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Table 2 Comparison of study sizes, proportion of events, and effect estimates between RCTs and RWE studies

From: Real-world data emulating randomized controlled trials of non-vitamin K antagonist oral anticoagulants in patients with venous thromboembolism

Trial emulation

RCT

RWE

RCT

RWE

Patients

Events (%)

Patients

Events (%)

Incidence ratea

Effect estimatesb (95% CI)

AMPLIFY

 Recurrent VTE or related death

  Warfarin

2635

71 (2.69)

1,753

78 (4.45)

6.33

1.00 (ref)

1.00 (ref)

  Apixaban

2609

59 (2.26)

1,753

50 (2.85)

4.63

0.84 (0.60–1.18)

0.81 (0.70 to 0.94)

 Major bleeding

  Warfarin

2689

49 (1.82)

1753

20 (1.14)

1.60

1.00 (ref)

1.00 (ref)

  Apixaban

2676

15 (0.56)

1753

20 (1.14)

1.85

0.31 (0.17–0.55)

0.99 (0.73 to 1.37)

RE-COVER II

 Recurrent VTE or related death

  Warfarin

1289

28 (2.17)

1226

44 (3.59)

7.85

1.00 (ref)

1.00 (ref)

  Dabigatran

1279

30 (2.34)

1226

29 (2.37)

7.58

1.08 (0.64–1.80)

0.60 (0.37 to 0.96)

 Major bleeding

  Warfarin

1289

22 (1.70)

1226

9 (0.73)

1.57

1.00 (ref)

1.00 (ref)

  Dabigatran

1279

15 (1.17)

1226

6 (0.49)

1.53

0.69 (0.36–1.32)

0.62 (0.22 to 1.77)

Hokusai-VTE

 Recurrent VTE or related death

  Warfarin

4122

146 (3.54)

1505

48 (3.19)

8.31

1.00 (ref)

1.00 (ref)

  Edoxaban

4118

130 (3.15)

1505

28 (1.86)

5.51

0.89 (0.70–1.13)

0.49 (0.31 to 0.78)

 Major bleeding

  Warfarin

4122

66 (1.60)

1505

13 (0.86)

2.23

1.00 (ref)

1.00 (ref)

  Edoxaban

4118

56 (1.35)

1505

8 (0.53)

1.56

0.84 (0.59–1.21)

0.61 (0.25 to 1.51)

EINSTEIN-DVT

 Recurrent VTE

  Warfarin

1718

51 (2.96)

2135

50 (2.34)

4.22

1.00 (ref)

1.00 (ref)

  Rivaroxaban

1731

36 (2.07)

2135

23 (1.08)

3.60

0.69 (0.44–1.04)

0.54 (0.33 to 0.89)

 Major bleeding

  Warfarin

1711

20 (1.16)

2135

17 (0.80)

1.40

1.00 (ref)

1.00 (ref)

  Rivaroxaban

1718

14 (0.81)

2135

12 (0.56)

1.87

0.65 (0.33–1.30)

1.62 (0.70 to 3.72)

EINSTEIN-PE

 Recurrent VTE

  Warfarin

2413

44 (1.82)

2801

91 (3.25)

5.42

1.00 (ref)

1.00 (ref)

  Rivaroxaban

2419

50 (2.06)

2801

38 (1.36)

3.83

1.12 (0.75–1.68)

0.50 (0.34 to 0.74)

 Major bleeding

  Warfarin

2405

52 (2.16)

2801

37 (1.32)

2.16

1.00 (ref)

1.00 (ref)

  Rivaroxaban

2412

26 (1.07)

2801

16 (0.57)

1.60

0.49 (0.31–0.79)

0.65 (0.35 to 1.21)

  1. Abbreviations: CI confidence interval, VTE venous thromboembolism
  2. aCrude incidence rate per 100 person-years. The incidence rates were not reported in the RCTs
  3. bMantel–Haenszel relative risk was estimated following the protocol of the AMPLIFY trial; hazard ratio was estimated, unless specified otherwise
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