LEADERS FREE Data Support Biosensors' BioFreedom DCS With 1-Month DAPT in High Bleeding-Risk Patients

October 14, 2015—Results from LEADERS FREE, a randomized clinical trial dedicated to high bleeding-risk patients treated with 1 month of dual-antiplatelet therapy (DAPT), found that a polymer-free BioFreedom drug-coated stent (DCS; Biosensors International Group, Ltd.) was superior to a bare-metal stent (BMS). Findings from the LEADERS FREE study were presented today at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium of the Cardiovascular Research Foundation. The study results were also published online in The New England Journal of Medicine. 

Biosensors’ BioFreedom DCS uses stent-surface modification rather than a drug delivery polymer to elute lipophilic drug Biolimus A9. The LEADERS FREE study was funded by Biosensors Europe Ltd.

In the TCT press release, LEADERS FREE lead investigator Philip M. Urban, MD, commented, “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. The LEADERS FREE trial clearly showed that a drug-eluting stent combined with a 1-month only DAPT course was both significantly safer and more effective than a bare metal stent in this subset of patients.” Dr. Urban is Director of Interventional Cardiology at La Tour Hospital in Geneva, Switzerland.

The LEADERS FREE 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 1 year postprocedure) was met with 112 (9.4%) for DCS and 154 (12.9%) for BMS (risk difference -3.6%; 95% confidence interval [CI], -6.1% to -1.0%; hazard ratio [HR], 0.71; 95% CI, 0.56 to 0.91; P < .0001 for noninferiority and P = .005 for superiority).

The results for the primary efficacy endpoint of clinically driven TLR at 1 year were 5.1% for DCS versus 9.8% for BMS (risk difference, -4.8%; 95% CI, -6.9% to -2.6%; HR 0.5; 95% CI, 0.37 to 0.69;  P < .001 for superiority).