Table 4.

Adjusted 6-Month Outcomes

	OAC Alone (n=4239)	OAC+ASA (n=2301)	Unadjusted		Adjusted
			HR (95% CI)	p-Value	HR (95% CI)	p-Value
Major Bleeding	74 (1.8)	68 (3.0)	1.62 (1.16 – 2.26)	0.004	1.53 (1.20 – 1.96)	0.0006
Nuisance Bleeding*	428 (10)	250 (11)	1.33 (1.31 – 1.36)	<0.001	1.09 (0.96 – 1.25)	0.18
All-cause Hospitalization	815 (19)	523 (23)	1.17 (1.04 – 1.31)	0.008	1.08 (1.00 – 1.17)	0.06
Cardiovascular	463 (10.9)	306 (13.3)	1.18 (1.01–1.37)	0.03	1.08 (0.97–1.21)	0.14
Bleeding	69 (1.6)	60 (2.6)	1.59 (1.12 – 2.26)	0.009	1.52 (1.17 – 1.97)	0.002
Other	366 (8.6)	220 (9.6)	1.09 (0.92 – 1.30)	0.33	0.98 (0.87 – 1.11)	0.72
Death	80 (1.9)	59 (2.6)	1.37 (0.98 – 1.93)	0.07	1.26 (0.98 – 1.63)	0.08

Raw rates presented as counts (%). Hazard ratios presented for OAC + ASA compared with OAC alone. Major bleeding defined by International Society on Thrombosis and Haemostasis criteria.

^*For nuisance bleeding odds ratios are presented, as dates of events are not included in the analysis.

OAC: oral anticoagulation; ASA: aspirin; HR: hazard ratio; CI: confidence interval.