Produção Nacional
Revisado por pares
2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents
2016; Elsevier BV; Volume: 69; Issue: 2 Linguagem: Inglês
10.1016/j.jacc.2016.10.009
ISSN1558-3597
AutoresPhilippe Garot, Marie‐Claude Morice, Damras Tresukosol, Stuart J. Pocock, Ian T. Meredith, Alexandre Abizaid, Didier Carrié, Christoph Naber, Andrés Íñiguez, Suneel Talwar, Ian Menown, Evald Høj Christiansen, John Gregson, Samuel Copt, Thomas Hovasse, Philipp Lurz, Luc Maillard, Florian Krackhardt, Paul Jau Lueng Ong, Jonathan Byrne, Simon Redwood, U. Windhövel, Samantha Greene, Hans‐Peter Stoll, Philip Urban, Philip Urban, Marie‐Claude Morice, Alexandre Abizaid, Ian T. Meredith, Stuart J. Pocock, Didier Carrié, Christoph Naber, Samantha Greene, Hans‐Peter Stoll,
Tópico(s)Cardiac Valve Diseases and Treatments
ResumoA 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. This study analyzed 2-year outcomes to determine whether these benefits are maintained. 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. 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. 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)
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