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稳定型冠心病患者初始有创与保守治疗策略的比较
Initial Invasive or Conservative Strategy for Stable Coronary Disease


David J. Maron ... 心脑血管疾病 • 2020.04.09
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• 一种有创策略可能对一些稳定型缺血性心脏病合并心力衰竭患者有帮助 • 磁共振灌注与血流储备分数指导冠心病治疗的比较

稳定型冠心病——到底要不要放支架

 

高微

复旦大学附属中山医院心内科

 

无论在学术界还是冠心病患者眼中,经皮冠状动脉介入治疗(PCI)有时候会是一个争议性话题。根据指南,急性冠脉综合征(ACS,包括不稳定型心绞痛和急性心肌梗死)患者毫无疑问应该接受血运重建治疗1,包括PCI和冠状动脉搭桥,其中PCI因为其创伤小、恢复快等优势已成为目前临床实践的主流,在国内尤其如此。但对于稳定型冠心病患者,情况就变得有点复杂了。

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摘要


背景

在有中度或重度缺血的稳定型冠心病患者中,目前尚未明确接受有创介入联合药物治疗的患者的临床结局是否优于接受单独药物治疗的患者。

 

方法

我们将有中度或重度缺血的5,179例患者随机分组,一组采用初始有创治疗(血管造影,可行的情况下进行血运重建)+药物治疗策略,另一组采用初始保守治疗策略(单独药物治疗,药物治疗失败的情况下进行血管造影)。主要结局是由心血管原因死亡、心肌梗死、因不稳定型心绞痛或心力衰竭住院或者心脏停搏复苏构成的复合结局。关键次要结局是心血管原因死亡或心肌梗死。

 

结果

在中位3.2年期间,有创策略组和保守策略组分别发生了318起和352起主要结局事件。6个月时,有创策略组和保守策略组的事件累积发生率分别为5.3%和3.4%(差异,1.9个百分点;95%置信区间[CI],0.8~3.0);5年时,两组的事件累积发生率分别为16.4%和18.2%(差异,-1.8个百分点;95% CI,-4.7~1.0)。关键次要结局的结果相似。主要结局发生率易受心肌梗死定义的影响;次要分析产生了较多临床意义不明的围手术期心肌梗死。有创策略组和保守策略组分别有145例和144例患者死亡(风险比,1.05;95% CI,0.83~1.32)。

 

结论

在有中度或重度缺血的稳定型冠心病患者中,我们发现并无证据表明在中位3.2年期间,与初始保守治疗策略相比,初始有创治疗策略可降低缺血性心血管事件或全因死亡风险。试验结果易受所使用的心肌梗死定义的影响(由美国国立心肺和血液研究所[National Heart, Lung, and Blood Institute]等资助,ISCHEMIA在ClinicalTrials.gov注册号为NCT01471522)。





作者信息

David J. Maron, M.D., Judith S. Hochman, M.D., Harmony R. Reynolds, M.D., Sripal Bangalore, M.D., M.H.A., Sean M. O’Brien, Ph.D., William E. Boden, M.D., Bernard R. Chaitman, M.D., Roxy Senior, M.D., D.M., Jose López-Sendón, M.D., Karen P. Alexander, M.D., Renato D. Lopes, M.D., Ph.D., Leslee J. Shaw, Ph.D., et al., for the ISCHEMIA Research Group*
From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars–Sinai Medical Center, Los Angeles (D.S.B.) — both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York–Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York–Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) — all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) — both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women’s Hospital (R.Y.K., D.O.W.) — all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke’s Mid America Heart Institute and the University of Missouri–Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) — all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) — all in Spain; Canadian Heart Research Centre and St. Michael’s Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) — all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) — all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine–Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique–Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.). Address reprint requests to Dr. Maron at the Department of Medicine, Stanford University School of Medicine, 1265 Welch Rd., Medical School Office Bldg. x314, Stanford, CA 94305, or at david.maron@stanford.edu; or to Dr. Hochman at the New York University Grossman School of Medicine–New York University Langone Health, 530 First Ave., Skirball 9R, New York, NY 10016, or at judith.hochman@nyumc.org. *A full list of ISCHEMIA Research Group members is provided in the Supplementary Appendix, available at NEJM.org.

 

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