Restarting oral anticoagulant therapy after major bleeding in atrial fibrillation: A systematic review and meta-analysis

Abstract

BackgroundUse of oral anticoagulant (OAC) therapy in atrial fibrillation (AF) is associated with an inherited risk of bleeding. Benefits and risks of OAC restarting after a major bleeding are still uncertain. We aimed to assess effectiveness and safety of restarting OAC in AF patients after a major bleeding event. MethodsWe performed a systematic review and meta-analysis of all studies reporting data about AF patients that sustained a major bleeding, reporting data on restarting or not restarting OAC therapy. ResultsA total of seven studies were included, involving 5685 patients. No significant difference was found in “any stroke” occurrence between OAC restarters and non-restarters (odds ratio [OR]: 0.75, 95% confidence interval [CI]: 0.37–1.51), with a significant 46% relative risk reduction (RRR) (p < 0.00001) for “any thromboembolism” in OAC restarters, with consistent results when the index bleeding event was an intracranial or gastrointestinal bleeding. A significantly higher risk of recurrent major bleeding was seen (OR: 1.85, 95% CI: 1.48–2.30), but no difference in risk for recurrence of index event. OAC restarters had a 10.8% absolute risk reduction for all-cause death (OR: 0.38, 95% CI: 0.24–0.60); p < 0.00001). Net clinical benefit (NCB) analysis demonstrated that restarting OAC therapy after a major bleeding was significantly associated with a clinical advantage (NCB: 0.11, 95% CI: 0.09–0.14; p < 0.001). ConclusionsRestarting OAC therapy after a major bleeding event in AF was associated with a positive clinical benefit when compared to non-restarting OAC, with a significant reduction in any thromboembolism and all-cause mortality.