Sherry Boschert

SAN FRANCISCO – Heart attacks at a regional Greek hospital spiked 44% during the country’s financial crisis, with higher rates in women, older people, and the indigent or uninsured, a study has shown.

The findings, reported by Dr. Emmanouil Makaris at the annual meeting of the American College of Cardiology, highlight some of the health costs to be paid by the populace when governments, politicians, or bankers send economies into tailspins or at least stress their underpinnings. 

The retrospective study of data on 22,093 patients admitted to the cardiology department at the General Hospital of Kalamata found 1,406 incident heart attacks among the 10,870 patients admitted from 2004 through 2007, before the Greek financial crisis, and 1,508 heart attacks among the 11,223 patients admitted in 2008 through 2011, during the ongoing crisis. The relative 44% increase in the incidence of acute MI was significant, said Dr. Makaris, a consulting cardiologist at the hospital.

In women, the incidence of acute MI rose by 51% from the period before the crisis (251 acute MIs) to the crisis era (394). The incidence of acute MI in men increased by 40% from precrisis (795) to the crisis era (1,114).

The incidence of acute MI increased by 41% for patients older than 45 years (from 944 heart attacks before to 1,363 during the crisis). In comparison, the incidence increased by 30% for patients aged 45 years or younger (from 64 before to 83 during the crisis).

The indigent or uninsured faced a 76% increased incidence of acute MI (66 heart attacks before the crisis and 116 since then), while insured patients saw a 42% increased incidence (980 before and 1,392 during the crisis).

Dr. Makaris said that many doctors at the meeting have asked him to explain how the crisis contributed to heart attacks. He described one woman who could no longer afford to buy clopidogrel, and suffered an acute MI. A man who lost his job and had no means to support his family had a heart attack, presumably with stress as a contributor.

Some people are losing their homes, unable to pay huge tax increases. Greek women are more likely to be unemployed than men and more likely to be responsible for children. Families are searching through trash bins for food, and some children faint in school from hunger. At the same time, the government’s fiscal austerity measures have slashed medical staff levels and supplies when there is greater need, he said.

Greece’s crisis is much more severe than the latest U.S. recession, in which more than 8 million people lost their jobs, but the findings should add extra concern about the effects of our homegrown financial crises.

In the United States, more women now are unemployed than men, the Los Angeles Times reported.

The U.S. Government Accountability Office reported in late 2012 that workers aged 55 years and older are less likely to be laid off in our recession than are younger workers, but once unemployed, older people have a harder time getting rehired and are more likely to take a pay cut if they do find work.

A separate study showing cardiovascular harm from Argentina’s 1999-2002 financial crisis support the Greek findings, Dr. Makaris said (Thromb. J. 2005;3:22). And a more recent U.S. study showed that employment instability increased the risk of cardiovascular events (Arch. Intern. Med. 2012;172:1731-7).

At a press briefing, moderator Dr. Fred Bove suggested that the United States should heed this warning from Greece. "I think we all see ourselves as potential victims if we don’t manage our finances," said Dr. Bove of Temple University, Philadelphia.

Dr. Makaris reported having no relevant financial disclosures.

*This story was updated on March 12, 2013.

SAN FRANCISCO – Heart attacks at a regional Greek hospital spiked 44% during the country’s financial crisis, with higher rates in women, older people, and the indigent or uninsured, a study has shown.

The findings, reported by Dr. Emmanouil Makaris at the annual meeting of the American College of Cardiology, highlight some of the health costs to be paid by the populace when governments, politicians, or bankers send economies into tailspins or at least stress their underpinnings. 

The retrospective study of data on 22,093 patients admitted to the cardiology department at the General Hospital of Kalamata found 1,406 incident heart attacks among the 10,870 patients admitted from 2004 through 2007, before the Greek financial crisis, and 1,508 heart attacks among the 11,223 patients admitted in 2008 through 2011, during the ongoing crisis. The relative 44% increase in the incidence of acute MI was significant, said Dr. Makaris, a consulting cardiologist at the hospital.

In women, the incidence of acute MI rose by 51% from the period before the crisis (251 acute MIs) to the crisis era (394). The incidence of acute MI in men increased by 40% from precrisis (795) to the crisis era (1,114).

The incidence of acute MI increased by 41% for patients older than 45 years (from 944 heart attacks before to 1,363 during the crisis). In comparison, the incidence increased by 30% for patients aged 45 years or younger (from 64 before to 83 during the crisis).

The indigent or uninsured faced a 76% increased incidence of acute MI (66 heart attacks before the crisis and 116 since then), while insured patients saw a 42% increased incidence (980 before and 1,392 during the crisis).

Dr. Makaris said that many doctors at the meeting have asked him to explain how the crisis contributed to heart attacks. He described one woman who could no longer afford to buy clopidogrel, and suffered an acute MI. A man who lost his job and had no means to support his family had a heart attack, presumably with stress as a contributor.

Some people are losing their homes, unable to pay huge tax increases. Greek women are more likely to be unemployed than men and more likely to be responsible for children. Families are searching through trash bins for food, and some children faint in school from hunger. At the same time, the government’s fiscal austerity measures have slashed medical staff levels and supplies when there is greater need, he said.

Greece’s crisis is much more severe than the latest U.S. recession, in which more than 8 million people lost their jobs, but the findings should add extra concern about the effects of our homegrown financial crises.

In the United States, more women now are unemployed than men, the Los Angeles Times reported.

The U.S. Government Accountability Office reported in late 2012 that workers aged 55 years and older are less likely to be laid off in our recession than are younger workers, but once unemployed, older people have a harder time getting rehired and are more likely to take a pay cut if they do find work.

A separate study showing cardiovascular harm from Argentina’s 1999-2002 financial crisis support the Greek findings, Dr. Makaris said (Thromb. J. 2005;3:22). And a more recent U.S. study showed that employment instability increased the risk of cardiovascular events (Arch. Intern. Med. 2012;172:1731-7).

At a press briefing, moderator Dr. Fred Bove suggested that the United States should heed this warning from Greece. "I think we all see ourselves as potential victims if we don’t manage our finances," said Dr. Bove of Temple University, Philadelphia.

Dr. Makaris reported having no relevant financial disclosures.

*This story was updated on March 12, 2013.

SAN FRANCISCO – Heart attacks at a regional Greek hospital spiked 44% during the country’s financial crisis, with higher rates in women, older people, and the indigent or uninsured, a study has shown.

The findings, reported by Dr. Emmanouil Makaris at the annual meeting of the American College of Cardiology, highlight some of the health costs to be paid by the populace when governments, politicians, or bankers send economies into tailspins or at least stress their underpinnings. 

The retrospective study of data on 22,093 patients admitted to the cardiology department at the General Hospital of Kalamata found 1,406 incident heart attacks among the 10,870 patients admitted from 2004 through 2007, before the Greek financial crisis, and 1,508 heart attacks among the 11,223 patients admitted in 2008 through 2011, during the ongoing crisis. The relative 44% increase in the incidence of acute MI was significant, said Dr. Makaris, a consulting cardiologist at the hospital.

In women, the incidence of acute MI rose by 51% from the period before the crisis (251 acute MIs) to the crisis era (394). The incidence of acute MI in men increased by 40% from precrisis (795) to the crisis era (1,114).

The incidence of acute MI increased by 41% for patients older than 45 years (from 944 heart attacks before to 1,363 during the crisis). In comparison, the incidence increased by 30% for patients aged 45 years or younger (from 64 before to 83 during the crisis).

The indigent or uninsured faced a 76% increased incidence of acute MI (66 heart attacks before the crisis and 116 since then), while insured patients saw a 42% increased incidence (980 before and 1,392 during the crisis).

Dr. Makaris said that many doctors at the meeting have asked him to explain how the crisis contributed to heart attacks. He described one woman who could no longer afford to buy clopidogrel, and suffered an acute MI. A man who lost his job and had no means to support his family had a heart attack, presumably with stress as a contributor.

Some people are losing their homes, unable to pay huge tax increases. Greek women are more likely to be unemployed than men and more likely to be responsible for children. Families are searching through trash bins for food, and some children faint in school from hunger. At the same time, the government’s fiscal austerity measures have slashed medical staff levels and supplies when there is greater need, he said.

Greece’s crisis is much more severe than the latest U.S. recession, in which more than 8 million people lost their jobs, but the findings should add extra concern about the effects of our homegrown financial crises.

In the United States, more women now are unemployed than men, the Los Angeles Times reported.

The U.S. Government Accountability Office reported in late 2012 that workers aged 55 years and older are less likely to be laid off in our recession than are younger workers, but once unemployed, older people have a harder time getting rehired and are more likely to take a pay cut if they do find work.

A separate study showing cardiovascular harm from Argentina’s 1999-2002 financial crisis support the Greek findings, Dr. Makaris said (Thromb. J. 2005;3:22). And a more recent U.S. study showed that employment instability increased the risk of cardiovascular events (Arch. Intern. Med. 2012;172:1731-7).

At a press briefing, moderator Dr. Fred Bove suggested that the United States should heed this warning from Greece. "I think we all see ourselves as potential victims if we don’t manage our finances," said Dr. Bove of Temple University, Philadelphia.

Dr. Makaris reported having no relevant financial disclosures.

*This story was updated on March 12, 2013.

SAN FRANCISCO – Treating patients with high-risk hypertension to bring systolic blood pressure below 140 mmHg but no lower than 130 mmHg appeared to be the best therapeutic target in a pre-specified analysis of data on 10,705 patients from the ACCOMPLISH trial.

Sherry Boschert/IMNG Medical Media

Every endpoint used to assess outcomes improved significantly if systolic pressure was brought to 130-139 mmHg, compared with higher pressures. Achieving a systolic pressure of 120-129 mmHg was not much more beneficial for patients, however, and more aggressive reductions to 110-119 mmHg were harmful to some patients, Dr. Michael A. Weber and his associates reported at the annual meeting of the American College of Cardiology.

Reaching systolic pressures below 120 mmHg reduced the risk of stroke, but was associated with two coronary events for every stroke prevented, said Dr. Weber, professor of medicine at the State University of New York Downstate College of Medicine, Brooklyn.

The investigators pooled data on patients in the randomized, controlled avoiding cardiovascular events through combination therapy in patients Living with systolic hypertension (ACCOMPLISH) trial, which found that combination therapy using an angiotensin converting enzyme (ACE) inhibitor plus the calcium channel blocker amlodipine was superior to an ACE inhibitor plus the diuretic hydrochlorothiazide (New Engl. J. Med. 2008; 359:2417-28).

For the current analysis, the researchers divided the patients into four groups based on the blood pressure goals they achieved: 110 mmHg to less than 120 mmHg; 120 mmHg to less than 130 mmHg; 130 mmHg to less than 140 mmHg, and 140 mmHg or higher.

Reducing systolic pressure to 130-139 mmHg reduced the relative risk for the trial’s primary endpoint (a composite of cardiovascular death, non-fatal MI, or non-fatal stroke) by 38%. The actual risk reduction was to a rate of 5%,  compared with an 8% risk with pressures of 140 mmHg or higher.

All but one of the individual outcomes also improved significantly in the 130-139 mmHg range, as compared with higher pressures. Relative risk of cardiovascular death decreased by 36%; the total MI rate fell by 37%; and the total stroke rate decreased by 47%. Only the risk of coronary revascularization did not improve significantly in patients whose systolic pressure declined to 130-139 mmHg.

Lowering systolic pressure further to 120-129 mmHg produced benefits similar to those seen in the 130-139 mmHg group, with the exception of kidney function, Dr. Weber said. Serum creatinine measurements showed that optimal blood pressures for the kidneys were below 140 mmHg but not less than 130 mmHg.

Compared with a systolic pressure of 130-139 mmHg, reducing pressure to 120-129 mmHg did not significantly reduce risks beyond a reduced likelihood of an increased serum creatinine level.

Except for total stroke risk, the benefits of lowering systolic pressure declined if systolic pressure went below 120 mmHg. The relative risk of the composite endpoint was 37% higher and the relative risk of MI was 48% higher in the under 120 mmHg group, compared with the 120-129 mmHg group, but the risk of stroke was 40% lower.

The stroke risk was a mixed picture, however. There was a blip of increased stroke risk in the 120-129 mmHg group, compared with the 110-119 mmHg and the 130-139 mmHg groups. Dr. Weber speculated that the risks for different kinds of strokes vary, with low blood pressures better for preventing hemorrhagic stroke and higher levels better for preventing ischemic stroke.

Compared with patients with systolic pressures of 120-129 mmHg, those with systolic pressures less than 120 mmHg avoided three strokes per 100 patient-years but had 6 coronary events per 100 patient-years. "So, the cost of preventing one stroke is two coronary events," he said.

Patients in the analysis had a mean age of 68 years; 61% were male, 60% had diabetes, and 46% had a history of coronary disease. After treatment, 22% had systolic pressures of 140 mmHg or higher, 32% had levels of 130-130 mmHg, 34% reached 120-129 mmHg, and 12% reached pressures below 120 mmHg.

In previous randomized trials, significantly fewer cardiovascular events occurred if systolic pressures were below 160 mmHg, as compared with higher pressures. Major guidelines recommend a systolic blood pressure goal of less than 140 mmHg, though prospective trial data to support this target have been lacking, he said.

Novartis funded the ACCOMPLISH trial. Dr. Weber has reported financial associations with Novartis, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi, Sankyo, Forest Pharmaceuticals, GlaxoSmith-Kline, Sanofi-Aventis, Gilead, and Takeda Pharmaceuticals North America. Some of his associates in the trial reported associations with multiple companies.

SAN FRANCISCO – Treating patients with high-risk hypertension to bring systolic blood pressure below 140 mmHg but no lower than 130 mmHg appeared to be the best therapeutic target in a pre-specified analysis of data on 10,705 patients from the ACCOMPLISH trial.

Sherry Boschert/IMNG Medical Media

Every endpoint used to assess outcomes improved significantly if systolic pressure was brought to 130-139 mmHg, compared with higher pressures. Achieving a systolic pressure of 120-129 mmHg was not much more beneficial for patients, however, and more aggressive reductions to 110-119 mmHg were harmful to some patients, Dr. Michael A. Weber and his associates reported at the annual meeting of the American College of Cardiology.

Reaching systolic pressures below 120 mmHg reduced the risk of stroke, but was associated with two coronary events for every stroke prevented, said Dr. Weber, professor of medicine at the State University of New York Downstate College of Medicine, Brooklyn.

The investigators pooled data on patients in the randomized, controlled avoiding cardiovascular events through combination therapy in patients Living with systolic hypertension (ACCOMPLISH) trial, which found that combination therapy using an angiotensin converting enzyme (ACE) inhibitor plus the calcium channel blocker amlodipine was superior to an ACE inhibitor plus the diuretic hydrochlorothiazide (New Engl. J. Med. 2008; 359:2417-28).

For the current analysis, the researchers divided the patients into four groups based on the blood pressure goals they achieved: 110 mmHg to less than 120 mmHg; 120 mmHg to less than 130 mmHg; 130 mmHg to less than 140 mmHg, and 140 mmHg or higher.

Reducing systolic pressure to 130-139 mmHg reduced the relative risk for the trial’s primary endpoint (a composite of cardiovascular death, non-fatal MI, or non-fatal stroke) by 38%. The actual risk reduction was to a rate of 5%,  compared with an 8% risk with pressures of 140 mmHg or higher.

All but one of the individual outcomes also improved significantly in the 130-139 mmHg range, as compared with higher pressures. Relative risk of cardiovascular death decreased by 36%; the total MI rate fell by 37%; and the total stroke rate decreased by 47%. Only the risk of coronary revascularization did not improve significantly in patients whose systolic pressure declined to 130-139 mmHg.

Lowering systolic pressure further to 120-129 mmHg produced benefits similar to those seen in the 130-139 mmHg group, with the exception of kidney function, Dr. Weber said. Serum creatinine measurements showed that optimal blood pressures for the kidneys were below 140 mmHg but not less than 130 mmHg.

Compared with a systolic pressure of 130-139 mmHg, reducing pressure to 120-129 mmHg did not significantly reduce risks beyond a reduced likelihood of an increased serum creatinine level.

Except for total stroke risk, the benefits of lowering systolic pressure declined if systolic pressure went below 120 mmHg. The relative risk of the composite endpoint was 37% higher and the relative risk of MI was 48% higher in the under 120 mmHg group, compared with the 120-129 mmHg group, but the risk of stroke was 40% lower.

The stroke risk was a mixed picture, however. There was a blip of increased stroke risk in the 120-129 mmHg group, compared with the 110-119 mmHg and the 130-139 mmHg groups. Dr. Weber speculated that the risks for different kinds of strokes vary, with low blood pressures better for preventing hemorrhagic stroke and higher levels better for preventing ischemic stroke.

Compared with patients with systolic pressures of 120-129 mmHg, those with systolic pressures less than 120 mmHg avoided three strokes per 100 patient-years but had 6 coronary events per 100 patient-years. "So, the cost of preventing one stroke is two coronary events," he said.

Patients in the analysis had a mean age of 68 years; 61% were male, 60% had diabetes, and 46% had a history of coronary disease. After treatment, 22% had systolic pressures of 140 mmHg or higher, 32% had levels of 130-130 mmHg, 34% reached 120-129 mmHg, and 12% reached pressures below 120 mmHg.

In previous randomized trials, significantly fewer cardiovascular events occurred if systolic pressures were below 160 mmHg, as compared with higher pressures. Major guidelines recommend a systolic blood pressure goal of less than 140 mmHg, though prospective trial data to support this target have been lacking, he said.

Novartis funded the ACCOMPLISH trial. Dr. Weber has reported financial associations with Novartis, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi, Sankyo, Forest Pharmaceuticals, GlaxoSmith-Kline, Sanofi-Aventis, Gilead, and Takeda Pharmaceuticals North America. Some of his associates in the trial reported associations with multiple companies.

SAN FRANCISCO – Treating patients with high-risk hypertension to bring systolic blood pressure below 140 mmHg but no lower than 130 mmHg appeared to be the best therapeutic target in a pre-specified analysis of data on 10,705 patients from the ACCOMPLISH trial.

Sherry Boschert/IMNG Medical Media

Every endpoint used to assess outcomes improved significantly if systolic pressure was brought to 130-139 mmHg, compared with higher pressures. Achieving a systolic pressure of 120-129 mmHg was not much more beneficial for patients, however, and more aggressive reductions to 110-119 mmHg were harmful to some patients, Dr. Michael A. Weber and his associates reported at the annual meeting of the American College of Cardiology.

Reaching systolic pressures below 120 mmHg reduced the risk of stroke, but was associated with two coronary events for every stroke prevented, said Dr. Weber, professor of medicine at the State University of New York Downstate College of Medicine, Brooklyn.

The investigators pooled data on patients in the randomized, controlled avoiding cardiovascular events through combination therapy in patients Living with systolic hypertension (ACCOMPLISH) trial, which found that combination therapy using an angiotensin converting enzyme (ACE) inhibitor plus the calcium channel blocker amlodipine was superior to an ACE inhibitor plus the diuretic hydrochlorothiazide (New Engl. J. Med. 2008; 359:2417-28).

For the current analysis, the researchers divided the patients into four groups based on the blood pressure goals they achieved: 110 mmHg to less than 120 mmHg; 120 mmHg to less than 130 mmHg; 130 mmHg to less than 140 mmHg, and 140 mmHg or higher.

Reducing systolic pressure to 130-139 mmHg reduced the relative risk for the trial’s primary endpoint (a composite of cardiovascular death, non-fatal MI, or non-fatal stroke) by 38%. The actual risk reduction was to a rate of 5%,  compared with an 8% risk with pressures of 140 mmHg or higher.

All but one of the individual outcomes also improved significantly in the 130-139 mmHg range, as compared with higher pressures. Relative risk of cardiovascular death decreased by 36%; the total MI rate fell by 37%; and the total stroke rate decreased by 47%. Only the risk of coronary revascularization did not improve significantly in patients whose systolic pressure declined to 130-139 mmHg.

Lowering systolic pressure further to 120-129 mmHg produced benefits similar to those seen in the 130-139 mmHg group, with the exception of kidney function, Dr. Weber said. Serum creatinine measurements showed that optimal blood pressures for the kidneys were below 140 mmHg but not less than 130 mmHg.

Compared with a systolic pressure of 130-139 mmHg, reducing pressure to 120-129 mmHg did not significantly reduce risks beyond a reduced likelihood of an increased serum creatinine level.

Except for total stroke risk, the benefits of lowering systolic pressure declined if systolic pressure went below 120 mmHg. The relative risk of the composite endpoint was 37% higher and the relative risk of MI was 48% higher in the under 120 mmHg group, compared with the 120-129 mmHg group, but the risk of stroke was 40% lower.

The stroke risk was a mixed picture, however. There was a blip of increased stroke risk in the 120-129 mmHg group, compared with the 110-119 mmHg and the 130-139 mmHg groups. Dr. Weber speculated that the risks for different kinds of strokes vary, with low blood pressures better for preventing hemorrhagic stroke and higher levels better for preventing ischemic stroke.

Compared with patients with systolic pressures of 120-129 mmHg, those with systolic pressures less than 120 mmHg avoided three strokes per 100 patient-years but had 6 coronary events per 100 patient-years. "So, the cost of preventing one stroke is two coronary events," he said.

Patients in the analysis had a mean age of 68 years; 61% were male, 60% had diabetes, and 46% had a history of coronary disease. After treatment, 22% had systolic pressures of 140 mmHg or higher, 32% had levels of 130-130 mmHg, 34% reached 120-129 mmHg, and 12% reached pressures below 120 mmHg.

In previous randomized trials, significantly fewer cardiovascular events occurred if systolic pressures were below 160 mmHg, as compared with higher pressures. Major guidelines recommend a systolic blood pressure goal of less than 140 mmHg, though prospective trial data to support this target have been lacking, he said.

Novartis funded the ACCOMPLISH trial. Dr. Weber has reported financial associations with Novartis, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi, Sankyo, Forest Pharmaceuticals, GlaxoSmith-Kline, Sanofi-Aventis, Gilead, and Takeda Pharmaceuticals North America. Some of his associates in the trial reported associations with multiple companies.

SAN FRANCISCO –Patients with stable angina need to be explicitly told that percutaneous coronary intervention will not prevent heart attacks, survey results of 1,678 people suggest.

Even if patients are informed that percutaneous coronary intervention (PCI) does not reduce myocardial infarction (MI) risk, there’s still a good chance that roughly a third of patients may leave an office thinking that it does, Dr. Mohammad A. Kashef and his associates reported at the annual meeting of the American College of Cardiology.

Sherry Boschert/IMNG Medical Media

During a hypothetical visit with a cardiologist, 69% of patients who were uninformed that PCI doesn’t reduce MI risk said that they would choose to undergo PCI to treat stable angina, compared with 49%, 46%, and 44% of patients in three groups who were informed that PCI has no effect on MI risk but would still choose to undergo the procedure, said Dr. Kashef, an internal medicine resident at Baystate Medical Center, Springfield, Mass.

"In the absence of information to the contrary, most patients assume that PCI prevents MI in stable angina and are biased towards choosing PCI," he said. "Explicit information can partially overcome that bias and influence decision making." The most effective way to overcome bias toward PCI is to explain why PCI doesn’t prevent MI, the the survey results suggest.

Participants in the Web-based surveys were aged 50 years or older and had never undergone PCI. All were asked to imagine that they had experienced occasional chest pain "like someone is pressing down on your chest, when you climb up four flights of stairs or exercise vigorously," said Dr. Kashef. They were to imagine that the feeling is uncomfortable but does not interfere with their normal activities, and that they are visiting a cardiologist for management of stable angina with a positive stress test.

All were told, by the hypothetical cardiologist, the options for treating with medication or with medication plus PCI, about the potential complications of PCI and the role of PCI in reducing angina, and about the risks and benefits of medication. In other ways, though, the scenarios diverged.

In the first scenario, the hypothetical cardiologist did not mention whether PCI does or does not affect MI risk. In the second scenario, participants specifically were told that PCI does not reduce the risk of MI. In the third scenario, patients were told why PCI does not reduce MI risk, with a description of how the "clogged-pipe model" of angina is flawed. In the fourth scenario, patients were informed that PCI does not reduce MI risk, and coronary artery disease was described as inflammation of the arteries, not as artery blockage.

A questionnaire followed, asking patients if they would undergo PCI and take medicine, and how effective they believed PCI or medical therapy to be for prevention of MI.

The proportions that said they believed PCI prevented MI were 71% in scenario one, 39% in scenario two, 31% in scenario three, and 39% in scenario four.

Patients who heard no mention of PCI’s effects on MI risk were less likely to say they would take medication (83%), compared with patients in scenarios two (87%), three (92%), and four (90%).

When asked which they thought to be more effective in preventing MI – medication or PCI – patients in group one favored PCI, while those in the other three groups favored medication.

Fully, 52% of patients in the first group falsely remembered that the doctor said PCI prevents MI, when asked if they were told this. In contrast, 19% in the other three groups reported this false memory.

Previous data have shown that PCI can relieve symptoms but does not reduce the risks for MI or death, yet 71%-88% of patients believe that PCI benefits MI and mortality risks.

The hypothetical nature of the current study’s scenarios, and the fact that the patients did not actually have stable angina, limited the significance of the findings, but the percentages of patients who chose PCI were similar to percentages in previous studies that surveyed real patients, Dr. Kashef said.

Participants had a mean age of 60 years, 51% were female, and 79% were white. Thirty-four percent had an associate’s or bachelor’s college degree, and 12% had higher degrees. Patients who completed the survey were rewarded by being entered in a lottery sponsored by the survey company

Dr. Kashef reported having no financial disclosures.

*This article was updated 3/19/13.

[email protected] <[lb]>

SAN FRANCISCO –Patients with stable angina need to be explicitly told that percutaneous coronary intervention will not prevent heart attacks, survey results of 1,678 people suggest.

Even if patients are informed that percutaneous coronary intervention (PCI) does not reduce myocardial infarction (MI) risk, there’s still a good chance that roughly a third of patients may leave an office thinking that it does, Dr. Mohammad A. Kashef and his associates reported at the annual meeting of the American College of Cardiology.

Sherry Boschert/IMNG Medical Media

During a hypothetical visit with a cardiologist, 69% of patients who were uninformed that PCI doesn’t reduce MI risk said that they would choose to undergo PCI to treat stable angina, compared with 49%, 46%, and 44% of patients in three groups who were informed that PCI has no effect on MI risk but would still choose to undergo the procedure, said Dr. Kashef, an internal medicine resident at Baystate Medical Center, Springfield, Mass.

"In the absence of information to the contrary, most patients assume that PCI prevents MI in stable angina and are biased towards choosing PCI," he said. "Explicit information can partially overcome that bias and influence decision making." The most effective way to overcome bias toward PCI is to explain why PCI doesn’t prevent MI, the the survey results suggest.

Participants in the Web-based surveys were aged 50 years or older and had never undergone PCI. All were asked to imagine that they had experienced occasional chest pain "like someone is pressing down on your chest, when you climb up four flights of stairs or exercise vigorously," said Dr. Kashef. They were to imagine that the feeling is uncomfortable but does not interfere with their normal activities, and that they are visiting a cardiologist for management of stable angina with a positive stress test.

All were told, by the hypothetical cardiologist, the options for treating with medication or with medication plus PCI, about the potential complications of PCI and the role of PCI in reducing angina, and about the risks and benefits of medication. In other ways, though, the scenarios diverged.

In the first scenario, the hypothetical cardiologist did not mention whether PCI does or does not affect MI risk. In the second scenario, participants specifically were told that PCI does not reduce the risk of MI. In the third scenario, patients were told why PCI does not reduce MI risk, with a description of how the "clogged-pipe model" of angina is flawed. In the fourth scenario, patients were informed that PCI does not reduce MI risk, and coronary artery disease was described as inflammation of the arteries, not as artery blockage.

A questionnaire followed, asking patients if they would undergo PCI and take medicine, and how effective they believed PCI or medical therapy to be for prevention of MI.

The proportions that said they believed PCI prevented MI were 71% in scenario one, 39% in scenario two, 31% in scenario three, and 39% in scenario four.

Patients who heard no mention of PCI’s effects on MI risk were less likely to say they would take medication (83%), compared with patients in scenarios two (87%), three (92%), and four (90%).

When asked which they thought to be more effective in preventing MI – medication or PCI – patients in group one favored PCI, while those in the other three groups favored medication.

Fully, 52% of patients in the first group falsely remembered that the doctor said PCI prevents MI, when asked if they were told this. In contrast, 19% in the other three groups reported this false memory.

Previous data have shown that PCI can relieve symptoms but does not reduce the risks for MI or death, yet 71%-88% of patients believe that PCI benefits MI and mortality risks.

The hypothetical nature of the current study’s scenarios, and the fact that the patients did not actually have stable angina, limited the significance of the findings, but the percentages of patients who chose PCI were similar to percentages in previous studies that surveyed real patients, Dr. Kashef said.

Participants had a mean age of 60 years, 51% were female, and 79% were white. Thirty-four percent had an associate’s or bachelor’s college degree, and 12% had higher degrees. Patients who completed the survey were rewarded by being entered in a lottery sponsored by the survey company

Dr. Kashef reported having no financial disclosures.

*This article was updated 3/19/13.

[email protected] <[lb]>

SAN FRANCISCO –Patients with stable angina need to be explicitly told that percutaneous coronary intervention will not prevent heart attacks, survey results of 1,678 people suggest.

Even if patients are informed that percutaneous coronary intervention (PCI) does not reduce myocardial infarction (MI) risk, there’s still a good chance that roughly a third of patients may leave an office thinking that it does, Dr. Mohammad A. Kashef and his associates reported at the annual meeting of the American College of Cardiology.

Sherry Boschert/IMNG Medical Media

During a hypothetical visit with a cardiologist, 69% of patients who were uninformed that PCI doesn’t reduce MI risk said that they would choose to undergo PCI to treat stable angina, compared with 49%, 46%, and 44% of patients in three groups who were informed that PCI has no effect on MI risk but would still choose to undergo the procedure, said Dr. Kashef, an internal medicine resident at Baystate Medical Center, Springfield, Mass.

"In the absence of information to the contrary, most patients assume that PCI prevents MI in stable angina and are biased towards choosing PCI," he said. "Explicit information can partially overcome that bias and influence decision making." The most effective way to overcome bias toward PCI is to explain why PCI doesn’t prevent MI, the the survey results suggest.

Participants in the Web-based surveys were aged 50 years or older and had never undergone PCI. All were asked to imagine that they had experienced occasional chest pain "like someone is pressing down on your chest, when you climb up four flights of stairs or exercise vigorously," said Dr. Kashef. They were to imagine that the feeling is uncomfortable but does not interfere with their normal activities, and that they are visiting a cardiologist for management of stable angina with a positive stress test.

All were told, by the hypothetical cardiologist, the options for treating with medication or with medication plus PCI, about the potential complications of PCI and the role of PCI in reducing angina, and about the risks and benefits of medication. In other ways, though, the scenarios diverged.

In the first scenario, the hypothetical cardiologist did not mention whether PCI does or does not affect MI risk. In the second scenario, participants specifically were told that PCI does not reduce the risk of MI. In the third scenario, patients were told why PCI does not reduce MI risk, with a description of how the "clogged-pipe model" of angina is flawed. In the fourth scenario, patients were informed that PCI does not reduce MI risk, and coronary artery disease was described as inflammation of the arteries, not as artery blockage.

A questionnaire followed, asking patients if they would undergo PCI and take medicine, and how effective they believed PCI or medical therapy to be for prevention of MI.

The proportions that said they believed PCI prevented MI were 71% in scenario one, 39% in scenario two, 31% in scenario three, and 39% in scenario four.

Patients who heard no mention of PCI’s effects on MI risk were less likely to say they would take medication (83%), compared with patients in scenarios two (87%), three (92%), and four (90%).

When asked which they thought to be more effective in preventing MI – medication or PCI – patients in group one favored PCI, while those in the other three groups favored medication.

Fully, 52% of patients in the first group falsely remembered that the doctor said PCI prevents MI, when asked if they were told this. In contrast, 19% in the other three groups reported this false memory.

Previous data have shown that PCI can relieve symptoms but does not reduce the risks for MI or death, yet 71%-88% of patients believe that PCI benefits MI and mortality risks.

The hypothetical nature of the current study’s scenarios, and the fact that the patients did not actually have stable angina, limited the significance of the findings, but the percentages of patients who chose PCI were similar to percentages in previous studies that surveyed real patients, Dr. Kashef said.

Participants had a mean age of 60 years, 51% were female, and 79% were white. Thirty-four percent had an associate’s or bachelor’s college degree, and 12% had higher degrees. Patients who completed the survey were rewarded by being entered in a lottery sponsored by the survey company

Dr. Kashef reported having no financial disclosures.

*This article was updated 3/19/13.

[email protected] <[lb]>

Two major studies on transfemoral aortic valve replacement technologies will be among the late-breaking clinical trials presented at the annual meeting of the American College of Cardiology March 9-11.

The results come at a key time, when surgeons are starting to consider transfemoral aortic valve replacement (TAVR) for low-risk as well as high-risk patients, said ACC.13 Cochair Dr. Mark G. Davies.

Other highlights among the late-breakers at the meeting include studies on biodegradable versus durable stents, statins to prevent kidney injury during percutaneous coronary intervention (PCI), short-acting antiplatelet therapy, new drugs that may reduce the size or long-term effects of heart attacks, ranolazine therapy to reduce angina in patients with diabetes, using digitalis in older patients with heart failure, and more.

He and a roster of other ACC officials provided these highlights:

• PARTNER trial: Two-year data from the Placement of Aortic Transcatheter Valve (PARTNER) trial already have suggested that results with TAVR were reasonably comparable to results with surgical aortic valve replacement (SAVR), though perhaps with increased risk of early stroke after TAVR. "But the one Achilles heel that everyone is worried about is that there will be more early strokes in TAVR," said Dr. Davies, a senior member at the Methodist Hospital Research Institute, Houston.

Three-year data from the PARTNER trial, to be presented at the meeting, should show whether the level of valvular regurgitation is increasing or not – important findings that will change practices, he said. "This is significant because we’re entering an era of entertaining these technologies for what’s considered normal or low-risk patients who might avoid a surgical aortic revascularization," said Dr. Davies. For hospitals, "it will be interesting to see if the cost-effectiveness is carried out to 3 years," he added.

• PARTNER II: This trial used a second-generation Edwards Sapien XT transcatheter heart valve and delivery system, which has a lower profile compared with the first-generation device.

The Food and Drug Administration required the Sapien and Edwards investigators to compare the newer version against SAVR before taking it to market, according to ACC Vice President Dr. Patrick T. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, Boston.

"Most investigators and clinicians in this area are keen to hear the results of this trial, and I think most anticipate that a lower-profile device will be an improvement," he said.

• NEXT trial: Enthusiasm for a potential future of biodegradable stent products rides on hopes that biodegradable polymers might cause less arterial injury and stent thrombosis, "although it seems to me very difficult to beat very low rates of stent thrombosis with present-generation drug-eluting stents," Dr. O’Gara said. This large Japanese trial comparing a biodegradable stent polymer and a durable stent polymer in more than 3,000 patients is a major data source. The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent (NEXT) trial likely will contribute "very important information in this growing field," he said.

• DKCRUSH-III trial: A highly technical and impressively large study in China compared two interventional strategies in more than 400 patients with unprotected left main bifurcation lesions. Historically, interventionalists have been challenged by management of lesions at the distal end of the left main coronary artery and extending to the origins of the left anterior descending (LAD) artery and the circumflex artery, he said. "Manipulation of the left main in this particular area is fraught with complications and relatively high rates of recurrent events."

The prospective, multicenter Comparison of Double Kissing Crush Versus Culotte Stenting for Unprotected Distal Left Main Bifurcation Lesions (DKCRUSH-III) study randomized patients to intervention with stents placed in the LAD and circumflex arteries or to high-pressure balloons being placed in those arteries and inflated simultaneously.

• CHAMPION PHOENIX trial: Results of previous studies of the experimental antiplatelet drug cangrelor have been neutral or positive, but none of the studies were as large as the Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX), which boasts nearly 11,000 patients. Preliminary results of the phase III trial suggested that this intravenously administered P2Y2-receptor inhibitor outperformed clopidogrel in patients requiring PCI in a composite endpoint of death, MI, ischemia-driven revascularization, and stent thrombosis at 48 hours.

The potential advantage of cangrelor is its very rapid onset and rapid offset of effects. "I think there is very keen expectation to hear the results of this trial as to whether or not this medication should be considered in the armamentarium at the time of PCI," Dr. O’Gara said.

• PRATO-ACS trial: The open-label Statin Contrast Induced Neuropathy Prevention (PRATO-ACS) trial randomized patients with non–ST-elevation acute coronary syndrome who are undergoing PCI to usual care or to taking a 40-mg dose of rosuvastatin at admission and then 20 mg/day for 1 month, to see if the statin will reduce acute kidney injury from the angiographic contrast medium.

"This is a very interesting look at the efficacy of a medication which, in this context, is likely to be extremely safe," Dr. O’Gara said.

Dr. Gary S. Mintz, chief medical officer at the Cardiovascular Research Foundation, New York, added, "This is an important problem. When you have a patient presenting acutely, you really don’t have much of a choice" but to send the patient to a catheterization lab, where almost invariably a stent is implanted, a procedure requiring angiographic contrast, which can induce acute renal insufficiency or worsen preexisting renal insufficiency. "Patients who develop significant renal insufficiency have an awful outcome, both acutely and long-term. If there’s any safe way, any easy, efficacious way to prevent acute renal insufficiency in this setting, this will become the standard of care."

• MASS COMM trial: The use of PCI is increasing in smaller hospitals as more of them develop non-open coronary artery based practices, and there’s controversy over whether these practices should have the backup of on-site cardiac surgery services, Dr. Davies said. The PCI Outcomes in Community Versus Tertiary Settings (MASS COMM) trial randomized nearly 4,000 Massachusetts residents undergoing elective PCI to one of 10 hospitals without on-site surgical backup or one of 7 hospitals with on-site backup.

• REMINDER trial: Despite all the advances in treating acute MI, a subgroup of patients still suffer enough heart damage that they go on to develop heart failure. The large, multicenter Impact of Eplerenone on Cardiovascular in Patients Post Myocardial Infarction (REMINDER) trial randomized more than 1,000 patients who’d had heart attacks within 24 hours to treatment with placebo or the aldosterone-blocker eplerenone. Outcomes to be reported include some clinical signs of worsening heart function, clinical signs that predict heart failure, and some biomarkers of worsening cardiac function.

• Select ACS trial: This multicenter, randomized, double-blind, placebo-controlled study looks at whether or not giving the investigational drug inclacumab to patients with non–ST-elevation MI who are undergoing PCI reduces short-term markers of infarct size. Inclacumab is a fully human antibody targeting P-selectin, a molecule that plays a role in sending white blood cells to the site of injury during inflammation.

"If, in fact, this agent reduces the size of the heart attack in this subgroup of patients, it potentially could have benefits long term," said ACC.13 Chairman Dr. Miguel A. Quiñones, chair of the department of cardiology in the Methodist Hospital System, Houston, and professor of medicine at Weill Cornell Medical College, New York.

• ASTRONAUT trial: Can add-on therapy with the potent direct renin inhibitor aliskiren improve outcomes in patients presenting with acute heart failure? Results of a trial in roughly 1,600 patients – the Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients with Acute Decompensated Heart Failure (ASTRONAUT) trial – may tell us.

• TERISA trial: The Type 2 Diabetes Evaluation of Ranolazine in Subjects with Chronic Stable Angina (TERISA) trial looked at whether the drug reduced the weekly average frequency of angina in patients with diabetes, coronary artery disease, and chronic stable angina. Revascularization procedures can be challenging in diabetics, who often have small vessels, so a helpful medical therapy would be a boon, said ACC.13 Cochair Dr. Christie M. Ballantyne, director of the Center for Cardiovascular Disease Prevention at Methodist DeBakey Heart Center, Houston.

• DIG trial: An analysis of data from the Digitalis Investigation Group (DIG) trial will report whether giving the inexpensive drug digoxin to patients aged 65 years or older who have heart failure reduced hospitalizations and mortality.

• STOP-HF trial: The St. Vincent’s Screening To Prevent Heart Failure (STOP-HF) study took a "very creative approach" to try and reduce the impact of the current epidemic of heart failure by catching patients before they develop symptoms, Dr. Ballantyne said. They screened people over age 40 who had risk factors for heart failure using a blood test for natriuretic peptide; those with high levels of the peptide were sent for echocardiography and were comanaged by their primary care physician with recommendations from a specialty cardiology service. The control group of patients with risk factors for heart failure received usual care without the blood test screening or collaborative management. Results will compare the prevalence and severity of left ventricular dysfunction over 5 years in the two groups.

A list of these and other late-breaking presentations can be found on the ACC.13 website.

Dr. Quinones and Dr. Davies reported having no financial disclosures. Dr. Ballantyne reported receiving speaker and consulting fees and research funds from many pharmaceutical companies. Dr. Mintz has received fees for consulting or speaking from Boston Scientific, Volcano, Medtronic, LightLab, and Pfizer. Dr. O’Gara has been on the Data and Safety Monitoring Board of Lantheus Medical Imaging.

[email protected]

On Twitter @sherryboschert

Two major studies on transfemoral aortic valve replacement technologies will be among the late-breaking clinical trials presented at the annual meeting of the American College of Cardiology March 9-11.

The results come at a key time, when surgeons are starting to consider transfemoral aortic valve replacement (TAVR) for low-risk as well as high-risk patients, said ACC.13 Cochair Dr. Mark G. Davies.

Other highlights among the late-breakers at the meeting include studies on biodegradable versus durable stents, statins to prevent kidney injury during percutaneous coronary intervention (PCI), short-acting antiplatelet therapy, new drugs that may reduce the size or long-term effects of heart attacks, ranolazine therapy to reduce angina in patients with diabetes, using digitalis in older patients with heart failure, and more.

He and a roster of other ACC officials provided these highlights:

• PARTNER trial: Two-year data from the Placement of Aortic Transcatheter Valve (PARTNER) trial already have suggested that results with TAVR were reasonably comparable to results with surgical aortic valve replacement (SAVR), though perhaps with increased risk of early stroke after TAVR. "But the one Achilles heel that everyone is worried about is that there will be more early strokes in TAVR," said Dr. Davies, a senior member at the Methodist Hospital Research Institute, Houston.

Three-year data from the PARTNER trial, to be presented at the meeting, should show whether the level of valvular regurgitation is increasing or not – important findings that will change practices, he said. "This is significant because we’re entering an era of entertaining these technologies for what’s considered normal or low-risk patients who might avoid a surgical aortic revascularization," said Dr. Davies. For hospitals, "it will be interesting to see if the cost-effectiveness is carried out to 3 years," he added.

• PARTNER II: This trial used a second-generation Edwards Sapien XT transcatheter heart valve and delivery system, which has a lower profile compared with the first-generation device.

The Food and Drug Administration required the Sapien and Edwards investigators to compare the newer version against SAVR before taking it to market, according to ACC Vice President Dr. Patrick T. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, Boston.

"Most investigators and clinicians in this area are keen to hear the results of this trial, and I think most anticipate that a lower-profile device will be an improvement," he said.

• NEXT trial: Enthusiasm for a potential future of biodegradable stent products rides on hopes that biodegradable polymers might cause less arterial injury and stent thrombosis, "although it seems to me very difficult to beat very low rates of stent thrombosis with present-generation drug-eluting stents," Dr. O’Gara said. This large Japanese trial comparing a biodegradable stent polymer and a durable stent polymer in more than 3,000 patients is a major data source. The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent (NEXT) trial likely will contribute "very important information in this growing field," he said.

• DKCRUSH-III trial: A highly technical and impressively large study in China compared two interventional strategies in more than 400 patients with unprotected left main bifurcation lesions. Historically, interventionalists have been challenged by management of lesions at the distal end of the left main coronary artery and extending to the origins of the left anterior descending (LAD) artery and the circumflex artery, he said. "Manipulation of the left main in this particular area is fraught with complications and relatively high rates of recurrent events."

The prospective, multicenter Comparison of Double Kissing Crush Versus Culotte Stenting for Unprotected Distal Left Main Bifurcation Lesions (DKCRUSH-III) study randomized patients to intervention with stents placed in the LAD and circumflex arteries or to high-pressure balloons being placed in those arteries and inflated simultaneously.

• CHAMPION PHOENIX trial: Results of previous studies of the experimental antiplatelet drug cangrelor have been neutral or positive, but none of the studies were as large as the Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX), which boasts nearly 11,000 patients. Preliminary results of the phase III trial suggested that this intravenously administered P2Y2-receptor inhibitor outperformed clopidogrel in patients requiring PCI in a composite endpoint of death, MI, ischemia-driven revascularization, and stent thrombosis at 48 hours.

The potential advantage of cangrelor is its very rapid onset and rapid offset of effects. "I think there is very keen expectation to hear the results of this trial as to whether or not this medication should be considered in the armamentarium at the time of PCI," Dr. O’Gara said.

• PRATO-ACS trial: The open-label Statin Contrast Induced Neuropathy Prevention (PRATO-ACS) trial randomized patients with non–ST-elevation acute coronary syndrome who are undergoing PCI to usual care or to taking a 40-mg dose of rosuvastatin at admission and then 20 mg/day for 1 month, to see if the statin will reduce acute kidney injury from the angiographic contrast medium.

"This is a very interesting look at the efficacy of a medication which, in this context, is likely to be extremely safe," Dr. O’Gara said.

Dr. Gary S. Mintz, chief medical officer at the Cardiovascular Research Foundation, New York, added, "This is an important problem. When you have a patient presenting acutely, you really don’t have much of a choice" but to send the patient to a catheterization lab, where almost invariably a stent is implanted, a procedure requiring angiographic contrast, which can induce acute renal insufficiency or worsen preexisting renal insufficiency. "Patients who develop significant renal insufficiency have an awful outcome, both acutely and long-term. If there’s any safe way, any easy, efficacious way to prevent acute renal insufficiency in this setting, this will become the standard of care."

• MASS COMM trial: The use of PCI is increasing in smaller hospitals as more of them develop non-open coronary artery based practices, and there’s controversy over whether these practices should have the backup of on-site cardiac surgery services, Dr. Davies said. The PCI Outcomes in Community Versus Tertiary Settings (MASS COMM) trial randomized nearly 4,000 Massachusetts residents undergoing elective PCI to one of 10 hospitals without on-site surgical backup or one of 7 hospitals with on-site backup.

• REMINDER trial: Despite all the advances in treating acute MI, a subgroup of patients still suffer enough heart damage that they go on to develop heart failure. The large, multicenter Impact of Eplerenone on Cardiovascular in Patients Post Myocardial Infarction (REMINDER) trial randomized more than 1,000 patients who’d had heart attacks within 24 hours to treatment with placebo or the aldosterone-blocker eplerenone. Outcomes to be reported include some clinical signs of worsening heart function, clinical signs that predict heart failure, and some biomarkers of worsening cardiac function.

• Select ACS trial: This multicenter, randomized, double-blind, placebo-controlled study looks at whether or not giving the investigational drug inclacumab to patients with non–ST-elevation MI who are undergoing PCI reduces short-term markers of infarct size. Inclacumab is a fully human antibody targeting P-selectin, a molecule that plays a role in sending white blood cells to the site of injury during inflammation.

"If, in fact, this agent reduces the size of the heart attack in this subgroup of patients, it potentially could have benefits long term," said ACC.13 Chairman Dr. Miguel A. Quiñones, chair of the department of cardiology in the Methodist Hospital System, Houston, and professor of medicine at Weill Cornell Medical College, New York.

• ASTRONAUT trial: Can add-on therapy with the potent direct renin inhibitor aliskiren improve outcomes in patients presenting with acute heart failure? Results of a trial in roughly 1,600 patients – the Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients with Acute Decompensated Heart Failure (ASTRONAUT) trial – may tell us.

• TERISA trial: The Type 2 Diabetes Evaluation of Ranolazine in Subjects with Chronic Stable Angina (TERISA) trial looked at whether the drug reduced the weekly average frequency of angina in patients with diabetes, coronary artery disease, and chronic stable angina. Revascularization procedures can be challenging in diabetics, who often have small vessels, so a helpful medical therapy would be a boon, said ACC.13 Cochair Dr. Christie M. Ballantyne, director of the Center for Cardiovascular Disease Prevention at Methodist DeBakey Heart Center, Houston.

• DIG trial: An analysis of data from the Digitalis Investigation Group (DIG) trial will report whether giving the inexpensive drug digoxin to patients aged 65 years or older who have heart failure reduced hospitalizations and mortality.

• STOP-HF trial: The St. Vincent’s Screening To Prevent Heart Failure (STOP-HF) study took a "very creative approach" to try and reduce the impact of the current epidemic of heart failure by catching patients before they develop symptoms, Dr. Ballantyne said. They screened people over age 40 who had risk factors for heart failure using a blood test for natriuretic peptide; those with high levels of the peptide were sent for echocardiography and were comanaged by their primary care physician with recommendations from a specialty cardiology service. The control group of patients with risk factors for heart failure received usual care without the blood test screening or collaborative management. Results will compare the prevalence and severity of left ventricular dysfunction over 5 years in the two groups.

A list of these and other late-breaking presentations can be found on the ACC.13 website.

Dr. Quinones and Dr. Davies reported having no financial disclosures. Dr. Ballantyne reported receiving speaker and consulting fees and research funds from many pharmaceutical companies. Dr. Mintz has received fees for consulting or speaking from Boston Scientific, Volcano, Medtronic, LightLab, and Pfizer. Dr. O’Gara has been on the Data and Safety Monitoring Board of Lantheus Medical Imaging.

[email protected]

On Twitter @sherryboschert

Two major studies on transfemoral aortic valve replacement technologies will be among the late-breaking clinical trials presented at the annual meeting of the American College of Cardiology March 9-11.

The results come at a key time, when surgeons are starting to consider transfemoral aortic valve replacement (TAVR) for low-risk as well as high-risk patients, said ACC.13 Cochair Dr. Mark G. Davies.

Other highlights among the late-breakers at the meeting include studies on biodegradable versus durable stents, statins to prevent kidney injury during percutaneous coronary intervention (PCI), short-acting antiplatelet therapy, new drugs that may reduce the size or long-term effects of heart attacks, ranolazine therapy to reduce angina in patients with diabetes, using digitalis in older patients with heart failure, and more.

He and a roster of other ACC officials provided these highlights:

• PARTNER trial: Two-year data from the Placement of Aortic Transcatheter Valve (PARTNER) trial already have suggested that results with TAVR were reasonably comparable to results with surgical aortic valve replacement (SAVR), though perhaps with increased risk of early stroke after TAVR. "But the one Achilles heel that everyone is worried about is that there will be more early strokes in TAVR," said Dr. Davies, a senior member at the Methodist Hospital Research Institute, Houston.

Three-year data from the PARTNER trial, to be presented at the meeting, should show whether the level of valvular regurgitation is increasing or not – important findings that will change practices, he said. "This is significant because we’re entering an era of entertaining these technologies for what’s considered normal or low-risk patients who might avoid a surgical aortic revascularization," said Dr. Davies. For hospitals, "it will be interesting to see if the cost-effectiveness is carried out to 3 years," he added.

• PARTNER II: This trial used a second-generation Edwards Sapien XT transcatheter heart valve and delivery system, which has a lower profile compared with the first-generation device.

The Food and Drug Administration required the Sapien and Edwards investigators to compare the newer version against SAVR before taking it to market, according to ACC Vice President Dr. Patrick T. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, Boston.

"Most investigators and clinicians in this area are keen to hear the results of this trial, and I think most anticipate that a lower-profile device will be an improvement," he said.

• NEXT trial: Enthusiasm for a potential future of biodegradable stent products rides on hopes that biodegradable polymers might cause less arterial injury and stent thrombosis, "although it seems to me very difficult to beat very low rates of stent thrombosis with present-generation drug-eluting stents," Dr. O’Gara said. This large Japanese trial comparing a biodegradable stent polymer and a durable stent polymer in more than 3,000 patients is a major data source. The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent (NEXT) trial likely will contribute "very important information in this growing field," he said.

• DKCRUSH-III trial: A highly technical and impressively large study in China compared two interventional strategies in more than 400 patients with unprotected left main bifurcation lesions. Historically, interventionalists have been challenged by management of lesions at the distal end of the left main coronary artery and extending to the origins of the left anterior descending (LAD) artery and the circumflex artery, he said. "Manipulation of the left main in this particular area is fraught with complications and relatively high rates of recurrent events."

The prospective, multicenter Comparison of Double Kissing Crush Versus Culotte Stenting for Unprotected Distal Left Main Bifurcation Lesions (DKCRUSH-III) study randomized patients to intervention with stents placed in the LAD and circumflex arteries or to high-pressure balloons being placed in those arteries and inflated simultaneously.

• CHAMPION PHOENIX trial: Results of previous studies of the experimental antiplatelet drug cangrelor have been neutral or positive, but none of the studies were as large as the Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX), which boasts nearly 11,000 patients. Preliminary results of the phase III trial suggested that this intravenously administered P2Y2-receptor inhibitor outperformed clopidogrel in patients requiring PCI in a composite endpoint of death, MI, ischemia-driven revascularization, and stent thrombosis at 48 hours.

The potential advantage of cangrelor is its very rapid onset and rapid offset of effects. "I think there is very keen expectation to hear the results of this trial as to whether or not this medication should be considered in the armamentarium at the time of PCI," Dr. O’Gara said.

• PRATO-ACS trial: The open-label Statin Contrast Induced Neuropathy Prevention (PRATO-ACS) trial randomized patients with non–ST-elevation acute coronary syndrome who are undergoing PCI to usual care or to taking a 40-mg dose of rosuvastatin at admission and then 20 mg/day for 1 month, to see if the statin will reduce acute kidney injury from the angiographic contrast medium.

"This is a very interesting look at the efficacy of a medication which, in this context, is likely to be extremely safe," Dr. O’Gara said.

Dr. Gary S. Mintz, chief medical officer at the Cardiovascular Research Foundation, New York, added, "This is an important problem. When you have a patient presenting acutely, you really don’t have much of a choice" but to send the patient to a catheterization lab, where almost invariably a stent is implanted, a procedure requiring angiographic contrast, which can induce acute renal insufficiency or worsen preexisting renal insufficiency. "Patients who develop significant renal insufficiency have an awful outcome, both acutely and long-term. If there’s any safe way, any easy, efficacious way to prevent acute renal insufficiency in this setting, this will become the standard of care."

• MASS COMM trial: The use of PCI is increasing in smaller hospitals as more of them develop non-open coronary artery based practices, and there’s controversy over whether these practices should have the backup of on-site cardiac surgery services, Dr. Davies said. The PCI Outcomes in Community Versus Tertiary Settings (MASS COMM) trial randomized nearly 4,000 Massachusetts residents undergoing elective PCI to one of 10 hospitals without on-site surgical backup or one of 7 hospitals with on-site backup.

• REMINDER trial: Despite all the advances in treating acute MI, a subgroup of patients still suffer enough heart damage that they go on to develop heart failure. The large, multicenter Impact of Eplerenone on Cardiovascular in Patients Post Myocardial Infarction (REMINDER) trial randomized more than 1,000 patients who’d had heart attacks within 24 hours to treatment with placebo or the aldosterone-blocker eplerenone. Outcomes to be reported include some clinical signs of worsening heart function, clinical signs that predict heart failure, and some biomarkers of worsening cardiac function.

• Select ACS trial: This multicenter, randomized, double-blind, placebo-controlled study looks at whether or not giving the investigational drug inclacumab to patients with non–ST-elevation MI who are undergoing PCI reduces short-term markers of infarct size. Inclacumab is a fully human antibody targeting P-selectin, a molecule that plays a role in sending white blood cells to the site of injury during inflammation.

"If, in fact, this agent reduces the size of the heart attack in this subgroup of patients, it potentially could have benefits long term," said ACC.13 Chairman Dr. Miguel A. Quiñones, chair of the department of cardiology in the Methodist Hospital System, Houston, and professor of medicine at Weill Cornell Medical College, New York.

• ASTRONAUT trial: Can add-on therapy with the potent direct renin inhibitor aliskiren improve outcomes in patients presenting with acute heart failure? Results of a trial in roughly 1,600 patients – the Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients with Acute Decompensated Heart Failure (ASTRONAUT) trial – may tell us.

• TERISA trial: The Type 2 Diabetes Evaluation of Ranolazine in Subjects with Chronic Stable Angina (TERISA) trial looked at whether the drug reduced the weekly average frequency of angina in patients with diabetes, coronary artery disease, and chronic stable angina. Revascularization procedures can be challenging in diabetics, who often have small vessels, so a helpful medical therapy would be a boon, said ACC.13 Cochair Dr. Christie M. Ballantyne, director of the Center for Cardiovascular Disease Prevention at Methodist DeBakey Heart Center, Houston.

• DIG trial: An analysis of data from the Digitalis Investigation Group (DIG) trial will report whether giving the inexpensive drug digoxin to patients aged 65 years or older who have heart failure reduced hospitalizations and mortality.

• STOP-HF trial: The St. Vincent’s Screening To Prevent Heart Failure (STOP-HF) study took a "very creative approach" to try and reduce the impact of the current epidemic of heart failure by catching patients before they develop symptoms, Dr. Ballantyne said. They screened people over age 40 who had risk factors for heart failure using a blood test for natriuretic peptide; those with high levels of the peptide were sent for echocardiography and were comanaged by their primary care physician with recommendations from a specialty cardiology service. The control group of patients with risk factors for heart failure received usual care without the blood test screening or collaborative management. Results will compare the prevalence and severity of left ventricular dysfunction over 5 years in the two groups.

A list of these and other late-breaking presentations can be found on the ACC.13 website.

Dr. Quinones and Dr. Davies reported having no financial disclosures. Dr. Ballantyne reported receiving speaker and consulting fees and research funds from many pharmaceutical companies. Dr. Mintz has received fees for consulting or speaking from Boston Scientific, Volcano, Medtronic, LightLab, and Pfizer. Dr. O’Gara has been on the Data and Safety Monitoring Board of Lantheus Medical Imaging.

[email protected]

On Twitter @sherryboschert

Improvements in the quality of health care don’t just happen. They’re created, in physician practices large and small, and driven by the desire to improve. Three oncologists, one in a solo practice, a second practicing in a midsize group, and a third in a large medical system, spoke at the 2012 ASCO Quality Care Symposium in San Diego about their quality-improvement initiatives — what they’re doing, how they’re doing it, and the obstacles they face in their efforts to improve the quality of cancer care.

*Click on the links to the left for a PDF of the full article and accompanying Commentary.

Improvements in the quality of health care don’t just happen. They’re created, in physician practices large and small, and driven by the desire to improve. Three oncologists, one in a solo practice, a second practicing in a midsize group, and a third in a large medical system, spoke at the 2012 ASCO Quality Care Symposium in San Diego about their quality-improvement initiatives — what they’re doing, how they’re doing it, and the obstacles they face in their efforts to improve the quality of cancer care.

*Click on the links to the left for a PDF of the full article and accompanying Commentary.

Improvements in the quality of health care don’t just happen. They’re created, in physician practices large and small, and driven by the desire to improve. Three oncologists, one in a solo practice, a second practicing in a midsize group, and a third in a large medical system, spoke at the 2012 ASCO Quality Care Symposium in San Diego about their quality-improvement initiatives — what they’re doing, how they’re doing it, and the obstacles they face in their efforts to improve the quality of cancer care.

*Click on the links to the left for a PDF of the full article and accompanying Commentary.

Several studies to be presented at the annual meeting of the American College of Cardiology March 9-11 could change clinical practices. And then there are the mummies.

That’s right, mummies. More than 100 of them. They won’t be lumbering along the hallways of San Francisco’s Moscone Center, but they could tell us whether human ancestors in different parts of the world had atherosclerosis when they died and got mummified.

Following CT scans that showed atherosclerosis was common in a previous study of 52 Egyptian mummies (JACC Cardiovasc. Imaging 2011;4:315-27), investigators have imaged more than 100 mummies of people who lived 3,800 years ago in different cultures around the world. The findings should advance understanding of atherosclerosis in human civilization, ACC.13 Chairman Dr. Miguel A. Quiñones said in a teleconference preview for the press.

Some practice-changing news could come from some of the 22 late-breaking clinical trials and 2,130 abstracts accepted for presentation at the meeting, starting with highly anticipated results from a study of an intervention for atrial fibrillation, said Dr. Quiñones, chair of the department of cardiology in the Methodist Hospital System, Houston, and professor of medicine at Weill Cornell Medical College, New York.

He and a roster of other ACC officials provided these highlights:

• PREVAIL trial: Some of the most anticipated results will come from a trial of elderly patients with atrial fibrillation who were randomized to treatment with a device that allows an electrophysiologist to seal the left atrial appendage (LAA) or to conventional treatment with warfarin to reduce the risk of clots and stroke. For the nearly 1 in 10 U.S. residents aged in their 80s and 90s with atrial fibrillation, a frail physical status puts them at risk of falling, which can cause problematic bleeding if they’re being treated with anticoagulants.

Dr. Quiñones said that he expects the results of the PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients with Atrial Fibrillation Versus Long-term Warfarin Therapy) trial to be "extremely powerful in knowing whether this type of therapy is warranted in a selected group of patients with atrial fibrillation."

• RELAX trial: Treatment for heart failure in patients with a normal ejection fraction hasn’t advanced significantly in 10-15 years, but the RELAX (Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Diastolic Heart Failure) trial could change that, he said. Roughly half of patients with heart failure have a normal ejection fraction, which is increasingly common. The trial studied whether the phosphodiesterase inhibitor sildenafil (Viagra) can improve the relaxation functions of the heart and improve clinical outcomes in these patients who have preserved pumping action but fibroses and stiffness in the heart that produce the symptoms of heart failure.

"Will this new class of agents be a breakthrough in the treatment of a disease that is very important for public health, the cost of health care, and management of diseases?" he asked.

• TACT trial: Preliminary results of TACT (Randomized Comparison of High-dose Oral Vitamins vs. Placebo in the Trial to Assess Chelation Therapy), reported at the annual meeting of the American Heart Association last fall, suggested that chelation therapy for atherosclerosis might be beneficial. Investigators will report results of treatment with chelation, high-dose oral vitamins, or placebo, alone or in combination with each other. The results "could be a game changer," Dr. Quiñones said.

• HPS2-THRIVE trial: This study of whether adding niacin and laropiprant to statins is better than statins alone in preventing future myocardial infarction in patients with previous MI or heart disease failed to reach its primary endpoint, Merck announced in late 2012. But the data on more than 25,000 patients provides enough power for potentially useful subgroup analyses, ACC.13 cochair Dr. Christie M. Ballantyne said. The cohort as a whole had low LDL levels at the start of HPS2-THRIVE (Heart Protection Study 2–Treatment of HDL to Reduce the Incidence of Vascular Events, but U.S. adults tend to have high LDL levels. Subgroup analyses may or may not show a beneficial effect of niacin/laropiprant in some populations, though it will be impossible to say whether any effect is due to the niacin or to laropiprant, which is given to reduce the side effect of flushing caused by niacin, said Dr. Ballantyne, director of the Center for Cardiovascular Disease Prevention at Methodist DeBakey Heart Center, Houston.

• PEITHO trial: Results of the PEITHO (Pulmonary Embolism Thrombolysis) study are of particular interest after tennis star Venus Williams had to drop off the competitive circuit due to pulmonary embolus. The study randomized about 1,000 patients with acute pulmonary embolism in 13 countries to anticoagulation treatment with heparin alone or to heparin plus the clot-busting agent tenecteplase. "The results will help guide therapy and probably will influence the next set of chest guidelines," said ACC.13 cochair Dr. Mark G. Davies, a senior member at the Methodist Hospital Research Institute, Houston.

• Off-pump CABG: A Monday morning session combines three late-breaking trials comparing off-pump and on-pump coronary artery bypass grafting (CABG) that "probably will lead to a very spirited discussion," Dr. Davies said. One of them – the PRAGUE-6 (Off-Pump Versus On-Pump Coronary Artery Bypass Graft Surgery in High-Risk Patients) trial – could be one of the most significant presentations at the meeting, he suggested. Elderly patients were the focus of the GOPCABE (German Off Pump Coronary Artery Bypass Grafting in Elderly Patients) study. In addition, 1-year results will be presented from the CORONARY (Coronary Artery Bypass Grafting Surgery Off or On Pump Revascularization) study.

• STREAM trial: Guidelines recommend that patients with acute ST-elevation MI who present to a facility that does not perform percutaneous coronary intervention be transferred to a PCI-capable facility if the procedure can be performed within 2 hours of first medical contact. But rural residents don’t live within a stone’s throw of a catheterization lab, and even urban traffic congestion can block this strategy. The multinational STREAM (Strategic Reperfusion Early After Myocardial Infarction) trial compared this routine-transfer strategy with routine administration of a potent bolus dose of a fibrinolytic agent if PCI cannot be performed within 1 hour, instead of the usual 2-hour window.

"This gets to the question of whether we have embedded an unnecessary and potentially dangerous time delay in a patient’s total ischemic period by stipulating that all patients should be transferred routinely for primary PCI, and whether we’re not taking advantage of this 1-hour window of opportunity, said ACC Vice President Patrick T. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, Boston. The field of STEMI has not seen a trial of this type for many years, he said.

A list of these and other late-breaking clinical trial presentations can be found on the ACC.13 website.

Dr. Quiñones and Dr. Davies reported having no financial disclosures. Dr. Ballantyne reported receiving speaker and consulting fees and research funds from many pharmaceutical companies. Dr. O’Gara has been on the data and safety monitoring board of Lantheus Medical Imaging.

[email protected]

On Twitter @sherryboschert

Several studies to be presented at the annual meeting of the American College of Cardiology March 9-11 could change clinical practices. And then there are the mummies.

That’s right, mummies. More than 100 of them. They won’t be lumbering along the hallways of San Francisco’s Moscone Center, but they could tell us whether human ancestors in different parts of the world had atherosclerosis when they died and got mummified.

Following CT scans that showed atherosclerosis was common in a previous study of 52 Egyptian mummies (JACC Cardiovasc. Imaging 2011;4:315-27), investigators have imaged more than 100 mummies of people who lived 3,800 years ago in different cultures around the world. The findings should advance understanding of atherosclerosis in human civilization, ACC.13 Chairman Dr. Miguel A. Quiñones said in a teleconference preview for the press.

Some practice-changing news could come from some of the 22 late-breaking clinical trials and 2,130 abstracts accepted for presentation at the meeting, starting with highly anticipated results from a study of an intervention for atrial fibrillation, said Dr. Quiñones, chair of the department of cardiology in the Methodist Hospital System, Houston, and professor of medicine at Weill Cornell Medical College, New York.

He and a roster of other ACC officials provided these highlights:

• PREVAIL trial: Some of the most anticipated results will come from a trial of elderly patients with atrial fibrillation who were randomized to treatment with a device that allows an electrophysiologist to seal the left atrial appendage (LAA) or to conventional treatment with warfarin to reduce the risk of clots and stroke. For the nearly 1 in 10 U.S. residents aged in their 80s and 90s with atrial fibrillation, a frail physical status puts them at risk of falling, which can cause problematic bleeding if they’re being treated with anticoagulants.

Dr. Quiñones said that he expects the results of the PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients with Atrial Fibrillation Versus Long-term Warfarin Therapy) trial to be "extremely powerful in knowing whether this type of therapy is warranted in a selected group of patients with atrial fibrillation."

• RELAX trial: Treatment for heart failure in patients with a normal ejection fraction hasn’t advanced significantly in 10-15 years, but the RELAX (Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Diastolic Heart Failure) trial could change that, he said. Roughly half of patients with heart failure have a normal ejection fraction, which is increasingly common. The trial studied whether the phosphodiesterase inhibitor sildenafil (Viagra) can improve the relaxation functions of the heart and improve clinical outcomes in these patients who have preserved pumping action but fibroses and stiffness in the heart that produce the symptoms of heart failure.

"Will this new class of agents be a breakthrough in the treatment of a disease that is very important for public health, the cost of health care, and management of diseases?" he asked.

• TACT trial: Preliminary results of TACT (Randomized Comparison of High-dose Oral Vitamins vs. Placebo in the Trial to Assess Chelation Therapy), reported at the annual meeting of the American Heart Association last fall, suggested that chelation therapy for atherosclerosis might be beneficial. Investigators will report results of treatment with chelation, high-dose oral vitamins, or placebo, alone or in combination with each other. The results "could be a game changer," Dr. Quiñones said.

• HPS2-THRIVE trial: This study of whether adding niacin and laropiprant to statins is better than statins alone in preventing future myocardial infarction in patients with previous MI or heart disease failed to reach its primary endpoint, Merck announced in late 2012. But the data on more than 25,000 patients provides enough power for potentially useful subgroup analyses, ACC.13 cochair Dr. Christie M. Ballantyne said. The cohort as a whole had low LDL levels at the start of HPS2-THRIVE (Heart Protection Study 2–Treatment of HDL to Reduce the Incidence of Vascular Events, but U.S. adults tend to have high LDL levels. Subgroup analyses may or may not show a beneficial effect of niacin/laropiprant in some populations, though it will be impossible to say whether any effect is due to the niacin or to laropiprant, which is given to reduce the side effect of flushing caused by niacin, said Dr. Ballantyne, director of the Center for Cardiovascular Disease Prevention at Methodist DeBakey Heart Center, Houston.

• PEITHO trial: Results of the PEITHO (Pulmonary Embolism Thrombolysis) study are of particular interest after tennis star Venus Williams had to drop off the competitive circuit due to pulmonary embolus. The study randomized about 1,000 patients with acute pulmonary embolism in 13 countries to anticoagulation treatment with heparin alone or to heparin plus the clot-busting agent tenecteplase. "The results will help guide therapy and probably will influence the next set of chest guidelines," said ACC.13 cochair Dr. Mark G. Davies, a senior member at the Methodist Hospital Research Institute, Houston.

• Off-pump CABG: A Monday morning session combines three late-breaking trials comparing off-pump and on-pump coronary artery bypass grafting (CABG) that "probably will lead to a very spirited discussion," Dr. Davies said. One of them – the PRAGUE-6 (Off-Pump Versus On-Pump Coronary Artery Bypass Graft Surgery in High-Risk Patients) trial – could be one of the most significant presentations at the meeting, he suggested. Elderly patients were the focus of the GOPCABE (German Off Pump Coronary Artery Bypass Grafting in Elderly Patients) study. In addition, 1-year results will be presented from the CORONARY (Coronary Artery Bypass Grafting Surgery Off or On Pump Revascularization) study.

• STREAM trial: Guidelines recommend that patients with acute ST-elevation MI who present to a facility that does not perform percutaneous coronary intervention be transferred to a PCI-capable facility if the procedure can be performed within 2 hours of first medical contact. But rural residents don’t live within a stone’s throw of a catheterization lab, and even urban traffic congestion can block this strategy. The multinational STREAM (Strategic Reperfusion Early After Myocardial Infarction) trial compared this routine-transfer strategy with routine administration of a potent bolus dose of a fibrinolytic agent if PCI cannot be performed within 1 hour, instead of the usual 2-hour window.

"This gets to the question of whether we have embedded an unnecessary and potentially dangerous time delay in a patient’s total ischemic period by stipulating that all patients should be transferred routinely for primary PCI, and whether we’re not taking advantage of this 1-hour window of opportunity, said ACC Vice President Patrick T. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, Boston. The field of STEMI has not seen a trial of this type for many years, he said.

A list of these and other late-breaking clinical trial presentations can be found on the ACC.13 website.

Dr. Quiñones and Dr. Davies reported having no financial disclosures. Dr. Ballantyne reported receiving speaker and consulting fees and research funds from many pharmaceutical companies. Dr. O’Gara has been on the data and safety monitoring board of Lantheus Medical Imaging.

[email protected]

On Twitter @sherryboschert

Several studies to be presented at the annual meeting of the American College of Cardiology March 9-11 could change clinical practices. And then there are the mummies.

That’s right, mummies. More than 100 of them. They won’t be lumbering along the hallways of San Francisco’s Moscone Center, but they could tell us whether human ancestors in different parts of the world had atherosclerosis when they died and got mummified.

Following CT scans that showed atherosclerosis was common in a previous study of 52 Egyptian mummies (JACC Cardiovasc. Imaging 2011;4:315-27), investigators have imaged more than 100 mummies of people who lived 3,800 years ago in different cultures around the world. The findings should advance understanding of atherosclerosis in human civilization, ACC.13 Chairman Dr. Miguel A. Quiñones said in a teleconference preview for the press.

Some practice-changing news could come from some of the 22 late-breaking clinical trials and 2,130 abstracts accepted for presentation at the meeting, starting with highly anticipated results from a study of an intervention for atrial fibrillation, said Dr. Quiñones, chair of the department of cardiology in the Methodist Hospital System, Houston, and professor of medicine at Weill Cornell Medical College, New York.

He and a roster of other ACC officials provided these highlights:

• PREVAIL trial: Some of the most anticipated results will come from a trial of elderly patients with atrial fibrillation who were randomized to treatment with a device that allows an electrophysiologist to seal the left atrial appendage (LAA) or to conventional treatment with warfarin to reduce the risk of clots and stroke. For the nearly 1 in 10 U.S. residents aged in their 80s and 90s with atrial fibrillation, a frail physical status puts them at risk of falling, which can cause problematic bleeding if they’re being treated with anticoagulants.

Dr. Quiñones said that he expects the results of the PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients with Atrial Fibrillation Versus Long-term Warfarin Therapy) trial to be "extremely powerful in knowing whether this type of therapy is warranted in a selected group of patients with atrial fibrillation."

• RELAX trial: Treatment for heart failure in patients with a normal ejection fraction hasn’t advanced significantly in 10-15 years, but the RELAX (Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Diastolic Heart Failure) trial could change that, he said. Roughly half of patients with heart failure have a normal ejection fraction, which is increasingly common. The trial studied whether the phosphodiesterase inhibitor sildenafil (Viagra) can improve the relaxation functions of the heart and improve clinical outcomes in these patients who have preserved pumping action but fibroses and stiffness in the heart that produce the symptoms of heart failure.

"Will this new class of agents be a breakthrough in the treatment of a disease that is very important for public health, the cost of health care, and management of diseases?" he asked.

• TACT trial: Preliminary results of TACT (Randomized Comparison of High-dose Oral Vitamins vs. Placebo in the Trial to Assess Chelation Therapy), reported at the annual meeting of the American Heart Association last fall, suggested that chelation therapy for atherosclerosis might be beneficial. Investigators will report results of treatment with chelation, high-dose oral vitamins, or placebo, alone or in combination with each other. The results "could be a game changer," Dr. Quiñones said.

• HPS2-THRIVE trial: This study of whether adding niacin and laropiprant to statins is better than statins alone in preventing future myocardial infarction in patients with previous MI or heart disease failed to reach its primary endpoint, Merck announced in late 2012. But the data on more than 25,000 patients provides enough power for potentially useful subgroup analyses, ACC.13 cochair Dr. Christie M. Ballantyne said. The cohort as a whole had low LDL levels at the start of HPS2-THRIVE (Heart Protection Study 2–Treatment of HDL to Reduce the Incidence of Vascular Events, but U.S. adults tend to have high LDL levels. Subgroup analyses may or may not show a beneficial effect of niacin/laropiprant in some populations, though it will be impossible to say whether any effect is due to the niacin or to laropiprant, which is given to reduce the side effect of flushing caused by niacin, said Dr. Ballantyne, director of the Center for Cardiovascular Disease Prevention at Methodist DeBakey Heart Center, Houston.

• PEITHO trial: Results of the PEITHO (Pulmonary Embolism Thrombolysis) study are of particular interest after tennis star Venus Williams had to drop off the competitive circuit due to pulmonary embolus. The study randomized about 1,000 patients with acute pulmonary embolism in 13 countries to anticoagulation treatment with heparin alone or to heparin plus the clot-busting agent tenecteplase. "The results will help guide therapy and probably will influence the next set of chest guidelines," said ACC.13 cochair Dr. Mark G. Davies, a senior member at the Methodist Hospital Research Institute, Houston.

• Off-pump CABG: A Monday morning session combines three late-breaking trials comparing off-pump and on-pump coronary artery bypass grafting (CABG) that "probably will lead to a very spirited discussion," Dr. Davies said. One of them – the PRAGUE-6 (Off-Pump Versus On-Pump Coronary Artery Bypass Graft Surgery in High-Risk Patients) trial – could be one of the most significant presentations at the meeting, he suggested. Elderly patients were the focus of the GOPCABE (German Off Pump Coronary Artery Bypass Grafting in Elderly Patients) study. In addition, 1-year results will be presented from the CORONARY (Coronary Artery Bypass Grafting Surgery Off or On Pump Revascularization) study.

• STREAM trial: Guidelines recommend that patients with acute ST-elevation MI who present to a facility that does not perform percutaneous coronary intervention be transferred to a PCI-capable facility if the procedure can be performed within 2 hours of first medical contact. But rural residents don’t live within a stone’s throw of a catheterization lab, and even urban traffic congestion can block this strategy. The multinational STREAM (Strategic Reperfusion Early After Myocardial Infarction) trial compared this routine-transfer strategy with routine administration of a potent bolus dose of a fibrinolytic agent if PCI cannot be performed within 1 hour, instead of the usual 2-hour window.

"This gets to the question of whether we have embedded an unnecessary and potentially dangerous time delay in a patient’s total ischemic period by stipulating that all patients should be transferred routinely for primary PCI, and whether we’re not taking advantage of this 1-hour window of opportunity, said ACC Vice President Patrick T. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, Boston. The field of STEMI has not seen a trial of this type for many years, he said.

A list of these and other late-breaking clinical trial presentations can be found on the ACC.13 website.

Dr. Quiñones and Dr. Davies reported having no financial disclosures. Dr. Ballantyne reported receiving speaker and consulting fees and research funds from many pharmaceutical companies. Dr. O’Gara has been on the data and safety monitoring board of Lantheus Medical Imaging.

[email protected]

On Twitter @sherryboschert

A specific molecular subtype of colorectal cancer is more likely in people with greater obesity and physical inactivity, analyses of prospective data on 861 cancer patients found.

For every 5-kg/m² increase in body mass index, the likelihood that a biomarker called CTNNB1 would be absent in colorectal cancer tumors increased significantly by 34%. Increasing BMI was not associated with CTNNB1-positive tumors, however, Dr. Teppei Morikawa and his associates reported.

Activity levels were reported as a metabolic equivalent task (MET) score calculated as the metabolic rate for leisure time activities such as walking, specific exercises, sports, or other vigorous activities divided by the resting metabolic rate. MET scores for individual activities were added together as total MET hours per week (MET-h/week). For every 10 MET-h/week increase in activity, the risk of CTNNB1-negative cancer decreased significantly by 7% but the chances of CTNNB1-positive colorectal cancer did not change significantly.

In other words, greater obesity and physical inactivity were associated with significantly higher risk for CTNNB1-negative but not CTNNB1-positive colorectal cancer. This suggests that a person’s energy balance and metabolism affect a specific pathway of carcinogenesis that is different from that of some other colorectal cancer subtypes, reported Dr. Morikawa of the Dana-Farber Cancer Institute, Boston.

The findings were published in the March 1 issue of Cancer Research (2013;73:1600-10).

Previous studies have pointed to the activation of a network of proteins known as the WNT signaling pathway as a critical player in colorectal carcinogenesis. Beta-catenin (CTNBB1) is a major mediator of the WNT pathway, and previous studies have implicated WNT-CTNNB1 signaling in adipogenesis, obesity, glucose metabolism, and metabolic disease. The current findings suggest that energy metabolism affects carcinogenesis in ways that are less dependent on WNT/CTNNB1 activation, Dr. Morikawa reported.

Colon cancer typically is treated as a single disease, and most population-based studies do not consider tumor heterogeneity. Additional epidemiologic studies of the molecular pathology might help identify people who are susceptible to CTNNB1-negative colorectal tumors, determine if CTNNB1 could be a target of treatment, or illuminate prevention strategies for subsets of people, the investigators suggested.

They tapped data on 109,046 women from the Nurses’ Health Study and 47,684 men in the Health Professionals Follow-Up Study to analyze the records of 861 patients who developed rectal and colon cancers between 1986 and 2004 and who had tissue immunohistochemistry data on nuclear CTNNB1 expression.

The current investigators reviewed participants’ medical records and pathology reports and identified deaths from unreported cancers through the National Death Index. They obtained paraffin-embedded tissue blocks from hospitals where participants had undergone tumor resection to confirm colorectal cancer and to conduct immunohistochemistry for CTNNB1 expression. Dr. Morikawa was blinded to other study data when he interpreted the CTNNB1 results in all cases.

The association with higher BMI was seen in subgroups of men or women and in the combined cohort. Compared with patients who had BMIs of 18.5-22.9 kg/m² , BMIs of 27.5-29.9 kg/m² were associated with a 77% increased likelihood of CTNNB1-negative colorectal cancer, and BMIs of 30 kg/m² or greater were associated with an 84% increased risk of CTNNB1-negative cancer.

The analysis of activity levels included 767 patients with activity data whose CTNNB1 status could be determined. Activity level seemed to be associated with lower risk of CTNNB1-negative cancer in subgroups based on sex, but this did not reach statistical significance in men. Combining the two subgroups produced the small but statistically significant 7% lower risk for CTNNB1-negative cancer with increasing levels of physical activity.

An exploratory analysis that combined BMI and activity level suggested that patients with high BMI (25 kg/m² or greater) and low activity (less than 9 MET-h/week) were 82% more likely to have CTNNB1-negative colorectal cancer compared with patients with low BMI (less than 25 kg/m²) and high activity level (9 or more MET-h/week). BMI and activity level combined were not associated with CTNNB1-positive cancer.

The Cox proportional hazards model used for risk analysis controlled for the effects of other factors that have been associated with colorectal cancer risk, including age; intakes of folate, vitamin D, and calcium; total caloric intake; red meat consumption; smoking status; pack-years of smoking before age 30 years; alcohol intake; use of multivitamins or aspirin; having had a sigmoidoscopy or colonoscopy; family history of colorectal cancer; menopausal status; and use of postmenopausal hormone therapy.

Dr. Morikawa reported having no financial disclosures

[email protected]

On Twitter @sherryboschert

A specific molecular subtype of colorectal cancer is more likely in people with greater obesity and physical inactivity, analyses of prospective data on 861 cancer patients found.

For every 5-kg/m² increase in body mass index, the likelihood that a biomarker called CTNNB1 would be absent in colorectal cancer tumors increased significantly by 34%. Increasing BMI was not associated with CTNNB1-positive tumors, however, Dr. Teppei Morikawa and his associates reported.

Activity levels were reported as a metabolic equivalent task (MET) score calculated as the metabolic rate for leisure time activities such as walking, specific exercises, sports, or other vigorous activities divided by the resting metabolic rate. MET scores for individual activities were added together as total MET hours per week (MET-h/week). For every 10 MET-h/week increase in activity, the risk of CTNNB1-negative cancer decreased significantly by 7% but the chances of CTNNB1-positive colorectal cancer did not change significantly.

In other words, greater obesity and physical inactivity were associated with significantly higher risk for CTNNB1-negative but not CTNNB1-positive colorectal cancer. This suggests that a person’s energy balance and metabolism affect a specific pathway of carcinogenesis that is different from that of some other colorectal cancer subtypes, reported Dr. Morikawa of the Dana-Farber Cancer Institute, Boston.

The findings were published in the March 1 issue of Cancer Research (2013;73:1600-10).

Previous studies have pointed to the activation of a network of proteins known as the WNT signaling pathway as a critical player in colorectal carcinogenesis. Beta-catenin (CTNBB1) is a major mediator of the WNT pathway, and previous studies have implicated WNT-CTNNB1 signaling in adipogenesis, obesity, glucose metabolism, and metabolic disease. The current findings suggest that energy metabolism affects carcinogenesis in ways that are less dependent on WNT/CTNNB1 activation, Dr. Morikawa reported.

Colon cancer typically is treated as a single disease, and most population-based studies do not consider tumor heterogeneity. Additional epidemiologic studies of the molecular pathology might help identify people who are susceptible to CTNNB1-negative colorectal tumors, determine if CTNNB1 could be a target of treatment, or illuminate prevention strategies for subsets of people, the investigators suggested.

They tapped data on 109,046 women from the Nurses’ Health Study and 47,684 men in the Health Professionals Follow-Up Study to analyze the records of 861 patients who developed rectal and colon cancers between 1986 and 2004 and who had tissue immunohistochemistry data on nuclear CTNNB1 expression.

The current investigators reviewed participants’ medical records and pathology reports and identified deaths from unreported cancers through the National Death Index. They obtained paraffin-embedded tissue blocks from hospitals where participants had undergone tumor resection to confirm colorectal cancer and to conduct immunohistochemistry for CTNNB1 expression. Dr. Morikawa was blinded to other study data when he interpreted the CTNNB1 results in all cases.

The association with higher BMI was seen in subgroups of men or women and in the combined cohort. Compared with patients who had BMIs of 18.5-22.9 kg/m² , BMIs of 27.5-29.9 kg/m² were associated with a 77% increased likelihood of CTNNB1-negative colorectal cancer, and BMIs of 30 kg/m² or greater were associated with an 84% increased risk of CTNNB1-negative cancer.

The analysis of activity levels included 767 patients with activity data whose CTNNB1 status could be determined. Activity level seemed to be associated with lower risk of CTNNB1-negative cancer in subgroups based on sex, but this did not reach statistical significance in men. Combining the two subgroups produced the small but statistically significant 7% lower risk for CTNNB1-negative cancer with increasing levels of physical activity.

An exploratory analysis that combined BMI and activity level suggested that patients with high BMI (25 kg/m² or greater) and low activity (less than 9 MET-h/week) were 82% more likely to have CTNNB1-negative colorectal cancer compared with patients with low BMI (less than 25 kg/m²) and high activity level (9 or more MET-h/week). BMI and activity level combined were not associated with CTNNB1-positive cancer.

The Cox proportional hazards model used for risk analysis controlled for the effects of other factors that have been associated with colorectal cancer risk, including age; intakes of folate, vitamin D, and calcium; total caloric intake; red meat consumption; smoking status; pack-years of smoking before age 30 years; alcohol intake; use of multivitamins or aspirin; having had a sigmoidoscopy or colonoscopy; family history of colorectal cancer; menopausal status; and use of postmenopausal hormone therapy.

Dr. Morikawa reported having no financial disclosures

[email protected]

On Twitter @sherryboschert

A specific molecular subtype of colorectal cancer is more likely in people with greater obesity and physical inactivity, analyses of prospective data on 861 cancer patients found.

For every 5-kg/m² increase in body mass index, the likelihood that a biomarker called CTNNB1 would be absent in colorectal cancer tumors increased significantly by 34%. Increasing BMI was not associated with CTNNB1-positive tumors, however, Dr. Teppei Morikawa and his associates reported.

Activity levels were reported as a metabolic equivalent task (MET) score calculated as the metabolic rate for leisure time activities such as walking, specific exercises, sports, or other vigorous activities divided by the resting metabolic rate. MET scores for individual activities were added together as total MET hours per week (MET-h/week). For every 10 MET-h/week increase in activity, the risk of CTNNB1-negative cancer decreased significantly by 7% but the chances of CTNNB1-positive colorectal cancer did not change significantly.

In other words, greater obesity and physical inactivity were associated with significantly higher risk for CTNNB1-negative but not CTNNB1-positive colorectal cancer. This suggests that a person’s energy balance and metabolism affect a specific pathway of carcinogenesis that is different from that of some other colorectal cancer subtypes, reported Dr. Morikawa of the Dana-Farber Cancer Institute, Boston.

The findings were published in the March 1 issue of Cancer Research (2013;73:1600-10).

Previous studies have pointed to the activation of a network of proteins known as the WNT signaling pathway as a critical player in colorectal carcinogenesis. Beta-catenin (CTNBB1) is a major mediator of the WNT pathway, and previous studies have implicated WNT-CTNNB1 signaling in adipogenesis, obesity, glucose metabolism, and metabolic disease. The current findings suggest that energy metabolism affects carcinogenesis in ways that are less dependent on WNT/CTNNB1 activation, Dr. Morikawa reported.

Colon cancer typically is treated as a single disease, and most population-based studies do not consider tumor heterogeneity. Additional epidemiologic studies of the molecular pathology might help identify people who are susceptible to CTNNB1-negative colorectal tumors, determine if CTNNB1 could be a target of treatment, or illuminate prevention strategies for subsets of people, the investigators suggested.

They tapped data on 109,046 women from the Nurses’ Health Study and 47,684 men in the Health Professionals Follow-Up Study to analyze the records of 861 patients who developed rectal and colon cancers between 1986 and 2004 and who had tissue immunohistochemistry data on nuclear CTNNB1 expression.

The current investigators reviewed participants’ medical records and pathology reports and identified deaths from unreported cancers through the National Death Index. They obtained paraffin-embedded tissue blocks from hospitals where participants had undergone tumor resection to confirm colorectal cancer and to conduct immunohistochemistry for CTNNB1 expression. Dr. Morikawa was blinded to other study data when he interpreted the CTNNB1 results in all cases.

The association with higher BMI was seen in subgroups of men or women and in the combined cohort. Compared with patients who had BMIs of 18.5-22.9 kg/m² , BMIs of 27.5-29.9 kg/m² were associated with a 77% increased likelihood of CTNNB1-negative colorectal cancer, and BMIs of 30 kg/m² or greater were associated with an 84% increased risk of CTNNB1-negative cancer.

The analysis of activity levels included 767 patients with activity data whose CTNNB1 status could be determined. Activity level seemed to be associated with lower risk of CTNNB1-negative cancer in subgroups based on sex, but this did not reach statistical significance in men. Combining the two subgroups produced the small but statistically significant 7% lower risk for CTNNB1-negative cancer with increasing levels of physical activity.

An exploratory analysis that combined BMI and activity level suggested that patients with high BMI (25 kg/m² or greater) and low activity (less than 9 MET-h/week) were 82% more likely to have CTNNB1-negative colorectal cancer compared with patients with low BMI (less than 25 kg/m²) and high activity level (9 or more MET-h/week). BMI and activity level combined were not associated with CTNNB1-positive cancer.

The Cox proportional hazards model used for risk analysis controlled for the effects of other factors that have been associated with colorectal cancer risk, including age; intakes of folate, vitamin D, and calcium; total caloric intake; red meat consumption; smoking status; pack-years of smoking before age 30 years; alcohol intake; use of multivitamins or aspirin; having had a sigmoidoscopy or colonoscopy; family history of colorectal cancer; menopausal status; and use of postmenopausal hormone therapy.

Dr. Morikawa reported having no financial disclosures

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Adding bevacizumab to the FOLFOXIRI regimen significantly delayed the median time to progression of metastatic colorectal cancer to 12.2 months, compared with 9.7 months when bevacizumab was added to the FOLFIRI regimen, a phase III trial of 508 patients found.

Previous data had shown inferior progression-free survival, treatment response, and overall survival rates when treating metastatic colorectal cancer with FOLFIRI – which combines folinic acid (leucovorin), fluorouracil, and irinotecan – compared with FOLFOXIRI, which adds oxaliplatin to the drugs used in FOLFIRI.

Courtesy the American Society of Clinical Oncology

The current study confirms the superiority of first-line FOLFOXIRI over FOLFIRI and shows that FOLFOXIRI remains the better regimen when adding bevacizumab (Avastin) for select patients, Dr. Fotios Loupakis said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology.

At 2 years of follow-up, 20% of patients in the FOLFOXIRI/bevacizumab group and 11% in the FOLFIRI/bevacizumab group were free of disease progression, a significant difference, reported Dr. Loupakis of the University of Pisa (Italy) and his associates.

"Based on these results, FOLFOXIRI plus bevacizumab represents a new option for the treatment of metastatic colorectal cancer patients selected according to the eligibility criteria of this study," he said.

The multicenter study, known as the TRIBE trial, randomized adults in Italy aged 18-75 years who had unresectable metastatic colon cancer with histologically proven adenocarcinoma; at least one measurable lesion; and adequate bone marrow, liver, and renal functions. Patients younger than 71 years had to have an Eastern Cooperative Oncology Group performance status score of 0, and patients aged 71-75 years had a performance status score no higher than 2. Previous adjuvant chemotherapy containing oxaliplatin was allowed if more than 12 months had passed between the end of adjuvant therapy and the first relapse.

Subgroup analyses found better progression-free survival with FOLFOXIRI/bevacizumab in all subgroups.

Among secondary outcomes, the treatment response rate was significantly higher in the FOLFOXIRI/bevacizumab group (65%), compared with the FOLFIRI/bevacizumab group (53%), an intent-to-treat analysis showed.

Safety data on 504 patients revealed "moderately" increased rates of grade 3 or 4 diarrhea (19%), stomatitis (9%), and neutropenia (50%) in the FOLFOXIRI/bevacizumab group, compared with rates in the FOLFIRI/bevacizumab group (11% had diarrhea, 4% had stomatitis, and 20% had neutropenia), he said. The differences between groups in adverse events were statistically significant.

The two groups did not differ significantly, however, in the rate of grade 3 or 4 febrile neutropenia, the overall rate of serious adverse events, or the rate of treatment-related death. Nine percent of patients in the FOLFOXIRI/bevacizumab group developed grade 3 or 4 febrile neutropenia, compared with 6% of patients in the FOLFIRI/bevacizumab group. Serious adverse events were seen in 20% of each group, and approximately 2% in each group died of causes related to treatment.

Dr. Loupakis called the overall safety profile of FOLFOXIRI plus bevacizumab "acceptable." The study did not collect data on patients’ quality of life, he said.

Baseline demographics and disease characteristics were similar between groups.

The investigators are in the process of analyzing data on overall survival, secondary resections, treatment after disease progression, and potential biomarkers of response to treatment.

A previous phase II clinical trial of FOLFOXIRI plus bevacizumab had suggested promising results in terms of progression-free survival with acceptable toxicity, he said.

Dr. Loupakis has been a consultant for Bayer. Roche, which markets bevacizumab, provided support for the study. One of his associates in the study reported financial relationships with Roche, Amgen, Merck, and Sanofi.

[email protected]

On Twitter @SherryBoschert

SAN FRANCISCO – Adding bevacizumab to the FOLFOXIRI regimen significantly delayed the median time to progression of metastatic colorectal cancer to 12.2 months, compared with 9.7 months when bevacizumab was added to the FOLFIRI regimen, a phase III trial of 508 patients found.

Previous data had shown inferior progression-free survival, treatment response, and overall survival rates when treating metastatic colorectal cancer with FOLFIRI – which combines folinic acid (leucovorin), fluorouracil, and irinotecan – compared with FOLFOXIRI, which adds oxaliplatin to the drugs used in FOLFIRI.

Courtesy the American Society of Clinical Oncology

The current study confirms the superiority of first-line FOLFOXIRI over FOLFIRI and shows that FOLFOXIRI remains the better regimen when adding bevacizumab (Avastin) for select patients, Dr. Fotios Loupakis said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology.

At 2 years of follow-up, 20% of patients in the FOLFOXIRI/bevacizumab group and 11% in the FOLFIRI/bevacizumab group were free of disease progression, a significant difference, reported Dr. Loupakis of the University of Pisa (Italy) and his associates.

"Based on these results, FOLFOXIRI plus bevacizumab represents a new option for the treatment of metastatic colorectal cancer patients selected according to the eligibility criteria of this study," he said.

The multicenter study, known as the TRIBE trial, randomized adults in Italy aged 18-75 years who had unresectable metastatic colon cancer with histologically proven adenocarcinoma; at least one measurable lesion; and adequate bone marrow, liver, and renal functions. Patients younger than 71 years had to have an Eastern Cooperative Oncology Group performance status score of 0, and patients aged 71-75 years had a performance status score no higher than 2. Previous adjuvant chemotherapy containing oxaliplatin was allowed if more than 12 months had passed between the end of adjuvant therapy and the first relapse.

Subgroup analyses found better progression-free survival with FOLFOXIRI/bevacizumab in all subgroups.

Among secondary outcomes, the treatment response rate was significantly higher in the FOLFOXIRI/bevacizumab group (65%), compared with the FOLFIRI/bevacizumab group (53%), an intent-to-treat analysis showed.

Safety data on 504 patients revealed "moderately" increased rates of grade 3 or 4 diarrhea (19%), stomatitis (9%), and neutropenia (50%) in the FOLFOXIRI/bevacizumab group, compared with rates in the FOLFIRI/bevacizumab group (11% had diarrhea, 4% had stomatitis, and 20% had neutropenia), he said. The differences between groups in adverse events were statistically significant.

The two groups did not differ significantly, however, in the rate of grade 3 or 4 febrile neutropenia, the overall rate of serious adverse events, or the rate of treatment-related death. Nine percent of patients in the FOLFOXIRI/bevacizumab group developed grade 3 or 4 febrile neutropenia, compared with 6% of patients in the FOLFIRI/bevacizumab group. Serious adverse events were seen in 20% of each group, and approximately 2% in each group died of causes related to treatment.

Dr. Loupakis called the overall safety profile of FOLFOXIRI plus bevacizumab "acceptable." The study did not collect data on patients’ quality of life, he said.

Baseline demographics and disease characteristics were similar between groups.

The investigators are in the process of analyzing data on overall survival, secondary resections, treatment after disease progression, and potential biomarkers of response to treatment.

A previous phase II clinical trial of FOLFOXIRI plus bevacizumab had suggested promising results in terms of progression-free survival with acceptable toxicity, he said.

Dr. Loupakis has been a consultant for Bayer. Roche, which markets bevacizumab, provided support for the study. One of his associates in the study reported financial relationships with Roche, Amgen, Merck, and Sanofi.

[email protected]

On Twitter @SherryBoschert

SAN FRANCISCO – Adding bevacizumab to the FOLFOXIRI regimen significantly delayed the median time to progression of metastatic colorectal cancer to 12.2 months, compared with 9.7 months when bevacizumab was added to the FOLFIRI regimen, a phase III trial of 508 patients found.

Previous data had shown inferior progression-free survival, treatment response, and overall survival rates when treating metastatic colorectal cancer with FOLFIRI – which combines folinic acid (leucovorin), fluorouracil, and irinotecan – compared with FOLFOXIRI, which adds oxaliplatin to the drugs used in FOLFIRI.

Courtesy the American Society of Clinical Oncology

The current study confirms the superiority of first-line FOLFOXIRI over FOLFIRI and shows that FOLFOXIRI remains the better regimen when adding bevacizumab (Avastin) for select patients, Dr. Fotios Loupakis said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology.

At 2 years of follow-up, 20% of patients in the FOLFOXIRI/bevacizumab group and 11% in the FOLFIRI/bevacizumab group were free of disease progression, a significant difference, reported Dr. Loupakis of the University of Pisa (Italy) and his associates.

"Based on these results, FOLFOXIRI plus bevacizumab represents a new option for the treatment of metastatic colorectal cancer patients selected according to the eligibility criteria of this study," he said.

The multicenter study, known as the TRIBE trial, randomized adults in Italy aged 18-75 years who had unresectable metastatic colon cancer with histologically proven adenocarcinoma; at least one measurable lesion; and adequate bone marrow, liver, and renal functions. Patients younger than 71 years had to have an Eastern Cooperative Oncology Group performance status score of 0, and patients aged 71-75 years had a performance status score no higher than 2. Previous adjuvant chemotherapy containing oxaliplatin was allowed if more than 12 months had passed between the end of adjuvant therapy and the first relapse.

Subgroup analyses found better progression-free survival with FOLFOXIRI/bevacizumab in all subgroups.

Among secondary outcomes, the treatment response rate was significantly higher in the FOLFOXIRI/bevacizumab group (65%), compared with the FOLFIRI/bevacizumab group (53%), an intent-to-treat analysis showed.

Safety data on 504 patients revealed "moderately" increased rates of grade 3 or 4 diarrhea (19%), stomatitis (9%), and neutropenia (50%) in the FOLFOXIRI/bevacizumab group, compared with rates in the FOLFIRI/bevacizumab group (11% had diarrhea, 4% had stomatitis, and 20% had neutropenia), he said. The differences between groups in adverse events were statistically significant.

The two groups did not differ significantly, however, in the rate of grade 3 or 4 febrile neutropenia, the overall rate of serious adverse events, or the rate of treatment-related death. Nine percent of patients in the FOLFOXIRI/bevacizumab group developed grade 3 or 4 febrile neutropenia, compared with 6% of patients in the FOLFIRI/bevacizumab group. Serious adverse events were seen in 20% of each group, and approximately 2% in each group died of causes related to treatment.

Dr. Loupakis called the overall safety profile of FOLFOXIRI plus bevacizumab "acceptable." The study did not collect data on patients’ quality of life, he said.

Baseline demographics and disease characteristics were similar between groups.

The investigators are in the process of analyzing data on overall survival, secondary resections, treatment after disease progression, and potential biomarkers of response to treatment.

A previous phase II clinical trial of FOLFOXIRI plus bevacizumab had suggested promising results in terms of progression-free survival with acceptable toxicity, he said.

Dr. Loupakis has been a consultant for Bayer. Roche, which markets bevacizumab, provided support for the study. One of his associates in the study reported financial relationships with Roche, Amgen, Merck, and Sanofi.

[email protected]

On Twitter @SherryBoschert

SAN FRANCISCO – Five-year survival rates for 41 patients with locoregionally advanced esophageal cancer who underwent induction chemotherapy and definitive chemoradiotherapy were 53% for patients with a clinical complete response who avoided surgery, 33% for patients with suspected residual disease, and 41% for patients with suspected residual disease who were able to undergo surgery.

The multicenter phase II Radiation Therapy Oncology Group (RTOG) 0246 trial suggests that the organ-preserving strategy of selective esophageal resection after definitive chemoradiation can be an effective approach, Dr. Stephen Swisher said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).

Courtesy of the American Society of Clinical Oncology

Forty-one of the 43 patients enrolled with nonmetastatic resectable esophageal cancer had enough data to be included in the final analysis. Thirty-seven patients completed both induction chemotherapy and definitive chemoradiotherapy. Four patients died from problems associated with treatment (10%), two related to induction chemotherapy, one related to chemoradiation, and one related to surgery.

The overall 5-year survival rate after a median follow-up of 6.7 years was 37% in an intention-to-treat analysis, which is similar to results of trials of other treatment modalities for locoregionally advanced esophageal cancer, he said. Patients with a clinical complete response to chemoradiotherapy had a median survival of 66 months, compared with 15 months for all patients with suspected residual disease and 36 months for patients with suspected residual disease who were able to undergo surgery, reported Dr. Swisher of the University of Texas M.D. Anderson Cancer Center, Houston, and his associates.

During enrollment in 2003-2006, 15 patients came from the M.D. Anderson Cancer Center; 18 other sites contributed 1-3 patients each. Twenty-nine patients had adenocarcinomas (73%). Pretreatment clinical stages were T3 or greater in 31 patients (76%) and N1 in 29 patients (71%).

All underwent two cycles of induction chemotherapy with 5-fluorouracil (5-FU), cisplatin, and paclitaxel, followed by concurrent chemoradiation and daily 5-FU with cisplatin over the first 5 days.

After definitive chemoradiation, patients underwent chest and abdominal imaging to look for residual locoregional disease using CT scans, esophageal ultrasound, and optional PET scans. Those with no suspected residual disease were observed and monitored for recurrence every 3 months for the first 6 months, then every 6 months for the next 18 months, and then yearly. Patients with suspected residual disease were considered for immediate surgery.

Ultimately, 21 patients (51% of the total) underwent surgery: 17 had selective esophagectomies due to suspected residual cancer; 1 patient with a clinical complete response after chemoradiotherapy requested surgery; and 3 patients who were thought to have clinical complete responses underwent salvage esophagectomies due to recurrent cancer 5-15 months after chemoradiotherapy.

Besides the 17 patients with suspected residual cancer who underwent surgery, 4 others with a noncomplete response to chemoradiotherapy did not have esophagectomies because of metastatic disease in 3 patients and inoperable local disease in 1 patient.

The investigators previously reported preliminary results showing an overall 1-year survival rate of 71% in the study.

The meeting was cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Dr. Swisher reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Five-year survival rates for 41 patients with locoregionally advanced esophageal cancer who underwent induction chemotherapy and definitive chemoradiotherapy were 53% for patients with a clinical complete response who avoided surgery, 33% for patients with suspected residual disease, and 41% for patients with suspected residual disease who were able to undergo surgery.

The multicenter phase II Radiation Therapy Oncology Group (RTOG) 0246 trial suggests that the organ-preserving strategy of selective esophageal resection after definitive chemoradiation can be an effective approach, Dr. Stephen Swisher said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).

Courtesy of the American Society of Clinical Oncology

Forty-one of the 43 patients enrolled with nonmetastatic resectable esophageal cancer had enough data to be included in the final analysis. Thirty-seven patients completed both induction chemotherapy and definitive chemoradiotherapy. Four patients died from problems associated with treatment (10%), two related to induction chemotherapy, one related to chemoradiation, and one related to surgery.

The overall 5-year survival rate after a median follow-up of 6.7 years was 37% in an intention-to-treat analysis, which is similar to results of trials of other treatment modalities for locoregionally advanced esophageal cancer, he said. Patients with a clinical complete response to chemoradiotherapy had a median survival of 66 months, compared with 15 months for all patients with suspected residual disease and 36 months for patients with suspected residual disease who were able to undergo surgery, reported Dr. Swisher of the University of Texas M.D. Anderson Cancer Center, Houston, and his associates.

During enrollment in 2003-2006, 15 patients came from the M.D. Anderson Cancer Center; 18 other sites contributed 1-3 patients each. Twenty-nine patients had adenocarcinomas (73%). Pretreatment clinical stages were T3 or greater in 31 patients (76%) and N1 in 29 patients (71%).

All underwent two cycles of induction chemotherapy with 5-fluorouracil (5-FU), cisplatin, and paclitaxel, followed by concurrent chemoradiation and daily 5-FU with cisplatin over the first 5 days.

After definitive chemoradiation, patients underwent chest and abdominal imaging to look for residual locoregional disease using CT scans, esophageal ultrasound, and optional PET scans. Those with no suspected residual disease were observed and monitored for recurrence every 3 months for the first 6 months, then every 6 months for the next 18 months, and then yearly. Patients with suspected residual disease were considered for immediate surgery.

Ultimately, 21 patients (51% of the total) underwent surgery: 17 had selective esophagectomies due to suspected residual cancer; 1 patient with a clinical complete response after chemoradiotherapy requested surgery; and 3 patients who were thought to have clinical complete responses underwent salvage esophagectomies due to recurrent cancer 5-15 months after chemoradiotherapy.

Besides the 17 patients with suspected residual cancer who underwent surgery, 4 others with a noncomplete response to chemoradiotherapy did not have esophagectomies because of metastatic disease in 3 patients and inoperable local disease in 1 patient.

The investigators previously reported preliminary results showing an overall 1-year survival rate of 71% in the study.

The meeting was cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Dr. Swisher reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Five-year survival rates for 41 patients with locoregionally advanced esophageal cancer who underwent induction chemotherapy and definitive chemoradiotherapy were 53% for patients with a clinical complete response who avoided surgery, 33% for patients with suspected residual disease, and 41% for patients with suspected residual disease who were able to undergo surgery.

The multicenter phase II Radiation Therapy Oncology Group (RTOG) 0246 trial suggests that the organ-preserving strategy of selective esophageal resection after definitive chemoradiation can be an effective approach, Dr. Stephen Swisher said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).

Courtesy of the American Society of Clinical Oncology

Forty-one of the 43 patients enrolled with nonmetastatic resectable esophageal cancer had enough data to be included in the final analysis. Thirty-seven patients completed both induction chemotherapy and definitive chemoradiotherapy. Four patients died from problems associated with treatment (10%), two related to induction chemotherapy, one related to chemoradiation, and one related to surgery.

The overall 5-year survival rate after a median follow-up of 6.7 years was 37% in an intention-to-treat analysis, which is similar to results of trials of other treatment modalities for locoregionally advanced esophageal cancer, he said. Patients with a clinical complete response to chemoradiotherapy had a median survival of 66 months, compared with 15 months for all patients with suspected residual disease and 36 months for patients with suspected residual disease who were able to undergo surgery, reported Dr. Swisher of the University of Texas M.D. Anderson Cancer Center, Houston, and his associates.

During enrollment in 2003-2006, 15 patients came from the M.D. Anderson Cancer Center; 18 other sites contributed 1-3 patients each. Twenty-nine patients had adenocarcinomas (73%). Pretreatment clinical stages were T3 or greater in 31 patients (76%) and N1 in 29 patients (71%).

All underwent two cycles of induction chemotherapy with 5-fluorouracil (5-FU), cisplatin, and paclitaxel, followed by concurrent chemoradiation and daily 5-FU with cisplatin over the first 5 days.

After definitive chemoradiation, patients underwent chest and abdominal imaging to look for residual locoregional disease using CT scans, esophageal ultrasound, and optional PET scans. Those with no suspected residual disease were observed and monitored for recurrence every 3 months for the first 6 months, then every 6 months for the next 18 months, and then yearly. Patients with suspected residual disease were considered for immediate surgery.

Ultimately, 21 patients (51% of the total) underwent surgery: 17 had selective esophagectomies due to suspected residual cancer; 1 patient with a clinical complete response after chemoradiotherapy requested surgery; and 3 patients who were thought to have clinical complete responses underwent salvage esophagectomies due to recurrent cancer 5-15 months after chemoradiotherapy.

Besides the 17 patients with suspected residual cancer who underwent surgery, 4 others with a noncomplete response to chemoradiotherapy did not have esophagectomies because of metastatic disease in 3 patients and inoperable local disease in 1 patient.

The investigators previously reported preliminary results showing an overall 1-year survival rate of 71% in the study.

The meeting was cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Dr. Swisher reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

The Centers for Disease Control and Prevention is inviting all iPad users to join the agency’s Epidemic Intelligence Service and help solve disease outbreaks – virtually, that is.

It’s only a game, but the three fictional outbreaks in the CDC’s new iPad app are based on real-life events. Users get clues, review data, and make decisions in trying to identify the cause of the disease outbreak.

Courtesy of the CDC

Along the way, they learn health tips, definitions, and information about epidemiology, and they can advance in "rank" as they earn points from the game’s activities. They also can share their results and challenge other participants through social media such as Twitter and Facebook.

The CDC says it will add new cases of disease outbreaks to its "Solve the Outbreak" app over time.

If you enjoyed the film "Contagion" or delight in the writings of Berton Roueché (such as "The Medical Detectives" or my personal favorite, "Eleven Blue Men"), this mobile game may be for you.

The CDC’s own real-life disease detectives, also known as Epidemic Intelligence Service officers, are called on to drop everything and fly anywhere in the world when they’re needed to investigate mysterious disease outbreaks, natural and man-made disasters, and public health emergencies. Now, in a certain way, you can go with them.

"Solve the Outbreak" is available for free in the iTunes store.

[email protected]

On Twitter @sherryboschert

The Centers for Disease Control and Prevention is inviting all iPad users to join the agency’s Epidemic Intelligence Service and help solve disease outbreaks – virtually, that is.

It’s only a game, but the three fictional outbreaks in the CDC’s new iPad app are based on real-life events. Users get clues, review data, and make decisions in trying to identify the cause of the disease outbreak.

Courtesy of the CDC

Along the way, they learn health tips, definitions, and information about epidemiology, and they can advance in "rank" as they earn points from the game’s activities. They also can share their results and challenge other participants through social media such as Twitter and Facebook.

The CDC says it will add new cases of disease outbreaks to its "Solve the Outbreak" app over time.

If you enjoyed the film "Contagion" or delight in the writings of Berton Roueché (such as "The Medical Detectives" or my personal favorite, "Eleven Blue Men"), this mobile game may be for you.

The CDC’s own real-life disease detectives, also known as Epidemic Intelligence Service officers, are called on to drop everything and fly anywhere in the world when they’re needed to investigate mysterious disease outbreaks, natural and man-made disasters, and public health emergencies. Now, in a certain way, you can go with them.

"Solve the Outbreak" is available for free in the iTunes store.

[email protected]

On Twitter @sherryboschert

The Centers for Disease Control and Prevention is inviting all iPad users to join the agency’s Epidemic Intelligence Service and help solve disease outbreaks – virtually, that is.

It’s only a game, but the three fictional outbreaks in the CDC’s new iPad app are based on real-life events. Users get clues, review data, and make decisions in trying to identify the cause of the disease outbreak.

Courtesy of the CDC

Along the way, they learn health tips, definitions, and information about epidemiology, and they can advance in "rank" as they earn points from the game’s activities. They also can share their results and challenge other participants through social media such as Twitter and Facebook.

The CDC says it will add new cases of disease outbreaks to its "Solve the Outbreak" app over time.

If you enjoyed the film "Contagion" or delight in the writings of Berton Roueché (such as "The Medical Detectives" or my personal favorite, "Eleven Blue Men"), this mobile game may be for you.

The CDC’s own real-life disease detectives, also known as Epidemic Intelligence Service officers, are called on to drop everything and fly anywhere in the world when they’re needed to investigate mysterious disease outbreaks, natural and man-made disasters, and public health emergencies. Now, in a certain way, you can go with them.

"Solve the Outbreak" is available for free in the iTunes store.

[email protected]

On Twitter @sherryboschert