Results of a Multicenter Prospective Randomized Trial of Carotid Artery Stenting vs. Carotid Endarterectomy
Background: Carotid artery stenosis (CAS) is a common etiology for ischemic stroke. While carotid endarterectomy (CEA) is a safe and effective treatment for CAS, endovascular therapy using carotid stenting may be a reasonable alternative. This multicenter study was designed to determine if carotid stenting was equivalent to CEA in patients with symptomatic CAS. Methods: Patients with symptomatic CAS of 60–99% by cerebral angiogram were prospectively randomized to CEA or carotid stenting. All enrolled patients were reviewed by a multidisciplinary team that included neurologists, surgeons, and interventionalists. Patients in the stent group were treated with the WALLSTENT endoprosthesis and received aspirin 325 mg bid and ticlopidine 250 mg bid for 4 weeks. Neurologic assessments were performed 24 hrs post-procedure, then at 1, 6 and 12 months. The primary end-point was ipsilateral stroke, procedure-related death, or vascular death within 1 year. P-values are from 2-sided Fisher’s Exact Test. Results: A total of 219 patients were enrolled; 107 in the stent group (mean age 66.5, 66% male) and 112 in the CEA group (mean age 70, 62% male). The mean baseline degree of stenosis was 76% in the stent group vs 75% in the CEA group. 65% of stent patients had a TIA vs 68% in the CEA group. Median follow-up days for stent and CEA patients were 354 and 341, respectively. The primary end-point rate at approximately one year was 12.1% in the stent group vs. 3.6% for CEA (p = 0.022). The rate of any major stroke was 3.7% for stent vs. 0.9% for CEA (p = 0.204). A post-stent angiogram showed that 97% of patients had less than 30% stenosis. The 30 day peri-procedure complication rate (any stroke or death) was 12.1% for stents and 4.5% for CEA (p = 0.049). The 2 day peri-procedure complication rate was 7.5% for stents and 1.8% for CEA (p=0.055). Other common peri-procedure complications of stenting were severe bradycardia (7%) and groin hematoma (4%). Conclusions: This study did not find that carotid stenting was equivalent to CEA in patients with symptomatic CAS. Based on these data and a futility analysis, the study was terminated before the planned maximum of 700 patients were enrolled.