Has evidence changed practice? Appropriateness of carotid endarterectomy after the clinical trials
Has evidence changed practice? Appropriateness of carotid endarterectomy after the clinical trials
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DOI：
10.1212/01.wnl.0000251197.98197.e9
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发表时间：
2007-01-16
期刊：
影响因子：
9.9
通讯作者：
Chassin, M. R.
中科院分区：
文献类型：
--
作者：
Halm, E. A.;Tuhrim, S.;Chassin, M. R.
目的：评估在几项旨在合理使用颈动脉内膜切除术（CEA）的大型国际随机对照试验（RCT）发表后，CEA的适当性和适应症发生了哪些变化。研究方法：纽约颈动脉手术研究（NYCAS）是一项基于人群的队列研究，研究对象是1998年1月至1999年6月在纽约州对老年患者进行的所有CEA。从病历中提取详细的临床数据，使用由国家专家使用兰德适当性方法制定的1，557种CEA适应症列表评估手术适应症和适当性。手术后30天内的死亡和中风由两名医生确定和确认。结果：9,588例患者中，平均年龄为74.6岁，93.6%的患者颈动脉狭窄程度为70%~ 99%。近四分之三的患者（72.3%）因无症状性狭窄接受了CEA，18.6%的患者因TIA接受了CEA，9.1%的患者因卒中接受了CEA。总体而言，87.1%的手术是出于适当的原因，4.3%是出于不确定的原因，8.6%是出于不适当的原因（与RCT前的32%相比，p < 0.0001）。在被判定为不适当的手术中，最常见的原因是无症状患者的高合并症（62.2%），大卒中后手术（14.2%）或轻微狭窄（10.5%）。在无症状患者中，合并症高的患者死亡或中风的风险是没有合并症高的患者的两倍多（7.13%比2.69%，p < 0.0001）。结论：自随机对照试验发表以来，因不适当原因接受颈动脉内膜切除术（CEA）的患者比例有所下降。向许多接受CEA的无症状患者的转变令人担忧，因为这些患者手术的净获益较低，并且对于高合并症患者进一步降低。
Objective: To assess how appropriateness of and indications for carotid endarterectomy (CEA) have changed following the publication of several large international randomized controlled trials (RCTs) designed to rationalize use of CEA. Methods: The New York Carotid Artery Surgery Study (NYCAS) is a population-based cohort study of all CEAs performed on elderly patients from January 1998 through June 1999 in New York State. Detailed clinical data were abstracted from medical charts to assess indications for and appropriateness of surgery using a list of 1,557 indications for CEA developed by national experts using RAND appropriateness methods. Deaths and strokes within 30 days of surgery were ascertained and confirmed by two physicians. Results: Among the 9,588 patients, the mean age was 74.6 years and 93.6% had 70 to 99% carotid stenosis. Nearly three-quarters of patients (72.3%) underwent CEA for asymptomatic stenosis, 18.6% for TIA, and 9.1% for stroke. Overall, 87.1% of operations were done for appropriate reasons, 4.3% for uncertain reasons, and 8.6% for inappropriate reasons (vs 32% inappropriate before the RCTs, p < 0.0001). Among procedures judged inappropriate, the most common reasons were high comorbidity in asymptomatic patients (62.2%), operating after a major stroke (14.2%), or for minimal stenosis (10.5%). Among asymptomatic patients, those with high comorbidity had over twice the risk of death or stroke compared to those without high comorbidity (7.13% vs 2.69%, p < 0.0001). Conclusions: Since publication of the randomized controlled trials, there has been a reduction in the proportion of patients undergoing carotid endarterectomy (CEA) for inappropriate reasons. The shift toward many asymptomatic patients undergoing CEA is concerning because the net benefit from surgery for these patients is low and is reduced further for patients with high comorbidity.