Table 2.

Risk of bleeding with DOACs versus Warfarin in RCTs and real-world studies on NVAF stroke prevention

RCTs
	Dabigatran		Rivaroxaban	Apixaban	Edoxaban
	RE-LY [6]		ROCKET-AF [7]	ARISTOTLE [8]	ENGAGE- AF TIMI 48 [9]
	110 mg	150 mg			30 mg	60 mg
Stroke or SE	=	↓	=	↓	=	=
MB or CRNMB	↓	↓	=	↓	↓	↓
MB	↓	=	=	↓	↓	↓
ICH	↓	↓	↓	↓	↓	↓
MGIB	=	↑	↑	=	↓	↑

Real-world data
	Dabigatran [10, 11]	Rivaroxaban [10, 11]	Apixaban [10, 11]	Edoxaban [12]a
Stroke or SE	=	=	=	↓
MB	↓	= ↑	↓	↓
ICH	↓	↓	↓	↓
GIB	↑	↑	↓	↓b

CRNMB clinically relevant non-major bleeding, GIB gastrointestinal bleeding, ICH intracerebral hemorrhage, MB major bleeding, MGIB major gastrointestinal bleeding, NVAF non-valvular atrial fibrillation, SE systemic embolism

Symbols: = , similar; ↓, minor; ↑ higher [hazard ratio (HR) of events with DOACs versus warfarin]

^aOnly one study available

^bMGIB