Carotid revascularization using endarterectomy or stenting systems (CARESS): phase I clinical trial.
OBJECTIVE
To determine whether carotid stenting with embolic protection is equivalent to carotid endarterectomy (CEA) in a broad risk population of patients with symptomatic and asymptomatic carotid stenosis.


METHODS
A prospective, multicenter Phase I trial was conducted comparing standard CEA to carotid stenting systems (CSS) in patients with symptomatic (> or =50%) and asymptomatic (> or =75%) carotid stenosis. Patients were enrolled using selection criteria reflective of broad clinical practice. The enrollment ratio at each clinical site was designed to be 2:1 (CEA to CSS) to achieve a planned enrollment of 450 patients: 300 in the CEA arm and 150 in the CSS cohort, which would ensure adequate precision with a coefficient of variation < or =0.35. The primary endpoint for comparison was 30-day all-cause mortality and nonfatal stroke.


RESULTS
Between April 2001 and December 2002, 14 clinical sites enrolled 439 patients, of which 397 (247 men; mean age 71 years, range 44-89) were treated: 254 with CEA and 143 patients with CSS (ratio 1.8 to 1.0). More than 90% of patients had >75% stenosis; approximately 68% of patients were asymptomatic. There were no significant differences in baseline patient characteristics between the treatment groups with the exception of a more frequent history of prior CEA (30% CSS versus 11% for CEA, p<0.0001) and prior carotid stent placement in the CSS group (6% versus 0% for CEA, p=0.0002). There was no significant difference in the 30-day combined all-cause mortality and stroke rate by Kaplan-Meier estimate between CEA (2%) and CSS (2%). There was no significant difference in the secondary endpoint of combined 30-day all-cause mortality, stroke, and myocardial infarction between CEA (3%) and CSS (2%).


CONCLUSIONS
This study suggests that the 30-day risk of stroke or death following carotid stenting with cerebral protection is equivalent to standard carotid endarterectomy in a broad risk population of patients with carotid stenosis.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography / Q000379:methods; D000800:Angioplasty, Balloon / Q000295:instrumentation*; D016893:Carotid Stenosis / Q000175:diagnosis / Q000401:mortality / Q000601:surgery* / Q000628:therapy; D016894:Endarterectomy, Carotid / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000209:etiology; D011336:Probability; D011446:Prospective Studies; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000401:mortality; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler