Carotid Revascularization Using Endarterectomy or Stenting Systems (CaRESS) phase I clinical trial: 1-year results.

OBJECTIVE: Current clinical trials evaluating carotid stenting have focused on high-risk patients and may not reflect the broad population of patients with carotid stenosis who undergo treatment to prevent stroke. The Carotid Revascularization Using Endarterectomy or Stenting Systems (CaRESS) phase I study is a multicenter, prospective, nonrandomized trial designed to address the question of whether carotid stenting (CAS) with cerebral protection is comparable to carotid endarterectomy (CEA) in patients with symptomatic and asymptomatic carotid stenosis.

METHODS: Patients with symptomatic (with >50% stenosis) or asymptomatic (with >75% stenosis) carotid stenosis were entered into the study in a 2:1 ratio of carotid stent and GuardWire Plus distal protection device. This unique trial model was developed through collaboration with the International Society of Endovascular Specialists, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the National Institutes of Health, and industry representatives. The primary end points included death and stroke at 30 days and a composite 1-year end point of death, stroke, or myocardial infarction (MI) from 0 to 30 days and death or stroke from 31 days to 1 year. The secondary end points included residual stenosis, restenosis, repeat angiography, and carotid revascularization at 30 days and 1 year and quality-of-life changes at 1 year.

RESULTS: A total of 397 patients (254 CEA and 143 CAS) were enrolled in the study: 32% were symptomatic and 68% were asymptomatic. There were no significant differences in patient characteristics, symptoms, or surgical risk profiles between groups at baseline. Kaplan-Meier analysis revealed no significant differences in combined death/stroke rates at 30 days (3.6% CEA vs 2.1% CAS) or at 1 year (13.6% CEA vs 10.0% CAS). Similarly, there was no significant difference in the combined end point 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). There were no significant differences between CEA and CAS in the secondary end points of 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), carotid revascularization (1.0% CEA vs 1.8% CAS), or change in quality of life (-1.56 points CEA vs -4.22 points CAS).

CONCLUSIONS: The CaRESS phase I study suggests that the 30-day and 1-year risk of death, stroke, or MI with CAS is equivalent to that with CEA in symptomatic and asymptomatic patients with carotid stenosis.