Department of Neurology, Mayo Clinic, Jacksonville, FL, USA.
Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, DHU Neurovasc Sorbonne Paris Cité, INSERM U894, Paris, France.
Lancet Neurol. 2019 Apr;18(4):348-356. doi: 10.1016/S1474-4422(19)30028-6. Epub 2019 Feb 6.
The risk of periprocedural stroke or death is higher after carotid artery stenting (CAS) than carotid endarterectomy (CEA) for the treatment of symptomatic carotid stenosis. However, long-term outcomes have not been sufficiently assessed. We sought to combine individual patient-level data from the four major randomised controlled trials of CAS versus CEA for the treatment of symptomatic carotid stenosis to assess long-term outcomes.
We did a pooled analysis of individual patient-level data, acquired from the four largest randomised controlled trials assessing the relative efficacy of CAS and CEA for treatment of symptomatic carotid stenosis (Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis trial, Stent-Protected Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy trial, International Carotid Stenting Study, and Carotid Revascularization Endarterectomy versus Stenting Trial). The risk of ipsilateral stroke was assessed between 121 days and 1, 3, 5, 7, 9, and 10 years after randomisation. The primary outcome was the composite risk of stroke or death within 120 days after randomisation (periprocedural risk) or subsequent ipsilateral stroke up to 10 years after randomisation (postprocedural risk). Analyses were intention-to-treat, with the risk of events calculated using Kaplan-Meier methods and Cox proportional hazards analysis with adjustment for trial.
In the four trials included, 4775 patients were randomly assigned, of whom a total of 4754 (99·6%) patients were followed up for a maximum of 12·4 years. 21 (0·4%) patients immediately withdrew consent after randomisation and were excluded. Median length of follow-up across the studies ranged from 2·0 to 6·9 years. 129 periprocedural and 55 postprocedural outcome events occurred in patients allocated CEA, and 206 and 57 for those allocated CAS. After the periprocedural period, the annual rates of ipsilateral stroke per person-year were similar for the two treatments: 0·60% (95% CI 0·46-0·79) for CEA and 0·64% (0·49-0·83) for CAS. Nonetheless, the periprocedural and postprocedural risks combined favoured CEA, with treatment differences at 1, 3, 5, 7, and 9 years all ranging between 2·8% (1·1-4·4) and 4·1% (2·0-6·3).
Outcomes in the postprocedural period after CAS and CEA were similar, suggesting robust clinical durability for both treatments. Although long-term outcomes (periprocedural and postprocedural risks combined) continue to favour CEA, the similarity of the postprocedural rates suggest that improvements in the periprocedural safety of CAS could provide similar outcomes of the two procedures in the future.
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与颈动脉内膜切除术（CEA）相比，颈动脉支架置入术（CAS）治疗症状性颈动脉狭窄的围手术期卒中或死亡风险更高。然而，长期结果尚未得到充分评估。我们试图结合四项主要的 CAS 与 CEA 治疗症状性颈动脉狭窄的随机对照试验的个体患者水平数据，以评估长期结果。
我们对四项最大的随机对照试验评估 CAS 和 CEA 治疗症状性颈动脉狭窄的相对疗效的个体患者水平数据进行了汇总分析（症状性严重颈动脉狭窄患者的颈动脉内膜切除术与血管成形术试验、颈动脉支架保护经皮血管成形术与内膜切除术试验、国际颈动脉支架研究和颈动脉血运重建内膜切除术与支架置入术试验）。随机分组后 121 天至 1、3、5、7、9 和 10 年评估同侧卒中风险。主要结局为随机分组后 120 天内（围手术期风险）或随机分组后 10 年内同侧卒中（术后风险）的复合风险。分析采用意向治疗，使用 Kaplan-Meier 方法计算事件风险，并采用 Cox 比例风险分析，根据试验进行调整。
在纳入的四项试验中，4775 名患者被随机分配，其中共有 4754 名（99.6%）患者接受了最长 12.4 年的随访。21 名（0.4%）患者在随机分组后立即撤回同意并被排除。研究中中位随访时间范围为 2.0 至 6.9 年。CEA 组发生 129 例围手术期和 55 例术后结局事件，CAS 组分别发生 206 例和 57 例。围手术期后，两种治疗方法的同侧卒中每年发生率相似：CEA 组为 0.60%（95%CI 0.46-0.79），CAS 组为 0.64%（0.49-0.83）。尽管如此，围手术期和术后联合风险仍然有利于 CEA，1、3、5、7 和 9 年的治疗差异分别在 2.8%（1.1-4.4）和 4.1%（2.0-6.3）之间。
CAS 和 CEA 术后的长期结果相似，表明两种治疗方法都具有稳健的临床耐久性。尽管长期结果（围手术期和术后联合风险）仍然有利于 CEA，但术后率的相似性表明，未来 CAS 围手术期安全性的提高可能会为两种手术提供相似的结果。
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