Wennberg D E, Lucas F L, Birkmeyer J D, Bredenberg C E, Fisher E S
Division of Health Services Research, Maine Medical Center, Portland 04102, USA.
JAMA. 1998;279(16):1278-81. doi: 10.1001/jama.279.16.1278.
The North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the Asymptomatic Carotid Atherosclerosis Study (ACAS) demonstrated the efficacy of carotid endarterectomy (CEA) in reducing the risk of stroke and death in selected patients when surgery was performed in institutions whose participation depended on demonstrated excellence. Thirty-day mortality rates in the trials were very low: 0.6% in NASCET and 0.1% in ACAS.
To assess perioperative mortality among Medicare patients undergoing CEA in all nonfederal institutional settings.
Retrospective national cohort study.
All 113300 Medicare patients undergoing CEA during 1992 and 1993 in "trial hospitals" (those participating in NASCET and ACAS, n=86) and "nontrial hospitals" (all other nonfederal institutions performing CEAs, n=2613). Nontrial hospitals were stratified into terciles based on volume of CEAs performed.
Crude and adjusted perioperative (30 day) mortality rates.
The perioperative mortality rate was 1.4% (95% confidence interval [CI], 1.2%-1.7%) at trial hospitals; mortality in nontrial hospitals was higher: 1.7% (95% CI, 1.6%-1.8%) (high volume); 1.9% (95% CI, 1.7%-2.1 %) (average volume); 2.5% (95% CI, 2.0%-2.9%) (low volume); (P for trend, <.001). In multivariate modeling, patients undergoing their procedures at trial hospitals had a mortality risk reduction of 15% (95% CI, 0%-31%) compared with high-volume nontrial hospitals, 25% (95% CI, 7%-40%) compared with average-volume hospitals, and 43% (95% CI, 25%-56%) compared with low-volume hospitals (P for trend, <.001).
Medicare patients' perioperative mortality following CEA is substantially higher than that reported in the trials, even in those institutions that participated in the randomized studies. Caution is advised in translating the efficacy of carefully controlled studies of CEA to effectiveness in everyday practice.
北美症状性颈动脉内膜切除术试验(NASCET)和无症状性颈动脉粥样硬化研究(ACAS)表明,在那些因表现卓越而被纳入研究的机构进行手术时,颈动脉内膜切除术(CEA)在降低特定患者中风和死亡风险方面具有疗效。试验中的30天死亡率非常低:NASCET为0.6%,ACAS为0.1%。
评估在所有非联邦机构环境中接受CEA的医疗保险患者的围手术期死亡率。
回顾性全国队列研究。
1992年和1993年期间,所有113300名在“试验医院”(参与NASCET和ACAS的医院,n = 86)和“非试验医院”(所有其他进行CEA的非联邦机构,n = 2613)接受CEA的医疗保险患者。非试验医院根据CEA手术量分为三分位数。
粗死亡率和调整后的围手术期(30天)死亡率。
试验医院的围手术期死亡率为1.4%(95%置信区间[CI],1.2% - 1.7%);非试验医院的死亡率更高:1.7%(95% CI,1.6% - 1.8%)(高手术量);1.9%(95% CI,1.7% - 2.1%)(中等手术量);2.5%(95% CI,2.0% - 2.9%)(低手术量);(趋势P值,<.001)。在多变量模型中,与高手术量非试验医院相比,在试验医院接受手术的患者死亡风险降低了15%(95% CI,0% - 31%),与中等手术量医院相比降低了25%(95% CI,7% - 40%),与低手术量医院相比降低了43%(95% CI,25% - 56%)(趋势P值,<.001)。
医疗保险患者CEA后的围手术期死亡率显著高于试验报告的死亡率,即使在那些参与随机研究的机构也是如此。在将CEA精心控制研究的疗效转化为日常实践中的有效性时应谨慎。