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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}

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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.


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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  • Competing interests ATC is a medical consultant, and has received consultancy and clinical trial funding from pharmaceutical companies, including Astellas, AstraZeneca, Bayer, Boehringer-Ingelheim, BMS, Daiichi, GSK, Johnson & Johnson, Mitsubishi Pharma, Pfizer, Portola, Sanofi-aventis, Schering-Plough and Takeda. ATC is an advisor on VTE prevention to the UK Government Health Select Committee, the All-Party Working Group on Thrombosis, the Department of Health and the NHS. ATC is also an advisor to Lifeblood: The Thrombosis Charity and is the founder of the European educational charity the Coalition to Prevent VTE.

  • Provenance and peer review Not commissioned; externally peer reviewed.