The BioFreedom polymer-free drug-coated stent (DCS) remained significantly safer and more effective than the bare metal stent (BMS), according to the two-year results of the LEADERS FREE Trial presented Oct. 30 at TCT 2016 and simultaneously published in the Journal of the American College of Cardiology.

In the first randomized, prospective, double-blind trial dedicated to high-bleeding risk patients treated with one month of dual antiplatelet therapy (DAPT), Philip M. Urban, MD, FACC, et al., assessed the safety and efficacy of both stents in 2,466 patients from 68 centers. The primary safety endpoint was a composite of cardiac death, myocardial infarction (MI), or stent thrombosis (ST). The primary efficacy endpoint was clinically driven target-lesion revascularization. The one year results demonstrated superior safety and efficacy of the BioFreedom DCS.

The two-year results of the study showed that the BioFreedom DCS remained superior to the bare metal stent in both safety and efficacy in high-bleeding risk patients. The primary safety endpoint at two years was 12.6 percent for DCS compared to 15.3 percent for BMS, while the primary efficacy endpoint of clinically driven target-lesion revascularization at two years were 6.8 percent for DCS versus 12.0 percent for BMS. Major bleeding occurred in 8.9 percent DCS and 9.2 percent BMS patients, and a coronary thrombotic event (MI and/or ST) occurred in 8.2 percent DCS and 10.6 percent BMS patients.

According to Urban, “these patients suffer from a persistently high incidence of bleeding and coronary thrombotic events, both of which are associated with a high and similar mortality over a one-year period. Therefore, identification of predictors of both the composite primary safety event and major bleeding may help design future trials of DAPT duration for this population.”

The LEADERS FREE Trial was originally presented at TCT 2015. View the one year results on ACC.org.

Keywords: Transcatheter Cardiovascular Therapeutics, Angina, Stable, Coronary Artery Disease, Drug-Eluting Stents, Hemorrhage, Polymers, Stents, Double-Blind Method, Myocardial Infarction, Thrombosis, Prospective Studies

< Back to Listings