Leaders Free

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.

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