摘要：MV reports personal fees from Astra Zeneca, Alvimedica–CID, Abbott Vascular, Daiichi Sankyo, Bayer, CoreFLOW, Idorsia Pharmaceutic
冠状动脉疾病是一种以心脏动脉狭窄为特征的疾病，通常需要终身治疗以预防心脏病发作、中风和心血管死亡。传统观点是建议长期服用阿司匹林，但其长期疗效和安全性证据有限。此次对七项临床试验的数据分析发现，服用氯吡格雷的患者发生主要不良心脑血管事件（包括心脏病发作、中风或心血管死亡）的风险比服用阿司匹林的患者低14%。重要的是，两种药物的严重出血发生率相似，这消除了人们对氯吡格雷可能导致更多出血并发症的担忧。
该分析涵盖了不同的患者群体，包括接受过支架植入或患有急性冠脉综合征的患者，并对不同亚组进行了评估，以确保研究结果具有广泛适用性。值得注意的是，即使是因遗传或临床因素对氯吡格雷反应较差的患者，使用氯吡格雷仍比使用阿司匹林更有益。研究结果表明，对于已确诊冠状动脉疾病的患者，氯吡格雷应被视为首选的长期抗血小板药物。
作者指出，由于这两种药物均具有广泛的可获得性，该研究结果有望影响全球临床指南，并改善患者预后。未来还需进一步研究氯吡格雷的成本效益研究和开展更大范围的人群研究，以支持治疗标准的调整。
氯吡格雷与阿司匹林在冠状动脉疾病二级预防中的比较：
系统综述与个体患者数据meta分析
背景
阿司匹林单药治疗被推荐为确诊冠状动脉粥样硬化性心脏病（CAD）患者的长期二级预防方案。本研究旨在通过个体患者数据meta分析，全面评估氯吡格雷与阿司匹林单药治疗在确诊冠状动脉疾病患者中的疗效和安全性，这些患者大多数接受过经皮冠状动脉介入治疗（PCI）或患有急性冠脉综合征（ACS）。
方法
我们在PubMed、Scopus、Web of Science和Embase数据库中进行了系统检索，筛选截至2025年4月12日发表的随机对照试验，在已停止或未开始双联抗血小板治疗的确诊冠状动脉粥样硬化性心脏病患者中，比较氯吡格雷单药与阿司匹林单药的疗效和安全性。纳入此个体患者数据meta分析的试验均包含初始阶段的双联抗血小板治疗。主要分析采用半参数共享对数正态脆弱性模型（单阶段分析），其中包括通过随机截距调整不同试验的基线风险差异，随机斜率调整治疗效应的异质性。主要疗效终点为心血管病死亡、心肌梗死或卒中的复合事件（主要不良心脑血管事件，MACCE）；主要安全终点为严重出血。该研究已在PROSPERO注册，编号CRD42025645594。
结果
本研究共纳入7项随机对照试验，涵盖28982名患者（氯吡格雷组14507人，阿司匹林组14475人），中位随访期2.3年（四分位距1.1-4.0年）。5.5年时，氯吡格雷组MACCE发生率显著低于阿司匹林组（929例，2.61/100人年vs 1062例，2.99/100人年；风险比0.86，95%CI 0.77-0.96；p=0.0082）。两组在全因死亡率和严重出血事件发生率（氯吡格雷组256例，0.71/100人年；阿司匹林组279例，0.77/100人年；风险比0.94，95%CI 0.74-1.21；p=0.64）上无显著差异。
解释
研究结果进一步证明，氯吡格雷单药治疗在预防主要不良心脑血管事件方面优于阿司匹林单药治疗，且不会增加出血风险，这支持在确诊冠状动脉粥样硬化性心脏病患者的二级预防中优先使用氯吡格雷。 END
Funding
Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Switzerland.
Declaration of interests
MV reports personal fees from Astra Zeneca, Alvimedica–CID, Abbott Vascular, Daiichi Sankyo, Bayer, CoreFLOW, Idorsia Pharmaceuticals, Universität Basel Depart Klinische Forschung, Bristol Myers Squibb, Medscape, Biotronik, and Novartis; and grants and personal fees from Terumo. KHC reports funding from the Korean Society of Cardiology and Abbott Vascular. FG reports personal fees from Sanofi for participation on an advisory board. TK reports research grants from Abbott and Boston Scientific. MW is a consultant for Freeline and has, in the past 12 months, been a consultant to Amgen. DLB is on advisory boards for Angiowave, Bayer, Boehringer Ingelheim, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, and Stasys; is on the board of directors for American Heart Association New York City; holds stock options at Angiowave and DRS.LINQ; holds stock at Bristol Myers Squibb and High Enroll; is a consultant for Broadview Ventures, GlaxoSmithKline, Hims, SFJ, and Youngene; and is on the data monitoring committees of Acesion Pharma, Assistance PubliqueHôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic, Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, and Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo). DLB is funded by Concept Medical (for the ABILITY-DM trial), by Alleviant Medical, Novartis, and Population Health Research Institute (for ALLAY-HF), and by Rutgers University (for the NIxnded MINT Trial). DLB reports honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi–Bristol Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim, AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), CSL Behring (AHA lecture), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor and Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence–ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), WebMD (CME steering committees), and Wiley (steering committee). DLB is a deputy editor for Clinical Cardiology; and is named on a patent for sotagliflozin assigned to Brigham and Women’s Hospital, who subsequently assigned it to Lexicon; neither DLB nor the Brigham and Women’s Hospital receive any income from this patent. DLB reports research funding from Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Alnylam, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CinCor, Cleerly, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Otsuka, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, and 89Bio. DLB reports receiving royalties from Elsevier (Editor, Braunwald’s Heart Disease); is a site co-investigator for Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, and Vascular Solutions; is a trustee for the American College of Cardiology; and reports unfunded research for FlowCo. DJA reports consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, CSL Behring, Daiichi-Sankyo, Eli Lilly, Faraday, Haemonetics, Janssen, Merck, Novartis, Novo Nordisk, PhaseBio, PLx Pharma, Pfizer, and Sanofi; and research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Faraday, Gilead, Idorsia, Janssen, Matsutani Chemical Industry Co, Merck, Novartis, and the Scott R MacKenzie Foundation, all paid to institution. RM reports grants or contracts from Abbott, Affluent Medical, Alleviant Medical, Amgen, AstraZeneca, BAIM, Beth Israel Deaconess Medical Center, Boston Scientific, Bristol Myers Squibb, CardiaWave, CERC, Chiesi, Concept Medical, Daiichi Sankyo, Duke, Faraday, Idorsia, Janssen, MedAlliance, Medscape, Mediasphere, Medtelligence, Medtronic, Novartis, OrbusNeich, Pi-Cardia, Protembis, RM Global Bioaccess Fund Management, Sanofi, and Zoll (paid to their institution); consulting fees from Affluent Medical, Boehringer Ingelheim, Chiesi USA, Cordis, Daiichi Sankyo, Esperion Science– Innovative Biopharma, Gaffney Events, Educational Trust, Global Clinical Trial Partners, IQVIA, Medscape–WebMD Global, Novo Nordisk, PeerView Institute for Medical Education, TERUMO Europe NV, and Radcliffe (personal fees); honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from the American College of Cardiology Board of trustees, Steering Committee Member, and American Medical Association (for being an Associate Editor at JAMA); leadership or a fiduciary role in other board, society, committee, or advocacy group, paid or unpaid, from the American Medical Association (Scientific Advisory Board, and as Associate Editor for JAMA Cardiology), American College of Cardiology (Board of Trustees Member and Steering Committee Member of the Clinical Trial Research Program), and the Society for Cardiovascular Angiography & Interventions (Women in Innovations committee member); stock or stock options for Elixir Medical, Stel, and ControlRad; and was a faculty member but receives no fees from the Cardiovascular Research Foundation. YBS reports funding from the Korean Society of Cardiology and Microport. J-YH reports funding from the South Korean National Evidence-based Healthcare Collaborating Agency, the South Korean Ministry of Health & Welfare, Abbott Vascular, Biosensors, Biotronik, Boston Scientific, Daiichi Sankyo, Dong-A ST, Hanmi Pharmaceutical, and Medtronic. All other authors declare no competing interests.
中文翻译仅供参考，所有内容以英文原文为准。
https://doi.org/10.1016/S0140-6736(25)01562-4
来源：柳叶刀TheLancet