Efficacy and safety outcomes of patients with atrial fibrillation compared between warfarin and non-vitamin K antagonist oral anticoagulants based on SAMe-TT2R2 score

Table 3 Primary and secondary outcomes of patients with atrial fibrillation after adjustment for potential confounders

Outcomes	All OAC (N = 2568)
	Warfarin vs. NOACs
	Adjusted hazard ratio (95%CI)	p value
Primary efficacy outcome^a	1.43 (0.90–2.26)	0.127
All-cause death	1.55 (0.93–2.57)	0.094
IS/TIA and/or SE	1.89 (0.69–5.21)	0.217
Primary safety outcome^b	1.55 (0.79–3.06)	0.204
Intracranial hemorrhage	1.33 (0.48–3.69)	0.587
Extracranial major bleeding	1.86 (0.75–4.61)	0.180
Secondary outcome
CV death^c	–	–
CV death^c or IS/TIA/SE	1.56 (0.79–3.07)	0.200
CV death^c or IS/TIA/SE or major bleeding	1.74 (1.01–2.99)	*0.045*

Outcomes	OAC-Low SAMe-TT₂R₂ (n = 617)
	Warfarin vs. NOACs
	Adjusted hazard ratio (95%CI)^d	p value
Primary efficacy outcome^a	1.60 (0.58–4.45)	0.367
All-cause death	1.49 (0.54–4.16)	0.444
IS/TIA and/or SE	–	–
Primary safety outcome^b	1.41 (0.43–4.62)	0.574
Intracranial hemorrhage	0.92 (0.21–4.08)	0.910
Extracranial major bleeding	2.23 (0.29–16.89)	0.439
Secondary outcome
CV death^c	–	–
CV death^c or IS/TIA/SE	3.01 (0.40–22.33)	0.282
CV death^c or IS/TIA/SE or major bleeding	1.95 (0.61–6.31)	0.263

Outcomes	OAC-High SAMe-TT₂R₂ (n = 1951)
	Warfarin vs. NOACs
	Adjusted hazard ratio (95%CI)	p value
Primary efficacy outcome^a	1.36 (0.81–2.26)	0.245
All-cause death	1.53 (0.85–2.76)	0.157
IS/TIA and/or SE	1.58 (0.57–4.38)	0.379
Primary safety outcome^b	1.62 (0.71–3.70)	0.257
Intracranial hemorrhage	1.69 (0.40–7.09)	0.473
Extracranial major bleeding	1.69 (0.61–4.68)	0.310
Secondary outcome
CV death^c	–	–
CV death^c or IS/TIA/SE	1.38 (0.67–2.84)	0.387
CV death^c or IS/TIA/SE or major bleeding	1.67 (0.90–3.08)	0.103

OAC oral anticoagulant, NOAC non-vitamin K antagonist oral anticoagulant, CI confidence interval, IS ischemic stroke, TIA transient ischemic attack, SE systemic embolism, CV cardiovascular, SAMe-TT₂R₂ score, S female sex (1 point), A age < 60 years (1 point), Me medical history > 2 of the following: hypertension, diabetes, coronary artery disease/myocardial infarction, peripheral arterial disease, congestive heart failure, previous stroke, pulmonary disease, and hepatic or renal disease (1 point), T treatment (interacting drugs, e.g., amiodarone for rhythm control) (1 point), T₂ tobacco use within 2 years (2 points), R₂ non-Caucasian race (2 points)
A p value < 0.05 indicates statistical significance (bold and italic)
^aPrimary efficacy outcome, including death, IS/TIA, and/or SE
^bPrimary safety outcome, including major bleeding
^cCV death, including IS/TIA, myocardial infarction, and/or SE

ISSN: 1471-2261