Table 7.

Effectiveness and safety outcomes of 546 evaluable patients at day 30 after transition from VKA to dabigatran or rivaroxaban, according to adherence to label recommendations regarding switching procedure

	All evaluable patients n = 546 n (%; 95% CI)	Switching according to label n = 299 n (%, 95% CI)	Switching not according to label n = 247 n (%, 95% CI)	P value
Major CV events	n = 4 (0.7%; 0.2, 1.9)	n = 4 (1.3%; 0.4, 3.4)	n = 0 (0.0%; 0.0, 1.5)	0.130
Any bleeding	n = 72 (13.2%; 10.5, 16.3)	n = 40 (13.4%; 9.7, 17.8)	n = 32 (13.0%; 9.0, 17.8)	0.900
Minor bleeding	n = 37 (6.8%; 4.8, 9.2)	n = 18 (6.0%; 3.6, 9.3)	n = 19 (7.7%; 7.7, 11.8)	0.495
NMCR bleeding	n = 24 (4.4%; 2.8, 6.5)	n = 15 (5.0%; 2.8, 8.1)	n = 9 (3.6%; 1.7, 6.8)	0.531
Major bleeding	n = 2 (0.4%; 0.0, 1.3)	n = 2 (0.7%; 0.0, 2.4)	n = 0 (0.0%; 0.0, 1.5)	0.504
Death	n = 2 (0.4%; 0.0, 1.3)	n = 1 (0.3%; 0.0, 1.8)	n = 1 (0.4%; 0.0, 2.2)	>0.999

NMCR, non-major clinially relevant bleeding.