Paris, France, 18 May 2011 – Plans for Global LEADERS (“LEADERS II”), the largest ever randomized clinical trial involving a head-to-head comparison between two drug-eluting stents (DES), were announced yesterday during the opening session of EuroPCR by Co-Principal Investigator Professor Patrick W. Serruys. The trial will enroll more than 10,000 patients from an “all-comers” population eligible for PCI, allocated to receive either BioMatrix Flex™ (Biosensors’ Biolimus A9™-eluting stent system with abluminal biodegradable polymer), or the market-leading DES system with a durable polymer. Recruitment into the study, involving over 100 sites around the globe, is due to start in early 2012, with data being collected for up to two years following stent implantation.
The protocol of the study is currently under development, and is likely to involve a “2x2 factorial” design, with the second randomization being to either a short or long duration of anti-platelet therapy. The primary endpoint will be a true clinical evaluation, assessing patient safety. Global LEADERS will be independently designed, implemented and analyzed by the study investigators, who in addition to Prof. Serruys (Erasmus Medical Center, Rotterdam, Netherlands) will include Co-Principal Investigator Professor Stephan Windecker (University Hospital, Bern, Switzerland). The study will also have regional Principal Investigators in Europe, South America and Asia. Dr. Marco Valgimigli (University of Ferrara, Italy) will act as Principal Investigator for the anti-platelet therapy portion of the study.
Global LEADERS aims to build on the concept of the landmark LEADERS study, which was the first head-to-head randomized trial between two limus DES in an “all-comers” patient population using clinical outcomes as its endpoint. LEADERS results suggested that a DES with biodegradable polymer could be safer in the long term than a DES with durable polymer – especially in high-risk patient populations – under conditions which resemble those of routine clinical practice.
sgxstockpicker says: The randomized trials will only make Biosensor's DES more acceptable over the world, provided the clinical trials are successful. The trials themselves are likely to increase expenses. But if the trials show that Biosensor's DES has an edge over its rival (J&J probably), the sales team will be in a better position to market and hence increase revenue.