Murad M Hassan, Flynn David N, Elamin Mohamed B, Guyatt Gordon H, Hobson Robert W, Erwin Patricia J, Montori Victor M
Divisions of Preventive, Occupational and Aerospace Medicine, Mayo Clinic, Rochester, Minn, USA.
J Vasc Surg. 2008 Aug;48(2):487-93. doi: 10.1016/j.jvs.2008.05.035.
The relative efficacy and safety of endarterectomy and stenting in patients with carotid stenosis remain unclear. In this review we synthesize the available evidence derived from randomized controlled trials (RCTs) that compared the two procedures in terms of the risks of death, stroke (disabling and nondisabling), and nonfatal myocardial infarction.
We searched for RCTs in MEDLINE, EMBASE, Current Contents, and Cochrane CENTRAL; expert files, and bibliographies of included articles. Two reviewers, working independently, determined trial eligibility and extracted descriptive, methodologic, and outcome data from each eligible RCT. Random-effects meta-analysis was used to assess relative and absolute risks and the I(2) statistic was used to assess heterogeneity of treatment effect among trials.
Ten RCTs with 3182 participants proved eligible. At 30 days and compared with endarterectomy, carotid stenting was associated with a nonsignificant reduction in the risk of death (relative risk [RR], 0.61; 95% confidence interval [CI], 0.27-1.37; I(2) = 0%), a nonsignificant reduction in the risk of nonfatal myocardial infarction (RR, 0.43; 95% CI 0.17-1.11; I(2) = 0%), and a nonsignificant increase in the risk of any stroke (RR, 1.29; 95% CI, 0.73-2.26; I(2) = 40%) and major/disabling stroke (RR, 1.06; 95% CI, 0.32-3.52; I(2) = 45%). If one considers the two procedures equivalent if the absolute difference in events is <2%, these results provide moderate-quality evidence for equivalence with respect to death (risk difference [RD] -0.40, 95% CI -1.02 to 0.40) and nonfatal myocardial infarction (RD, -0.70; 95% CI -1.90 to 0.50), but because of much wider CI, only low-quality evidence of equivalence in stroke (RD, 1.00; 95% CI, -1.00 to 3.10).
In RCTs, carotid stenting and carotid endarterectomy seem equivalent in terms of death and nonfatal myocardial infarction. Although the impact on stroke remains unestablished, results are consistent with a clinically important increase in stroke risk with stenting, an intervention that aims at reducing the risk of stroke.
颈动脉狭窄患者中行动脉内膜切除术和支架置入术的相对疗效及安全性仍不明确。在本综述中,我们综合了来自随机对照试验(RCT)的现有证据,这些试验比较了这两种手术在死亡、中风(致残性和非致残性)及非致命性心肌梗死风险方面的差异。
我们在MEDLINE、EMBASE、《现刊目次》和Cochrane CENTRAL中检索RCT;查阅专家档案以及纳入文章的参考文献。两名独立工作的审阅者确定试验的合格性,并从每项合格的RCT中提取描述性、方法学和结果数据。采用随机效应荟萃分析评估相对风险和绝对风险,并用I²统计量评估各试验间治疗效果的异质性。
10项RCT共3182名参与者符合要求。在30天时,与动脉内膜切除术相比,颈动脉支架置入术在死亡风险方面有非显著性降低(相对风险[RR]为0.61;95%置信区间[CI]为0.27 - 1.37;I² = 0%),在非致命性心肌梗死风险方面有非显著性降低(RR为0.43;95% CI为0.17 - 1.11;I² = 0%),而在任何中风风险方面有非显著性增加(RR为1.29;95% CI为0.73 - 2.26;I² = 40%)以及在严重/致残性中风风险方面有非显著性增加(RR为1.06;95% CI为0.32 - 3.52;I² = 45%)。如果认为当事件的绝对差异<2%时这两种手术等效,那么这些结果为死亡(风险差[RD] -0.40,95% CI -1.02至0.40)和非致命性心肌梗死(RD,-0.70;95% CI -1.90至0.50)方面的等效性提供了中等质量的证据,但由于置信区间宽得多,在中风方面仅为等效性的低质量证据(RD,1.00;95% CI,-1.00至3.10)。
在RCT中,颈动脉支架置入术和颈动脉内膜切除术在死亡和非致命性心肌梗死方面似乎等效。尽管对中风的影响仍未明确,但结果与支架置入术(一种旨在降低中风风险的干预措施)使中风风险出现临床上重要增加的情况一致。