TY - JOUR
T1 - Restarting oral anticoagulant therapy after major bleeding in atrial fibrillation
T2 - A systematic review and meta-analysis
AU - Proietti, Marco
AU - Romiti, Giulio Francesco
AU - Romanazzi, Imma
AU - Farcomeni, Alessio
AU - Staerk, Laila
AU - Nielsen, Peter Brønnum
AU - Lip, Gregory Y H
N1 - Copyright © 2018 Elsevier B.V. All rights reserved.
PY - 2018/6/15
Y1 - 2018/6/15
N2 - 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.
AB - 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.
KW - Atrial fibrillation
KW - Major bleeding
KW - Oral anticoagulant therapy
KW - Restarting
UR - http://www.scopus.com/inward/record.url?scp=85044117012&partnerID=8YFLogxK
U2 - 10.1016/j.ijcard.2018.03.053
DO - 10.1016/j.ijcard.2018.03.053
M3 - Review article
C2 - 29572080
SN - 0167-5273
VL - 261
SP - 84
EP - 91
JO - International Journal of Cardiology
JF - International Journal of Cardiology
ER -