Two-Year Outcomes of High Bleeding Risk Patients after Polymer-Free Drug-Coated Stents

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

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Background For patients at high risk for bleeding, a polymer-free metallic stent coated with biolimus-A9 followed by one-month dual antiplatelet therapy was safer and more effective than a bare metal stent at one year. Objectives Longer-term follow-up is needed to determine whether these benefits are maintained. Methods In a prospective, multi-center, double blind trial, we randomly assigned 2466 high bleeding risk patients to receive a drug coated stent (DCS) or a bare metal stent (BMS) followed by one month dual antiplatelet therapy and 98.1% completed a two-year follow-up. The primary safety end point was a composite of cardiac death, myocardial infarction (MI), or stent thrombosis (ST). The primary efficacy end point was clinically driven target-lesion revascularization. Results At 2 years, the primary safety endpoint had occurred in 147 DCS (12.6%) and 180 BMS patients (15.3%) (hazard ratio 0.80; 95% CI, 0.64 to 0.99; p=0.039). Clinically driven target-lesion revascularization occurred for 77 DCS (6.8%) and 136 BMS patients (12.0%) (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P<0.0001). Major bleeding occurred in 8.9% DCS and 9.2% BMS patients (p=0.95), and a coronary thrombotic event (MI and/or ST) in 8.2% DCS and 10.6% BMS patients (p=0.045). Mortality was 27.1% one year after a major bleed, and 26.3% one year after a thrombotic event. At two years, multivariate correlates of major bleeding were age > 75, 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 The safety and efficacy benefits of DCS over BMS were maintained up to two years in high bleeding risk patients. During that period, overall rates of major bleeding and coronary thrombotic events were no different and associated with a substantial and comparable mortality risk.
Original languageEnglish
JournalJournal of the American College of Cardiology
Early online date30 Oct 2016
Publication statusE-pub ahead of print - 30 Oct 2016


  • drug-coated stent
  • DAPT
  • bleeding
  • thrombosis
  • bare-metal stent


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