Management of venous thromboembolism: an update

Thrombosis Journal

Table 4 Comparison of extended duration DOAC trials

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: 1.3^a vs 7.1	Recurrent symptomatic VTE or all-cause mortality: 3.8^a vs 4.2^a vs 11.6	Recurrent symptomatic VTE or related mortality: 1.8^a vs 1.3	Recurrent symptomatic VTE or related mortality: 0.4^a 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 (%)	6.0^a vs 1.2	3.2 vs 4.3 vs 2.7	5.6^a vs 10.2	5.3^a vs 1.8

DOAC direct oral anticoagulant, CRNM clinically relevant non-major, DOAC direct oral anticoagulants, VKA vitamin K antagonists, VTE venous thromboembolism
^aStatistically significant difference between the two groups

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