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): van der Hulle T(1), Kooiman J, den Exter PL, Dekkers OM, Klok FA, Huisman MV.
Affiliation(s): Author information:
(1)Department of Thrombosis and Hemostasis, Leiden University Medical Center,
Leiden, The Netherlands.
Publication date & source: 2014, J Thromb Haemost. , 12(3):320-8
INTRODUCTION: New direct oral anticoagulants (NOACs) 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 (VKAs) and have suggested a more favorable safety profile . We
performed a meta-analysis to determine the efficacy and safety of NOACs as
compared with those of VKAs 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 NOACs with VKAs in patients with acute VTE. Relative
risks (RRs), absolute risk differences and numbers needed to treat (NNTs) 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 NOACs (rivaroxaban,
dabigatran, apixaban, and edoxaban) in 24 455 patients with acute VTE. RRs for
recurrent VTE, fatal PE and overall mortality for NOACs vs. VKAs 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 NOACs 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 NOACs and rivaroxaban.
CONCLUSIONS: NOACs have comparable efficacy to that of VKAs, and are associated
with a significantly lower risk of bleeding complications, although the NNT to
prevent one major bleed was relatively high.
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