Table 1.

Risk of ICH in patients treated with DOACs or VKI in RCT.

RCT	DOACs	Year	ICH n° pt (%)		HR (95% CI)
			DOACs	VKI	DOACs vs VKI	P value
RE-LY trial (72)	Dabigatran	2009	14 (0.2)*	45 (0.7)	0.31 (0.17–0.56)	<0.001
			12 (0.2)§		0.26 (0.14–0.49)	<0.001
ROCKET (73)	Rivaroxaban	2011	55 (0.8)	84 (1.2)	0.67 (0.47–0.93)	0.02
ARISTOTLE (71)	Apixaban	2011	40 (0.4)	78 (0.8)	0.51 (0.35–0.75)	<0.001
ENGAGE TIMI-48 (74)	Edoxaban	2013	49 (0.7)	90 (1.3)	0.54 (0.38–0.77)	0.001

DOACs, direct oral anticoagulant; CI, confidence interval; HR, hazard ratio; ICH, intracranial hemorrhage; RCT: a randomized controlled trial;.

^*110 mg.

^§150 mg.