Ying Bai1, Hai Deng1, Alena Shantsila1, Gregory Y H Lip2. 1. From the University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom (Y.B., H.D., A.S., G.Y.H.L.); Cardiovascular Center, Beijing Tongren Hospital, Capital Medical University, China (Y.B.); Guangdong Cardiovascular Institute, Guangdong General Hospital, Guangdong Academy of Medical Science, Guangzhou, China (H.D.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Denmark (G.Y.H.L.). 2. From the University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom (Y.B., H.D., A.S., G.Y.H.L.); Cardiovascular Center, Beijing Tongren Hospital, Capital Medical University, China (Y.B.); Guangdong Cardiovascular Institute, Guangdong General Hospital, Guangdong Academy of Medical Science, Guangzhou, China (H.D.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Denmark (G.Y.H.L.). g.y.h.lip@bham.ac.uk.
Abstract
BACKGROUND AND PURPOSE: This study was designed to evaluate the effectiveness and safety of rivaroxaban in real-world practice compared with effectiveness and safety of dabigatran or warfarin for stroke prevention in atrial fibrillation through meta-analyzing observational studies. METHODS: Seventeen studies were included after searching in PubMed for studies reporting the comparative effectiveness and safety of rivaroxaban versus dabigatran (n=3), rivaroxaban versus Warfarin (n=11), or both (n=3) for stroke prevention in atrial fibrillation. RESULTS: Overall, the risks of stroke/systematic thromboembolism with rivaroxaban were similar when compared with those with dabigatran (stroke/thromboembolism: hazard ratio, 1.02; 95% confidence interval, 0.91-1.13; I2=70.2%, N=5), but were significantly reduced when compared with those with warfarin (hazard ratio, 0.75; 95% confidence interval, 0.64-0.85; I2=45.1%, N=9). Major bleeding risk was significantly higher with rivaroxaban than with dabigatran (hazard ratio, 1.38; 95% confidence interval, 1.27-1.49; I2=26.1%, N=5), but similar to that with warfarin (hazard ratio, 0.99; 95% confidence interval, 0.91-1.07; I2=0.0%, N=6). Rivaroxaban was associated with increased all-cause mortality and gastrointestinal bleeding, but similar risk of acute myocardial infarction and intracranial hemorrhage when compared with dabigatran. When compared with warfarin, rivaroxaban was associated with similar risk of any bleeding, mortality, and acute myocardial infarction, but a higher risk of gastrointestinal bleeding and lower risk of intracranial hemorrhage. CONCLUSIONS: In this systematic review and meta-analysis, rivaroxaban was as effective as dabigatran, but was more effective than warfarin for the prevention of stroke/thromboembolism in atrial fibrillation patients. Major bleeding risk was significantly higher with rivaroxaban than with dabigatran, as was all-cause mortality and gastrointestinal bleeding. Rivaroxaban was comparable to warfarin for major bleeding, with an increased risk in gastrointestinal bleeding and decreased risk of intracranial hemorrhage.
BACKGROUND AND PURPOSE: This study was designed to evaluate the effectiveness and safety of rivaroxaban in real-world practice compared with effectiveness and safety of dabigatran or warfarin for stroke prevention in atrial fibrillation through meta-analyzing observational studies. METHODS: Seventeen studies were included after searching in PubMed for studies reporting the comparative effectiveness and safety of rivaroxaban versus dabigatran (n=3), rivaroxaban versus Warfarin (n=11), or both (n=3) for stroke prevention in atrial fibrillation. RESULTS: Overall, the risks of stroke/systematic thromboembolism with rivaroxaban were similar when compared with those with dabigatran (stroke/thromboembolism: hazard ratio, 1.02; 95% confidence interval, 0.91-1.13; I2=70.2%, N=5), but were significantly reduced when compared with those with warfarin (hazard ratio, 0.75; 95% confidence interval, 0.64-0.85; I2=45.1%, N=9). Major bleeding risk was significantly higher with rivaroxaban than with dabigatran (hazard ratio, 1.38; 95% confidence interval, 1.27-1.49; I2=26.1%, N=5), but similar to that with warfarin (hazard ratio, 0.99; 95% confidence interval, 0.91-1.07; I2=0.0%, N=6). Rivaroxaban was associated with increased all-cause mortality and gastrointestinal bleeding, but similar risk of acute myocardial infarction and intracranial hemorrhage when compared with dabigatran. When compared with warfarin, rivaroxaban was associated with similar risk of any bleeding, mortality, and acute myocardial infarction, but a higher risk of gastrointestinal bleeding and lower risk of intracranial hemorrhage. CONCLUSIONS: In this systematic review and meta-analysis, rivaroxaban was as effective as dabigatran, but was more effective than warfarin for the prevention of stroke/thromboembolism in atrial fibrillationpatients. Major bleeding risk was significantly higher with rivaroxaban than with dabigatran, as was all-cause mortality and gastrointestinal bleeding. Rivaroxaban was comparable to warfarin for major bleeding, with an increased risk in gastrointestinal bleeding and decreased risk of intracranial hemorrhage.
Authors: Antonios Douros; Madeleine Durand; Carla M Doyle; Sarah Yoon; Pauline Reynier; Kristian B Filion Journal: Drug Saf Date: 2019-10 Impact factor: 5.606
Authors: Madeleine Durand; Mireille E Schnitzer; Menglan Pang; Greg Carney; Sherif Eltonsy; Kristian B Filion; Anat Fisher; Min Jun; I Fan Kuo; Christel Renoux; J Michael Paterson; Jacqueline Quail; Alexis Matteau Journal: CMAJ Open Date: 2020-12-18
Authors: Mariam Ujeyl; Ingrid Köster; Hans Wille; Thomas Stammschulte; Rebecca Hein; Sebastian Harder; Ursula Gundert-Remy; Julian Bleek; Peter Ihle; Helmut Schröder; Gerhard Schillinger; Anette Zawinell; Ingrid Schubert Journal: Eur J Clin Pharmacol Date: 2018-06-16 Impact factor: 2.953