Biosensors International has announced enrolment of the first patient in LEADERS Free Japan, a trial involving BioFreedom, the company’s novel polymer and carrier-free drug-coated stent.
LEADERS Free is the world’s first prospective, randomised double-blind clinical trial employing only a one-month course of dual anti-platelet therapy after implantation of an active stent. The trial is focused on patients at high risk of bleeding, and has been designed to confirm that BioFreedom is as safe as a bare-metal stent in this patient group, while delivering the anti-restenotic benefit of a drug-eluting stent. LEADERS Free Japan will apply the same principles as LEADERS Free (patient selection criteria and duration of dual anti-platelet therapy), but with just the BioFreedom treatment arm.
The objective of LEADERS Free Japan is to confirm that the safety and efficacy of BioFreedom in Japanese patients is equivalent to that observed in patients of other ethnicities, as assessed in the active (BioFreedom) arm of LEADERS Free. Safety is to be measured by the composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year, and efficacy by the incidence of clinically driven target lesion revascularisation at one year.
LEADERS Free Japan aims to enrol 139 patients identified as having a high risk of bleeding from 12 centres across the country. All patients are being prescribed only one month of dual anti-platelet therapy. The first patient has been enrolled in LEADERS Free Japan by the trial’s principal investigator, Shigeru Saito, Shonan Kamakura General Hospital, Kanagawa, Japan.
“I am very excited about starting a trial in Japan using BioFreedom,” comments Saito. “It is a unique clinical trial, not only for the stent itself but for the challenging trial design and the patient population. We expect to gain both valuable scientific and clinical findings from the trial and the technology may offer unique clinical benefits for patients in the future.”
“We hope that the results from LEADERS Free Japan will show, for the first time, that a drug-coated stent can be used safely and effectively in Japanese patients at high risk of bleeding with only one month of dual anti-platelet therapy,” adds Philip Urban, principal investigator for LEADERS Free.
LEADERS Free has now completed enrolment, with 2466 patients identified as having a high risk of bleeding from 68 sites across Europe, Asia, Australia and Canada. The trial plans to conduct two years of follow-up. Patients in both arms of the trial are being prescribed only one month of dual anti-platelet therapy. Primary endpoint data is expected in late 2015.
BioFreedom received CE mark approval in January 2013 and is currently available in select markets. Last month Biosensors announced that they had received conditional IDE approval to conduct a US-based clinical trial of BioFreedom, designed to collect additional safety and effectiveness data to support a future pivotal IDE study.