Carotid angioplasty and stenting versus carotid endarterectomy for treatment of asymptomatic carotid stenosis: a randomized trial in a community hospital. Efficacy of carotid endarterectomy for asymptomatic carotid stenosis. The Veterans Affairs Cooperative Study Group.
Carotid endarterectomy (CEA) is effective in reducing the risk of stroke in individuals with more than 60% carotid stenosis. Carotid angioplasty and stenting (CAS) has been proffered as effective and used in treating individuals with asymptomatic carotid stenosis despite the absence of proven clinical equivalency. This randomized trial was designed to explore the hypothesis that CAS is equivalent to CEA for treating asymptomatic carotid stenosis.
                A total of 85 individuals presenting with asymptomatic carotid stenosis of more than 80% were selected randomly for CAS or CEA and followed up for 48 months.
                Stenosis decreased to an average of 5% after CAS. The patency of the reconstructed artery remained satisfactory regardless of the technique, as determined by carotid ultrasonography. No major complications such as cerebral ischemia or death occurred. Procedural complications associated with CAS (n = 5) were hypotension and/or bradycardia; those concomitant with CEA (n = 3) were cervical nerve injury or complications related to general anesthesia (n = 4). Both procedures were well tolerated in the context of pain and discomfort. Hospital stay was similar in the two groups (mean, 1.1 versus 1.2 d). The occurrence of complications associated with CAS or CEA prolonged hospitalization by 3 days (mean, 4.0 versus 4.5 d). Return to full activity was achieved within 1 week by more than 85% of patients; all returned to their usual lifestyle by 2 weeks. Although hospital charges were slightly higher for CAS, costs were similar.
                CAS and CEA may be equally effective and safe in treating individuals with asymptomatic carotid stenosis. The efficacy of carotid endarterectomy in patients with asymptomatic carotid stenosis has not been confirmed in randomized clinical trials, despite the widespread use of operative intervention in such patients.
                We conducted a multicenter clinical trial at 11 Veterans Affairs medical centers to determine the effect of carotid endarterectomy on the combined incidence of transient ischemic attack, transient monocular blindness, and stroke. We studied 444 men with asymptomatic carotid stenosis shown arteriographically to reduce the diameter of the arterial lumen by 50 percent or more. The patients were randomly assigned to optimal medical treatment including antiplatelet medication (aspirin) plus carotid endarterectomy (the surgical group; 211 patients) or optimal medical treatment alone (the medical group; 233 patients). All the patients at each center were followed independently by a vascular surgeon and a neurologist for a mean of 47.9 months.
                The combined incidence of ipsilateral neurologic events was 8.0 percent in the surgical group and 20.6 percent in the medical group (P < 0.001), giving a relative risk (for the surgical group vs. the medical group) of 0.38 (95 percent confidence interval, 0.22 to 0.67). The incidence of ipsilateral stroke alone was 4.7 percent in the surgical group and 9.4 percent in the medical group. An analysis of stroke and death combined within the first 30 postoperative days showed no significant differences. Nor were there significant differences between groups in an analysis of all strokes and deaths (surgical, 41.2 percent; medical, 44.2 percent; relative risk, 0.92; 95 percent confidence interval, 0.69 to 1.22). Overall mortality, including postoperative deaths, was primarily due to coronary atherosclerosis.
                Carotid endarterectomy reduced the overall incidence of ipsilateral neurologic events in a selected group of male patients with asymptomatic carotid stenosis. We did not find a significant influence of carotid endarterectomy on the combined incidence of stroke and death, but because of the size of our sample, a modest effect could not be excluded.
Despite about a 3% perioperative stroke or death rate, CEA for asymptomatic carotid stenosis reduces the risk of ipsilateral stroke, and any stroke, by approximately 30% over three years. However, the absolute risk reduction is small (approximately 1% per annum over the first few years of follow up in the two largest and most recent trials) but it could be higher with longer follow up.