Drug-eluting coronary stents with a biodegradable polymer significantly improve overall clinical outcomes and reduce stent thrombosis by 50% compared with drug-eluting coronary stents using a durable polymer over a three-year period. These were the findings from a new independent patient-level meta-analysis involving over 4,000 patients, presented at EuroPCR.
The incidence of the composite primary endpoint (cardiac death, myocardial infarction or clinically-indicated target vessel revascularisation) at three years was significantly lower in the biodegradable polymer drug-eluting stent treated group than in the durable polymer drug-eluting stent treated group (18.2% vs. 20.1%: p=0.04). Rates of definite stent thrombosis at three years were also significantly lower in the biodegradable polymer drug-eluting stent treated group than in the durable polymer drug-eluting stent treated group (1.2% vs. 2.1%: p=0.013).
The meta-analysis involved pooling three-year outcome data from the three largest published randomised clinical trials comparing biodegradable polymer drug-eluting stent with durable polymer sirolimus-eluting drug-eluting stent: LEADERS, ISAR-TEST 3 and ISAR-TEST 4.
LEADERS used BioMatrix Flex (Biosensors International) a biolimus-eluting stent with abluminal biodegradable polymer. The two ISAR-TEST trials used a sirolimus-eluting stent with biodegradable polymer. In total, 4,062 patients were included: 2,358 treated with a biodegradable polymer drug-eluting stent and 1,704 with a durable polymer sirolimus-eluting drug-eluting stent.
The LEADERS study was the first head-to-head randomised trial between two limus-eluting stents, Biosensors’ Biolimus A9-eluting stent system with abluminal biodegradable polymer and Cordis’ Cypher sirolimus-eluting stent system with durable polymer, in an “all-comers” patient population using clinical outcomes. BioMatrix Flex was shown to be non-inferior to Cypher in terms of its primary endpoint, major adverse cardiac events (a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation) at nine months. Three-year results for LEADERS suggested a strong trend towards significantly lower major adverse cardiac events rate for BioMatrix Flex compared to results at both one and two years.
The BioMatrix Flex stent system offers the unique combination of Biolimus A9 (BA9), an anti-restenotic drug developed and patented by Biosensors specifically for use with drug-eluting stents, combined with a biodegradable poly-lactic acid (PLA) polymer abluminally coated onto an advanced, highly flexible stent platform designed for enhanced deliverability. BA9 has the highest lipophilic profile of the common limus drugs, enabling rapid absorption by the tissue and minimising systemic exposure. The poly-lactic acid polymer fully degrades into carbon dioxide and water over six to nine months as it releases BA9.