The BioFreedom drug-coated stent demonstrated superiority to bare metal stents in patients undergoing percutaneous coronary intervention (PCI) with a high risk of bleeding, according to the results of the LEADERS FREE trial, presented Oct. 14 at TCT 2015 and simultaneously published in the New England Journal of Medicine.

In a prospective, double-blind randomized trial, Philip M. Urban, MD, FACC, et al., tested the efficacy and noninferiority of the BioFreedom drug-coated stent compared to the Gazelle bare-metal stent in 2466 high-bleeding risk PCI patients, with one month of dual antiplatelet therapy only. The primary safety endpoint was a composite of cardiac death, myocardial infarction and stent thrombosis at one year, while the efficacy endpoint was clinically-driven target lesion revascularization.

The results of the study showed that the BioFreedom drug-coated stent was both safer and more effective than a bare metal stent in PCI patients with a high risk of bleeding.

“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,” says Urban. The LEADERS FREE trial clearly showed the benefit of the BioFreedom drug-coated stent in this subset of patients, he continues.

Keywords: Transcatheter Cardiovascular Therapeutics, Coronary Artery Disease, Coronary Disease, Drug-Eluting Stents, Hemorrhage, Metals, Polymers, Stents, Myocardial Infarction, Percutaneous Coronary Intervention, Thrombosis

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