Five-Year LEADERS Data Compare Biolimus-Eluting Stents Versus Sirolimus-Eluting Stents

August 19, 2013—The final 5-year report of the LEADERS trial was published by Patrick W. Serruys, MD, et al in the Journal of American College of Cardiology (JACC): Cardiovascular Interventions (2013;6:777–789). The investigators noted that the landmark LEADERS (Limus Eluted From a Durable Versus Erodable Stent Coating) trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES.

The LEADERS investigators concluded that the safety benefit of biodegradable polymer biolimus-eluting stents (BES), compared with the durable polymer sirolimus-eluting stents (SES), was related to a significant reduction in very late stent thrombosis (> 1 year) and associated composite clinical outcomes.

The final 5-year LEADERS data were presented last October at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida. The LEADERS trial compared the performance of BioMatrix Flex BES (Biosensors International Group, Ltd., Singapore), compared with Cypher Select SES (Cordis Corporation, Bridgewater, NJ).

European CE Mark approval of the BioMatrix Flex BES was announced by Biosensors in January 2010. On May 20, 2013, the company announced CE Mark approval for the next-generation BioMatrix NeoFlex BES. Both devices feature an abluminal biodegradable polymer coating and Biosensors limus drug, Biolimus A9.

As summarized in JACC: Cardiovascular Interventions, the LEADERS trial was a 10-center, assessor-blind, noninferiority, “all-comers” trial (N = 1,707). All patients were centrally randomized to treatment with BES (n = 857) or SES (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (Academic Research Consortium definition). Analysis was by intention to treat.

The LEADERS investigators found that at 5 years the BES compared with SES was noninferior for the primary endpoint: 186 versus 216 (22.3% vs 26.1%; rate ratio [RR], 0.83; 95% confidence interval [CI], 0.68 to 1.02; P for noninferiority < .0001, P for superiority = .069).

The BES was associated with a significant reduction in the more comprehensive patient-orientated composite endpoint of all-cause death, any myocardial infarction, and all-cause revascularization: 297 versus 339 (35.1% vs 40.4%; RR, 0.84; 95% CI, 0.71 to 0.98; P for superiority = .023).

A significant reduction in very late definite stent thrombosis from 1 to 5 years was evident with the BES: n = 5 versus n = 19 (0.7% vs 2.5%; RR, 0.26; 95% CI, 0.1 to 0.68; P = .003), corresponding to a significant reduction in stent thrombosis-associated clinical events (primary endpoint) over the same time period: n = 3 of 749 versus n = 14 of 738 (RR, 0.2; 95% CI, 0.06 to 0.71; P = .005), reported the LEADERS investigators in JACC: Cardiovascular Interventions.