Table 2.

Clinical outcomes in the “as-treated” population (main analysis)

Outcome	Incidence in Apixaban Users	Incidence in Nonusers	Crude Hazard Ratio (95% Confidence Interval)	P Value	Adjusteda Hazard Ratio (95% Confidence Interval)	P Value
Any stroke, TIA, or embolism	7.5 (13)	7.0 (114)	1.24 (0.69 to 2.23)	0.47	1.29 (0.72 to 2.33)	0.39
Any stroke	5.8 (<11)	5.8 (96)	1.13 (0.58 to 2.19)	0.72	1.17 (0.60 to 2.28)	0.64
Major bleeding	4.9 (<11)	1.6 (45)	2.74 (1.37 to 5.47)	0.004	2.76 (1.38 to 5.52)	0.004
Clinically important bleeding	59.2 (77)	56.9 (695)	1.15 (0.90 to 1.47)	0.26	1.15 (0.90 to 1.46)	0.26
Ischemic stroke or MI	27.6 (43)	25.1 (373)	1.24 (0.90 to 1.71)	0.18	1.25 (0.91 to 1.72)	0.17
Ischemic stroke	3.5 (<11)	5.0 (81)	0.81 (0.35 to 1.89)	0.63	0.85 (0.36 to 1.98)	0.71
Hemorrhagic stroke	2.3 (<11)	1.3 (22)	1.89 (0.65 to 5.47)	0.24	1.89 (0.65 to 5.49)	0.24

Incidence rates are presented as number of events per 100 patient-years, with the number of events per group shown in parentheses. Patients were followed up to the date of death; kidney transplantation; December 31, 2015; loss of Medicare A–B or D coverage; or the date of the last available apixaban prescription (plus drug supply days). Death was considered as a competing risk. TIA, transient ischemic attack; MI, myocardial infarction.

^aHazard ratios were adjusted for the CHA₂DS₂-Vasc (congestive heart failure, hypertension, age, diabetes, stroke, vascular history) score for the outcomes of any stroke; any stroke, TIA, or systemic thromboembolism; and ischemic stroke; for a modified HAS-BLED (hypertension, kidney disease, liver disease, stroke, prior bleeding or predisposition to bleeding, labile international normalized ratio, age, medication, alcohol use) score for major bleeding, hemorrhagic stroke, and clinically important bleeding; and for history of hypertension, diabetes mellitus, dyslipidemia, and MI for the outcome of ischemic stroke or MI. Statistically significant differences appear in bold.