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Randomised controlled trial
Evidence suggests dabigatran is an effective and safe treatment for patients with VTE requiring early parenteral therapy
  1. Serena Granziera1,
  2. Alexander T Cohen2
  1. 1Department of Medicine - DIMED, University hospital, Padova, Italy
  2. 2Department of Thrombosis and Haemostasis, Guy's and St Thomas' Hospitals, London, UK
  1. Correspondence to: Dr Alexander T Cohen, Department of Thrombosis and Haemostasis, Guy's and St Thomas’ Hospitals, Westminster Bridge Road, London SE1 7EH, UK; alexander.cohen{at}kcl.ac.uk

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Context

Until recently, an initial course of parenteral anticoagulation followed by vitamin K antagonist (VKA) was the standard of care for the treatment of venous thromboembolism (VTE). In the past few years, direct oral anticoagulants (DOAC) have been found to be non-inferior to VKA.1–3 The RE-COVER study found dabigatran to be non-inferior to warfarin, with a reduced risk for clinically relevant bleeding.4 In order to confirm these findings, the RE-COVER II trial was performed and the results of both studies pooled.

Methods

Almost identical to the RE-COVER study, RE-COVER II was a randomised, double-blind, double-dummy trial. It enrolled 2589 patients with acute, proximal deep vein thrombosis (DVT) or pulmonary embolism. Exclusion criteria included haemodynamic instability, thrombolytic therapy, recent unstable cardiovascular disease, high bleeding …

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