Slim, Flexible Stents Approved to Treat Heart Disease

A new generation of drug-coated stents—the small scaffoldlike devices that hold clogged arteries open—is now available for people with coronary artery disease. The newest stents, which the Food and Drug Administration approved last week, are slimmer and more flexible than earlier models and use a different drug to inhibit the growth of scar tissue that can lead to reblockage. Illinois-based Abbott Laboratories won approval for its Xience V stent. Another company, Boston Scientific, is also offering the Abbott-manufactured stent under the brand name Promus. The companies say the stents are immediately available to doctors.

Video: The Dangers of Heart Disease

The second-generation stents, which are made from cobalt-chromium wire rather than steel and are treated with the drug everolimus rather than paclitaxel or sirolimus, have performed well in clinical trials. In May, researchers presented data that showed that only 10.7 percent of patients with the newer stents experienced adverse events related to the stented vessel—such as death, heart attack, or the need for additional stenting—within two years in comparison with 15.4 percent of patients who received a first-generation stent. The same study showed that 7.3 percent of patients who received the new stents experienced any major adverse cardiac events compared with 12.8 percent of patients with first-generation stents in the same time period.

Cardiologists are apt to approach these second-generation drug-coated stents cautiously, however. "The proof of the pudding is really in much larger scale data sets," says Jeffrey Moses, the director of the Center for Interventional Vascular Therapy at New York-Presbyterian University Hospital of Columbia and Cornell, noting that in the recent study, researchers followed only 669 patients. Larger studies that should offer more reliable information are in progress, he says, and results should start to become available within a year.

The first generation of coated stents, heavily hyped initially, took a public bruising after research emerged in 2006 suggesting that coated stents triggered more dangerous blood clots than bare metal stents. The use of coated stents plunged for a time, then stabilized as it became clear that the magnitude of that risk is rather small—especially, as U.S. News reported last year, if patients stick with prescribed regimes of the anticlotting medications Plavix and aspirin.

U.S. News reporter Avery Comarow explained what else medical consumers need to know about drug eluting stents and clotting risk in a piece published last year.