Improved Safety and Reduction in Stent Thrombosis Associated With Biodegradable Polymer-Based Biolimus-Eluting Stents Versus Durable Polymer-Based Sirolimus-Eluting Stents in Patients With Coronary Artery Disease

• Published in: JACC. Cardiovascular interventions 2013-08, Vol.6 (8), p.777-789
• Main Authors: Serruys, Patrick W., MD, PhD, Farooq, Vasim, MB, ChB, Kalesan, Bindu, PhD, MPH, de Vries, Ton, MSc, Buszman, Pawel, MD, PhD, Linke, Axel, MD, Ischinger, Thomas, MD, Klauss, Volker, MD, Eberli, Franz, MD, Wijns, William, MD, PhD, Morice, Marie Claude, MD, Di Mario, Carlo, MD, PhD, Corti, Roberto, MD, Antoni, Diethmar, MD, Sohn, Hae Y., MD, Eerdmans, Pedro, MD, PhD, Rademaker-Havinga, Tessa, MSc, van Es, Gerrit-Anne, PhD, Meier, Bernhard, MD, PhD, Jüni, Peter, MD, Windecker, Stephan, MD
• Format: Article
• Language: English
• Subjects: biodegradable polymer; Cardiovascular; drug-eluting stents; durable polymer; stent thrombosis
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2013.04.011

Objectives This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. Background The LEADERS trial is the first randomized study to evaluate biodegradable polymer–based drug-eluting stents (DES) against durable polymer DES. Methods The LEADERS trial was a 10-center, assessor-blind, noninferiority, “all-comers” trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. Results At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority 1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220 )