. 2022 Aug 9;328(6):534–542. doi: 10.1001/jama.2022.12000

Table 2. Primary and Secondary Outcomes.

	No./total (%)		Incidence difference, % (95% CI)^b	Hazard ratio (95% CI)^b	P value^c
	Percutaneous transluminal angioplasty and stenting group (n = 176)	Medical therapy alone group (n = 181)^a	Incidence difference, % (95% CI)^b	Hazard ratio (95% CI)^b	P value^c
Components of the primary outcome	14/176 (8.0)	13/181 (7.2)	0.4 (−5.0 to 5.9)	1.10 (0.52 to 2.35)	.82
Stroke or death within 30 d after enrollment^d	9/176 (5.1)^e	4/181 (2.2)^f
Stroke in territory of qualifying artery beyond 30 d through 1 y^d	5/176 (2.8)	9/181 (5.0)
Secondary outcomes
Stroke in the same territory within 2 y	17/171 (9.9)^g	16/178 (9.0)^h	0.7 (−5.4 to 6.7)	1.10 (0.56 to 2.16)	.80
Stroke in the same territory within 3 y	19/168 (11.3)ⁱ	19/170 (11.2)^j	−0.2 (−7.0 to 6.5)	1.00 (0.53 to 1.90)	>.99
Disabling stroke or death within 3 y	19/168 (11.3)^k	15/166 (9.0)^l	2.0 (−4.6 to 8.6)	1.28 (0.65 to 2.52)	.49
Any stroke, TIA, cardiovascular events related to stenting or medical therapy within 3 y	24/169 (14.2)^m	31/172 (18.0)ⁿ	−4.1 (−12.0 to 3.7)	0.76 (0.45 to 1.30)	.31
Death within 3 y	7/160 (4.4)^o^,^p	2/159 (1.3)^q^,^r	3.2 (−0.5 to 6.9)	3.75 (0.77 to 18.13)	.08
Stroke-related death^d	4/160 (2.5)	2/159 (1.3)
Nonstroke-related death^d	3/160 (1.9)	0/159 (0)

Abbreviation: TIA, transient ischemic attack.

^{^a}

One participant randomized to the medical therapy alone group was not included due to missing outcome data. See Figure 1.

^{^b}

Adjusted for site effect.

^{^c}

Log-rank test adjusted for site effect.

^{^d}

Post hoc analysis.

^{^e}

There were 5 ischemic stroke and 4 hemorrhagic strokes. Of the 4 symptomatic hemorrhagic strokes, 1 was periprocedural subarachnoid hemorrhage immediately after percutaneous transluminal angioplasty and stenting (probably related to guidewire perforation); 1 was periprocedural parenchymal and subdural brain hemorrhage evident immediately after percutaneous transluminal angioplasty and stenting (probably related to guidewire perforation); 1 was cerebellar and occipital hemorrhage that occurred 3 days after percutaneous transluminal angioplasty and stenting (probably related to reperfusion); and 1 was subarachnoid hemorrhage within 24 hours after percutaneous transluminal angioplasty and stenting (probably related to reperfusion). A total of 2 of these hemorrhages were fatal (1 developed massive cerebral infarction and brain hernia, and 1 had parenchymal brain hemorrhage), and 2 were nondisabling (1 cerebellar and occipital hemorrhage and 1 subarachnoid hemorrhage).

^{^f}

There were 4 ischemic strokes and 0 hemorrhagic strokes. Of the 4 ischemic strokes, 2 were disabling, 2 were nondisabling, and none were fatal.

^{^g}

One missing follow-up and 4 died.

^{^h}

Four missing follow-up and 0 died.

^ⁱ

Four missing follow-up and 4 died.

^{^j}

Eleven missing follow-up and 1 died.

^{^k}

Eight missing follow-up, including 4 with primary outcomes (but no disabling stroke or death).

^{^l}

Sixteen missing follow-up, including 5 with primary outcomes (but no disabling stroke or death).

^{^m}

Four missing follow-up and 3 died.

^ⁿ

Ten missing follow-up and 0 died.

^{^o}

Sixteen missing follow-up, including 12 with primary outcomes.

^{^p}

The causes of death in the percutaneous transluminal angioplasty and stenting group were as follows: brain hemorrhage (n = 2), ischemic stroke (n = 2), sudden cardiac arrest (n = 1), intrahepatic cholangiocarcinoma (n = 1), and aortic artery aneurysm (n = 1).

^{^q}

Twenty-three missing follow-up, including 12 with primary outcomes.

^{^r}

The causes of death in the medical management group were as follows: ischemic stroke (n = 1) and brain hemorrhage (n = 1).