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Table 1 Comparison of study design and treatment protocols of trials on DOACs Versus VKA for treatment of acute VTE

From: Management of venous thromboembolism: an update

Trial name

RE-COVER

RE-COVER II

EINSTEIN-DVT

EINSTEIN-PE

AMPLIFY

Hokusai-VTE

Year of Publication [Ref]

2009 [15]

2014 [16]

2010 [17]

2012 [18]

2013 [19]

2013 [20]

Design

Double-blinded

Double-blinded

PROBE

PROBE

Double-blinded

Double-blinded

Number of Patients

2539

2589

3449

4832

5395

8292

Indication for Anticoagulation

Acute VTE

Acute VTE

Acute DVT

Acute PE

Acute VTE

Acute VTE

DOAC Treatment Protocol

Dabigatran 150 mg twice daily

Dabigatran 150 mg twice daily

Rivaroxaban 15 mg twice daily for 3 weeks; then 20 mg once daily

Rivaroxaban 15 mg twice daily for 3 weeks; then 20 mg once daily

Apixaban 10 mg twice daily for days; then 5 mg twice daily

Edoxaban 60 once daily; patients with CrCl 30–50 mL/min, body weight ≤60 kg, or receiving strong P-glycoprotein inhibitors: edoxaban 30 mg once daily

Non-inferiority Margin for Hazard Ratio

2.75

2.75

2.0

2.0

1.8

1.5

Need for initial Parenteral Anticoagulation

Yes

Yes

No

No

No

Yes

Duration of Therapy (months)

6

6

3, 6, or 12

3, 6, or 12

6

≤12

TTR (%)

60

57

58

63

61

64

  1. DOAC direct oral anticoagulant, DVT deep vein thrombosis, PE pulmonary embolism, PROBE prospective, randomized, open-label, blinded end point, TTR time in therapeutic range for warfarin, VKA vitamin K antagonists, VTE venous thromboembolism, CrCl creatinine clearance