. 2018 Nov 30;1(7):e185239. doi: 10.1001/jamanetworkopen.2018.5239

Table 2. Unadjusted Polyvascular Disease Outcomes: Efficacy and Safety .

Outcome	PAD Only (n = 7804)	PAD + CAD (n = 2639)			PAD + CVD (n = 2049)			PAD + CAD + CVD (n = 1393)
Outcome	Rate (Count)^a	Rate (Count)^a	HR (95% CI)	P Value^b	Rate (Count)^a	HR (95% CI)	P Value^b	Rate (Count)^a	HR (95% CI)	P Value^b
Composite end points
CV death, MI, stroke	3.37 (639)	5.74 (357)	1.70 (1.50-1.94)	<.001	4.78 (234)	1.42 (1.22-1.65)	<.001	8.12 (261)	2.41 (2.09-2.78)	<.001
Efficacy end points
CV death	1.70 (331)	2.48 (162)	1.46 (1.21-1.76)	<.001	2.18 (111)	1.28 (1.03-1.59)	.02	2.96 (102)	1.74 (1.39-2.17)	<.001
MI	1.22 (232)	3.03 (190)	2.49 (2.06-3.02)	<.001	2.06 (102)	1.70 (1.34-2.14)	<.001	4.90 (159)	4.03 (3.30-4.94)	<.001
Ischemic stroke	0.75 (144)	0.79 (51)	1.06 (0.77-1.45)	.74	1.12 (56)	1.49 (1.09-2.03)	.01	1.45 (49)	1.93 (1.40-2.67)	<.001
ALI requiring hospitalization	0.71 (136)	0.62 (40)	0.87 (0.61-1.24)	.45	0.66 (33)	0.92 (0.63-1.35)	.69	0.68 (23)	0.96 (0.61-1.49)	.84
Major amputation	0.72 (138)	0.42 (27)	0.58 (0.38-0.88)	.01	0.56 (28)	0.77 (0.51-1.16)	.22	0.68 (23)	0.94 (0.61-1.46)	.79
LER	4.82 (870)	6.03 (361)	1.25 (1.10-1.41)	<.001	5.90 (274)	1.22 (1.07-1.40)	.004	7.58 (233)	1.57 (1.35-1.81)	<.001
Safety end points
TIMI major bleeding	0.70 (118)	0.84 (46)	1.20 (0.86-1.69)	.28	0.76 (33)	1.09 (0.74-1.60)	.67	0.89 (25)	1.27 (0.83-1.96)	.27
TIMI minor bleeding	0.43 (73)	0.48 (26)	1.10 (0.70-1.72)	.67	0.60 (26)	1.39 (0.89-2.17)	.15	0.93 (26)	2.14 (1.36-3.34)	.001

Abbreviations: ALI, acute limb ischemia; CAD, coronary artery disease; CV, cardiovascular; CVD, cerebrovascular disease; HR, hazard ratio; LER, lower-extremity revascularization; MI, myocardial infarction; PAD, peripheral artery disease; TIMI, Thrombolysis in Myocardial Infarction.

^{^a}

Event rates defined as number of events per 100 patient-years of follow-up.

^{^b}

P values are from the log-rank test comparing the Kaplan-Meier rates across groups.