Eversion versus conventional carotid endarterectomy: Late results of a prospective multicenter randomized trial

Objective: The durability of carotid endarterectomy (CEA) may be affected b y carotid restenosis. The data from randomized trials show that the highest incidence of restenosis after CEA occurs from 12 to 18 months after surger y. The optimal CEA technique to reduce perioperative complications and rest enosis rates is still undefined. This study examines the long-term clinical outcome and incidence of recurrent stenosis in patients who undergo eversi on CEA. Previously published perioperative results of this study did not sh ow statistically significant differences in study endpoints between the eve rsion and standard techniques. Methods: From October 1994 to March 1997, 1353 patients with surgical indic ations for carotid stenosis were randomly assigned to undergo eversion (n = 678) or standard CEA (n = 675; primary closure, 419; patch, 256). Withdraw al from the assigned treatment occurred in 1.6% of the patients (in 13 assi gned to eversion CEA, and in nine assigned to standard CEA). The clinical a nd duplex scan follow-up examination was 99% complete, and the mean follow- up interval was 33 months (range, 12 to 55 months). The primary outcomes we re perioperative and late major stroke and death, carotid restenosis (steno sis greater than or equal to 50% of the lumen diameter detected at duplex s canning), and carotid occlusion. The primary evaluation of study outcomes w as conducted on the basis of an intention-to-treat analysis. Results: Restenosis was found at duplex scanning in 56 patients (19 in the eversion group, and 37 in the standard group). Within the standard group, t he restenosis rates were 7.9% in the primary closure population and 1.5% in the patched population. Of the patients with restenosis, 36% underwent cer ebral angiography that confirmed restenosis in all cases. The cumulative re stenosis risk at 4 years was significantly lower in the group that underwen t treatment with eversion CEA as compared with the standard group (3.6% vs 9.2%; P = .01), with an absolute risk reduction of 5.6% and a relative risk reduction of 62%. Eighteen patients would have had to undergo treatment wi th eversion CEA to prevent one restenosis during the 4-year period. The inc idence rate of ipsilateral stroke was 3.3% in the eversion population and 2 .2% in the standard group. There were no significant differences in the cum ulative risks of ipsilateral stroke (3.9% for eversion, and 2.2% for standa rd; P = .2) and death (13.1% for eversion, and 12.7% for standard; P = .7) in the two groups. Of the 18 variables that were examined for their influen ce on restenosis, eversion CEA (hazard ratio, 0.3; 95% confidence interval, 0.2 to 0.6; P = .0004) and patch CEA.(hazard ratio, 0.2; 95% confidence in terval, 0.07 to 0.6; P = .002) were negative independent: predictors of res tenosis with multivariate Cox proportional hazards regression analysis. Con clusion: The EVEREST (EVERsion carotid Endarterectomy versus Standard Trial ) showed that eversion CEA is safe, effective, and durable. No statisticall y significant differences were found in late outcome between the eversion a nd standard techniques at the available follow-up examination.