McPhee James T, Hill Joshua S, Ciocca Rocco G, Messina Louis M, Eslami Mohammad H
Department of Surgery, University of Massachusetts Medical School, Worcester, MA 01655, USA.
J Vasc Surg. 2007 Dec;46(6):1112-1118. doi: 10.1016/j.jvs.2007.08.030.
Although carotid endarterectomy (CEA) is the gold standard for the treatment of carotid artery stenosis, the recent United States Food and Drug Administration approval of carotid artery stenting (CAS) may have led to its widespread use outside of clinical trials and registries. This study compared in-hospital postoperative stroke and mortality rates after CAS and CEA at the national level.
The Nationwide Inpatient Sample (NIS) was queried to identify all patient-discharges that occurred for revascularization of carotid artery stenosis. The International Classification of Diseases, 9th Revision, Clinical Modification procedure codes for CEA (38.12), CAS (00.63), and insertion of noncoronary stents (39.50, 39.90) were used in conjunction with the diagnostic codes for carotid artery stenosis, with (433.11) and without (433.10) stroke. Primary outcome measures included in-hospital postoperative stroke and death rates. Multivariate logistic regressions were performed to evaluate independent predictors of postoperative stroke and mortality. Adjustment was made for age, sex, medical comorbidities, admission diagnosis, procedure type, year, and hospital type.
During the calendar years 2003 and 2004, an estimated 259,080 carotid revascularization procedures were performed in the United States. CAS had a higher rate of in-hospital postoperative stroke (2.1% vs 0.88%, P < .0001) and higher postoperative mortality (1.3% vs 0.39%) than CEA. For asymptomatic patients (92%), the postoperative stroke rate was significantly higher for CAS than CEA (1.8% vs 0.86%, P < .0001), but the mortality rate was similar (0.44% vs 0.36%, P = .36). For symptomatic patients (8%), the rates for postoperative stroke (4.2% vs 1.1%, P < .0001) and mortality (7.5% vs 1.0%, P < .0001) were significantly higher after CAS. By multivariate regression, CAS was independently predictive of postoperative stroke (odds ratio [OR], 2.49; 95% confidence interval [CI], 1.91 to 3.25). CAS was also associated with in-hospital postoperative mortality for asymptomatic (OR, 2.37; 95% CI, 1.46 to 3.84) and symptomatic (OR, 2.64; 95% CI, 1.89 to 3.69) patients.
As determined from a large representative national sample including the years 2003 and 2004, the in-hospital stroke rate after CAS for asymptomatic patients was twofold higher than after CEA. For symptomatic patients, the respective in-hospital stroke and mortality rates were fourfold and sevenfold higher. These unexpected results indicate that further randomized controlled trials with homogenous symptomatic and asymptomatic patient groups should be performed.
虽然颈动脉内膜切除术（CEA）是治疗颈动脉狭窄的金标准，但美国食品药品监督管理局最近批准颈动脉支架置入术（CAS）可能导致其在临床试验和登记处之外广泛应用。本研究在全国范围内比较了CAS和CEA术后住院期间的卒中及死亡率。
查询全国住院患者样本（NIS）以确定所有因颈动脉狭窄血运重建而发生的患者出院情况。使用国际疾病分类第九版临床修订版中CEA（38.12）、CAS（00.63）以及非冠状动脉支架置入（39.50、39.90）的手术编码，并结合颈动脉狭窄的诊断编码，伴有（433.11）和不伴有（433.10）卒中。主要结局指标包括术后住院期间的卒中和死亡率。进行多因素逻辑回归以评估术后卒中和死亡的独立预测因素。对年龄、性别、合并症、入院诊断、手术类型、年份和医院类型进行了调整。
在2003年和2004年期间，美国估计进行了259,080例颈动脉血运重建手术。与CEA相比，CAS术后住院期间的卒中发生率更高（2.1%对0.88%，P <.0001），术后死亡率也更高（1.3%对0.39%）。对于无症状患者（92%），CAS术后卒中发生率显著高于CEA（1.8%对0.86%，P <.0001），但死亡率相似（0.44%对0.36%，P =.36）。对于有症状患者（8%），CAS术后卒中（4.2%对1.1%，P <.0001）和死亡率（7.5%对1.0%，P <.0001）显著更高。通过多因素回归分析，CAS是术后卒中的独立预测因素（比值比[OR]，2.49；95%置信区间[CI]，1.91至3.25）。CAS还与无症状（OR，2.37；95%CI，1.46至3.84）和有症状（OR，2.64；95%CI，1.89至3.69）患者的术后住院死亡率相关。
从2003年和2004年的大型代表性全国样本确定，无症状患者CAS术后住院卒中发生率比CEA术后高两倍。对于有症状患者，相应的住院卒中和死亡率分别高四倍和七倍。这些意外结果表明，应进行更具同质性的有症状和无症状患者组的进一步随机对照试验。
