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2021 ESC 主动脉和外周动脉疾病的抗栓治疗共识(一)

Victor Aboyans1*Rupert Bauersachs2Lucia Mazzolai3Marianne Brodmann4José F.Rodriguez Palomares5Sebastian Debus6Jean-Philippe Collet7Heinz Drexel8Christine Espinola-Klein9BasilS.Lewis10Marco Roffi11Dirk Sibbing12Henrik Sillesen13,14Eugenio Stabile15Oliver Schlager16、和MarcoDeCarlo17

1.Department of Cardiology, Dupuytren University Hospital, and INSERM 1094 & IRD, University of Limoges, 2, Martin Luther King ave, 87042, Limoges, France;

2. Department of Vascular Medicine, Klinikum Darmstadt GmbH, Darmstadt Germany, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz, Germany;

3. Division of Angiology,Heart and Vessel Department, Lausanne University Hospital (CHUV), Lausanne, Switzerland;

4. Division of Angiology, Medical University Graz, Austria;

5. Department ofCardiology, Vall d’Hebron Institut de Recerca (VHIR), Hospital Universitari Vall d’Hebron, Universitat Auto`noma de Barcelona, Centro de Investigacio´n Biome´dica en RedCV, CIBER CV, Barcelona, Spain;

6. Department of Vascular Medicine, University Heart Centre Hamburg, University Medical Centre HamburgEppendorf, Hamburg, Germany;

7. Sorbonne Universite´, ACTION Study Group (www.actioncoeur.org), INSERM UMRS 1166, Institut de Cardiologie, Hoˆ pital Pitie´Salpeˆtrie`re (APHP), Paris, France;

8. Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT), Landeskrankenhaus Feldkirch, Austria;

9. Section Angiology, Department of Cardiology, Cardiology I, University Medical Center Mainz, Mainz, Germany;

10. Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine, TechnionIsrael Institute of Technology, Haifa, Israel;

11. Division of Cardiology, University Hospitals, Geneva, Switzerland;

12. Ludwig Maximilians Universita¨t Mu¨nchen and Privatklinik Lauterbacher Mu¨hle am Ostersee, Munich,

Germany;

13. Department of Vascular Surgery, Rigshospitalet, University of Copenhagen, Denmark;

14. Department of Clinical Medicine, University of Copenhagen, Denmark;

15. Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples 'Federico II’, Naples, Italy;

16. Division of Angiology, 2nd Department of Medicine, Medical University of Vienna, Austria;

17. Cardiothoracic and Vascular Department, Azienda OspedalieroUniversitaria Pisana, Pisa, Italy


摘要
本合作文件的目的在于为临床医生提供有关主动脉和/或外周动脉疾病患者抗血栓治疗最佳策略的最新信息。
抗血栓治疗是极高心血管风险患者最佳药物治疗的支柱。尽管针对主动脉或外周动脉疾病患者进行抗血栓治疗的试验数量远少于针对冠状动脉疾病患者的试验,但仍有近期证据值得纳入临床实践。在因伴随心血管疾病导致慢性口服抗凝治疗没有特定适应症的情况下,单一抗血小板药物成为主动脉或外周动脉疾病患者长期抗血栓治疗的基础。
本文将基于患者的缺血和出血风险以及治疗途径(如血管内治疗)讨论其与另一种抗血小板药物或低剂量抗凝血剂的相关性。本共识文件旨在根据动脉疾病的定位和临床表现为抗血栓治疗提供指导。但其不能替代对于不确定缺血/出血平衡患者的多学科团队讨论。由于个体患者的这种平衡会随着时间推移发生变化,因此对抗血栓治疗定期进行重新评估至关重要。


外周动脉疾病患者的最佳和替代性抗血栓策略摘要。a在没有任何其他血管疾病情况下。b在小剂量阿司匹林和利伐沙班基础上加用氯吡格雷可在考虑支架类型和长度、疾病严重程度和出血风险情况下根据具体病例决定。如加用氯吡格雷,则应限制在1个月内,以减少出血并发症。100 c目前尚无直接比较R AA C策略的数据。后者已经依靠经验进行实施并被推荐用于血管内治疗,1而最近的一项随机试验对R A进行了评估。80此外,R A策略还可延长至血管重建后期,对MACEMALE均有好处。


关键词

抗血栓治疗·抗凝血剂·抗血小板药物·外周动脉疾病·主动脉·下肢动脉疾病·颈动脉·椎动脉·锁骨下动脉·肾动脉·肠系膜动脉·血栓形成


引言

2017年,欧洲心脏病学会(ESC)与欧洲血管外科学会合作发布了外周动脉疾病(PAD)诊断和处理指南。1该文件强调了抗血栓治疗对于预防主要不良心血管事件(MACE)的重要性,并强调了新型抗血栓治疗相关风险降低方面的主要证据空白。自此开始,主要随机对照试验(RCT)和注册的结果让这类患者的抗血栓方案发生极大的变化。此外,经常被归类为主要不良肢体事件(MALE)的外周事件也日益受到关注。为此,参与编撰本合作文件的三个工作组意识到为临床医生提供整体路线图的迫切需要,以便优化主动脉疾病和/PAD患者的抗血栓治疗,同时重点关注此类疾病的术后和慢性阶段。本文件按动脉区域编撰,最后以因相关疾病需要长期口服抗凝血剂患者的处理以及血管患者的出血风险评估作为结束。

颈动脉、椎动脉和锁骨下动脉

信息要点:颈动脉、锁骨下动脉或椎动脉疾病的抗血栓治疗

·对于有症状或无症状颈动脉狭窄患者,建议使用阿司匹林或氯吡格雷进行长期抗血小板治疗。

·双联抗血小板治疗(DAPT)(阿司匹林 替格瑞洛或氯吡格雷)可推荐用于轻度卒中或短暂性脑缺血发作(TIA)早期的有症状颈动脉狭窄患者。

·DAPT(阿司匹林 氯吡格雷)推荐用于接受颈动脉支架置入术的患者,至少使用1个月。

·计划接受CEA的患者应维持SAPT。

·对于无症状颈动脉狭窄患者或有颈部血管重建史的患者,如果其因相关并发症(尤其是多血管患者)被认为具有极高风险并且出血风险不高,可建议长期低剂量利伐沙班联合阿司匹林治疗。*

·在缺乏具体证据情况下,对于椎动脉和锁骨下动脉疾病采用与颈动脉疾病相同的抗血栓策略具有合理性。

* 禁忌用于:颅内出血或缺血性卒中病史、其他颅内病理史、近期胃肠出血或可能因胃肠道失血引起的贫血、与出血风险增加相关的其他胃肠道病理、肝功能衰竭、出血性素质或凝血障碍,极高龄或脆弱,或存在需要透析或eGFR<15mL/min/1.73m2的肾功能衰竭。

颈动脉疾病的抗血栓治疗

颈动脉斑块是发生栓塞性卒中的潜在原因,并且其与卒中以外的心血管事件风险增加存在相关性。由于目前尚无研究单一抗血小板治疗(SAPT,如阿司匹林)减少非狭窄颈动脉斑块患者心血管事件的相关试验,因此本文件将侧重于颈动脉狭窄(管腔狭窄>50%)的患者。

无症状颈动脉疾病

无症状颈动脉狭窄患者的抗血栓治疗仍然存在争议。作为该背景下的唯一试验,ACB研究未能显示阿司匹林与安慰剂相比的优效性,但其规模有限(表1)。3 在观察性研究中,主要由低剂量阿司匹林构成的SAPTMACE风险降低存在相关性,但中度狭窄(即50%–75%)的数据相互矛盾。12–14DAPT联合阿司匹林和氯吡格雷与SAPT相比没有优势。15 ESC指南建议对无症状且≥50%颈动脉狭窄的患者(如果患者出血风险较低)进行长期SAPT1

最近,COMPASS试验将慢性冠状动脉和/或外周动脉疾病患者随机分为三组:双通路抑制(DPI)联合阿司匹林100 mg o.d. 利伐沙班2.5 mg bid对比利伐沙班5 mg bid对比阿司匹林100 mg o.d.16总体而言,与单用阿司匹林的患者相比,分配使用DPI患者的MACE显著下降(表1),在1919例有颈动脉血管重建史或无症状≥50%狭窄的患者中观察到类似的趋势,尽管由于样本量有限可能没有统计学意义。16没有报告无症状颈动脉狭窄亚组的具体数据。

有症状颈动脉疾病

有症状颈动脉狭窄与脑血管缺血事件早期复发的高风险存在相关性。17在与大动脉疾病相关的脑血管意外患者中,SAPT(阿司匹林或氯吡格雷)在减少复发事件方面比口服维生素K拮抗剂(VKA)更为有效。2,3,18,19SOCRATES试验的同侧动脉粥样硬化性狭窄亚组分析表明,与接受阿司匹林的患者相比,接受替格瑞洛患者的MACE发生率显著降低(表1)。4

对于有症状颈动脉狭窄早期的DAPT,阿司匹林和氯吡格雷的合并用药降低了无症状脑栓塞和卒中的风险。20–23另外其还降低了轻微卒中缺血性发作和TIA后卒中复发的风险。2425最近,在轻微卒中或高风险TIA患者中使用替卡格雷t阿司匹林与单用阿司匹林对照的THALES试验(n=11 016)表明死亡或卒中风险显著降低17%。26在针对同侧颅外/颅内狭窄>30%患者进行的预先指定亚组分析中,风险降低更加显著(表1),并且具有非常高的收益/风险比。5有关双嘧达莫减少卒中疗效的数据存在不一致,没有针对颈动脉狭窄的特异性结果。27–29


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