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英国牛津大学纳菲尔德人口健康系Alison Halliday团队研究了颈动脉支架置入术与颈动脉内膜切除术对无症状颈动脉严重狭窄患者的疗效。相关论文于2021年8月29日发表于《柳叶刀》杂志上。

在无症状、颈动脉严重狭窄但无近期卒中或短暂性脑缺血的患者中，颈动脉支架置入术（CAS）或颈动脉内膜切除术（CEA）均可恢复通畅，降低长期卒中风险。然而，从最近的国家注册数据来看，每种选择都会导致大约1%的程序性中风或死亡风险。比较它们的长期保护作用仍需要大规模的随机证据。

研究组进行了一项国际性多中心随机试验，对被认为需要干预的无症状严重狭窄患者进行CAS与CEA的比较，并与所有其他相关试验一起解释。招募的患者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，但他们不确定应该选择哪一种。将患者随机分配到CAS或CEA组，随访1个月，然后每年随访，平均5年。程序性事件是干预后30天内的事件，提供意向处理分析。

2008年1月15日至2020年12月31日，130个中心共随机分配3625例患者，1811例接受CAS，814例接受CEA，依从性好，药物治疗良好，平均随访5年。总体而言，1%的患者有程序性致残性中风或死亡，其中CAS组15例，CEA组18例； 2%的患者有非致残性程序性中风，其中CAS组48例，CEA组29例。Kaplan-Meier估计每组致死性或致残性脑卒中的5年非程序性脑卒中发生率为2.5%，CAS组全因卒中发生率为5.3%，CEA组为4.5%。综合所有CAS和CEA组中任何非程序性脑卒中的RR，有症状和无症状患者的RR相似。

研究结果表明，经CAS和CEA有效治疗后，严重并发症均不常见，这两种颈动脉手术对致命或致残性中风的长期影响相似。

附：英文原文

Title: Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy

Author: Alison Halliday, Richard Bulbulia, Leo H Bonati, Johanna Chester, Andrea Cradduck-Bamford, Richard Peto, Hongchao Pan, Alison Halliday, Richard Bulbulia, Leo H Bonati, Richard Peto, Hongchao Pan, John Potter, Hans Henning Eckstein, Barbara Farrell, Marcus Flather, Averil Mansfield, Boby Mihaylova, Kazim Rahimi, David Simpson, Dafydd Thomas, Peter Sandercock, Richard Gray, Andrew Molyneux, Cliff P Shearman, Peter Rothwell, Anna Belli, Will Herrington, Parminder Judge, Peter Leopold, Marion Mafham, Michael Gough, Piergiorgio Cao, Sumaira MacDonald, Vasha Bari, Clive Berry, S Bradshaw, Wojciech Brudlo, Alison Clarke, Johanna Chester, Robin Cox, Andrea Cradduck-Bamford, Susan Fathers, Kamran Gaba, Mo Gray, Elizabeth Hayter, Constance Holliday, Rijo Kurien, Michael Lay, Steffi le Conte, Jessica McManus, Zahra Madgwick, Dylan Morris, Andrew Munday, Sandra Pickworth, Wiktor Ostasz, Michiel Poorthuis, Sue Richards, Louisa Teixeira, Sergey Tochlin, Lynda Tully, Carol Wallis, Monique Willet, Alan Young, Renato Casana, Chiara Malloggi, Andrea Odero Jr, Vincenzo Silani, Gianfranco Parati, Giuseppe Malchiodi, Giovanni Malferrari, Francesco Strozzi, Nicola Tusini, Enrico Vecchiati, Gioacchino Coppi, Antonio Lauricella, Roberto Moratto, Roberto Silingardi, Jessica Veronesi, Andrea Zini, Emanuele Ferrero, Michelangelo Ferri, Andrea Gaggiano, Carmelo Labate, Franco Nessi, Daniele Psacharopulo, Andrea Viazzo, Giovanni Malacrida, Daniela Mazzaccaro, Giovanni Meola, Alfredo Modafferi, Giovanni Nano, Maria Teresa Occhiuto, Paolo Righini, Silvia Stegher, Stefano Chiarandini, Filippo Griselli, Sandro Lepidi, Fabio Pozzi Mucelli, Marcello Naccarato, Mario DOria, Barbara Ziani, Andrea Stella, Mortalla Dieng, Gianluca Faggioli, Mauro Gargiulo, Sergio Palermo, Rodolfo Pini, Giovanni Maria Puddu, Andrea Vacirca, Domenico Angiletta, Claudio Desantis, Davide Marinazzo, Giovanni Mastrangelo, Guido Regina, Raffaele Pulli, Paolo Bianchi, Lea Cireni, Elisabetta Coppi, Rocco Pizzirusso, Filippo Scalise, Giovanni Sorropago, Valerio Tolva, Valeria Caso, Enrico Cieri, Paola DeRango, Luca Farchioni, Giacomo Isernia, Massimo Lenti, Gian Battista Parlani, Guglielmo Pupo, Grazia Pula, Gioele Simonte, Fabio Verzini, Federico Carimati, Maria Luisa Delodovici, Federico Fontana, Gabriele Piffaretti, Matteo Tozzi

Issue&Volume: 2021-08-29

Abstract: Background

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.

Methods

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.

Findings

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).

Interpretation

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.

DOI: 10.1016/S0140-6736(21)01910-3

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01910-3/fulltext

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