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Published on: May 14, 2013
Carotid Revascularization Using Endarterectomy or Stenting Systems (CaRESS) phase I clinical trial: 1-year results
Insights
Carotid stenting (CAS) with cerebral protection is as effective as carotid endarterectomy (CEA) for preventing stroke in patients with carotid stenosis. The CaRESS study found comparable rates of death, stroke, and myocardial infarction between the two procedures.
Area of Science:
- Vascular Surgery
- Neurology
- Interventional Cardiology
Background:
- Current trials for carotid stenting (CAS) often exclude lower-risk patients, limiting generalizability.
- Carotid stenosis poses a significant stroke risk, necessitating effective revascularization strategies.
Purpose of the Study:
- To compare the safety and efficacy of carotid stenting (CAS) with cerebral protection against carotid endarterectomy (CEA).
- To evaluate outcomes in both symptomatic and asymptomatic patients with carotid stenosis.
Main Methods:
- A prospective, nonrandomized, multicenter trial (CaRESS phase I) enrolled 397 patients (32% symptomatic, 68% asymptomatic).
- Patients were assigned to CAS with distal protection or CEA in a 2:1 ratio.
- Primary endpoints included 30-day and 1-year rates of death, stroke, and myocardial infarction (MI).
Main Results:
- No significant differences were observed in combined death/stroke rates at 30 days (2.1% CAS vs. 3.6% CEA) or 1 year (10.0% CAS vs. 13.6% CEA).
- Combined endpoints of death, stroke, or MI at 30 days (2.1% CAS vs. 4.4% CEA) and 1 year (10.9% CAS vs. 14.3% CEA) also showed no significant differences.
- Secondary outcomes including restenosis and revascularization rates were comparable between CAS and CEA.
Conclusions:
- Carotid stenting (CAS) with cerebral protection demonstrates equivalent safety and efficacy to carotid endarterectomy (CEA) for patients with symptomatic and asymptomatic carotid stenosis.
- The CaRESS phase I study supports CAS as a viable alternative to CEA in a broad patient population.
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.
