Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER®, RE-COVER™ II, and RE-MEDY™

Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1.


It is unclear whether thrombophilia causes resistance to anticoagulant therapy. Post hoc analyses of data from RE-COVER®, RE-COVER II, and RE-MEDY were performed to compare dabigatran etexilate with warfarin for the treatment and prevention of venous thromboembolism (VTE) in patients with thrombophilia or antiphospholipid antibody syndrome (APS). There were no significant differences in symptomatic VTE/VTE-related deaths between dabigatran etexilate and warfarin in patients with or without thrombophilia. All bleeding event categories were less frequent with dabigatran etexilate than with warfarin, regardless of whether patients had thrombophilia, no thrombophilia, or were not tested. However, these differences did not reach significance in every group. In patients with APS, there was no significant difference in VTE/VTE-related deaths between the two treatment arms. Rates of bleeding events tended to be lower with dabigatran etexilate than with warfarin, reaching statistical significance for any bleeding event. In conclusion, the efficacy and safety of dabigatran etexilate were not significantly affected by the presence of thrombophilia or APS. ClinicalTrials.gov RECOVER IDENTIFIER NCT00291330; RECOVER II IDENTIFIER NCT00680186; RE-MEDY IDENTIFIER NCT00329238.

Keywords: antiphospholipid antibody syndrome; dabigatran; thrombophilia; venous thromboembolism; warfarin.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Adult
  • Aged
  • Anticoagulants / adverse effects
  • Anticoagulants / therapeutic use*
  • Antithrombins / adverse effects
  • Antithrombins / therapeutic use*
  • Dabigatran / adverse effects
  • Dabigatran / therapeutic use*
  • Female
  • Fibrinolytic Agents / adverse effects
  • Fibrinolytic Agents / therapeutic use*
  • Hemorrhage / chemically induced
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Randomized Controlled Trials as Topic
  • Risk Factors
  • Thrombophilia / complications
  • Thrombophilia / diagnosis
  • Thrombophilia / drug therapy*
  • Thrombophilia / mortality
  • Time Factors
  • Treatment Outcome
  • Venous Thromboembolism / diagnosis
  • Venous Thromboembolism / drug therapy*
  • Venous Thromboembolism / etiology
  • Venous Thromboembolism / mortality
  • Warfarin / adverse effects
  • Warfarin / therapeutic use*


  • Anticoagulants
  • Antithrombins
  • Fibrinolytic Agents
  • Warfarin
  • Dabigatran

Associated data

  • ClinicalTrials.gov/NCT00291330
  • ClinicalTrials.gov/NCT00680186
  • ClinicalTrials.gov/NCT00329238