Carotid stenting with an emboli-protection device was not inferior to endarterectomy in high-risk patients with severe carotid stenosis (absolute difference -7.9%, p=0.004 for noninferiority).
Does carotid-artery stenting with an emboli-protection device reduce major cardiovascular events in high-risk patients with severe carotid-artery stenosis compared to carotid endarterectomy?
In high-risk patients with severe carotid stenosis, carotid stenting with an emboli-protection device is non-inferior to carotid endarterectomy at 1 year, primarily driven by fewer periprocedural myocardial infarctions in the stenting group.
Effect estimate: Absolute difference -7.9% (95% CI -16.4 to 0.7)
Absolute Event Rate: 12.2% vs 20.1%
p-value: p=0.004 for noninferiority, 0.053 for superiority
Background Carotid endarterectomy is more effective than medical management in the prevention of stroke in patients with severe symptomatic or asymptomatic atherosclerotic carotid-artery stenosis. Stenting with the use of an emboli-protection device is a less invasive revascularization strategy than endarterectomy in carotid-artery disease. Methods We conducted a randomized trial comparing carotid-artery stenting with the use of an emboli-protection device to endarterectomy in 334 patients with coexisting conditions that potentially increased the risk posed by endarterectomy and who had either a symptomatic carotid-artery stenosis of at least 50 percent of the luminal diameter or an asymptomatic stenosis of at least 80 percent. The primary end point of the study was the cumulative incidence of a major cardiovascular event at 1 year—a composite of death, stroke, or myocardial infarction within 30 days after the intervention or death or ipsilateral stroke between 31 days and 1 year. The study was designed to test the hypothesis that the less invasive strategy, stenting, was not inferior to endarterectomy. Results The primary end point occurred in 20 patients randomly assigned to undergo carotid-artery stenting with an emboli-protection device (cumulative incidence, 12.2 percent) and in 32 patients randomly assigned to undergo endarterectomy (cumulative incidence, 20.1 percent; absolute difference, −7.9 percentage points; 95 percent confidence interval, −16.4 to 0.7 percentage points; P=0.004 for noninferiority, and P=0.053 for superiority). At one year, carotid revascularization was repeated in fewer patients who had received stents than in those who had undergone endarterectomy (cumulative incidence, 0.6 percent vs. 4.3 percent; P=0.04). Conclusions Among patients with severe carotid-artery stenosis and coexisting conditions, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy.
Gottfried et al. (Sat,) conducted a review in Severe carotid-artery stenosis with coexisting conditions (n=334). Carotid-artery stenting with emboli-protection device vs. Carotid endarterectomy was evaluated on Cumulative incidence of a major cardiovascular event at 1 year (composite of death, stroke, or myocardial infarction within 30 days, or death or ipsilateral stroke between 31 days and 1 year) (Absolute difference -7.9%, 95% CI -16.4 to 0.7, p=0.004 for noninferiority, 0.053 for superiority). Carotid stenting with an emboli-protection device was not inferior to endarterectomy in high-risk patients with severe carotid stenosis (absolute difference -7.9%, p=0.004 for noninferiority).