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Table 4 Comparison of extended duration DOAC trials

From: Management of venous thromboembolism: an update

Trial Name EINSTEIN-EXTENSION AMPLIFY-EXT RE-MEDY RE-SONATE
Year of Publication [Ref] 2010 [17] 2013 [50] 2013 [51] 2013 [51]
Design Double-blinded Double-blinded Double-blinded Double-blinded
Comparison Arm Placebo Placebo Warfarin Placebo
Number of Patients 1197 2486 2866 1353
Treatment Protocol Rivaroxaban 20 mg once daily Apixaban 5 mg or 2.5 twice daily Dabigatran 150 mg twice daily Dabigatran 150 mg twice daily
Duration of Therapy (months) 6 to12 12 6 to 36 6
Primary Efficacy Outcome DOAC vs VKA or Placebo (%) Recurrent symptomatic VTE: 1.3a vs 7.1 Recurrent symptomatic VTE or all-cause mortality: 3.8a vs 4.2a vs 11.6 Recurrent symptomatic VTE or related mortality: 1.8a vs 1.3 Recurrent symptomatic VTE or related mortality: 0.4a vs 5.6
Major Bleeding DOAC vs VKA or Placebo (%) 0.7 vs 0 0.2 vs 0.1 vs 0.5 0.9 vs 1.8 0.3 vs 0
Major and CRNM Bleeding DOAC vs VKA or Placebo (%) 6.0a vs 1.2 3.2 vs 4.3 vs 2.7 5.6a vs 10.2 5.3a vs 1.8
  1. DOAC direct oral anticoagulant, CRNM clinically relevant non-major, DOAC direct oral anticoagulants, VKA vitamin K antagonists, VTE venous thromboembolism
  2. aStatistically significant difference between the two groups