Heart Health Articles

Drug-eluting Stents Are As Safe As Non-coated Stents For Large Arteries

August 09, 2017

For patients with narrowed large coronary arteries (greater than 3mm across), drug-eluting stents were as safe as non-coated stents, according to a late-breaking clinical trial reported at the American Heart Association's Scientific Sessions 2010.

The new trial showed no increase in deaths or heart attack at two years among patients receiving drug-eluting stents.

There has been concern that coronary artery stents that release drugs to prevent restenosis may increase the risk of so-called "late harm," such as death or heart attack months or even years after the stents were implanted. However, the 24-month Late Cardiac Death And Myocardial Infarction Associated With Late Stent Thrombosis In Large Vessel Stenting After 1st Or 2nd Generation Drug-eluting Compared To Bare-metal Stents: the BASKET PROspective Evaluation Examination (BASKET PROVE) trial shows no increase in these complications. Those treated with drug-eluting stents had fewer repeat procedures to widen the artery.

For small vessels, drug-covered stents are already the implant of choice, said Christoph Kaiser, M.D., a study co-author, who is assistant professor of cardiology and head of interventional cardiology at Switzerland's University Hospital Basel. Kaiser expects this newest data to bolster use of drug-eluting stents in large arteries. "Now that drug-eluting stents show no late harm in large vessels, I think doctors will change," he said.

The study, which enrolled 2,314 patients in Switzerland, Denmark, Austria and Italy, divided patients into three groups: sirolimus-eluting, everolimus-eluting and bare metal stent patients. The participants were enrolled from March 2007 to May 2008. After two years, the rate of cardiac death or heart attack was 2.7 percent for the sirolimus stents, 3.3 percent for the everolimus stents and 4.8 percent for the bare metal stents.

"The results were not significantly different among the patient groups," Kaiser said. "That, coupled with the fact that the patients with drug-eluting stents experienced less reclogging of the blood vessel, should influence medical practice."

Although the study wasn't conducted in U.S. patients, he said the results should be applicable to American patients as well as those in other countries. Two-thirds of patients had presented with acute coronary syndromes, half of them with acute heart attack, and the remainder with stable chronic coronary artery disease (angina), so, Kaiser said, the findings apply to an "all-comer" stenting population.

"Drug-eluting stents have superior efficacy in reducing revascularization. That's what they were designed for. That's what they should do," Kaiser said. "There is no late harm for drug-eluting stents in patients with large vessels. The fear of using drug-eluting stents in large vessels is no longer justified."

All patients had aspirin and clopidogrel for 12 months in this study regardless of stent type. Among patients with a drug-eluting stent, there was no difference in outcomes between (first generation) sirolimus-eluting and (second generation) everolimus-eluting stents.

Kaiser was surprised by the positive results of the trial and by the overall low number of deaths and heart attacks. "We can only speculate, but it is probably due to the fact that stents are getting better over the years and so are doctors and implantation techniques," he said.

Next, Kaiser plans to explore the cost-effectiveness question, since drug-eluting stents cost up to three times the price of bare-metal stents. The trial had no industry support and was sponsored by the Basel Cardiovascular Research Foundation and the Swiss National Foundation for Research. The sponsors had no role in the design, conduct, analysis, interpretation or publication of the trial.

Principal investigator for BASKET PROVE is Matthias E. Pfisterer, M.D. Author disclosures are on the abstract.

American Heart Association