Stents that release sirolimus or paclitaxel have been known to be more effective than bare metal stents in improving angiographic (examination of the blood vessels using x-rays) and clinical outcomes after percutaneous coronary revascularization (procedures such as angioplasty in which a catheter-guided balloon is used to open a narrowed coronary artery). These drugs are effective after these procedures because they inhibit the growth of cells in blood vessels. It has not been clear if one drug-releasing stent is more effective than another, according to background information in the article.
Marie-Claude Morice, M.D., of the Institut Cardiovasculaire Paris Sud, Massy, France and colleagues compared the safety and efficacy of sirolimus-eluting vs. paclitaxel-eluting coronary stents in patients with new coronary artery lesions. The REALITY trial included 1,386 patients with angina pectoris (a heart condition marked by chest pain due to reduced blood flow to the heart) and 1 or 2 new coronary lesions. The study was conducted at 90 hospitals in Europe, Latin America, and Asia between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. Patients were randomly assigned to receive a sirolimus-eluting (releasing) stent or a paclitaxel-eluting stent.
The researchers found that the average restenosis (narrowing again of a coronary artery after treatment) rate, the primary study outcome the researchers were using to compare the stents, was 9.6 percent in the sirolimus-eluting stent group vs. 11.1 percent in the paclitaxel-eluting stent group, a difference that did not reach statistical significance. Likewise, there were no significant differences between the 2 study groups in rates of other in-hospital adverse clinical events, including target vessel revascularization, stent thrombosis, cerebral vascular events, and hemorrhagic complications. The overall, 12-month cumulative rate of major adverse cardiac events was 10.7 percent in the sirolimus-eluting stent group vs. 11.4 percent in the paclitaxel-eluting stent group.
"A longer follow-up may be required for the different degrees of neointimal [a new layer of cells on the inner surface] proliferation suppression to translate into significantly different rates of binary restenosis or adverse clinical events," the authors conclude.
(JAMA. 2006;295:895-904. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This study was sponsored by Cordis Corporation (a Johnson & Johnson Company) Clinical Research Europe, Waterloo, Belgium. Co-author Bernhard Meier, M.D., has received research support from both Cordis and Boston Scientific.
Editorial: Wish List and REALITY
In an accompanying editorial, Sorin J. Brener, M.D., of the Cleveland Clinic Lerner College of Medicine, Cleveland, comments on the study by Morice et al.
"Further analyses and studies are needed to learn about the effect of stent choice in patients with diabetes and those with long or bifurcating [split] lesions. More importantly, extended follow-up over 24 months may answer 2 critical clinical questions: Will the better inhibition of neointimal proliferation with sirolimus-eluting stents eventually result in a clinically meaningful improvement in outcome? And will the choice of stent affect the incidence of late stent thrombosis after discontinuation of dual antiplatelet therapy? Answers to these 2 questions may well determine the specific way these very helpful devices can be used best."
(JAMA. 2006;295:937-938. Available pre-embargo to the media at www.jamamedia.org)
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