An ultrathin, sirolimus-eluting biodegradable stent was noninferior to a durable everolimus-eluting stent for a primary endpoint of target lesion failure, according to the results of a 12-month randomized, single-blind trial presented at the annual congress of the European Society of Cardiology.
The noninferiority BIOSCIENCE trial in 2,119 patients – 1063 given the sirolimus-eluting, biodegradable stent, and 1,056 given the durable everolimus-eluting stent – recorded a 6.5% failure rate with sirolimus-eluting stent and 6.6% failure rate with the everolimus-eluting stent, and found no significant differences in the rates of definite stent thrombosis.
However, the investigators did note slightly better outcomes among patients with ST-segment elevation myocardial infarction given the biodegradable, stent compared with those given the durable polymer stent, according to a paper simultaneously published online September 1 in The Lancet [http://dx.doi.org/10.1016/ S0140-6736(14)61038-2].
"Our findings document excellent clinical outcomes for both stent types in a patient population with minimal exclusion criteria – a substantial proportion of whom presented with acute coronary syndromes and complex lesion characteristics," wrote Dr. Thomas Pilgrim, from University Hospital, Bern, Switzerland, and colleagues.
Biodegradable polymer stents have the potential to abolish the late adverse outcomes from durable polymer, such as late stent thrombosis and neoatherosclerosis, which may result from permanent contact between fluoropolymers and the vessel wall, an accompanying editorial noted.
"The large body of accumulated scientific evidence, including the important results from BIOSCIENCE, should trigger research efforts and economic resources to focus on functional restoration of the stented coronary artery, for example, with fully bioresorbable vascular scaffolds," wrote the editorial’s authors Dr. Julinda Mehilli from the Munich (Germany) University Clinic, and Dr. Steffen Massberg of the Munich Heart Alliance.
The study was partly funded by a grant from the Swiss National Science Foundation, and some authors declared travel expenses, grants, lecture fees and other funding from a range of companies including the stent’s manufacturer Biotronik. Dr Mehilli declared speaker’s fees from Abbott Vascular, Biotronik, and Lilly/Daiichi Sankyo.