Table 2.

Efficacy and safety endpoints in the primary and secondary prevention groups for stroke and systemic embolism (efficacy and safety populations)

	Primary prevention group (n = 5546)			Secondary prevention group (n = 1595)			P value
	Event, n	%/year	95% CI	Event, n	%/year	95% CI
Primary efficacy endpoint
Stroke (ischemic/hemorrhagic)/SE	92	0.7	0.53–0.81	84	2.2	1.72–2.65	< 0.001
Secondary efficacy endpoints
Stroke (ischemic/hemorrhagic)/SE/MI/cardiovascular death	173	1.3	1.08–1.45	118	3.1	2.51–3.62	< 0.001
Stroke (ischemic/hemorrhagic)	91	0.7	0.53–0.80	80	2.1	1.62–2.54	< 0.001
Ischemic stroke	62	0.5	0.34–0.57	68	1.8	1.35–2.19	< 0.001
Hemorrhagic stroke	28	0.2	0.13–0.28	12	0.3	0.14–0.49	0.21
TIA	18	0.1	0.07–0.19	19	0.5	0.27–0.72	< 0.001
SE	2	0.01	0.00–0.03	4	0.1	0.00–0.21	0.008
Acute MI/unstable angina pectoris	25	0.2	0.11–0.25	10	0.3	0.10–0.42	0.339
Deep vein thrombosis/pulmonary thromboembolism	4	0.03	0.00–0.06	2	0.05	0.00–0.12	0.497
PCI/CABG	30	0.2	0.14–0.30	14	0.4	0.17–0.55	0.109
Cardiovascular death	88	0.6	0.51–0.78	39	1.0	0.70–1.33	0.016
All-cause death	190	1.4	1.19–1.58	91	2.4	1.88–2.85	< 0.001
Primary safety endpoint
ISTH major bleeding	159	1.2	0.98–1.34	56	1.5	1.70–1.84	0.132
Intracranial hemorrhage	54	0.4	0.29–0.50	30	0.8	0.50–1.06	0.002
Gastrointestinal bleeding	67	0.5	0.37–0.61	16	0.4	0.21–0.62	0.42
Others	38	0.3	0.19–0.37	10	0.3	0.10–0.42	0.942
Secondary safety endpoints
Non-major bleeding (not defined using ISTH criteria)	668	4.9	4.51–5.25	188	4.9	4.19–5.59	0.963

CI confidence interval, SE systemic embolism, MI myocardial infarction, TIA transient ischemic attack, PCI percutaneous coronary intervention, CABG coronary artery bypass graft, ISTH International Society on Thrombosis and Haemostasis