Halm E A, Tuhrim S, Wang J J, Rojas M, Hannan E L, Chassin M R
Division of General Internal Medicine, Department of Health Policy, Mount Sinai School of Medicine, New York, NY 10029, USA.
Neurology. 2007 Jan 16;68(3):187-94. doi: 10.1212/01.wnl.0000251197.98197.e9.
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.
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.
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).
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.
评估旨在使颈动脉内膜切除术(CEA)的使用合理化的多项大型国际随机对照试验(RCT)发表后,CEA的适宜性和适应证有何变化。
纽约颈动脉手术研究(NYCAS)是一项基于人群的队列研究,纳入了1998年1月至1999年6月在纽约州对老年患者进行的所有CEA手术。从病历中提取详细的临床数据,使用由国家专家采用RAND适宜性方法制定的1557条CEA适应证清单,评估手术适应证和适宜性。手术30天内的死亡和卒中情况由两名医生确定并确认。
在9588例患者中,平均年龄为74.6岁,93.6%有70%至99%的颈动脉狭窄。近四分之三的患者(72.3%)因无症状狭窄接受CEA,18.6%因短暂性脑缺血发作(TIA)接受手术,9.1%因卒中接受手术。总体而言,87.1%的手术理由恰当,4.3%理由不确定,8.6%理由不恰当(随机对照试验之前为32%不恰当,p<0.0001)。在判断为不恰当的手术中,最常见的原因是无症状患者合并症严重(62.2%)、重大卒中后手术(14.2%)或狭窄程度轻微(10.5%)。在无症状患者中,合并症严重者死亡或卒中风险是无严重合并症者的两倍多(7.13%对2.69%,p<0.0001)。
自随机对照试验发表以来,因不恰当理由接受颈动脉内膜切除术(CEA)的患者比例有所下降。许多无症状患者接受CEA的转变令人担忧,因为这些患者手术的净获益较低,而合并症严重的患者净获益进一步降低。