A RANDOMIZED STUDY ON EVERSION VERSUS STANDARD CAROTID ENDARTERECTOMY- STUDY DESIGN AND PRELIMINARY-RESULTS - THE EVEREST TRIAL

Purpose: The EVEREST Trial was designed to determine whether the surgi cal technique influences the durability and complications of carotid e ndarterectomy (CEA). The current report focuses on the study design an d preliminary results. Methods: EVEREST is a randomized multicenter tr ial. A total of 1353 patients with carotid stenosis requiring surgical treatment were randomly assigned to received standard (n = 675) or ev ersion (n = 678) CEA. Primary end points included carotid occlusion, m ajor stroke, death, and restenosis rate. Results: The rate of perioper ative major stroke and death (1.3 for each study group) and the incide nce of early carotid occlusion (0.6% for eversion vs 0.4% for standard ) were similar. No significant differences were found between eversion and standard CEA with respect to incidence of perioperative transient ischemic accident, minor stroke, cranial nerve injuries, neck hematom a, myocardial infarction, or surgical defects as detected with intraop erative quality controls. Clamping time was significantly shorter for eversion CEA compared with patch standard procedures (31.7 +/- 15.9 vs 34.5 +/- 14.4 minutes, p = 0.02). A shunt was inserted in 11% of pati ents undergoing eversion CEAs and in 16% of patients undergoing standa rd procedures. Overall 30-day events occurred in 13.3% of the eversion group and in 11.4% of the standard group (p = 0.3). At a mean follow- up of 14.9 months (range, 1 to 38 months), 16 (2.4%) restenoses occurr ed in the eversion group and 28 (4.1%) occurred in the standard group (odds ratio, 0.56; 95% confidence interval, 0.3 to 1.1; p = 0.08). Con clusion: The preliminary results of the EVEREST Trial suggest that eve rsion CEA is a safe and rapid procedure with low major complication-ra tes. No significant differences in restenosis rates were observed betw een eversion and standard CEA at the available follow-up. Longer-term results are necessary to assess whether the eversion technique influen ces the durability of CEA.