Table 2.

Outcomes of the published, phase III acute DVT treatment trials for the novel oral anticoagulants

	Rivaroxaban	Dabigatran	Dabigatran	Apixaban
Name of phase III treatment trial	EINSTEIN-DVT	RE-COVER	RE-COVER II	AMPLIFY
PE patients included	No	Yes	Yes	Yes
Initial therapy with heparinoids	Warfarin arm only	Both arms	Both arms	Warfarin arm only
Number of patients	3449	2564	2568	5395
Study drug dosing schedule	15mg twice daily for 3 weeks, then 20mg daily	150mg twice daily	150mg twice daily	10mg twice daily for 7 days, then 5mg twice daily
Primary outcome	Recurrent VTE	Recurrent VTE or VTE-related death	Recurrent VTE or VTE-related death	Recurrent VTE or VTE-related death
Primary outcome rate (study drug vs. standard therapy, p value for noninferiority)	2.1% vs 3.0% (p<0.001)	2.4% vs 2.1% (p<0.001)	2.4% vs 2.2% (p<0.0001)	2.3% vs 2.7% (p<0.001)
Major bleeding rate (study drug vs. standard therapy)	0.8% vs 1.2% [HR 0.65, 95% CI 0.33–1.30]	1.6% vs 1.9% [HR 0.82, 95% CI 0.45–1.48]	1.2% vs 1.7%, [HR 0.69, 95% CI 0.36–1.32]	0.6% vs 1.8% [RR 0.31, 95% CI 0.17–0.55; p<0.001 for superiority]

CI: confidence interval; HR: hazard ratio; PE: pulmonary embolism; RR: relative risk; VTE: venous thromboembolism.