Table 2.

Vascular Event and Mortality Rates Over 2 Years (RWP and DPP).

Event Category	RWP (n = 10,322)			DPP (n = 3992)
	No. of Events	Risk Rate (events per 100 patient-years)	95% CI	No. of Events	Risk Rate (events per 100 patient-years)	95% CI
Composite Event	528	3.28	3.00–3.57	351	5.71	5.13–6.34
Cerebrovascular Event	175	1.07	0.92–1.24	104	1.64	1.34–1.98
Cerebral infarction	128	0.78	0.65–0.93	82	1.29	1.03–1.60
Intracerebral hemorrhage	24	0.15	0.09–0.22	12	0.19	0.10–0.33
Subarachnoid hemorrhage	9	0.05	0.02–0.10	5	0.08	0.03–0.18
Transient ischemic attack	16	0.10	0.06–0.16	7	0.11	0.04–0.23
Cardiovascular Event	206	1.26	1.09–1.45	131	2.08	1.74–2.47
Myocardial infarction	48	0.29	0.21–0.39	31	0.49	0.33–0.69
Unstable angina	48	0.29	0.22–0.39	31	0.49	0.33–0.69
Heart failure	117	0.71	0.59–0.85	72	1.13	0.89–1.43
Peripheral Vascular Event	180	1.10	0.95–1.27	139	2.21	1.86–2.61
Amputation	70	0.43	0.33–0.54	59	0.93	0.71–1.20
Development of critical limb ischemia	38	0.23	0.16–0.32	31	0.49	0.33–0.69
Acute limb ischemia	54	0.33	0.25–0.43	45	0.71	0.52–0.95
New onset of end-stage renal failure	17	0.10	0.06–0.17	8	0.12	0.05–0.25
Acute aortic dissection	4	0.02	0.01–0.06	0	0.00	0.00–0.00
Rupture of abdominal aortic aneurysm	5	0.03	0.01–0.07	2	0.03	0.00–0.11
Acute pulmonary thromboembolism	1	0.01	0.00–0.03	0	0.00	0.00–0.00
Fatal SEASON Event	84	0.51	0.41–0.63	44	0.69	0.50–0.92
Fatal cerebrovascular event	31	0.19	0.13–0.27	20	0.31	0.19–0.48
Fatal cardiovascular event	40	0.24	0.17–0.33	21	0.33	0.20–0.50
Fatal peripheral vascular event	13	0.08	0.04–0.13	3	0.05	0.01–0.14
Death From Any Cause	520	3.15	2.89–3.44	249	3.89	3.42–4.40
Any SEASON Event or Death From Any Cause	922	5.72	5.36–6.10	528	8.59	7.88–9.36

Abbreviations: CI, confidence interval; DPP, definite peripheral arterial disease population; RWP, real-world population.