Table 2 Principal outcomes of phase III studies of non-VKA OACs for acute VTE treatment
Study name | Interventions | Patients | Treatment duration | Primary efficacy outcome | Bleeding outcomes |
|---|---|---|---|---|---|
EINSTEIN PE [12] | Oral rivaroxaban 15 mg bid for 3 weeks then 20 mg od vs. enoxaparin s.c. 1.0 mg/kg bid for ≥ 5 days plus VKA started ≤ 48 h after randomisation | ≥ 18 years with confirmed acute symptomatic PE with or without DVT (n = 4,832) | 3, 6 or 12 months | Symptomatic, recurrent VTE: 2.1% vs. 1.8% (P = 0.003 for non-inferiority) | Major or non-major clinically relevant bleeding: 10.3% vs. 11.4% (P = 0.23) |
Major bleeding: 1.1% vs. 2.2% (P = 0.003) | |||||
EINSTEIN DVT [13] | As for EINSTEIN PE | ≥ 18 years with confirmed proximal DVT without symptomatic PE (n = 3,449) | 3, 6 or 12 months | Symptomatic, recurrent VTE: 2.1% vs. 3.0% (P < 0.001 for non-inferiority) | Major and non-major clinically relevant bleeding: 8.1% vs. 8.1% (P = 0.77) |
Major bleeding: 0.8% vs. 1.2% (P = 0.21) | |||||
RE-COVER [20] | Parenteral anticoagulant indication then oral dabigatran etexilate 150 mg bid vs. oral warfarin (INR 2.0-3.0) od | ≥ 18 years with acute, symptomatic VTE (n = 2,564) | 6 months | Symptomatic VTE or VTE-related death: 2.4% vs. 2.1% (P < 0.001 for non-inferiority) | Major or non-major clinically relevant bleeding: 5.6% vs. 8.8% (P = 0.002) |
Major bleeding: 1.6% vs. 1.9% (HR = 0.82; 95% CI 0.45-1.48) | |||||
RE-COVER II [21] | As for RE-COVER | ≥ 18 years with acute, symptomatic VTE (n = 2,568) | 6 months | Symptomatic VTE or VTE-related death: 2.4% vs. 2.2% (P < 0.0001 for non-inferiority) | Any bleeding: 200 vs. 285 patients (HR = 0.67; 95% CI 0.56-0.81) |
Major bleeding: 15 vs. 22 patients (HR = 0.69; 95% CI 0.36-1.32) |