June 21, 2012 — Plans for a new study involving BioFreedom, the polymer-free drug-coated stent (DCS) from Biosensors, were announced at EuroPCR by principal investigator Dr. Philip Urban, Hôpital de la Tour, Geneva.
Leaders Free is the world’s first prospective, randomized double-blind trial between a DCS and bare-metal stent (BMS), assessing the potential to deliver the anti-restenotic benefit of a drug-eluting stent with a shorter course of dual anti-platelet therapy (DAPT) in patients at high risk of bleeding.
Leaders Free will enroll approximately 2,500 patients from 60 sites across Europe, Asia and South America, with follow-up for two years. The trial will include patients identified as having a high risk of bleeding. Patients in both arms of the study will be prescribed only one month of DAPT, although they will take a single anti-platelet drug indefinitely.
The co-primary endpoints of the study will be: 1) non-inferiority of BioFreedom compared with BMS in terms of specific safety factors (cardiac death, myocardial infarction, and definite/probable stent thrombosis) after one year and; 2) superiority over BMS in terms of clinically-driven target lesion revascularization (TLR) at 12 months.
Investigators anticipate enrolling the first patient within the next few months, and completing the process by early 2014. Primary endpoint data is likely to be presented during 2015.
BioFreedom represents development in Biosensors’ stent technology, featuring a micro-structured abluminal surface which permits the controlled release of Biolimus A9 (BA9) without the use of a polymer. BA9 is a highly lipophilic anti-restenotic drug developed by Biosensors specifically for use with stents.
Biosensors has applied for CE mark approval for BioFreedom. As with its other products, the company is committed to building a significant body of clinical evidence before making BioFreedom commercially available. Leaders Free will represent a major contribution to the evidence surrounding the use of BioFreedom in patients at high risk of bleeding.
For more information: www.biosensors.com