Table 1. Characteristics of included studies.

Trial, year	Design	NOAC class	Mean age (years) Men (%)	VKA- naïve patients	Patients with CHADS2 score <2 (%)	ITT	Mean follow-up (months)	TTR (%)
RE-LY, 2009	Phase III PROBE	Thrombin inhibitor	71.64%	50%*	32%	All outcomes	24.0	64
ROCKET, 2011	Phase III Double-Blind	Anti- factor Xa†	73.60%	37%**	0%	Stroke and SE	23.2	55
ARISTOTLE, 2011	Phase III Double-Blind	Anti- factor Xa†	70.65%	43***	34%	All outcomes	21.6	62

ITT: intention-to-treat analysis; PROBE: prospective, randomized, open trial with a blind evaluation; SE, systemic embolism; TTR: time during which the INR was in the therapeutic range. † Doses were reduced in patients with renal failure. VKA-naïve was defined as * <63 and ***<31 days of lifetime VKA exposure, respectively, ** not defined in the trial protocol