Sirolimus- and paclitaxel-eluting stents produce similar results in patients with new coronary artery lesions, according to findings from a major international study published in the February 22 issue of the Journal of the American Medical Association.

Marie-Claude Morice, MD, of the Institut Cardiovasculaire Paris Sud, Massy, France and colleagues on three continents compared the safety and efficacy of sirolimus-eluting versus paclitaxel-eluting coronary stents in patients with new coronary artery lesions.

The REALITY trial included 1,386 patients with angina pectoris and one or two new coronary lesions who were randomized to a sirolimus- or paclitaxel-eluting stent. The study was conducted at 90 hospitals in Europe, South America, and Asia between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months.

The average restenosis rate, the primary study outcome, was 9.6 percent in the sirolimus-eluting stent group versus 11.1 percent in the paclitaxel-eluting stent group, a difference that did not reach statistical significance.

Likewise, there were no significant differences between study groups in rates of 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 versus 11.4 percent in the paclitaxel-eluting stent group.

“A longer follow-up may be required for the different degrees of neointimal proliferation suppression to translate into significantly different rates of binary restenosis or adverse clinical events,” the authors concluded.

In an accompanying editorial, Sorin J. Brener, MD, of the Cleveland Clinic Lerner College of Medicine, Cleveland, commented on the study:

“Further analyses and studies are needed to learn about the effect of stent choice in patients with diabetes and those with long or bifurcating lesions. More importantly, extended follow-up over 24 months may answer two 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 two questions may well determine the specific way these very helpful devices can be used best.”