NORTH-AMERICAN SYMPTOMATIC CAROTID ENDARTERECTOMY TRIAL - METHODS, PATIENT CHARACTERISTICS, AND PROGRESS
NORTH-AMERICAN SYMPTOMATIC CAROTID ENDARTERECTOMY TRIAL - METHODS, PATIENT CHARACTERISTICS, AND PROGRESS
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DOI：
10.1161/01.str.22.6.711
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发表时间：
1991-06-01
期刊：
影响因子：
8.3
通讯作者：
BARNETT, HJM
中科院分区：
文献类型：
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作者：
BARNETT, HJM
50个北美中心联合评估了随机患者颈动脉内膜切除术的益处，这些患者经历了与颈动脉硬化性狭窄相关的症状，并且接受了最好的药物治疗或最好的药物治疗加颈动脉内膜切除术。结果事件是非致命的和致命的中风或死亡。一个三层系统确定并判定每种中风的类型、严重程度和位置以及任何死亡的原因。在试验之外接受颈动脉内膜切除术的患者的数据在梅奥诊所的非随机数据中心进行汇编。在1987年12月27日至1990年10月1日期间，1212名患者被随机分组，596名患者接受药物治疗，616名患者接受颈动脉内膜切除术。从内科到外科的交叉比例很低（4.2%）。符合试验条件但非随机化的患者共计1,044例；他们的特征与随机患者相似，因此，对于本研究中有症状的患者类型，我们关于颈动脉内膜切除术益处的结论可以普遍化。经医学标准排除的患者共计679例。另有1,591例患者行颈动脉内膜切除术，但他们要么没有研究中的疾病，要么无症状，要么接受的调查不充分，无法满足入组标准。我们将样本量设定为1,900例患者，并继续纳入。监测委员会每隔一段时间审查对中度（30-69%）和重度（70-99%）狭窄组进行的保密分析。如果确定了明确的利益或损害，将对一个或两个群体调用停止规则。
Fifty North American centers have combined to evaluate the benefit of carotid endarterectomy in randomized patients who have experienced symptoms related to arteriosclerotic stenosis of the carotid artery and who have received either best medical therapy alone or best medical therapy plus carotid endarterectomy. The outcome events are nonfatal and fatal stroke or death. A three-tier system identifies and adjudicates the type, severity, and location of each stroke and the cause of any death. Data about patients submitted to carotid endarterectomy outside the trial are compiled at the Nonrandomized Data Center at the Mayo Clinic. Between December 27, 1987, and October 1, 1990, 1,212 patients were randomized, 596 to medical therapy, 616 to carotid endarterectomy. Cross-over from the medical to the surgical arm has been low (4.2%). Patients eligible for the trial, but not randomized totaled 1,044; their characteristics were similar to those randomized so that, for the type of symptomatic patient in this study, our conclusions about the benefit of carotid endarterectomy can be generalized. Patients excluded by medical criteria totaled 679. Another 1,591 had carotid endarterectomy, but either lacked the disease under study, were asymptomatic, or received inadequate investigation to meet entry criteria. We set sample size at 1,900 patients, with continuing enrollment. The Monitoring Committee reviews at intervals the confidential analyses performed on the groups with moderate (30-69%) and severe (70-99%) stenosis. Stopping rules will be invoked for one or both groups if unequivocal benefit or harm is identified.