Management of Venous Thromboembolism in Patients with Advanced Gastrointestinal Cancers: What Is the Role of Novel Oral Anticoagulants?

Table 4

Summary of completed phase III trials of novel oral anticoagulants.

Study	Agent investigated	Control	Setting	Treatment duration	N/N with cancer-related VTE	Primary; outcome	HR (95% CI)	𝑃 value	VTE recurrence	Clinically relevant bleeding
RE-COVER	Dabigatran etexilate*	Warfarin*	Acute symptomatic VTE	6 months	2539/121	Non-inferiority	1.1 (0.65, 1.84)	<0.001	E: 2.4%; C: 2.1%	E: 5.6%; C: 8.8%
RE-SONATE^a	Dabigatran etexilate	Placebo	Treated VTE	6 months	1343/NA**	Superiority	0.08 (0.02, 0.25)	<0.0001	E: 0.4%; C: 5.6%	E: 5.3%; C: 1.8%
RE-MEDY^a	Dabigatran etexilate	Warfarin	Treated VTE	6–36 months	2856/NA	Non-inferiority	1.44 (0.78, 2.64)	0.03	E: 1.8%; C: 1.3%	NA**; NA**
EINSTEIN-DVT	Rivaroxaban	LMWH/VKA	Acute DVT	3, 6 or 12 months	3449/207	Non-inferiority	0.68 (0.44, 1.04)	<0.001	E: 2.1%; C: 3%	E: 8.1%; C: 8.1%
EINSTEIN-Extension	Rivaroxaban	Placebo	Treated VTE	6 or 12 months	1196/54	Superiority	0.18 (0.09, 0.39)	<0.001	E: 1.3%; C: 7.1%	E: 6%; C: 1.2%

*Following initial treatment with intravenous anticoagulation.
**Not available.
*Abstract only.