Biosensors Announces Large Global Trial of BioMatrix Flex DES

May 18, 2011—Biosensors International Group, Ltd. (Singapore) announced plans for the Global LEADERS (LEADERS II) randomized clinical trial, which involves a head-to-head comparison between two drug-eluting stents (DES). Prof. Patrick W. Serruys, MD, Coprincipal Investigator of LEADERS II, presented plans for the trial at the EuroPCR 2011 conference in Paris.

LEADERS II will study Biosensors' BioMatrix Flex stent system, which combines the company's antirestenotic drug, Biolimus A9 (BA9), with a biodegradable polylactic acid polymer that is abluminally coated onto a flexible stent platform. The company stated that BA9 has a high lipophilic profile that enables rapid absorption by the tissue and minimizes systemic exposure. The polylactic acid polymer fully degrades into carbon dioxide and water during a period of 6 to 9 months as it releases BA9.

According to the company, the trial will enroll more than 10,000 patients from an all-comers population of patients who are eligible for percutaneous coronary intervention at more than 100 sites around the world. The patients will be allocated to receive either the BioMatrix Flex or a market-leading DES system with a durable polymer. The data will be collected for up to 2 years after stent implantation. Recruitment into the study is due to start in early 2012. CE Mark approval of the BioMatrix Flex device was announced in January 2010, as reported in Cardiac Interventions Today.

Biosensors advised that the protocol of the study is currently under development and is likely to involve a 2 X 2 factorial design, with the second randomization being to either a short- or long-duration course of antiplatelet therapy. The primary endpoint will be a clinical evaluation to assess patient safety. LEADERS II will be independently designed, implemented, and analyzed by the study investigators. Prof. Serruys and Coprincipal Investigator Prof. Stephan Windecker, MD, will lead the trial with regional Principal Investigators in Europe, South America, and Asia. Marco Valgimigli, MD, will act as Principal Investigator for the antiplatelet therapy portion of the study.

The company stated that LEADERS II aims to build on the concept of the LEADERS (Limus Eluted From a Durable Versus Erodable Stent Coating) study, which was a head-to-head randomized trial between two limus DES in an all-comers patient population using clinical outcomes as its endpoint. According to Biosensors, the 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 that resemble those of routine clinical practice.

“I am delighted to be involved with this logical development of the original LEADERS study,” commented Prof. Serruys. “By continuing the concept of a head-to-head study against a widely used DES with durable polymer using a true clinical endpoint and involving nearly six times as many patients, we anticipate that the study will be sufficiently powered to produce meaningful results on the benefits of a DES with biodegradable polymer in a broad range of predefined patient subgroups.”

Prof. Windecker added, “Global LEADERS should provide us with further valuable information, in that it will evaluate the risks and benefits associated with a short- versus long-duration course of antiplatelet therapy following DES implantation in a large number of patients.”