Cao P, Giordano G, De Rango P, Zannetti S, Chiesa R, Coppi G, Palombo D, Spartera C, Stancanelli V, Vecchiati E
Unit of Vascular Surgery, Policlinico Monteluce, Perugia, Italy.
J Vasc Surg. 1998 Apr;27(4):595-605. doi: 10.1016/s0741-5214(98)70223-x.
The EVEREST Trial was designed to determine whether the surgical technique influences the durability and complications of carotid endarterectomy (CEA). The current report focuses on the study design and preliminary results.
EVEREST is a randomized multicenter trial. A total of 1353 patients with carotid stenosis requiring surgical treatment were randomly assigned to received standard (n = 675) or eversion (n = 678) CEA. Primary end points included carotid occlusion, major stroke, death, and restenosis rate.
The rate of perioperative major stroke and death (1.3 for each study group) and the incidence 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 hematoma, myocardial infarction, or surgical defects as detected with intraoperative 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 patients undergoing eversion CEAs and in 16% of patients undergoing standard 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 occurred 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).
The preliminary results of the EVEREST Trial suggest that eversion CEA is a safe and rapid procedure with low major complication rates. No significant differences in restenosis rates were observed between eversion and standard CEA at the available follow-up. Longer-term results are necessary to assess whether the eversion technique influences the durability of CEA.
“珠穆朗玛峰（EVEREST）试验”旨在确定手术技术是否会影响颈动脉内膜切除术（CEA）的耐久性及并发症。本报告重点关注研究设计及初步结果。
“珠穆朗玛峰试验”是一项随机多中心试验。共有1353例需要手术治疗的颈动脉狭窄患者被随机分配接受标准CEA（n = 675）或外翻式CEA（n = 678）。主要终点包括颈动脉闭塞、严重中风、死亡及再狭窄率。
围手术期严重中风和死亡率（每个研究组均为1.3%）以及早期颈动脉闭塞发生率（外翻式为0.6%，标准式为0.4%）相似。在围手术期短暂性脑缺血发作、轻微中风、颅神经损伤、颈部血肿、心肌梗死或术中质量控制检测出的手术缺陷发生率方面，外翻式CEA和标准CEA之间未发现显著差异。与补片标准手术相比，外翻式CEA的夹闭时间明显更短（31.7±15.9分钟对34.5±14.4分钟，p = 0.02）。接受外翻式CEA的患者中有11%插入了分流管，接受标准手术的患者中有16%插入了分流管。外翻组30天内总体事件发生率为13.3%，标准组为11.4%（p = 0.3）。平均随访14.9个月（范围1至38个月）时，外翻组发生16例（2.4%）再狭窄，标准组发生28例（4.1%）再狭窄（优势比，0.56；95%置信区间，0.3至1.1；p = 0.08）。
“珠穆朗玛峰试验”的初步结果表明，外翻式CEA是一种安全、快速且主要并发症发生率低的手术。在现有的随访中，外翻式CEA和标准CEA在再狭窄率方面未观察到显著差异。需要长期结果来评估外翻技术是否会影响CEA的耐久性。
