CARESS Equates Carotid Endarterectomy With Stenting

By Mark S. Lesney

The 30-day and 1-year risk of death, stroke, or myocardial infarction for carotid artery stenting is equivalent to that of carotid endarterectomy, according to the 1-year results of a phase I study comparing the two techniques.

The prospective, nonrandomized, carotid revascularization using endarterectomy or stenting systems (CARESS) trial enrolled a total of 397 patients--approximately one-third of whom were symptomatic patients who had greater than 50% stenosis, and the rest asymptomatic who had greater than 75% stenosis. These patients were divided into two groups: 254 endarterectomy (CEA) and 143 stenting (CAS). There were no significant differences in patient characteristics, symptoms, or surgical risk profiles at baseline, according to the report by the CARESS I trial steering committee (J. Vasc. Surg. 2005;42:213-9).

The primary end points for the phase I trial included all-cause mortality or stroke within 30 days and 1 year of the procedure.

The secondary end points included a composite of 30-day all-cause mortality, stroke, or acute myocardial infarction (AMI) and 1-year all-cause mortality or stroke; residual stenosis, restenosis, repeat angiography, and carotid revascularization at 30 days and 1 year; and quality of life changes at 1 year.

"Although the CAS rates were consistently lower than the CEA rates, the most notable difference was in stroke rates (30 days: 3.6% CEA vs. 2.1% CAS, not significant; 1 year: 9.8% CEA vs. 5.5% CAS, not significant)," the committee reported.

There was also no significant difference in the Kaplan-Meier analysis of the combined end point (major adverse events) of death, stroke, or MI at 30 days (4.4% CEA vs. 2.1% CAS) or at 1 year (14.3% CEA vs. 10.9% CAS). Similarly, there were no statistically significant differences in the secondary end points: residual stenosis (0% CEA vs. 0.9% CAS), restenosis (3.6% CEA vs. 6.3% CAS), repeat angiography (2.1% CEA vs. 3.6% CAS), and carotid revascularization (1.0% CEA vs. 1.8% CAS).

The study was funded by the International Society of Endovascular Specialists; the Monorail Wallstent (Boston Scientific Corp.) and the GuideWire Plus (Medtronic Vascular) devices were used in the CAS arm.

This study is one of many that compare carotid stenting to the standard of endarterectomy, according to the committee.

"Because the recent trials have focused on relatively narrow indications of high-risk patient populations, they are unlikely to answer the overall question of whether CAS with distal, embolic protection is equivalent to the standard of care [that is, CEA] for most patients with carotid stenosis who are at risk for stroke," according to the committee.

The "CARESS trial, however, is the only study that attempts to imitate true clinical environments in dealing with both high- and low-risk patients, according to the report".

CARESS IS THE ONLY STUDY THAT ATTEMPTS TO IMITATE THE CLINICAL ENVIRONMENT BY TREATING BOTH HIGH- AND LOW-RISK PATIENTS.