Different Finite Durations of Anticoagulation and Outcomes following Idiopathic Venous Thromboembolism: A Meta-Analysis

Table 4

Primary outcome events following cessation of therapy.

Trial	Patients	Tx (mos)	f/u (mos)	DVT	PE	VTE	Bleeding	Mortality	Adverse
Agnelli et al. [6]*	90	12	26.4	—	—	10 (5.1)	0 (0)	8 (3.1)	10 (5.1)
	91	3	31.7	—	—	11(4.6)	1 (0.4)	7 (2.9)	12 (5.0)
Agnelli et al. [7]*	134	12	29.4	—	—	17 (5.2)	0 (0)	7 (1.7)	17 (5.2)
	133	3	37.2	18 (4.4)	3 (0.7)	21 (5.1)	2 (0.5)	7 (1.7)	23 (5.6)
Farraj [20]	32	24	12	2 (6.3)	0 (0)	2 (6.3)	0 (0)	0 (0)	2 (6.3)
	32	6	30	5 (6.3)	2 (2.5)	7 (8.8)	0 (0)	0 (0)	7 (8.8)
Legnani et al. [24]	628	7	22.4	57 (5.5)	14 (1.3)	71 (6.8)	0 (0)	11 (1.1)	71 (6.8)
Kyrle et al. [22]*	453	9	38	—	—	28 (2.0)	0 (0)	—	28 (2.0)
	373	8	33	—	—	74 (7.2)	0 (0)	—	74 (7.2)
Palareti et al. [19]**	385	13.0	31.6	42 (4.1)	9 (0.9)	51 (5.0)	0 (0)	6 (0.6)	51 (5.0)
	120	10.8	28.7	20 (6.3)	8 (2.8)	28 (9.6)	0 (0)	2 (0.7)	28 (9.6)
Palareti et al. [25]	282	7.5	16.5	24 (6.2)	9 (2.3)	33 (8.5)	0 (0)	—	33 (8.5)
Schulman et al. [21]	289	6	42	—	—	55 (5.4)	0 (0)	31 (2.7)	55 (5.4)
Poli et al. [23]	183	14.9	28.6	23 (5.3)	6 (1.4)	29 (6.6)	0 (0)	3 (0.7)	29 (6.6)

( ): % per patient years, f/u is total, documented duration off of therapy; VTE: DVT and PE combined; Adverse Outcomes: VTE and major bleeding; Bleeding: see text for individual study definition of major bleeding
Major generally defined as clinically overt and associated with either a decrease Hgb ≥ 2 g/dL or transfusion ≥2 units pRBCs, if retroperitoneal or intracranial, or if warranted the permanent discontinuation of the study drug.
*VTE could not be separated into DVTs and PEs.
**Includes data from follow-up study by Cosmi et al. [18]