Table 1.

Characteristics of the studies and treatments.

Drug, trial	Dabigatran RE-LY [22, 48]	Rivaroxaban ROCKET [23, 49]	Apixaban ARISTOTLE [24, 50]
No. in sample	18113	14264	18201
Treatment characteristics
Experimental drug	Dabigatran 150 mg or 110 mg twice daily	Rivaroxaban 20 mg or 15 mg once daily	Apixaban 5 mg or 2.5 mg twice daily
Experimental, n	12091	7131	9120
High-dose	6076	5624	8702
Low-dose	6015	1597	428
Control drug	Warfarin dose-adjusted to INR 2-3, once daily	Warfarin dose-adjusted to INR 2-3, once daily	Warfarin dose-adjusted to INR 2-3, once daily
Control, n	6022	7133	9081
TTR (%)
Mean	64.4	55.2	62.2
Median	67	58	66
Trial phase	III	III	III
Design of randomised controlled trial	Multicentre, open-label PROBE	Multicentre, double-blind	Multicentre, double-blind
Adjudicating committee and blinded adjudication of outcomes	Yes	Yes	Yes
Interim analysis, n	2	1	1
Number of exclusion criteria	14	31	19
Main efficacy outcome	Stroke and SEE	Stroke and SEE	Stroke and SEE
Main analysis	Non-inferiority	Non-inferiority	Non-inferiority
Non-inferiority margin	Relative risk < 1.46	Relative risk < 1.46	Relative risk < 1.38
Main population of analysis	Intent-to-treat	Per protocol	Intent-to-treat
Main period of analysis	Until notification of study termination	On-treatment plus 2 days	Until notification of study termination
Main safety outcome	Major bleeding	Clinically relevant bleeding	Major bleeding
Main population of analysis	Safety population	Safety population	Safety population
Main period of analysis	On-treatment plus 6 days*	On-treatment plus 2 days*	On-treatment plus 2 days*
Jadad Score	3	5	5
Median length follow-up (days)	730	707	657

*After treatment discontinuation.

INR: international normalised ratio; PROBE: prospective, open-label, blinded endpoint; SEE: systemic embolic events; TTR: time in therapeutic range.