Marco Proietti1, Giulio Francesco Romiti2, Imma Romanazzi2, Alessio Farcomeni3, Laila Staerk4, Peter Brønnum Nielsen5, Gregory Y H Lip6. 1. Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom; IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Department of Neuroscience, Milan, Italy. 2. Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom. 3. Department of Public Health and Infectious Disease, Sapienza-University of Rome, Rome, Italy. 4. Cardiovascular Research Centre, Herlev and Gentofte University Hospital, Hellerup, Denmark. 5. Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Faculty of Health, Aalborg University, Aalborg, Denmark. 6. Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Faculty of Health, Aalborg University, Aalborg, Denmark. Electronic address: g.y.h.lip@bham.ac.uk.
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.
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 AFpatients after a major bleeding event. METHODS: We performed a systematic review and meta-analysis of all studies reporting data about AFpatients 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.
Authors: Agnieszka Kotalczyk; Michał Mazurek; Zbigniew Kalarus; Tatjana S Potpara; Gregory Y H Lip Journal: Nat Rev Cardiol Date: 2020-10-27 Impact factor: 32.419
Authors: Marco Proietti; José Miguel Rivera-Caravaca; María Asunción Esteve-Pastor; Giulio Francesco Romiti; Francísco Marin; Gregory Y H Lip Journal: J Am Heart Assoc Date: 2018-09-18 Impact factor: 5.501