Table 2.
Clinical trials of direct oral anticoagulants for thrombotic antiphospholipid syndrome.
| RAPS [50] | Re-Cover, Re-Cover II, and Remedy (Post-Hoc) [81] | TRAPS [51] | EUDRA [53] | |
|---|---|---|---|---|
| Publication year | 2016 | 2016 | 2018 | 2019 |
| Study design | Open label, phase II/III, non-inferiority RCT | Double-dummy, non-inferiority RCT | Open label, phase III, non-inferiority RCT | Open label, non-inferiority RCT |
| Sample size (DOAC/VKA) | 116 (57/59) | 151 (71/80) | 120 (59/61) | 190 (95/95) |
| % Triple positivity (DOACs/VKA) | 12/20 | NA | 100/100 | 61.1/60 |
| % prior arterial APS (DOACs/VKA) | 0/0 | NA | 19/23 | 38.9/35.8 |
| DOAC/dose (mg) | Rivaroxaban/20 OD | Dabigatran/150 BID | Rivaroxaban/20 OD | Rivaroxaban/20 OD |
| VKA/target INR | Warfarin/2.5 | Warfarin/2.5 | Warfarin/2.5 | Warfarin/2.5 |
| Follow-up (months) | 7 | 36 | 8 | 36 |
| % Thrombosis (DOAC/VKA), HR 95%CI | 0/0, not applicable | 4.2/5.0 0.43 (0.08–2.38) 1 |
12.0/0 7.4 (1.7–32.9) 2 |
11.6/6.3 1.94 (0.72–5.24) |
| % Major bleeding (DOAC/VKA), HR 95%CI | 0/0, not applicable | 1.4/2.6 0.46 (0.04–5.43) |
7.0/3.0 7.4 (1.7–32.9) |
9.5/5.3 0.88(0.30–2.63) |
1: Hazard ratio for Composite outcome, including venous thromboembolism and venous thromboembolism-related death. 2: Hazard ratio for composite outcome, including thromboembolic events, major bleeding, and vascular death. APS = antiphospholipid syndrome; BID = twice daily; CI = confidence interval; DOAC = direct oral anticoagulant; HR = hazard ratio; INR = international normalized ratio; NA = not available; OD = once daily; RCT = randomized controlled trial; VKA = vitamin k antagonist.