With enrolment now complete, the baseline patient population data from Biosensors’ LEADERS FREE study was presented for the first time at EuroPCR 2014 (20–23 May; Paris, France) by principal investigator Philip Urban.
LEADERS FREE is the world’s first prospective, randomised double-blind trial employing only a one-month course of dual anti-platelet therapy (DAPT) after implantation of an active stent. The study is focused on patients at high risk of bleeding, and has been designed to confirm that BioFreedom, Biosensors’ novel polymer and carrier-free drug-coated stent, is as safe as a bare-metal stent in this patient group, while delivering the anti-restenotic benefit of a drug-eluting stent.
The baseline data confirmed that patients considered by enrolling doctors to be at high bleed risk are significantly older and have more co-morbidities than the ‘all comers’ patient population routinely seen in clinical studies of cardiac stents. LEADERS FREE reported a mean average patient age of 76, more than a decade older than the norm. Analysis also revealed more patients than normal with additional conditions to coronary heart disease, predominantly cancer, peripheral vascular disease, prior stroke and renal failure.
“The results of this study will be particularly important as we hope that they will show, for the first time, that a drug-coated stent can be more effective than a bare metal stent, yet just as safe, in a subgroup of patients not previously studied,” Urban comments. “This study could potentially change clinical practice by permitting the use of a drug-coated stent in conjunction with only one month of DAPT.”
LEADERS FREE has enrolled 2466 patients identified as having a high risk of bleeding from 68 sites across Europe, Asia, Australia and Canada. The trial plans to conduct two years of follow-up. Patients in both arms of the study are being prescribed only one month of DAPT.
The co-primary endpoints of the study are: 1) non-inferiority of BioFreedom compared with a bare-metal stent after one year as measured by specific safety factors (cardiac death, myocardial infarction, and definite/probable stent thrombosis) and; 2) superiority over bare-metal stent in terms of clinically-driven TLR after one year.
Primary endpoint data is expected in late 2015.
