BioMatrix Flex™ Chosen for Largest Ever Clinical Trial Involving a Drug-Eluting Stent

Paris, France, 16 May 2012 – BioMatrix Flex™, Biosensors’ Biolimus A9™-eluting stent system with abluminal biodegradable polymer, has been chosen as the stent platform for GLOBAL LEADERS, the largest ever randomized clinical trial involving a drug-eluting stent (DES). The latest plans for the trial were announced yesterday at EuroPCR by Study Chairman Professor Patrick W. Serruys.

GLOBAL LEADERS, an investigator-driven trial supported by both Biosensors and AstraZeneca, a global biopharmaceutical company, aims to enroll around 16,000 patients from an “all-comers” population to compare the effectiveness of two different pharmaco-intervention strategies. All patients will receive BioMatrix Flex™, and then be randomized to either a study treatment strategy of one month’s acetyl salicylic acid (ASA), otherwise commonly known as aspirin, plus ticagrelor, a novel antiplatelet drug, followed by 23 month’s ticagrelor single-drug treatment; or a reference treatment strategy of 12 month’s DAPT (ASA plus ticagrelor for acute coronary syndrome patients; ASA plus clopidogrel for elective patients), followed by 12 month’s ASA single-drug treatment.

Recruitment is due to commence by the end of this year. Patients will be followed-up for two years.

“BioMatrix Flex is a logical choice as the stent platform for GLOBAL LEADERS”, commented Prof. Serruys. “Its abluminal biodegradable coating gives it the long-term safety profile of a bare-metal stent. In addition, the four-year results from the LEADERS trial have provided solid evidence of improved clinical outcomes versus the gold-standard first-generation sirolimus-eluting stent”.

GLOBAL LEADERS is being independently designed, implemented and analyzed by the study investigators, led by Professor Serruys (Erasmus Medical Center, Rotterdam, Netherlands), Professor Stephan Windecker (University Hospital, Bern, Switzerland) and Dr. Marco Valgimigli (University of Ferrara, Italy). This latest plan for the trial represents a significant evolution in the concept, protocol, management and support of GLOBAL LEADERS as originally conceived and announced at EuroPCR last year, which it supersedes and replaces.

“We are delighted that such a prestigious international group of physicians has independently chosen our DES for this landmark study”, added Dr. Jack Wang, CEO of Biosensors.