Key randomised trials of direct oral anticoagulants in the treatment of acute PE
| Study (no of patients) | Treatment arm (vs heparin/warfarin) | Efficacy | Safety |
| (study drug vs warfarin) | |||
| RE-COVER (2009) n=2564 | LMWH ≥5 days followed by dabigatran 150 mg twice a day | Recurrent VTE or fatal PE: 2.4% vs 2.1% | Major bleeding: 1.6% vs 1.9% |
| RE-COVER II (2014) n=2589 | LMWH ≥5 days followed by dabigatran 150 mg twice a day | Recurrent VTE or fatal PE: 2.3% vs 2.2% | Major bleeding: 15 patients vs 22 patients |
| EINSTEIN PE (2012)* n=4833 | Rivaroxaban 15 mg twice a day for 3 weeks followed by 20 mg once a day | Recurrent VTE or fatal PE: 2.1% vs 1.8% | Major or CRNM bleeding: 10.3% vs 11.4% |
| AMPLIFY study (2013) n=5400 | Apixaban 10 mg twice a day for 7 days followed by 5 mg twice a day | Recurrent VTE or fatal PE: 2.3% vs 2.7% | Major bleeding: 0.6% vs 1.8% |
| HOKUSAI-VTE (2013) n=8292 | LMWH ≥5 days followed by edoxaban 60 mg once a day (30 mg once a day if creatinine clearance 30–50 mL/min or bodyweight <60 kg) | Recurrent VTE or fatal PE: 3.2% vs 3.5% | Major or CRNM bleeding: 8.5% vs 10.3% |
*Only EINSTEIN PE included exclusively patients with PE.
CRNM, clinically relevant non-major bleeding; LMWH, low molecular weight heparin; VTE, venous thromboembolism.