Randomized control trials of direct oral anticoagulants in APS
| Trial . | Author . | Patient selection . | N . | Triple positive (%) . | Findings . |
|---|---|---|---|---|---|
| RAPS | Cohen | APS, prior ATE excluded | 116 (54 rivaroxaban) | 28 | • Endogenous thrombin potential greater with rivaroxaban (primary end point) • No recurrent thrombosis either arm in 6 months • No difference in MB: 5% DOAC vs 4% VKA |
| TRAPS | Pengo | Triple-positive APS | 120 (59 rivaroxaban) | 100 | • Higher recurrent thrombosis and MB with DOAC • 4 IS, 3 MI (12%) DOAC vs 0 events VKA • MB: 7% DOAC vs 3% VKA |
| EUDRA | Ordi-Ros | APS | 190 (95 rivaroxaban) | 60.5 | • Higher recurrent thrombosis with rivaroxaban • 11 (11.6%) VTE DOAC vs 6 (6.3%) VKA, RR 1.83 [95% CI, 0.71-4.76] • Higher rate of IS with DOAC • Livedo, small vessel disease, cardiac valvular disease associated with increased risk of thrombosis • Triple positivity not associated with increased risk • MB: No difference |
| ASTRO-APS | Woller | APS, protocol modification to exclude prior ATE | 48 (23 apixaban) | 30.4 | • Terminated prematurely • 6 strokes DOAC vs 0 events VKA • Strokes occurred in single-, double-, and triple-positive APS • MB: 0 DOAC vs 1 VKA |
| Trial . | Author . | Patient selection . | N . | Triple positive (%) . | Findings . |
|---|---|---|---|---|---|
| RAPS | Cohen | APS, prior ATE excluded | 116 (54 rivaroxaban) | 28 | • Endogenous thrombin potential greater with rivaroxaban (primary end point) • No recurrent thrombosis either arm in 6 months • No difference in MB: 5% DOAC vs 4% VKA |
| TRAPS | Pengo | Triple-positive APS | 120 (59 rivaroxaban) | 100 | • Higher recurrent thrombosis and MB with DOAC • 4 IS, 3 MI (12%) DOAC vs 0 events VKA • MB: 7% DOAC vs 3% VKA |
| EUDRA | Ordi-Ros | APS | 190 (95 rivaroxaban) | 60.5 | • Higher recurrent thrombosis with rivaroxaban • 11 (11.6%) VTE DOAC vs 6 (6.3%) VKA, RR 1.83 [95% CI, 0.71-4.76] • Higher rate of IS with DOAC • Livedo, small vessel disease, cardiac valvular disease associated with increased risk of thrombosis • Triple positivity not associated with increased risk • MB: No difference |
| ASTRO-APS | Woller | APS, protocol modification to exclude prior ATE | 48 (23 apixaban) | 30.4 | • Terminated prematurely • 6 strokes DOAC vs 0 events VKA • Strokes occurred in single-, double-, and triple-positive APS • MB: 0 DOAC vs 1 VKA |
APS, antiphospholipid syndrome; ATE, arterial thromboembolic event; DOAC, direct oral anticoagulant; IS, ischemic stroke; MB, major bleeding; MI, myocardial infarction; RR, relative risk; VKA, vitamin K antagonist; VTE, venous thromboembolic event.