{"id":"a52861d0d8d9","type":"article","url":"https://hartvaat.nl/2017/01/17/2-jaarsuitkomsten-van-drug-coated-stents-zonder-polymeer-bij-hoog-bloedingsrisic/","title":"2-jaarsuitkomsten van drug-coated stents zonder polymeer bij hoog bloedingsrisico","title_en":"2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2016.10.009","source_url":"https://doi.org/10.1016/j.jacc.2016.10.009","authors":["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"],"significance":6,"published":"2017-01-17","source_date":"2017-01-17","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/","https://hartvaat.nl/kennis/vasculair/antistolling-bij-vte/"],"congress":"","summary_en":"This study reported 2-year outcomes of polymer-free drug-coated stents in high-bleeding-risk patients, demonstrating durable safety with only 1 month of DAPT in this vulnerable population.","created":"2026-07-03T10:26:31Z","updated":"2026-07-03T13:25:50Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie naar 2-jaarsuitkomsten van polymeervrije drug-coated stents bij patiënten met hoog bloedingsrisico. Relevant voor de stentkeuze bij patiënten die slechts kort DAPT kunnen gebruiken.","abstract_original":"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)."}