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Effectiveness and safety of novel oral anticoagulants as compared with vitamin K antagonists in the treatment of acute symptomatic venous thromboembolism: a systematic review and meta‐analysis
Author(s) -
Hulle T.,
Kooiman J.,
Exter P. L.,
Dekkers O. M.,
Klok F. A.,
Huisman M. V.
Publication year - 2014
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/jth.12485
Subject(s) - medicine , venous thromboembolism , meta analysis , vitamin k , vitamin k antagonist , intensive care medicine , systematic review , medline , thrombosis , warfarin , atrial fibrillation , political science , law
Summary Introduction New direct oral anticoagulants ( NOAC s) constitute a novel treatment option for acute venous thromboembolism ( VTE ), with practical advantages. Individual studies have demonstrated comparable efficacy to that of vitamin K antagonists ( VKA s) and have suggested a more favorable safety profile . We performed a meta‐analysis to determine the efficacy and safety of NOAC s as compared with those of VKA s in patients with acute VTE . Methods We searched MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews and the Clinical Trials Registry up to October 2013. Eligible studies included phase 3 trials comparing NOAC s with VKA s in patients with acute VTE . Relative risks ( RR s), absolute risk differences and numbers needed to treat ( NNT s) to prevent one event were calculated for recurrent VTE , fatal pulmonary embolism ( PE ), overall mortality, major bleeding, and other bleeding complications, with random‐effects models. Results Five studies were included, investigating four NOAC s (rivaroxaban, dabigatran, apixaban, and edoxaban) in 24 455 patients with acute VTE . RR s for recurrent VTE , fatal PE and overall mortality for NOAC s vs. VKA s were 0.88 (95% confidence interval [ CI ] 0.74–1.05), 1.02 (95% CI 0.39–5.96), and 0.97 (95% CI 0.83–1.14), respectively. The RR for major bleeding was 0.60 (95% CI 0.41–0.88). The NNT with NOAC s instead of VKA to prevent one major bleed was 149. The RR and NNT for fatal bleeding were 0.36 (95% CI 0.15–0.87) and 1111. A fixed‐effect network analysis did not demonstrate significant differences between individual NOAC s and rivaroxaban. Conclusions NOAC s have comparable efficacy to that of VKA s, and are associated with a significantly lower risk of bleeding complications, although the NNT to prevent one major bleed was relatively high.