Five-year results from the LEADERS trial have shown improved long-term clinical outcomes for BioMatrix Flex Biolimus A9-eluting stent system (Biosensors) compared to Cypher Select sirolimus-eluting stent system (Johnson & Johnson). BioMatrix Flex significantly reduced the risk of clinical events compared with Cypher Select, which was associated with a reduced risk of very late stent thrombosis (VLST).
The final report from LEADERS was presented by Patrick W Serruys, Erasmus Medical Center, Rotterdam, The Netherlands, at the TCT congress.
“As a result of LEADERS, most drug-eluting stents currently being developed use biodegradable polymer technology,” said Stephan Windecker, University Hospital, Bern, Switzerland, principal investigator of the trial. “BioMatrix was one of the pioneering stent platforms to use a biodegradable polymer applied to the abluminal surface only.”
Results at five years demonstrated that the relative risk of major adverse cardiac events (MACE) was 17% lower in patients treated with BioMatrix Flex than in those treated with Cypher Select (22.3% vs. 26.1%; Psup = 0.071). During the one to five year period, BioMatrix Flex was also associated with a significant 74% reduction in definite VLST compared with Cypher Select (0.66% vs. 2.5%; Psup = 0.003). The study had an excellent follow-up rate of 96.5%.
“Results from LEADERS have helped patients to benefit from our superior technology, as this was the first study to actually show that a drug-eluting stent with a biodegradable polymer was better than one with a durable polymer,” said Jeffrey B Jump, president of Biosensors’ Cardiovascular Business Unit.
The initial results from LEADERS, presented at the European Society of Cardiology (ESC) congress in 2008 and simultaneously published in The Lancet1, demonstrated BioMatrix Flex to be non-inferior to Cypher Select in respect of the primary endpoint, incidence of MACE at nine months. The four-year results, published in The Lancet in 20112, reinforced the long-term benefits of BioMatrix Flex. Compared with Cypher Select, it significantly reduced the risk of cardiac events, which was associated with a reduced risk of VLST.
LEADERS was the first head-to-head randomised clinical study between two limus-eluting stents involving an “all-comers” patient population and the first randomised clinical study between two stents to be independently monitored and assessed by its investigators.
- Windecker S et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non inferiority trial. The Lancet 2008; 372 No. 9644:1163-1173.
- Stefanini GG, Kalesan B, Serruys PW et al. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. The Lancet 2011; 378: 1940 – 1948.