Replacing warfarin with a novel oral anticoagulant: Risk of recurrent bleeding and stroke in patients with warfarin ineligible or failure in patients with atrial fibrillation (The ROAR study)

Background A significant proportion of patients treated with warfarin for atrial fibrillation (AF) become warfarin ineligible (WI) due to major bleeding events (MBE) or systemic thromboembolism (STE). We report a large multicenter real-world experience of the use of DOACs in these WI patients. Methods We report the outcomes of 263 WI patients treated with DOACs. The primary objective was to evaluate clinical outcomes of STE and MBE with DOACs. Secondary objective was to assess clinical predictors of repeat MBE and STE on DOACs. Results 63% (166/263) patients had a repeat MBE on DOACs. Repeat MBE was significantly higher in patients with prior gastrointestinal bleeding (74.5% vs 30%, p