Abstract 16558: Safety of Rivaroxaban versus Vitamin K Antagonists: A Systematic Review and Meta-Analysis
Background: Rivaroxaban, a factor Xa inhibitor, is a new oral anti-coagulant that has been developed as an alternative to vitamin k antagonists (VKAs). However, its safety remains unclear.
Methods: We systematically searched MEDLINE, EMBASE, Cochrane, CINAHL, and Science Citation Index Expanded (SCIE) databases as well as clinical trials registries for randomized controlled trials (RCTs) comparing the safety of rivaroxaban to that of VKAs (warfarin, acenocoumarol, phenprocoumon, and fluindione). Inclusion was restricted to studies of > 30 days treatment duration. Safety endpoints examined included bleeding (major and clinically relevant non-major bleeding, bleeding associated with a fall in hemoglobin ≥2g/dl, intracranial, intraocular, and fatal bleeding) and mortality (all-cause and cancer). Data were pooled across RCTs using random-effects meta-analysis models.
Results: We identified 5 RCTs including 23,063 patients that met our inclusion criteria. Studies ranged from 246 to 14,264 patients, with a total of 11,536 patients randomized to rivaroxaban and 11,527 to VKAs. Patients received treatment for either nonvalvular atrial fibrillation (n = 14,264), deep vein thrombosis (n = 3,967), or acute symptomatic pulmonary embolism (n = 4,832). Rivaroxaban was not associated with major and clinically relevant non-major bleeding, bleeding associated with a fall in hemoglobin ≥2g/dl, intracranial bleeding, and intraocular bleeding (Table). Rivaroxaban was associated with a significant decrease in fatal bleeding (relative risk [RR] 0.48, 95% confidence interval [CI] 0.31-0.75); a total of 500 patients would need to be treated with rivaroxaban to prevent one fatal bleed (95% CI 200-inf.). However, it was not associated with an increased risk of all-cause mortality (RR 0.89, 95% CI 0.73-1.09).
Conclusions: With a decrease in fatal bleeding and no suggestion of an increase in all-cause mortality, rivaroxaban appears to be a safe alternative to VKAs.
- © 2012 by American Heart Association, Inc.