BACKGROUND: Use 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. METHODS: We 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. RESULTS: A 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). CONCLUSIONS: Restarting 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.
Restarting oral anticoagulant therapy after major bleeding in atrial fibrillation : a systematic review and meta-analysis / M. Proietti, G.F. Romiti, I. Romanazzi, A. Farcomeni, L. Staerk, P.B. Nielsen, G.Y.H. Lip. - In: INTERNATIONAL JOURNAL OF CARDIOLOGY. - ISSN 0167-5273. - 261(2018 Jun 15), pp. 84-91. [10.1016/j.ijcard.2018.03.053]
Restarting oral anticoagulant therapy after major bleeding in atrial fibrillation : a systematic review and meta-analysis
M. ProiettiPrimo
;
2018
Abstract
BACKGROUND: Use 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. METHODS: We 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. RESULTS: A 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). CONCLUSIONS: Restarting 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.File | Dimensione | Formato | |
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