2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents

Philippe Garot, Marie-Claude Laude Morice, Damras Tresukosol, Stuart J Pocock, Ian T. Meredith, Alexandre Abizaid, Didier Carrié, Christoph K Naber, Andres Iñiguez, Suneel Talwar, Ian B.A. Menown, Evald H Christiansen, John N S Gregson, Samuel Copt, Thomas Hovasse, Philipp C. Lurz, Luc Maillard, Florian Krackhardt, Paul Ong, Jonathan ByrneSimon Redwood, Ute Windhövel, Samantha Greene, Hans-Peter Stoll, Philip Urban, for the LEADERS FREE Investigators

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Background A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding. Objectives This study analyzed 2-year outcomes to determine whether these benefits are maintained. Methods In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization. Results At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio: 0.80; 95% confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (hazard ratio: 0.54; 95% confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045). One-year mortality was 27.1% for a major bleed and 26.3% for a thrombotic event. At 2 years, multivariate correlates of major bleeding were age >75 years, anemia, raised plasma creatinine, and planned long-term anticoagulation. Correlates of the primary safety endpoint were age, anemia, congestive heart failure, multivessel disease, number of stents implanted, and use of a BMS rather than a DCS. Conclusions Safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients. Rates of major bleeding and coronary thrombotic events were no different and were associated with a substantial and comparable mortality risk. (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding [LEADERS FREE]; NCT01623180)

Original languageEnglish
Pages (from-to)162-171
Number of pages10
JournalJournal of the American College of Cardiology
Issue number2
Publication statusPublished - 17 Jan 2017


  • bare-metal stent
  • bleeding
  • drug-coated stent
  • dual antiplatelet therapy
  • thrombosis

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