Early or late initiation of dabigatran versus vitamin-K-antagonists in acute ischemic stroke or TIA: The PRODAST study

作者：Gerrit M. Große, Anika Hüsing, Andreas Stang, Nils Kuklik, Marcus Brinkmann, Darius G. Nabavi, Paul Sparenberg, Karin Weißenborn, Klaus Gröschel, Georg Royl, Sven Poli, Dominik Michalski, Christoph Eschenfelder, Christian Weimar, Hans‐Christoph Diener, on behalf of the PRODAST Investigators · 发表于：International Journal of Stroke · 年份：2023 · DOI：10.1177/17474930231184366 · 被引用次数：16 · 研究领域：Atrial Fibrillation Management and Outcomes、Intracerebral and Subarachnoid Hemorrhage Research、Vitamin K Research Studies

BACKGROUND: The optimal timing of initiating or resuming anticoagulation after acute ischemic stroke (AIS) or transient ischemic attack (TIA) in patients with atrial fibrillation (AF) is debated. Dabigatran, a non-vitamin K oral anticoagulant (NOAC), has shown superiority against vitamin K antagonists (VKA) regarding hemorrhagic complications. AIMS: In this registry study, we investigated the initiation of dabigatran in the early phase after AIS or TIA. METHODS: PRODAST (Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA) is a prospective, multicenter, observational, post-authorization safety study. We recruited 10,039 patients at 86 German stroke units between July 2015 and November 2020. A total of 3,312 patients were treated with dabigatran or VKA and were eligible for the analysis that investigates risks for major hemorrhagic events within 3 months after early (⩽ 7 days) or late (> 7 days) initiation of dabigatran or VKA initiated at any time. Further endpoints were recurrent stroke, ischemic stroke, TIA, systemic embolism, myocardial infarction, death, and a composite endpoint of stroke, systemic embolism, life-threatening bleeding and death. RESULTS: Major bleeding event rates per 10,000 treatment days ranged from 1.9 for late administered dabigatran to 4.9 for VKA. Early or late initiation of dabigatran was associated with a lower hazard for major hemorrhages as compared to VKA use. The difference was pronounced for intracranial hemorrhage...