Mas Jean-Louis, Chatellier Gilles, Beyssen Bernard, Branchereau Alain, Moulin Thierry, Becquemin Jean-Pierre, Larrue Vincent, Lièvre Michel, Leys Didier, Bonneville Jean-François, Watelet Jacques, Pruvo Jean-Pierre, Albucher Jean-François, Viguier Alain, Piquet Philippe, Garnier Pierre, Viader Fausto, Touzé Emmanuel, Giroud Maurice, Hosseini Hassan, Pillet Jean-Christophe, Favrole Pascal, Neau Jean-Philippe, Ducrocq Xavier
Hôpitaux Sainte-Anne, Université René Descartes, Paris, France.
N Engl J Med. 2006 Oct 19;355(16):1660-71. doi: 10.1056/NEJMoa061752.
Carotid stenting is less invasive than endarterectomy, but it is unclear whether it is as safe in patients with symptomatic carotid-artery stenosis.
We conducted a multicenter, randomized, noninferiority trial to compare stenting with endarterectomy in patients with a symptomatic carotid stenosis of at least 60%. The primary end point was the incidence of any stroke or death within 30 days after treatment.
The trial was stopped prematurely after the inclusion of 527 patients for reasons of both safety and futility. The 30-day incidence of any stroke or death was 3.9% after endarterectomy (95% confidence interval [CI], 2.0 to 7.2) and 9.6% after stenting (95% CI, 6.4 to 14.0); the relative risk of any stroke or death after stenting as compared with endarterectomy was 2.5 (95% CI, 1.2 to 5.1). The 30-day incidence of disabling stroke or death was 1.5% after endarterectomy (95% CI, 0.5 to 4.2) and 3.4% after stenting (95% CI, 1.7 to 6.7); the relative risk was 2.2 (95% CI, 0.7 to 7.2). At 6 months, the incidence of any stroke or death was 6.1% after endarterectomy and 11.7% after stenting (P=0.02). There were more major local complications after stenting and more systemic complications (mainly pulmonary) after endarterectomy, but the differences were not significant. Cranial-nerve injury was more common after endarterectomy than after stenting.
In this study of patients with symptomatic carotid stenosis of 60% or more, the rates of death and stroke at 1 and 6 months were lower with endarterectomy than with stenting. (ClinicalTrials.gov number, NCT00190398 [ClinicalTrials.gov].).
颈动脉支架置入术的侵入性低于动脉内膜切除术，但对于有症状的颈动脉狭窄患者，其安全性是否相同尚不清楚。
我们进行了一项多中心、随机、非劣效性试验，比较支架置入术与动脉内膜切除术在至少60%有症状颈动脉狭窄患者中的疗效。主要终点是治疗后30天内任何卒中或死亡的发生率。
由于安全性和无效性原因，在纳入527例患者后，该试验提前终止。动脉内膜切除术后30天内任何卒中或死亡的发生率为3.9%（95%置信区间[CI]，2.0至7.2），支架置入术后为9.6%（95%CI，6.4至14.0）；与动脉内膜切除术相比，支架置入术后任何卒中或死亡的相对风险为2.5（95%CI，1.2至5.1）。动脉内膜切除术后30天内致残性卒中或死亡的发生率为1.5%（95%CI，0.5至4.2），支架置入术后为3.4%（95%CI，1.7至6.7）；相对风险为2.2（95%CI，0.7至7.2）。在6个月时，动脉内膜切除术后任何卒中或死亡的发生率为6.1%，支架置入术后为11.7%（P = 0.02）。支架置入术后主要局部并发症更多，动脉内膜切除术后全身并发症（主要是肺部）更多，但差异不显著。动脉内膜切除术后颅神经损伤比支架置入术后更常见。
在这项对60%或以上有症状颈动脉狭窄患者的研究中，动脉内膜切除术在1个月和6个月时的死亡和卒中发生率低于支架置入术。（ClinicalTrials.gov编号，NCT00190398 [ClinicalTrials.gov]。）
