Biosensors International Group says a three-year results of the Leaders trial showed a continuing positive trend towards a safety and efficacy benefit for BioMatrix Flex, Biosensors’ Biolimus A9-eluting stent system with abluminal biodegradable polymer, compared to Cypher Select, Johnson & Johnson’s sirolimus-eluting stent system with a durable polymer.

Although sponsored by Biosensors, Leaders was independently designed, implemented and analysed by the study investigators. Data management and analysis were performed by an independent academic institution.

In the overall study population, there were similar outcomes for BioMatrix Flex and Cypher Select in respect of MACE (major adverse cardiac events) at three years. However, there was a diverging trend towards a lower rate of MACE in patients treated with BioMatrix Flex versus those treated with Cypher Select when compared to both one and two year results.