Table 2.

Meta-analysis of Dabigatran Trials

Trial	Year	Regimen	No. of Patients Randomized	Treatment Duration	No. of VTEs	RR VTE*	No. of Major Bleeds	RR major bleeding*	No. of Major/Clinically Relevant Bleeds	RR Major/Clinically Relevant Bleeding*
RE-MODEL	2007	Dabigatran 150 mg QD	708	6–10 days	212	1.07 (0.92–1.25)	9	0.99 (0.39–2.47)	57	1.22 (0.84–1.78)
		Dabigatran 220 mg QD	694		182	0.96 (0.82–1.13)	10	1.14 (0.46–2.78)	50	1.11 (0.76–1.63)
		Enoxaparin 40 mg QD	699		193	–	9	–	46	–
RE-MOBILIZE	2009	Dabigatran 150 mg QD	877	12–15 days	218	1.33 (1.11–1.60)	5	0.42 (0.15–1.17)	27	0.82 (0.49–1.34)
		Dabigatran 220 mg QD	862		187	1.22 (1.02–1.46)	5	0.42 (0.15–1.19)	28	0.86 (0.52–1.41)
		Enoxaparin 30 mg BID	876		163	–	12	–	33	–
RE-NOVATE	2007	Dabigatran 150 mg QD	1174	28–35 days	74	1.27 (0.91–1.76)	15	0.83 (0.42–1.63)	70	1.20 (0.85–1.68)
		Dabigatran 220 mg QD	1157		51	0.87 (0.60–1.24)	23	1.29 (0.70–2.37)	71	1.23 (0.88–1.73)
		Enoxaparin 40 mg QD	1162		60	–	18	–	58	–
RE-NOVATE	2011	Dabigatran 220 mg QD	1036	28–35 days	61	0.88 (0.63–1.22)	14	1.54 (0.67–3.55)	37	1.27 (0.79–2.04)
II		Enoxaparin 40 mg QD	1019		69	–	9	–	29	–
Meta-analysis	2007–2011	Dabigatran 150 mg QD	2759	6–35 days	504	1.19 (0.98–1.44)	29	0.78 (0.48–1.27)	154	1.13 (0.90–1.41)
		Enoxaparin variable dose (compared to dabigatran 150 mg)	2737		416	–	39	–	137	–
		Dabigatran 220 mg QD	3749		481	1.04 (0.87–1.24)	52	1.19 (0.80–1.77)	186	1.14 (0.93–1.40)
		Enoxaparin variable dose (compared to dabigatran 220 mg)	3756		485	–	48	–	166	–

^*RR compared to enoxaparin. Values in parentheses denote a 95% confidence interval. Abbreviations: RR, relative risk; VTE, venous thromboembolism