2-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 Byrne, Simon Redwood, Ute Windhövel, Samantha Greene, Hans-Peter Stoll, Philip Urban, LEADERS FREE Investigators, Philip Urban, Marie-Claude Morice, Alexander Abizaid, Ian T Meredith, Stuart J Pocock, Didier Carrié, Christoph Naber, Samantha Greene, Hans-Peter Stoll, 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 Byrne, Simon Redwood, Ute Windhövel, Samantha Greene, Hans-Peter Stoll, Philip Urban, LEADERS FREE Investigators, Philip Urban, Marie-Claude Morice, Alexander Abizaid, Ian T Meredith, Stuart J Pocock, Didier Carrié, Christoph Naber, Samantha Greene, Hans-Peter Stoll
Abstract
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).
Keywords: bare-metal stent; bleeding; drug-coated stent; dual antiplatelet therapy; thrombosis.
Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed