Table 2.
Comparison of study sizes, proportion of events, and effect estimates between RCTs and RWE studies
| 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) |
Abbreviations: CI confidence interval, VTE venous thromboembolism
aCrude incidence rate per 100 person-years. The incidence rates were not reported in the RCTs
bMantel–Haenszel relative risk was estimated following the protocol of the AMPLIFY trial; hazard ratio was estimated, unless specified otherwise