A stent eluting biolimus from a biodegradable polymer represents a safe and effective alternative to a stent eluting sirolimus from a durable polymer in patients with chronic stable coronary artery disease or acute coronary syndromes, according to the LEADERS trial published in the Sept. 27 issue of the Lancet.
Stephan Windecker, MD, department of cardiology at the Bern University Hospital in Bern, Switzerland, and colleagues undertook a multicenter, assessor-blind, non-inferiority study in 10 European centers. Patients were centrally randomized to treatment with either biolimus-eluting (857) (Biosensors International, Singapore) or sirolimus-eluting (850) (Cordis, Miami Lakes, Fla.) stents.
The primary endpoint was a composite of cardiac death, MI or clinically-indicated target vessel revascularization within nine months, the investigators said. They randomly allocated 427 patients to angiographic follow-up, with in-stent percentage diameter stenosis as principal outcome measure at nine months.
Windecker and colleagues found that biolimus-eluting stents were non-inferior to sirolimus-eluting stents for the primary endpoint at nine months (9 percent of patients vs. 11 percent of patients) and in in-stent percentage diameter stenosis (20.9 vs. 23.3 percent).
Additionally, they found that the frequency of cardiac death (1.6 vs. 2.5 percent), MI (5.7 vs. 4.6 percent) and clinically-indicated target vessel revascularization (4.4 vs. 5.5 percent) were similar for both stent types.
“The results from LEADERS are very significant as they demonstrate for the first time that a drug-eluting stent with an abluminal biodegradable polymer is as safe and effective at nine months as a conventional drug-eluting stent with a durable polymer, considered to be the most effective,” Windecker commented. “Longer-term follow-up of the patients in LEADERS or studies of a similar nature are now needed to confirm the theoretical advantage of the abluminal biodegradable polymer in terms of reduced risk of late thrombosis.”
Biosensors Europe funded the study.