Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis

Abstract

Conclusion: Compared with carotid artery stenting (CAS), carotid endarterectomy (CEA) in patients with symptomatic carotid stenosis of >60% to 99% provides lower rates of stroke and death at 1 and 6 months. Summary: This was a randomized, publicly funded, noninferiority trial conducted in 10 nonacademic and 20 academic medical centers in France. Eligible for the trial were patients with symptomatic carotid stenosis, defined as retinal or hemispheric transient ischemic attacks or a nondisabling stroke occurring ≤120 days from study enrollment, and who had >60% to 99% carotid stenosis. Confirmation of stenosis was by contrast angiography or a combination of duplex scanning and magnetic resonance angiography. Patients had to be suitable candidates for either CEA or CAS. All evaluations were performed by neurologists at 48 hours, 30 days, and 6 months after treatment, and every 6 months thereafter. The primary end point was stroke or death ≤30 days of treatment. The Data Safety and Monitoring Committee stopped this trial after inclusion of 527 patients for reasons of both safety and futility. The 30-day incidence of any stroke or death after CEA was 3.9% (95% confidence interval [CI], 2.0% to 7.2%). After stenting, the 30-day incidence of stroke or death was 9.6% (95% CI, 6.4% to 14.0%). The relative risk of any stroke or death after stenting was 2.5 times that of CEA (95% CI, 1.2 to 5.1). There was a 1.5% incidence of disabling stroke after CEA (95% CI, 0.5% to 4.2%) and a 3.4% incidence of disabling stroke after CAS (95% CI, 1.7% to 6.7%). The relative risk of disabling stroke in stented patients vs patients undergoing CEA was 2.2 (95% CI, 0.7 to 7.2). The incidence of any stroke or death >6 months was 6.1% after CEA and 11.7% after stenting (P = .02). CAS had more local major complications, and CEA had more systemic major complications (mainly pulmonary). Differences were not significant. Cranial nerve injury was more common after CEA than after CAS. Comment: This was a publicly funded, prospective, randomized trial. It has the great benefit of not being tainted by industry sponsorship. There was a lower-than-predicted stroke and death rate for CEA and a higher-than-predicted stroke and death rate for CAS. A criticism of the trial will obviously be a possible learning curve effect in the stented patients and the continuing evolving of CAS techniques and devices. This study is far cleaner than the SAPPHIRE trial (New Engl J Med 2004;351:1493-501) that was used to generate United States Food and Drug Administration approval of CAS for symptomatic high-risk patients. At the very least, the current trial raises serious concern about the relative safety of CAS in symptomatic patients of standard surgical risk. Given current data, it remains that the only patients who should undergo CAS outside of a clinical trial are very high-risk patients with symptomatic stenosis. Determination of high surgical risk should be by a multidisciplinary team that is able to evaluate perioperative systemic and surgical risk. It is not acceptable or ethical for high surgical risk to be determined by individuals who are only capable of performing carotid stents or who have financial incentives to participate in industry-sponsored trials.