Long-Term Clinical Benefits of BioMatrix FlexTM Confirmed in The Lancet: Proof of Concept for Biodegradable Polymer

Press release   •   Dec 05, 2011 17:59 GMT

5 December 2011 – Four-year results from the LEADERS trial, published in the latest issue of The Lancet, show that BioMatrix Flex™, Biosensors’ Biolimus A9™-eluting stent system with a biodegradable polymer coating, significantly reduces the risk of very late stent thrombosis (VLST) compared to that of a drug-eluting stent (DES) system with a durable polymer coating. This reduced risk of VLST is positively associated with a reduced risk of cardiac events, therefore demonstrating for the first time ‘proof of concept’ that a DES with biodegradable polymer improves long-term clinical outcomes compared to a DES with durable polymer.
“This study shows that the problem of very late stent thrombosis, which was prevalent with first-generation durable-polymer drug-eluting stents, is markedly reduced by a stent using a biodegradable polymer”, commented Principal Investigator Professor Stephan Windecker, University Hospital, Bern, Switzerland. “This translates into a late benefit in terms of cardiac death or myocardial infarction.”
The LEADERS study is a head-to-head randomized trial between two limus-eluting stents, BioMatrix Flex and Cypher® Select™, Johnson & Johnson’s sirolimus-eluting stent system with a durable polymer. The study involves an “all-comers” patient population and measures clinical outcomes. The primary endpoint from LEADERS, published in The Lancet in 2008, demonstrated BioMatrix Flex to be non-inferior to Cypher Select with respect to the primary endpoint, incidence of MACE (a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularization) at nine months. This non-inferiority has been confirmed in the one, two, three and four-year results, during which time a diverging trend towards a safety benefit for BioMatrix Flex was observed.
At four years, the risk of MACE was lower in patients treated with BioMatrix Flex than in those treated with Cypher Select (18.7% vs. 22.6%: p = 0.050, 96% of patients followed up).  The benefit of BioMatrix Flex appeared more pronounced between years one and four.   During this one to four year period, BioMatrix Flex was associated with a significant 80% relative risk reduction in definite VLST compared with Cypher Select (p=0.004).
An analysis of the correlation between MACE and definite stent thrombosis events showed that the benefit in favor of BioMatrix Flex in terms of MACE was largely driven by a lower risk of MACE associated with definite VLST.
“We are very encouraged by these results, which further support the long-term patient benefit of BioMatrix Flex”, added Jeffrey B. Jump, Co-CEO of Biosensors. “LEADERS shows that improvement in drug-eluting stent technology directly translates into improved patient safety”.
Sponsored by Biosensors, LEADERS was independently designed, implemented and analyzed by the study investigators.