Table 1 Double-blind randomized trials... | American Society of Hematology

Table 1

Double-blind randomized trials comparing a DOAC with placebo in patients with proximal DVT and/or PE

Study	Drug	Dose (mg)	N	Intended treatment duration (mo)	Recurrent VTE % vs placebo; HR (95% CI)	Major bleeding % vs placebo; HR (95% CI)	Major or CRNM bleeding % vs placebo; HR (95% CI)
EINSTEIN extension	Rivaroxaban	20 OD	1196	6-12	1.3 vs 7.1	0.7 vs 0	6 vs 1.2
EINSTEIN extension	Rivaroxaban	20 OD	1196	6-12	0.18 (0.09-0.39)	0.7 vs 0	5.19 (2.3-11.7)
RE-SONATE	Dabigatran	150 BID	1343	6-12	0.4 vs 5.6	0.3 vs 0	5.3 vs 1.8
RE-SONATE	Dabigatran	150 BID	1343	6-12	0.08 (0.02-0.25)	0.3 vs 0	2.92 (1.52-5.60)
AMPLIFY extension	Apixaban	2.5 BID	2486	12	3.8 vs 11.6	0.2 vs 0.5	3.2 vs 2.7
		5 BID			0.33 (0.22-0.48)	0.49 (0.09-2.64)	1.20 (0.69-2.10)
					4.2 vs 11.6	0.1 vs 0.5	4.3 vs 2.7
					0.36 (0.25-0.53)	0.25 (0.03-2.24)	1.62 (0.96-2.73)

Study	Drug	Dose (mg)	N	Intended treatment duration (mo)	Recurrent VTE % vs placebo; HR (95% CI)	Major bleeding % vs placebo; HR (95% CI)	Major or CRNM bleeding % vs placebo; HR (95% CI)
EINSTEIN extension	Rivaroxaban	20 OD	1196	6-12	1.3 vs 7.1	0.7 vs 0	6 vs 1.2
EINSTEIN extension	Rivaroxaban	20 OD	1196	6-12	0.18 (0.09-0.39)	0.7 vs 0	5.19 (2.3-11.7)
RE-SONATE	Dabigatran	150 BID	1343	6-12	0.4 vs 5.6	0.3 vs 0	5.3 vs 1.8
RE-SONATE	Dabigatran	150 BID	1343	6-12	0.08 (0.02-0.25)	0.3 vs 0	2.92 (1.52-5.60)
AMPLIFY extension	Apixaban	2.5 BID	2486	12	3.8 vs 11.6	0.2 vs 0.5	3.2 vs 2.7
		5 BID			0.33 (0.22-0.48)	0.49 (0.09-2.64)	1.20 (0.69-2.10)
					4.2 vs 11.6	0.1 vs 0.5	4.3 vs 2.7
					0.36 (0.25-0.53)	0.25 (0.03-2.24)	1.62 (0.96-2.73)

BID, twice daily; CRNM, clinically relevant nonmajor; HR, hazard ratio; OD, once daily.