Biosensors International Group, Ltd ("Biosensors", "Company", BIG:SP) today announced three-year results of the LEADERS trial, which 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. Results were presented by Professor Patrick W. Serruys, Erasmus Medical Center, Netherlands, at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
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. There was a diverging trend towards a lower rate of MACE (15.7% vs. 19.0%; P value for superiority = 0.09) in patients treated with BioMatrix Flex versus those treated with Cypher Select when compared to both one and two year results.
In the high risk sub-group of STEMI patients (ST Elevation Myocardial Infarction), a statistically significant reduction in MACE rate was demonstrated with BioMatrix Flex compared to Cypher Select (9.6% vs. 20.7%; P value for superiority = 0.01). In another high-risk group of patients, those with SYNTAX High scores (>16), there was a significant 57% reduction in risk of cardiac death for BioMatrix Flex compared to Cypher Select (4.6% vs. 10.4%; P value for superiority = 0.02).
Although this was an all-comers study, occurrence of very late stent thrombosis (VLST) events was very low: a cumulative 0.2% for BioMatrix Flex out to three years, compared with 0.9% for Cypher Select observed within the same period. No VLST events were observed in BioMatrix Flex patients between years two and three of the study. VLST events in the BioMatrix Flex group were limited to patients with Saphenous Vein Grafts (SVG), who are traditionally excluded from drug-eluting stent trials. It was also notable there were no VLST events in patients treated with the BioMatrix Flex stent after discontinuation of dual anti-platelet therapy (DAPT).
"These further follow-up results from LEADERS confirm that the BioMatrix Flex stent continues to be safe and effective three years after implantation in an all-comers population, reflecting patients treated in routine clinical practice", commented Professor Serruys.
"We are very encouraged by these results, which demonstrate that BioMatrix Flex continues to offer superior patient benefits compared to the industry standard over the longer term", added Jeffrey B. Jump, President & CEO of Biosensors. "Our innovative drug-eluting stent, with its unique combination of anti-restenotic drug and abluminal biodegradable polymer, is providing an increasingly attractive alternative to conventional drug-eluting stents with durable polymers."
The nine-month results from LEADERS, presented at the European Society of Cardiology ("ESC") congress in 2008 and simultaneously published in The Lancet, demonstrated the BioMatrix Flex stent to be non-inferior to the Cypher Select stent in respect of the primary endpoint, incidence of MACE at nine months. This non-inferiority was confirmed in the one and two year results, during which time an increasing trend towards a safety benefit for the BioMatrix Flex stent was observed.
Sponsored by Biosensors, LEADERS was independently designed, implemented and analyzed by the study investigators. Data management and analysis were performed by an independent academic institution.