title: 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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Hôpital de la Tour, Geneva, Switzerland. philip.urban@latour.ch
authors.forename: Philip
authors.initials: P
authors.lastname: Urban
authors.forename: Alex
authors.initials: A
authors.lastname: Abizaid
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Samantha
authors.initials: S
authors.lastname: Greene
authors.forename: Ian
authors.initials: I
authors.lastname: Meredith
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.forename: Stuart
authors.initials: S
authors.lastname: Pocock
mesh_terms: D020341:Absorbable Implants; D001208:Asia / Q000453:epidemiology; D002170:Canada / Q000453:epidemiology; D003324:Coronary Artery Disease / Q000628:therapy*; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D005060:Europe / Q000453:epidemiology; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D013020:South America / Q000453:epidemiology; D013997:Time Factors
chemical_list: D010975:Platelet Aggregation Inhibitors