Rationale and design of the LEADERS FREE trial: A randomized double-blind comparison of the BioFreedom drug-coated stent vs the Gazelle bare metal stent in patients at high bleeding risk using a short (1 month) course of dual antiplatelet therapy.

BACKGROUND AND RATIONALE: Major bleeding is a powerful predictor of morbidity and mortality after percutaneous coronary intervention (PCI). To avoid prolonged dual antiplatelet therapy (DAPT), current guidelines recommend using a bare metal stent when PCI is indicated to treat patients at high risk of bleeding. The Biolimus A9-coated BioFreedom is a new stainless steel drug-coated stent devoid of polymer and has been shown to be associated with a low median late-loss of 0.17 mm at 12 months of follow-up. In an animal model, 98% of the drug has diffused into the vessel wall at 1 month. It is therefore reasonable to consider that such a device may have a potential safety advantage, and a lesser dependence on prolonged DAPT than a polymer-coated drug-eluting stent. TRIAL DESIGN: A total of 2456 patients considered at high risk of bleeding will be randomized in a double-blind fashion to the BioFreedom drug-coated stent or to a control arm (Gazelle bare metal stent). Both groups will be treated with DAPT during 1 month only, followed by long-term aspirin alone. At 1-year follow-up, the primary safety endpoint (a composite of cardiac death, myocardial infarction and stent thrombosis) will be assessed by a non-inferiority analysis, and the primary efficacy endpoint (clinically driven target lesion revascularization) by a superiority analysis. CONCLUSIONS: This trial should help better characterize a neglected subset of PCI patients and quantify both their thrombotic and bleeding risks. It has the potential to decrease the need for target lesion revascularization in patients unable to tolerate a prolonged course of DAPT and will assess the shortest DAPT course ever used with an active stent.