Two-year results of the LEADERS (Limus eluted from a durable versus erodible stent coating) trial show an increasing trend towards a safety benefit for the biolimus A9-eluting stent with abluminal biodegradable polymer (BES) (Biosensors International) compared to Johnson & Johnson’s sirolimus-eluting stent with a durable polymer (SES). Results were presented by Professor Volker Klauss, Klinikum der Universität München, Germany, during a late-breaking trial session at the Transcatheter Cardiovascular Therapeutics 2009 annual meeting in San Francisco, California, USA.
LEADERS is a multicentre, randomised study in which 1,707 patients eligible for percutaneous coronary intervention (PCI) for symptomatic coronary disease received either a Biosensors biolimus A9-eluting stent with an abluminal biodegradable polymer coating, or a sirolimus-eluting stent with a durable polymer. Inclusion criteria were broad, reflecting routine clinical practice, without limitations regarding type of coronary vessel, lesion length or number of treated lesions. The nine-month results, presented at the European Society of Cardiology congress in 2008 and simultaneously published in The Lancet, demonstrated BES to be non-inferior to SES in respect of the primary endpoint, incidence of major adverse cardiac events (MACE) at nine months. This non-inferiority was confirmed in the 12-month results, at which time a non-significant difference in the rates of stent thrombosis in favor of BES was also observed.
In the overall study population there were similar outcomes for BES and SES, with an increasing advantage observed for BES in both MACE (BES: 13% vs. SES: 15.4% p=0.18) and cardiac death/myocardial infarction (BES: 8.3% vs. SES: 9.1% p=0.59) compared with both 9- and 12-month results. The differences were not statistically significant. In the high-risk sub-group of ST elevation myocardial infarction (STEMI) patients, a statistically significant improved MACE rate was demonstrated with BES compared to SES (8.1% vs. 19.3% p<0.01).
Although this was an all-comers study, occurrence of very late stent thrombosis events was rare (BES 0.2% vs. SES 0.5% p=0.73). In the BES group, the two events observed were limited to patients with saphenous vein grafts (SVG), who are traditionally excluded from drug-eluting stent trials. Notably, there were no very late stent thrombosis events in BES patients after discontinuation of dual anti-platelet therapy (DAPT).
“These additional follow-up results from LEADERS confirm that the Biosensors biolimus A9-eluting stent is safe and effective two years after implantation in an all-comers population reflecting patients we treat in our routine clinical practice”, commented LEADERS principal investigator Stephan Windecker, University Hospital, Bern, Switzerland.