Table 3.

Event Rate and Risk of IS/SE, Bleeding, and Death in Anticoagulated Patients With AF

Variable	Event Rate/100 Person‐Years		Crude Data		Adjusted Dataa		Competing Riskb
	NOAC Users (n=4793)	Warfarin Users (n=2894)	HR (95% CI)	P Value	Adjusted hazard ratios (95% CI)	P Value	Adjusted hazard ratios (95% CI)	P Value
Hemoglobin ≥10 g/dL (n=7687)
IS/SE	5.10	6.67	0.62 (0.55–0.69)	<0.001	0.75 (0.66–0.85)	<0.001	0.74 (0.65–0.84)	<0.001
Major bleeding	7.35	12.36	0.46 (0.42–0.51)	<0.001	0.53 (0.48–0.59)	<0.001	0.52 (0.46–0.58)	<0.001
Gastrointestinal tract bleeding	4.27	5.76	0.58 (0.51–0.65)	<0.001	0.69 (0.60–0.78)	<0.001	0.67 (0.59–0.77)	<0.001
Death	3.06	2.97	0.95 (0.81–1.10)	0.492	1.05 (0.89–1.23)	0.576
Hemoglobin <10 g/dL (n = 669)
IS/SE	7.29	8.30	0.59 (0.41–0.86)	0.006	0.71 (0.47–1.06)	0.106	0.64 (0.42–0.97)	0.035
Major bleeding	7.61	14.27	0.37 (0.25–0.52)	<0.001	0.41 (0.28–0.60)	<0.001	0.40 (0.28–0.59)	<0.001
Gastrointestinal tract bleeding	3.76	7.18	0.37 (0.24–0.58)	<0.001	0.42 (0.26–0.68)	<0.001	0.41 (0.25–0.67)	<0.001
Death	8.10	5.94	1.07 (0.73–1.56)	0.743	1.11 (0.74–1.68)	0.643

AF indicates atrial fibrillation; HR, hazard ratio; IS, ischemic stroke; NOAC, non–vitamin K antagonist oral anticoagulant; SE, systemic embolism.

^aIS/SE or death, adjusted for age, sex, hypertension, diabetes mellitus, history of heart failure, estimated glomerular filtration rate <60 mL/min per 1.73 m², cancer, vascular disease, history of stroke, statins, hypertension medications, and antiplatelets; major bleeding or gastrointestinal tract bleeding, adjusted for age, sex, hypertension, diabetes mellitus, chronic liver disease, history of heart failure, estimated glomerular filtration rate <60 mL/min per 1.73 m², cancer, history of peptic ulcer disease, history of bleeding, history of stroke, nonsteroidal anti‐inflammatory drug, proton pump inhibitors, and antiplatelets.

^bDeath was considered as a competing risk factor in the Cox model.