Study Results from the LEADERS FREE Trial Presented at TCT 2015 and Published in the New England Journal of Medicine

SAN FRANCISCO – October 14, 2015 – Results from LEADERS FREE, the first randomized clinical trial dedicated to high bleeding risk patients treated with one month of dual anti-platelet therapy (DAPT), found that a polymer-free drug-coated stent (DCS) was superior to a bare-metal stent (BMS).

Findings from the LEADERS FREE study were presented today at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. Study results were also published in the New England Journal of Medicine.

Patients at high risk of bleeding during percutaneous coronary intervention (PCI) are mostly excluded from device and anti-platelet therapy trials. Current recommendations for high-risk patients are one month of DAPT after BMS implantation and a “shortened” DAPT regimen after DES. LEADERS FREE examined the use of one month of DAPT for both types of stents, specifically studying the BioFreedom DCS, which uses stent surface modification (rather than a drug delivery polymer) to elute lipophilic drug Biolimus A9.

The prospective double-blind randomized study enrolled 2,466 patients with high bleeding risk during PCI. Patients were randomized (1:1) to receive a DCS (n=1,221) or BMS (n=1,211). Superiority for the primary safety endpoint (composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis at one year post-procedure) was met with 112 (9.4%) for DCS and 154 (12.9%) for BMS. [Risk difference -3.6% (95% CI -6.1% to -1.0%), HR 0.71, (95% CI = 0.56 – 0.91), p < 0.0001 for non-inferiority and p = 0.005 for superiority].

The results for the primary efficacy endpoint of clinically-driven TLR at one year were 5.1% for DCS versus 9.8% for BMS. [Risk difference -4.8% (95% CI = -6.9% to -2.6%), HR 0.50, (95% CI = 0.37 – 0.69), p<0.001 for superiority].

“Patients who have a high risk of bleeding during PCI are often excluded from stent and drug trials but constitute a rapidly growing proportion of PCI candidates and they suffer high event rates,” said lead investigator Philip M. Urban, MD, Director of Interventional Cardiology at La Tour Hospital in Geneva, Switzerland. “The LEADERS FREE trial clearly showed that a drug-eluting stent combined with a one-month only DAPT course was both significantly safer and more effective than a bare-metal stent in this subset of patients.”

The LEADERS FREE trial was funded by Biosensors Europe Ltd. Dr. Urban is a paid consultant for Biosensors Europe Ltd.

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