Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy.
Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy.
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DOI：
10.1016/s0140-6736(21)01910-3
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发表时间：
2021-09-18
期刊：
影响因子：
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通讯作者：
ACST-2 Collaborative Group
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文献类型：
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作者：
Halliday A;Bulbulia R;Bonati LH;Chester J;Cradduck-Bamford A;Peto R;Pan H;ACST-2 Collaborative Group
在无症状的重度颈动脉狭窄但近期无卒中或短暂性脑缺血的患者中，颈动脉支架植入术（CAS）或颈动脉内膜切除术（CEA）可以恢复通畅性并降低长期卒中风险。然而，从最近的国家登记数据来看，每种选择都会导致约1%的致残性卒中或死亡的手术风险。比较它们的长期保护作用需要大规模的随机证据。ACST-2是一项在认为需要干预的无症状重度狭窄患者中比较CAS与CEA的国际多中心随机试验，与所有其他相关试验一起解释。如果患者患有严重的单侧或双侧颈动脉狭窄，并且医生和患者都同意应进行颈动脉手术，但他们基本上不确定选择哪一种，则患者符合资格。患者被随机分配到CAS或CEA组，随访1个月，然后每年一次，平均5年。手术事件是指干预后30天内发生的事件。提供意向治疗分析。包括手术危害的分析使用表格方法。非手术性中风的分析和荟萃分析使用Kaplan-Meier和对数秩方法。该试验已在ISRCTN登记研究中注册，ISRCTN 21144362。在2008年1月15日至2020年12月31日期间，130个中心的3625名患者被随机分配，其中1811人被分配到CAS，1814人被分配到CEA，他们具有良好的依从性，良好的药物治疗和平均5年的随访。总体而言，1%的患者发生了致残性卒中或手术死亡（15例分配至CAS，18例分配至CEA），2%的患者发生了非致残性手术卒中（48例分配至CAS，29例分配至CEA）。Kaplan-Meier法估计的致死性或致残性卒中的5年非手术性卒中发生率为2.5%，CAS组为5.3%，CEA组为4.5%（率比[RR] 1.16，95%CI 0.86 - 1.57; p= 0.33）。合并所有CAS与CEA试验中任何非手术性卒中的RR，有症状和无症状患者的RR相似（总体RR 1.11，95% CI 0.91 - 1.32; p= 0.21）。在合格的CAS和CEA后，严重的并发症同样罕见，这两种颈动脉手术对致死性或致残性卒中的长期影响相当。英国医学研究理事会和卫生技术评估计划。
Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. UK Medical Research Council and Health Technology Assessment Programme.