Biosensors International Group has completed enrolling the first patient in its polymer-free drug-coated stent's (DCS) clinical trial, designed to compare the safety of the BioFreedom with a bare-metal stent (BMS).
Designed for use in patients with high risk of bleeding, the BioFreedom DCS features a micro-structured abluminal surface and permits the controlled release of a highly lipophilic anti-restenotic drug, Biolimus A9 (BA9), without the use of a polymer.
The double-blind, prospective, randomized trial, which has enrolled the first patient at the Hopital de la Tour in Geneva, Switzerland, will include 2,500 patients with high risk of bleeding from 60 sites across Europe, Asia and South America, and will be followed-up for two years.
The trial will also demonstrate the ability of the BioFreedom DCS in delivering the anti-restenotic benefit of a drug-eluting stent (DES), with only a one-month course of DAPT.
The co-primary endpoints of the study include non-inferiority of BioFreedom compared with BMS as measured by specific safety factors (cardiac death, myocardial infarction, and definite/probable stent thrombosis) as well as superiority over BMS in terms of clinically-driven TLR at one year.
The trial, which anticipates completing the enrollment process by early 2014, is expected to present its primary endpoint data during 2015.
In addition, the BioFreedom FIM study’s three-year results showed similar rates of MACE, cardiac artery bypass graft and target lesion revascularization between BioFreedom and Boston Scientific’s Taxus Liberté DES, with no evidence of stent thrombosis in either group.
Biosensors cardiovascular business unit president Jeffrey Jump said, "We anticipate that the results from LEADERS FREE will bring real benefits to patients at high risk of bleeding, who cannot currently be given a drug-eluting stent due to the need for a prolonged course of DAPT."