Cardiology has advanced considerably in the past few decades, but there is a downside — extending those advances further in treatment becomes more difficult. At the European Society of Cardiology meeting, many clinical trial results were reported but few of those “Hot Line” studies had positive results.

One that stood out was presented by Italian researchers in the GISSI trial group. They determined that the use of omega-3 fatty acid supplementation produced a significant difference in outcomes for heart failure patients.

The trial enrolled 6,975 patients with chronic heart failure and assigned 3,484 of them to receive one gram of prescription fish oil (polyunsaturated fatty acid) supplements for about 54 months.

“Long-term administration of fish oil supplements was effective in reducing both all-cause mortality and hospitalizations for cardiovascular reasons in the large population of patients with heart failure included in the pragmatic GISSI-HF trial,” said Dr. Luigi Tavazzi, professor of medicine at the Fondazione Policlinico San Matteo, Pavia.

In the primary endpoint of the trial, 955 patients taking fish oil died during the course of the study compared with 1,014 patients on placebo—a two percent absolute reduction and a nine percent relative risk-reduction that reached statistical significance.

When doctors examined outcomes in patients who were adherent to the trial protocol—about 5,000 of the total group—there was a significant 14 percent relative risk-reduction.

Fluvastatin prevents events
In another study that may impact clinical practice, doctors exploring the Dutch Echographic Risk Evaluati, Applying Stress Echo III (DECREASE III) trial demonstrated that perioperative treatment of patients with extended release fluvastatin resulted in a marked decrease in cardiac ischemic events through 30 days following non-cardiac vascular surgery.

“Perioperative extended release fluvastatin use might be recommended in vascular surgery patients,” suggested Dr. Don Poldermans, professor of medicine at Erasmus University. He said that myocardial ischemia occurred in 10.6 percent of the 250 patients assigned to receive fluvastatin, significantly fewer than the 18.2 percent of the 247 patients who were randomly assigned to receive placebo in the study.

In addition, he said that after 30 days of the trial period, 12 (4.8 percent) of the patients on fluvastatin suffered the secondary endpoint of cardiovascular death and/or nonfatal myocardial infarction compared with 25 (10.1 percent) of patients on placebo, also a significant finding.

Dr. Poldermans also noted that the use of 80mg of extended release fluvastatin in the patients just prior to surgery and until 30 days after the vascular surgery was not accompanied by an increase in adverse side effects, liver dysfunction or myopathy.

More Vytorin controversy
The controversy over the cholesterol-lowering combination of simvastatin and ezetimibe (Vytorin) was left unsettled following the release of new data from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study.

Released earlier this year, the SEAS data indicated no particular benefit in the progression of aortic stenosis with the combination product and put an unexpected finding of additional cancers and fatal cancers in the Vytorin arm of the study, which raised concerns about the safety of the product.

“I personally think this finding is one of chance,”said Dr. Torje Pedersen, professor of medicine at the Ulleval University Hospital, Oslo, Norway, although conceding that the observation in the trial needs to be closely examined.

The SEAS data was presented along with simultaneous publication in the New England Journal of Medicine, which also added two commentaries to the report, generally advising caution in the use of ezetimibe for treatment of high cholesterol in favor or maximal use of statins.

Dr. Pedersen said that he found 70 cases of cancer among placebo patients in the SEAS trial compared with 105 cases among patients on Vytorin, a significant difference. He said 39 patients, or 4.1 percent of those taking Vytorin, died of their cancers compared with 23 (2.5 percent) of patients on placebo, also a significant difference.
There was no particular clustering of cancers in any organ, and the cancers included solid organ, skin and hematological malignancies, Dr. Pedersen said. He noted that other large trials involving the use of Vytorin have not found any signal of excess cancer.

Niacin as an alternative
Researchers suggested that use of niacin-based products could be an alternative to ezetimibe if statins don’t complete the job of cholesterol-lowering. But niacin is often problematic because it causes facial flushing which can be uncomfortable and frightening for patients with cardiovascular disease.

However, a new product Tredaptive, which combines niacin with lapopiprant—a novel drug that blocks the pathway that causes flushing—is said to address this problem.

In clinical trials that specifically scrutinized Asian populations, researchers demonstrated that the 50 percent decrease seen in flushing in the general population pertains to Asian populations as well.

“These findings further reinforce the results seen in the global Phase III clinical development program in which Tredaptive demonstrated a consistent benefit in mitigating nicotinic-acid (niacin) induced flushing,” said Dr. John Paolini, director of clinical research in cardiovascular disease at Merck Research Laboratories in the United States.

Surgery better than angioplasty
Doctors found that treatment of multivessel coronary artery disease or left main coronary artery disease performed with stent angioplasty is inferior to bypass graft surgery.

“This was an all-comers study design instead of a highly selected patient population,” said Dr. Patrick Serruys, medical director of the Thoraxcenter, Erasmus Medical Center, Rotterdam. Physicians evaluated the patients to determine who would be eligible for either bypass surgery of percutaneous intervention, and those patients were randomly assigned to either arm of the study.

After one year, all causes of death were virtually identical-7.6 percent of patients in the stent arm and 7.7 percent in the surgery arm, he reported. But there were more revascularizations among the stent patients-17.8 percent, compared with 12.1 percent in the surgery arm.

That difference prevented the angioplasty arm from meeting the test for non-inferiority in this group of patients, according to Dr. Serruys.

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