In the first study of its kind, a drug-eluting stent (DES) with a biodegradable polymer applied only to the outer surface has been demonstrated as safe and effective as one of the most established and widely used types of DES with a durable polymer, in equivalent conditions to everyday clinical practice. Results were presented in a Hot Line session at the European Society of Cardiology Congress 2008 and published online in The Lancet.

The LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) study randomly assigned 1,707 patients with 2,472 lesions to treatment with either a biolimus-eluting stent with a biodegradable polymer or a sirolimus-eluting stent with a durable polymer. The study involved a broad range of patients for whom a stenting procedure was considered suitable, designed to reflect routine clinical practice.

Nine months after the procedure, a similar proportion of patients with biolimus-eluting stents and sirolimus-eluting stents reached the primary endpoint (9.2% vs 10.5%; RR=0.88; 95% CI 0.64 to 1.19; p=0.003 for noninferiority). Regarding individual safety and efficacy outcomes at 9 months, patients in the biolimus- and sirolimus groups had similar rates of death (2.6% vs 2.8%; p=0.74), cardiac death (1.6% vs 2.5%; p=0.22), MI (5.7% vs 4.6%; p=0.30), or clinically indicated TRV (4.4% vs 5.5%; p=0.29) (p values for superiority). Biolimus-eluting stents were also non-inferior to sirolimus-eluting stents in in-stent percent diameter stenosis (20.9% versus 23.3%, p=0.001 for noninferiority), the principal angiographic endpoint of the study.

"The results from LEADERS are significant, as they demonstrate for the first time that a drug-eluting stent with a biodegradable polymer is just as safe and effective as a conventional drug-eluting stent with a durable polymer, under conditions which resemble those of routine clinical practice", commented LEADERS Principle Investigator Professor Stephan Windecker, University Hospital, Bern, Switzerland. "The next stage will be to investigate whether a biodegradable polymer leads to a lower risk of stent thrombosis in the longer term".