statin, treatment, a phosphodiesterase type 5 inhibitor,and testosterone treatment both individually and in combinations.
"Erectile dysfunction is the canary in the coal mine. It can be the first sign of cardiovascular disease," said Dr. Kostis, John G. Detwiler professor of cardiology, professor of medicine and pharmacology, and director of the Cardiovascular Institute at the Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J. "When a man has erectile dysfunction and no explanation like prostatectomy, he should be evaluated for his cardiovascular risk and treated with a statin if that’s justified," he said during the webcast.
"Over the years it’s become apparent that erectile dysfunction is an indication of reduced vascular health in men, and it is considered by many to be a significant cardiovascular disease risk factor," commented Dr. Jeffrey T. Kuvin of the division of cardiology at Tufts Medical Center in Boston. "The results of this meta-analysis strongly show that statin treatment improves erectile dysfunction after only a short duration of treatment. Whether erectile dysfunction improves because of reduced levels of low-density lipoprotein cholesterol or other pleiotropic effects of statins remains unclear," said Dr. Kuvin.
Dr. Kostis and his associate reviewed 11 randomized controlled trials that compared the effect of statin treatment on erectile function with placebo as a primary or secondary endpoint. The 11 studies involved a total of 647 men with ED and an average age of 58 years. The average duration of treatment was 4 months. On statin treatment the average level of LDL cholesterol fell from 138 mg/dL at baseline to 91 mg/dL, while men on placebo had no meaningful change in their LDL cholesterol level.
The meta-analysis showed that after treatment with a statin for an average of 4 months, the level of erectile function increased 3.4-fold compared with patients in the placebo group. "This benefit is clinically relevant. It’s about a third of what’s achieved with a phosphodiesterase type 5 inhibitor, and perhaps slightly more than what is achieved with nondrug treatments," Dr. Kostis said. The analyses he and his associate ran did not examine the impact of individual statin types or dosages, and he said that even though the study combined results from 11 studies, the overall number of patients remained relatively small.
Dr. Kostis noted that three actions of statins may contribute to the effect seen. Improved erectile function could result from the cholesterol-lowering effect and from their pleiotropic effects, such as boosting blood levels of nitric oxide, acting as antioxidants, and in general improving vascular function. "Erectile dysfunction is also endothelial dysfunction," Dr. Kostis said. Statin treatment may also worsen erectile function by reducing testosterone production as a consequence of reduced cholesterol. The net effect of statins likely results from all three of these pathways.
Dr. Kostis said that he had no relevant financial disclosures. Dr. Kuvin had no financial disclosures.
On Twitter @mitchelzoler
Men with erectile dysfunction had a better than threefold improvement in erectile function after receiving statin treatment compared with men randomized to placebo in a meta-analysis of 11 controlled studies with a total of more than 600 patients.
Although the result suggests that statin treatment helps men with erectile dysfunction (ED), the evidence is not strong enough to warrant starting statin treatment when the patient has no established indication for the drug, said Dr. John B. Kostis, who summarized the results of the study during a webcast held prior to the annual meeting of the American College of Cardiology, where he is presenting the data.
He called for a multifactorial trial that could assess the roles for statin, treatment, a phosphodiesterase type 5 inhibitor,and testosterone treatment both individually and in combinations.
"Erectile dysfunction is the canary in the coal mine. It can be the first sign of cardiovascular disease," said Dr. Kostis, John G. Detwiler professor of cardiology, professor of medicine and pharmacology, and director of the Cardiovascular Institute at the Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J. "When a man has erectile dysfunction and no explanation like prostatectomy, he should be evaluated for his cardiovascular risk and treated with a statin if that’s justified," he said during the webcast.
"Over the years it’s become apparent that erectile dysfunction is an indication of reduced vascular health in men, and it is considered by many to be a significant cardiovascular disease risk factor," commented Dr. Jeffrey T. Kuvin of the division of cardiology at Tufts Medical Center in Boston. "The results of this meta-analysis strongly show that statin treatment improves erectile dysfunction after only a short duration of treatment. Whether erectile dysfunction improves because of reduced levels of low-density lipoprotein cholesterol or other pleiotropic effects of statins remains unclear," said Dr. Kuvin.
Dr. Kostis and his associate reviewed 11 randomized controlled trials that compared the effect of statin treatment on erectile function with placebo as a primary or secondary endpoint. The 11 studies involved a total of 647 men with ED and an average age of 58 years. The average duration of treatment was 4 months. On statin treatment the average level of LDL cholesterol fell from 138 mg/dL at baseline to 91 mg/dL, while men on placebo had no meaningful change in their LDL cholesterol level.
The meta-analysis showed that after treatment with a statin for an average of 4 months, the level of erectile function increased 3.4-fold compared with patients in the placebo group. "This benefit is clinically relevant. It’s about a third of what’s achieved with a phosphodiesterase type 5 inhibitor, and perhaps slightly more than what is achieved with nondrug treatments," Dr. Kostis said. The analyses he and his associate ran did not examine the impact of individual statin types or dosages, and he said that even though the study combined results from 11 studies, the overall number of patients remained relatively small.
Dr. Kostis noted that three actions of statins may contribute to the effect seen. Improved erectile function could result from the cholesterol-lowering effect and from their pleiotropic effects, such as boosting blood levels of nitric oxide, acting as antioxidants, and in general improving vascular function. "Erectile dysfunction is also endothelial dysfunction," Dr. Kostis said. Statin treatment may also worsen erectile function by reducing testosterone production as a consequence of reduced cholesterol. The net effect of statins likely results from all three of these pathways.
Dr. Kostis said that he had no relevant financial disclosures. Dr. Kuvin had no financial disclosures.
On Twitter @mitchelzoler
AT ACC 14
Major finding: Statin-treated patients had a statistically-significant 3.4-fold increased rate of improved erectile function compared with men on placebo.
Data source: A meta-analysis of 11 randomized controlled studies with 647 patients.
Disclosures: Dr. Kostis said he had no relevant financial disclosures. Dr. Kuvin had no financial disclosures.
Fruit and Vegetable Consumption in Young Women Linked to Later CVD Benefit
A high intake of fruit and vegetables during early adulthood was associated with a lower risk of having calcified arterial plaque 20 years later, a benefit that was only evident in women, in the CARDIA (Coronary Artery Risk Development in Young Adults) study.
Previous studies have also found that women seem to benefit more from a diet that includes a high intake of fruit and vegetables, a disparity that "should be explored further," said Dr. Michael Miedema, a preventive cardiologist at the Minneapolis Heart Institute. He summarized the results of the study during a webcast held prior to the annual meeting of the American College of Cardiology, where he is presenting the data.
The study evaluated the association between the intake of fruit and vegetables in 2,648 people enrolled in the CARDIA study in 1985 and 1986, at an average age of 25 years, and the presence of coronary artery calcium (CAC), measured with electron-beam computed tomography, 20 years later. Participants were excluded if they consumed less than 800 kcal/day or more than 4,500 kcal/day, or if they had missing CAC scores.
Because there are fewer data in young adults, the study addressed the effect of fruit and vegetable intake during young adulthood on later cardiovascular disease risk. Previous studies have found that a diet high in fruit and vegetables is associated with a lower cardiovascular disease risk in middle-aged adults, with risk decreasing further as intake increases, a finding that has been less consistent in men, Dr. Miedema pointed out.
Fruit and vegetable intake was divided into tertiles, based on the number of servings the study participants reported consuming per day: Women in the top third ate 8-9 servings of fruit and vegetables per day, compared with 3-4 servings a day in the bottom third. The amount consumed was slightly lower in men, at 7-8 servings per day in the top third and 2-3 servings per day in the bottom third. Those in the top third had healthier behaviors, with slightly lower cholesterol and blood pressure levels, and were less likely to smoke.
After adjustment for a 2,000-calorie diet, women who consumed 8-9 servings of fruit and vegetables a day as young adults were about 40% less likely to have calcified plaque in their coronary arteries, compared with women who consumed about 3 servings of fruit and vegetables a day as young adults, Dr. Miedema said. This association was independent of age, weight, race, and lifestyle factors that included smoking, amount of exercise, and alcohol consumption.
"But in men, we did not find the same relationship," he said. Although two previous studies have also suggested that men derive fewer benefits from a diet high in fruit and vegetables, only 1,038 men were enrolled in this study, so it may have been underpowered to detect an effect in men, he added.
The results "reinforce the value of establishing healthy behaviors early in adulthood, and as we talk about population-based approaches to trying to reduce coronary vascular disease, it seems that we should probably include a focus on establishing a high intake of fruits and vegetables early in life," Dr. Miedema concluded
As for the gender difference, the message of the study should not be "that fruit and vegetable intake doesn’t matter in men," but that it is possible that a high intake of fruit and vegetables "doesn’t work quite as well in reducing heart disease risk for men as it does for women," he added. There is no biological explanation for the gender difference, which needs further study, he noted.
The CARDIA study, which is evaluating the development of cardiovascular risk factors and cardiovascular disease in healthy black and white adults, is sponsored by the National Institutes of Health. Dr. Miedema had no disclosures.
A high intake of fruit and vegetables during early adulthood was associated with a lower risk of having calcified arterial plaque 20 years later, a benefit that was only evident in women, in the CARDIA (Coronary Artery Risk Development in Young Adults) study.
Previous studies have also found that women seem to benefit more from a diet that includes a high intake of fruit and vegetables, a disparity that "should be explored further," said Dr. Michael Miedema, a preventive cardiologist at the Minneapolis Heart Institute. He summarized the results of the study during a webcast held prior to the annual meeting of the American College of Cardiology, where he is presenting the data.
The study evaluated the association between the intake of fruit and vegetables in 2,648 people enrolled in the CARDIA study in 1985 and 1986, at an average age of 25 years, and the presence of coronary artery calcium (CAC), measured with electron-beam computed tomography, 20 years later. Participants were excluded if they consumed less than 800 kcal/day or more than 4,500 kcal/day, or if they had missing CAC scores.
Because there are fewer data in young adults, the study addressed the effect of fruit and vegetable intake during young adulthood on later cardiovascular disease risk. Previous studies have found that a diet high in fruit and vegetables is associated with a lower cardiovascular disease risk in middle-aged adults, with risk decreasing further as intake increases, a finding that has been less consistent in men, Dr. Miedema pointed out.
Fruit and vegetable intake was divided into tertiles, based on the number of servings the study participants reported consuming per day: Women in the top third ate 8-9 servings of fruit and vegetables per day, compared with 3-4 servings a day in the bottom third. The amount consumed was slightly lower in men, at 7-8 servings per day in the top third and 2-3 servings per day in the bottom third. Those in the top third had healthier behaviors, with slightly lower cholesterol and blood pressure levels, and were less likely to smoke.
After adjustment for a 2,000-calorie diet, women who consumed 8-9 servings of fruit and vegetables a day as young adults were about 40% less likely to have calcified plaque in their coronary arteries, compared with women who consumed about 3 servings of fruit and vegetables a day as young adults, Dr. Miedema said. This association was independent of age, weight, race, and lifestyle factors that included smoking, amount of exercise, and alcohol consumption.
"But in men, we did not find the same relationship," he said. Although two previous studies have also suggested that men derive fewer benefits from a diet high in fruit and vegetables, only 1,038 men were enrolled in this study, so it may have been underpowered to detect an effect in men, he added.
The results "reinforce the value of establishing healthy behaviors early in adulthood, and as we talk about population-based approaches to trying to reduce coronary vascular disease, it seems that we should probably include a focus on establishing a high intake of fruits and vegetables early in life," Dr. Miedema concluded
As for the gender difference, the message of the study should not be "that fruit and vegetable intake doesn’t matter in men," but that it is possible that a high intake of fruit and vegetables "doesn’t work quite as well in reducing heart disease risk for men as it does for women," he added. There is no biological explanation for the gender difference, which needs further study, he noted.
The CARDIA study, which is evaluating the development of cardiovascular risk factors and cardiovascular disease in healthy black and white adults, is sponsored by the National Institutes of Health. Dr. Miedema had no disclosures.
A high intake of fruit and vegetables during early adulthood was associated with a lower risk of having calcified arterial plaque 20 years later, a benefit that was only evident in women, in the CARDIA (Coronary Artery Risk Development in Young Adults) study.
Previous studies have also found that women seem to benefit more from a diet that includes a high intake of fruit and vegetables, a disparity that "should be explored further," said Dr. Michael Miedema, a preventive cardiologist at the Minneapolis Heart Institute. He summarized the results of the study during a webcast held prior to the annual meeting of the American College of Cardiology, where he is presenting the data.
The study evaluated the association between the intake of fruit and vegetables in 2,648 people enrolled in the CARDIA study in 1985 and 1986, at an average age of 25 years, and the presence of coronary artery calcium (CAC), measured with electron-beam computed tomography, 20 years later. Participants were excluded if they consumed less than 800 kcal/day or more than 4,500 kcal/day, or if they had missing CAC scores.
Because there are fewer data in young adults, the study addressed the effect of fruit and vegetable intake during young adulthood on later cardiovascular disease risk. Previous studies have found that a diet high in fruit and vegetables is associated with a lower cardiovascular disease risk in middle-aged adults, with risk decreasing further as intake increases, a finding that has been less consistent in men, Dr. Miedema pointed out.
Fruit and vegetable intake was divided into tertiles, based on the number of servings the study participants reported consuming per day: Women in the top third ate 8-9 servings of fruit and vegetables per day, compared with 3-4 servings a day in the bottom third. The amount consumed was slightly lower in men, at 7-8 servings per day in the top third and 2-3 servings per day in the bottom third. Those in the top third had healthier behaviors, with slightly lower cholesterol and blood pressure levels, and were less likely to smoke.
After adjustment for a 2,000-calorie diet, women who consumed 8-9 servings of fruit and vegetables a day as young adults were about 40% less likely to have calcified plaque in their coronary arteries, compared with women who consumed about 3 servings of fruit and vegetables a day as young adults, Dr. Miedema said. This association was independent of age, weight, race, and lifestyle factors that included smoking, amount of exercise, and alcohol consumption.
"But in men, we did not find the same relationship," he said. Although two previous studies have also suggested that men derive fewer benefits from a diet high in fruit and vegetables, only 1,038 men were enrolled in this study, so it may have been underpowered to detect an effect in men, he added.
The results "reinforce the value of establishing healthy behaviors early in adulthood, and as we talk about population-based approaches to trying to reduce coronary vascular disease, it seems that we should probably include a focus on establishing a high intake of fruits and vegetables early in life," Dr. Miedema concluded
As for the gender difference, the message of the study should not be "that fruit and vegetable intake doesn’t matter in men," but that it is possible that a high intake of fruit and vegetables "doesn’t work quite as well in reducing heart disease risk for men as it does for women," he added. There is no biological explanation for the gender difference, which needs further study, he noted.
The CARDIA study, which is evaluating the development of cardiovascular risk factors and cardiovascular disease in healthy black and white adults, is sponsored by the National Institutes of Health. Dr. Miedema had no disclosures.
FROM ACC 2014
Fruit and vegetable consumption in young women linked to later CVD benefit
A high intake of fruit and vegetables during early adulthood was associated with a lower risk of having calcified arterial plaque 20 years later, a benefit that was only evident in women, in the CARDIA (Coronary Artery Risk Development in Young Adults) study.
Previous studies have also found that women seem to benefit more from a diet that includes a high intake of fruit and vegetables, a disparity that "should be explored further," said Dr. Michael Miedema, a preventive cardiologist at the Minneapolis Heart Institute. He summarized the results of the study during a webcast held prior to the annual meeting of the American College of Cardiology, where he is presenting the data.
The study evaluated the association between the intake of fruit and vegetables in 2,648 people enrolled in the CARDIA study in 1985 and 1986, at an average age of 25 years, and the presence of coronary artery calcium (CAC), measured with electron-beam computed tomography, 20 years later. Participants were excluded if they consumed less than 800 kcal/day or more than 4,500 kcal/day, or if they had missing CAC scores.
Because there are fewer data in young adults, the study addressed the effect of fruit and vegetable intake during young adulthood on later cardiovascular disease risk. Previous studies have found that a diet high in fruit and vegetables is associated with a lower cardiovascular disease risk in middle-aged adults, with risk decreasing further as intake increases, a finding that has been less consistent in men, Dr. Miedema pointed out.
Fruit and vegetable intake was divided into tertiles, based on the number of servings the study participants reported consuming per day: Women in the top third ate 8-9 servings of fruit and vegetables per day, compared with 3-4 servings a day in the bottom third. The amount consumed was slightly lower in men, at 7-8 servings per day in the top third and 2-3 servings per day in the bottom third. Those in the top third had healthier behaviors, with slightly lower cholesterol and blood pressure levels, and were less likely to smoke.
After adjustment for a 2,000-calorie diet, women who consumed 8-9 servings of fruit and vegetables a day as young adults were about 40% less likely to have calcified plaque in their coronary arteries, compared with women who consumed about 3 servings of fruit and vegetables a day as young adults, Dr. Miedema said. This association was independent of age, weight, race, and lifestyle factors that included smoking, amount of exercise, and alcohol consumption.
"But in men, we did not find the same relationship," he said. Although two previous studies have also suggested that men derive fewer benefits from a diet high in fruit and vegetables, only 1,038 men were enrolled in this study, so it may have been underpowered to detect an effect in men, he added.
The results "reinforce the value of establishing healthy behaviors early in adulthood, and as we talk about population-based approaches to trying to reduce coronary vascular disease, it seems that we should probably include a focus on establishing a high intake of fruits and vegetables early in life," Dr. Miedema concluded
As for the gender difference, the message of the study should not be "that fruit and vegetable intake doesn’t matter in men," but that it is possible that a high intake of fruit and vegetables "doesn’t work quite as well in reducing heart disease risk for men as it does for women," he added. There is no biological explanation for the gender difference, which needs further study, he noted.
The CARDIA study, which is evaluating the development of cardiovascular risk factors and cardiovascular disease in healthy black and white adults, is sponsored by the National Institutes of Health. Dr. Miedema had no disclosures.
A high intake of fruit and vegetables during early adulthood was associated with a lower risk of having calcified arterial plaque 20 years later, a benefit that was only evident in women, in the CARDIA (Coronary Artery Risk Development in Young Adults) study.
Previous studies have also found that women seem to benefit more from a diet that includes a high intake of fruit and vegetables, a disparity that "should be explored further," said Dr. Michael Miedema, a preventive cardiologist at the Minneapolis Heart Institute. He summarized the results of the study during a webcast held prior to the annual meeting of the American College of Cardiology, where he is presenting the data.
The study evaluated the association between the intake of fruit and vegetables in 2,648 people enrolled in the CARDIA study in 1985 and 1986, at an average age of 25 years, and the presence of coronary artery calcium (CAC), measured with electron-beam computed tomography, 20 years later. Participants were excluded if they consumed less than 800 kcal/day or more than 4,500 kcal/day, or if they had missing CAC scores.
Because there are fewer data in young adults, the study addressed the effect of fruit and vegetable intake during young adulthood on later cardiovascular disease risk. Previous studies have found that a diet high in fruit and vegetables is associated with a lower cardiovascular disease risk in middle-aged adults, with risk decreasing further as intake increases, a finding that has been less consistent in men, Dr. Miedema pointed out.
Fruit and vegetable intake was divided into tertiles, based on the number of servings the study participants reported consuming per day: Women in the top third ate 8-9 servings of fruit and vegetables per day, compared with 3-4 servings a day in the bottom third. The amount consumed was slightly lower in men, at 7-8 servings per day in the top third and 2-3 servings per day in the bottom third. Those in the top third had healthier behaviors, with slightly lower cholesterol and blood pressure levels, and were less likely to smoke.
After adjustment for a 2,000-calorie diet, women who consumed 8-9 servings of fruit and vegetables a day as young adults were about 40% less likely to have calcified plaque in their coronary arteries, compared with women who consumed about 3 servings of fruit and vegetables a day as young adults, Dr. Miedema said. This association was independent of age, weight, race, and lifestyle factors that included smoking, amount of exercise, and alcohol consumption.
"But in men, we did not find the same relationship," he said. Although two previous studies have also suggested that men derive fewer benefits from a diet high in fruit and vegetables, only 1,038 men were enrolled in this study, so it may have been underpowered to detect an effect in men, he added.
The results "reinforce the value of establishing healthy behaviors early in adulthood, and as we talk about population-based approaches to trying to reduce coronary vascular disease, it seems that we should probably include a focus on establishing a high intake of fruits and vegetables early in life," Dr. Miedema concluded
As for the gender difference, the message of the study should not be "that fruit and vegetable intake doesn’t matter in men," but that it is possible that a high intake of fruit and vegetables "doesn’t work quite as well in reducing heart disease risk for men as it does for women," he added. There is no biological explanation for the gender difference, which needs further study, he noted.
The CARDIA study, which is evaluating the development of cardiovascular risk factors and cardiovascular disease in healthy black and white adults, is sponsored by the National Institutes of Health. Dr. Miedema had no disclosures.
A high intake of fruit and vegetables during early adulthood was associated with a lower risk of having calcified arterial plaque 20 years later, a benefit that was only evident in women, in the CARDIA (Coronary Artery Risk Development in Young Adults) study.
Previous studies have also found that women seem to benefit more from a diet that includes a high intake of fruit and vegetables, a disparity that "should be explored further," said Dr. Michael Miedema, a preventive cardiologist at the Minneapolis Heart Institute. He summarized the results of the study during a webcast held prior to the annual meeting of the American College of Cardiology, where he is presenting the data.
The study evaluated the association between the intake of fruit and vegetables in 2,648 people enrolled in the CARDIA study in 1985 and 1986, at an average age of 25 years, and the presence of coronary artery calcium (CAC), measured with electron-beam computed tomography, 20 years later. Participants were excluded if they consumed less than 800 kcal/day or more than 4,500 kcal/day, or if they had missing CAC scores.
Because there are fewer data in young adults, the study addressed the effect of fruit and vegetable intake during young adulthood on later cardiovascular disease risk. Previous studies have found that a diet high in fruit and vegetables is associated with a lower cardiovascular disease risk in middle-aged adults, with risk decreasing further as intake increases, a finding that has been less consistent in men, Dr. Miedema pointed out.
Fruit and vegetable intake was divided into tertiles, based on the number of servings the study participants reported consuming per day: Women in the top third ate 8-9 servings of fruit and vegetables per day, compared with 3-4 servings a day in the bottom third. The amount consumed was slightly lower in men, at 7-8 servings per day in the top third and 2-3 servings per day in the bottom third. Those in the top third had healthier behaviors, with slightly lower cholesterol and blood pressure levels, and were less likely to smoke.
After adjustment for a 2,000-calorie diet, women who consumed 8-9 servings of fruit and vegetables a day as young adults were about 40% less likely to have calcified plaque in their coronary arteries, compared with women who consumed about 3 servings of fruit and vegetables a day as young adults, Dr. Miedema said. This association was independent of age, weight, race, and lifestyle factors that included smoking, amount of exercise, and alcohol consumption.
"But in men, we did not find the same relationship," he said. Although two previous studies have also suggested that men derive fewer benefits from a diet high in fruit and vegetables, only 1,038 men were enrolled in this study, so it may have been underpowered to detect an effect in men, he added.
The results "reinforce the value of establishing healthy behaviors early in adulthood, and as we talk about population-based approaches to trying to reduce coronary vascular disease, it seems that we should probably include a focus on establishing a high intake of fruits and vegetables early in life," Dr. Miedema concluded
As for the gender difference, the message of the study should not be "that fruit and vegetable intake doesn’t matter in men," but that it is possible that a high intake of fruit and vegetables "doesn’t work quite as well in reducing heart disease risk for men as it does for women," he added. There is no biological explanation for the gender difference, which needs further study, he noted.
The CARDIA study, which is evaluating the development of cardiovascular risk factors and cardiovascular disease in healthy black and white adults, is sponsored by the National Institutes of Health. Dr. Miedema had no disclosures.
FROM ACC 2014
Study links number of live births to future cardiac risk
The number of children a woman has may affect her future risk of cardiovascular disease – and the mechanism may be subclinical atherosclerosis, data from the Dallas Heart Study suggest.
Women who had had two or three live births had the lowest prevalence of subclinical atherosclerosis, compared with women who had four or more children and with women who had no live births or one live birth, depicting "a U-shaped association between the number of children a woman gives birth to and future risk of cardiovascular events," said Dr. Monika Sanghavi, chief cardiology fellow at the University of Texas Southwestern Medical Center, Dallas.
Dr. Sanghavi summarized the study results in a webcast held prior to the annual meeting of the American College of Cardiology, where she is presenting the data.
The number of children women have has been associated with their future cardiovascular disease risk, but the mechanism has not been clearly understood. For this study of 1,644 women enrolled in the Dallas Heart Study the researchers addressed whether the mechanism could be subclinical atherosclerosis by using coronary artery calcium (CAC) scores measured with CT imaging and aortic wall thickness (AWT) measured with magnetic resonance imaging. The average age of the women was 45 years, and 55% were black.
The Dallas Heart Study is a multiethnic population–based sample of Dallas County residents.
CAC scores were positive (greater than 10) in 11% of the women who had 2-3 live births, compared with 27% in those who had at least 4 live births, and 15% of those who had 0-1 live births, all significant differences.
AWTs were abnormal (greater than the 75th percentile for age and gender) in 22% of those with had 2-3 live births, compared with 33% of those who had at least 4 live births and 25% of those who had 0-1 live births. The association persisted after adjustment for cardiovascular disease risk factors, including socioeconomic status, race and education.
"The results support the hypothesis that subclinical atherosclerosis may be the mechanism for this association," Dr. Sanghavi said. As for the two groups identified at risk, she added, "we think that increased risk on either end of the curve likely represents two different processes, such that repeated pregnancies increase risk in a different way than those women who are unable to get pregnant."
These results need to be confirmed in future studies, which will also further explore why women with one or no live births are at increased risk, Dr. Sanghavi said. Those with four or more live births may be at increased risk because of "repeated exposure to an atherogenic milieu," with higher cholesterol levels, insulin resistance and other pregnancy-related changes, or factors not accounted for in the study, she noted.
But women with 0-1 live births may be at increased risk because of an underlying systemic condition such as polycystic ovarian syndrome "or some other inflammatory condition that is preventing them from getting pregnant or carrying multiple pregnancies to term," she added.
Dr. Sanghavi emphasized that the results should not be used to recommend that women should have two or three children.
Dr. Vera Bittner, chair of the ACC Prevention of Cardiovascular Disease Committee, said the results highlight the need to take "a better reproductive history when we’re trying to judge a woman’s cardiovascular risk when they present to our office."
Dr. Sanghavi had no disclosures.
The number of children a woman has may affect her future risk of cardiovascular disease – and the mechanism may be subclinical atherosclerosis, data from the Dallas Heart Study suggest.
Women who had had two or three live births had the lowest prevalence of subclinical atherosclerosis, compared with women who had four or more children and with women who had no live births or one live birth, depicting "a U-shaped association between the number of children a woman gives birth to and future risk of cardiovascular events," said Dr. Monika Sanghavi, chief cardiology fellow at the University of Texas Southwestern Medical Center, Dallas.
Dr. Sanghavi summarized the study results in a webcast held prior to the annual meeting of the American College of Cardiology, where she is presenting the data.
The number of children women have has been associated with their future cardiovascular disease risk, but the mechanism has not been clearly understood. For this study of 1,644 women enrolled in the Dallas Heart Study the researchers addressed whether the mechanism could be subclinical atherosclerosis by using coronary artery calcium (CAC) scores measured with CT imaging and aortic wall thickness (AWT) measured with magnetic resonance imaging. The average age of the women was 45 years, and 55% were black.
The Dallas Heart Study is a multiethnic population–based sample of Dallas County residents.
CAC scores were positive (greater than 10) in 11% of the women who had 2-3 live births, compared with 27% in those who had at least 4 live births, and 15% of those who had 0-1 live births, all significant differences.
AWTs were abnormal (greater than the 75th percentile for age and gender) in 22% of those with had 2-3 live births, compared with 33% of those who had at least 4 live births and 25% of those who had 0-1 live births. The association persisted after adjustment for cardiovascular disease risk factors, including socioeconomic status, race and education.
"The results support the hypothesis that subclinical atherosclerosis may be the mechanism for this association," Dr. Sanghavi said. As for the two groups identified at risk, she added, "we think that increased risk on either end of the curve likely represents two different processes, such that repeated pregnancies increase risk in a different way than those women who are unable to get pregnant."
These results need to be confirmed in future studies, which will also further explore why women with one or no live births are at increased risk, Dr. Sanghavi said. Those with four or more live births may be at increased risk because of "repeated exposure to an atherogenic milieu," with higher cholesterol levels, insulin resistance and other pregnancy-related changes, or factors not accounted for in the study, she noted.
But women with 0-1 live births may be at increased risk because of an underlying systemic condition such as polycystic ovarian syndrome "or some other inflammatory condition that is preventing them from getting pregnant or carrying multiple pregnancies to term," she added.
Dr. Sanghavi emphasized that the results should not be used to recommend that women should have two or three children.
Dr. Vera Bittner, chair of the ACC Prevention of Cardiovascular Disease Committee, said the results highlight the need to take "a better reproductive history when we’re trying to judge a woman’s cardiovascular risk when they present to our office."
Dr. Sanghavi had no disclosures.
The number of children a woman has may affect her future risk of cardiovascular disease – and the mechanism may be subclinical atherosclerosis, data from the Dallas Heart Study suggest.
Women who had had two or three live births had the lowest prevalence of subclinical atherosclerosis, compared with women who had four or more children and with women who had no live births or one live birth, depicting "a U-shaped association between the number of children a woman gives birth to and future risk of cardiovascular events," said Dr. Monika Sanghavi, chief cardiology fellow at the University of Texas Southwestern Medical Center, Dallas.
Dr. Sanghavi summarized the study results in a webcast held prior to the annual meeting of the American College of Cardiology, where she is presenting the data.
The number of children women have has been associated with their future cardiovascular disease risk, but the mechanism has not been clearly understood. For this study of 1,644 women enrolled in the Dallas Heart Study the researchers addressed whether the mechanism could be subclinical atherosclerosis by using coronary artery calcium (CAC) scores measured with CT imaging and aortic wall thickness (AWT) measured with magnetic resonance imaging. The average age of the women was 45 years, and 55% were black.
The Dallas Heart Study is a multiethnic population–based sample of Dallas County residents.
CAC scores were positive (greater than 10) in 11% of the women who had 2-3 live births, compared with 27% in those who had at least 4 live births, and 15% of those who had 0-1 live births, all significant differences.
AWTs were abnormal (greater than the 75th percentile for age and gender) in 22% of those with had 2-3 live births, compared with 33% of those who had at least 4 live births and 25% of those who had 0-1 live births. The association persisted after adjustment for cardiovascular disease risk factors, including socioeconomic status, race and education.
"The results support the hypothesis that subclinical atherosclerosis may be the mechanism for this association," Dr. Sanghavi said. As for the two groups identified at risk, she added, "we think that increased risk on either end of the curve likely represents two different processes, such that repeated pregnancies increase risk in a different way than those women who are unable to get pregnant."
These results need to be confirmed in future studies, which will also further explore why women with one or no live births are at increased risk, Dr. Sanghavi said. Those with four or more live births may be at increased risk because of "repeated exposure to an atherogenic milieu," with higher cholesterol levels, insulin resistance and other pregnancy-related changes, or factors not accounted for in the study, she noted.
But women with 0-1 live births may be at increased risk because of an underlying systemic condition such as polycystic ovarian syndrome "or some other inflammatory condition that is preventing them from getting pregnant or carrying multiple pregnancies to term," she added.
Dr. Sanghavi emphasized that the results should not be used to recommend that women should have two or three children.
Dr. Vera Bittner, chair of the ACC Prevention of Cardiovascular Disease Committee, said the results highlight the need to take "a better reproductive history when we’re trying to judge a woman’s cardiovascular risk when they present to our office."
Dr. Sanghavi had no disclosures.
FROM ACC.14
TAVR results among highlights of ACC 2014 late-breaking sessions
The results of clinical and registry studies on transcatheter aortic valve replacement are among the presentations slated for the late-breaking clinical trial sessions during the upcoming annual meeting of the American College of Cardiology meeting in Washington.
During an ACC telephone briefing on March 18, one of the meeting cochairs, Dr. Robert J. Siegel, said that results of a study comparing transcatheter placement of the CoreValve to surgical aortic valve replacement in 795 patients with severe aortic stenosis, was one of several studies that will be presented that represent "ongoing paradigm shifts" in the treatment of cardiovascular disease. The patients, whose average age was 82 years, were enrolled at 45 U.S. centers, and were randomized to surgical treatment or treatment with the self-expanding CoreValve system, which was approved by the Food and Drug Administration in January 2014 for patients who are too ill or frail to undergo surgical aortic valve replacement.
TAVR represents a "burgeoning field, and we can expect further expansion of TAVR technology into clinical practice," said Dr. Siegel, director of the Cardiac Noninvasive Laboratory, Cedars-Sinai Medical Center, Los Angeles. Another meeting cochair, Dr. Prediman K. Shah, director of the Oppenheimer Atherosclerosis Research Center and Atherosclerosis Prevention and Treatment Center at Cedars Sinai, predicted that surgical aortic valve replacement will become rare, and that as delivery methods and valve design improve over the next several years, "it’s going to be very hard to tell a patient, if they need an aortic valve, that surgery is their best option."
Results of the STS-ACC transcatheter valve registry, which has enrolled about 7,000 patients to date, will provide complementary data on TAVR, said Dr. Cindy L. Grines, the TCT-ACC-i2 chair, vice president, academic and clinical affairs at Detroit Medical Center Cardiovascular Institute, and professor of medicine Wayne State University, Detroit. This is a "very important" study, with results of 1-year outcomesin patients at 224 different sites, a far larger population than the highly selected population enrolled in clinical trials, presumably with less well-trained operators, and the use of valves other than applications studied in the original trials, she said.
The other studies that Dr. Siegel said represented paradigm shifts in treating cardiovascular disease are the CORP-2 trial, a multicenter study of patients with recurrent pericarditis comparing colchicine to placebo added to standard treatment. The third study is the 3-year follow-up results of the STAMPEDE trial, comparing the effects of bariatric surgery vs. intensive medical therapy on long-term glycemic control and diabetes complications.
Other highlights of the late-breaking clinical trials sessions include:
• Data on the safety and effectiveness of renal artery denervation to treat uncontrolled hypertension in a clinical trial comparing the treatment with medical management in more than 500 patients (SYMPLICITY HTN-3) and in the real world (the Global SYMPLICITY Registry). Dr. Shah said the clinical trial, which had a rigorous design with a sham control, "will provide us some very unique insight" into what the role of renal denervation might be for patients with difficult to control hypertension despite multiple medications." Referring to the manufacturer’s recent announcement that SYMPLICITY HTN-3 did not meet its primary efficacy endpoint, Dr. Shah said there are unanswered questions that will hopefully be addressed in this session, including whether the negative results reflect a problem with the concept of renal denervation or the technique used in the study.
• The results of a European trial addressing whether a highly sensitive troponin test can be used to identify patients who present with chest pain in the emergency department who are at low risk and do not require hospitalization.
One-year follow-up results of the noninvasively or minimally invasively implanted Melody transcatheter pulmonary valve in children and adults with congenital heart disease, who have narrowing of the pulmonic valve, which Dr. Shah said has significant implications fore the increasing population of pediatric and adult survivors of congenital heart disease.
• Two-year outcomes of the NEXT study, which compared the Nobori biodegradable polymer stent with the Xience everolimus-eluting stent, in 3,200 patients. At 1 year, when the polymer was still present, there were no differences, but at 2 years, when the polymer is gone, it will be interesting to see whether outcomes are improved further "making it superior to one of our very popular stents we are using right now," Dr. Grines said.
The results of clinical and registry studies on transcatheter aortic valve replacement are among the presentations slated for the late-breaking clinical trial sessions during the upcoming annual meeting of the American College of Cardiology meeting in Washington.
During an ACC telephone briefing on March 18, one of the meeting cochairs, Dr. Robert J. Siegel, said that results of a study comparing transcatheter placement of the CoreValve to surgical aortic valve replacement in 795 patients with severe aortic stenosis, was one of several studies that will be presented that represent "ongoing paradigm shifts" in the treatment of cardiovascular disease. The patients, whose average age was 82 years, were enrolled at 45 U.S. centers, and were randomized to surgical treatment or treatment with the self-expanding CoreValve system, which was approved by the Food and Drug Administration in January 2014 for patients who are too ill or frail to undergo surgical aortic valve replacement.
TAVR represents a "burgeoning field, and we can expect further expansion of TAVR technology into clinical practice," said Dr. Siegel, director of the Cardiac Noninvasive Laboratory, Cedars-Sinai Medical Center, Los Angeles. Another meeting cochair, Dr. Prediman K. Shah, director of the Oppenheimer Atherosclerosis Research Center and Atherosclerosis Prevention and Treatment Center at Cedars Sinai, predicted that surgical aortic valve replacement will become rare, and that as delivery methods and valve design improve over the next several years, "it’s going to be very hard to tell a patient, if they need an aortic valve, that surgery is their best option."
Results of the STS-ACC transcatheter valve registry, which has enrolled about 7,000 patients to date, will provide complementary data on TAVR, said Dr. Cindy L. Grines, the TCT-ACC-i2 chair, vice president, academic and clinical affairs at Detroit Medical Center Cardiovascular Institute, and professor of medicine Wayne State University, Detroit. This is a "very important" study, with results of 1-year outcomesin patients at 224 different sites, a far larger population than the highly selected population enrolled in clinical trials, presumably with less well-trained operators, and the use of valves other than applications studied in the original trials, she said.
The other studies that Dr. Siegel said represented paradigm shifts in treating cardiovascular disease are the CORP-2 trial, a multicenter study of patients with recurrent pericarditis comparing colchicine to placebo added to standard treatment. The third study is the 3-year follow-up results of the STAMPEDE trial, comparing the effects of bariatric surgery vs. intensive medical therapy on long-term glycemic control and diabetes complications.
Other highlights of the late-breaking clinical trials sessions include:
• Data on the safety and effectiveness of renal artery denervation to treat uncontrolled hypertension in a clinical trial comparing the treatment with medical management in more than 500 patients (SYMPLICITY HTN-3) and in the real world (the Global SYMPLICITY Registry). Dr. Shah said the clinical trial, which had a rigorous design with a sham control, "will provide us some very unique insight" into what the role of renal denervation might be for patients with difficult to control hypertension despite multiple medications." Referring to the manufacturer’s recent announcement that SYMPLICITY HTN-3 did not meet its primary efficacy endpoint, Dr. Shah said there are unanswered questions that will hopefully be addressed in this session, including whether the negative results reflect a problem with the concept of renal denervation or the technique used in the study.
• The results of a European trial addressing whether a highly sensitive troponin test can be used to identify patients who present with chest pain in the emergency department who are at low risk and do not require hospitalization.
One-year follow-up results of the noninvasively or minimally invasively implanted Melody transcatheter pulmonary valve in children and adults with congenital heart disease, who have narrowing of the pulmonic valve, which Dr. Shah said has significant implications fore the increasing population of pediatric and adult survivors of congenital heart disease.
• Two-year outcomes of the NEXT study, which compared the Nobori biodegradable polymer stent with the Xience everolimus-eluting stent, in 3,200 patients. At 1 year, when the polymer was still present, there were no differences, but at 2 years, when the polymer is gone, it will be interesting to see whether outcomes are improved further "making it superior to one of our very popular stents we are using right now," Dr. Grines said.
The results of clinical and registry studies on transcatheter aortic valve replacement are among the presentations slated for the late-breaking clinical trial sessions during the upcoming annual meeting of the American College of Cardiology meeting in Washington.
During an ACC telephone briefing on March 18, one of the meeting cochairs, Dr. Robert J. Siegel, said that results of a study comparing transcatheter placement of the CoreValve to surgical aortic valve replacement in 795 patients with severe aortic stenosis, was one of several studies that will be presented that represent "ongoing paradigm shifts" in the treatment of cardiovascular disease. The patients, whose average age was 82 years, were enrolled at 45 U.S. centers, and were randomized to surgical treatment or treatment with the self-expanding CoreValve system, which was approved by the Food and Drug Administration in January 2014 for patients who are too ill or frail to undergo surgical aortic valve replacement.
TAVR represents a "burgeoning field, and we can expect further expansion of TAVR technology into clinical practice," said Dr. Siegel, director of the Cardiac Noninvasive Laboratory, Cedars-Sinai Medical Center, Los Angeles. Another meeting cochair, Dr. Prediman K. Shah, director of the Oppenheimer Atherosclerosis Research Center and Atherosclerosis Prevention and Treatment Center at Cedars Sinai, predicted that surgical aortic valve replacement will become rare, and that as delivery methods and valve design improve over the next several years, "it’s going to be very hard to tell a patient, if they need an aortic valve, that surgery is their best option."
Results of the STS-ACC transcatheter valve registry, which has enrolled about 7,000 patients to date, will provide complementary data on TAVR, said Dr. Cindy L. Grines, the TCT-ACC-i2 chair, vice president, academic and clinical affairs at Detroit Medical Center Cardiovascular Institute, and professor of medicine Wayne State University, Detroit. This is a "very important" study, with results of 1-year outcomesin patients at 224 different sites, a far larger population than the highly selected population enrolled in clinical trials, presumably with less well-trained operators, and the use of valves other than applications studied in the original trials, she said.
The other studies that Dr. Siegel said represented paradigm shifts in treating cardiovascular disease are the CORP-2 trial, a multicenter study of patients with recurrent pericarditis comparing colchicine to placebo added to standard treatment. The third study is the 3-year follow-up results of the STAMPEDE trial, comparing the effects of bariatric surgery vs. intensive medical therapy on long-term glycemic control and diabetes complications.
Other highlights of the late-breaking clinical trials sessions include:
• Data on the safety and effectiveness of renal artery denervation to treat uncontrolled hypertension in a clinical trial comparing the treatment with medical management in more than 500 patients (SYMPLICITY HTN-3) and in the real world (the Global SYMPLICITY Registry). Dr. Shah said the clinical trial, which had a rigorous design with a sham control, "will provide us some very unique insight" into what the role of renal denervation might be for patients with difficult to control hypertension despite multiple medications." Referring to the manufacturer’s recent announcement that SYMPLICITY HTN-3 did not meet its primary efficacy endpoint, Dr. Shah said there are unanswered questions that will hopefully be addressed in this session, including whether the negative results reflect a problem with the concept of renal denervation or the technique used in the study.
• The results of a European trial addressing whether a highly sensitive troponin test can be used to identify patients who present with chest pain in the emergency department who are at low risk and do not require hospitalization.
One-year follow-up results of the noninvasively or minimally invasively implanted Melody transcatheter pulmonary valve in children and adults with congenital heart disease, who have narrowing of the pulmonic valve, which Dr. Shah said has significant implications fore the increasing population of pediatric and adult survivors of congenital heart disease.
• Two-year outcomes of the NEXT study, which compared the Nobori biodegradable polymer stent with the Xience everolimus-eluting stent, in 3,200 patients. At 1 year, when the polymer was still present, there were no differences, but at 2 years, when the polymer is gone, it will be interesting to see whether outcomes are improved further "making it superior to one of our very popular stents we are using right now," Dr. Grines said.
