A world premiere trial focusing on the « non comers »
Dr Philip Urban
LEADERS-FREE is a randomized double-blinded trial which was designed to assess the combination of a short course (1 month) of DAPT with either the BioFreedom DCS (drug-coated stent) or the Gazelle BMS in patients with at least one of several criteria for an increased bleeding risk: advanced age, oral anticoagulant treatment, recent bleeding, anaemia, and co-morbid conditions such as chronic renal failure or cancer.
The trial has three central features:
1. A focus on a “forgotten” patient subset
2. A double-blinded design (neither the patient or the operator will not know whether a BioFreedom DCS or a BMS control is implanted)
3. The use of two separate co-primary endpoints at 1 year: (BioFreedom vs. BMS) non-inferiority for safety (death, MI and urgent TLR) and superiority for efficacy (any clinically driven TLR)
It is planned to include > 2400 patients from > 60 centres in Europe, Asia and South America.
CERC is in charge of the study management and monitoring as well as the setting up the CEC and Corelab.