![]() ![]() Type 5b: Definite fatal bleeding: bleeding that is directly observed or confirmed on autopsy.Type 5a: Probably fatal bleeding: bleeding that is clinically suspicious as the cause of death, but the bleeding is not directly observed and there is no autopsy or confirmatory imaging.Major bleeding rate defined as Type 3 or greater based on the Bleeding Academic Research Consortium (BARC) definition was assessed Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis).Subcategories confirmed by autopsy/imaging/lumbar puncture.Intracranial hemorrhage including subdural hemorrhages.Bleeding requiring intravenous vasoactive drugs.Bleeding requiring surgical intervention for (Watchman).Overt bleeding+Hb drop ≥ 5 g/dL (provided Hb drop is related to bleed). ![]() Overt bleeding+Hb drop of ≥ 3 to Procedure related complications are adverse events adjudicated by the Clinical Events Committee (CEC), as procedure related and requiring either invasive surgical or percutaneous intervention.Īll-cause deaths (cardiovascular or non-cardiovascular) were assessed. Why Should I Register and Submit Results?. ![]()
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