透导管或手术治疗大动脉狭窄症
Stefan Blankenberg1, Moritz Seiffert1, Reinhard Vonthein1
1From the Department of Cardiology and the Center for Population Health Innovation, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf (S. Blankenberg, M.S., P.C., N.D., R.T., A.Z.), German Center for Cardiovascular Research (Deutsches Zentrum für Herz-Kreislauf-Forschung [DZHK]) partner site Hamburg-Kiel-Lübeck (S. Blankenberg, M.S., P.C., J.C., N.D., I.E., S.E., D.F., I.R.K., H.R., R.T.), and the Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg (H.R.), Hamburg, the Department of Cardiology and Angiology, BG University Hospital Bergmannsheil, Ruhr University Bochum, Bochum (M.S.), the Institute of Medical Biometry and Statistics, University of Lübeck (R.V., I.R.K.), the Departments of Cardiology, Angiology, and Intensive Care Medicine (I.E.) and Cardiovascular Surgery (S.E.), University Hospital of Schleswig-Holstein, Lübeck, the Department of Cardiology III-Adult Congenital and Valvular Heart Disease, University Hospital Münster, Müster (H.B.), the Departments of Thoracic and Cardiovascular Surgery (S. Bleiziffer) and General and Interventional Cardiology-Angiology (T.K.R.), Heart and Diabetes Center NRW, Ruhr University Bochum, Bad Oeynhausen, University Clinic of Cardiac Surgery (M.A.B.) and the Department of Internal Medicine (H.T.), Heart Center Leipzig at Leipzig University (M.A.B., H.T.), and Leipzig Heart Science (H.T.) and the Department of Cardiology at University Hospital Leipzig (A.H.), Leipzig, the Departments of Cardiac Surgery (Y.-H.C.) and Cardiology (W.-K.K.), Kerckhoff Clinic, Bad Nauheim, Medical Clinic I, the Department of Cardiology and Angiology, University of Giessen and Marburg (W.-K.K.), and Campus Kerckhoff and Medical Clinic I, University of Giessen (C. Hamm), Giessen, the Departments of Cardiovascular Surgery (J.C.) and Internal Medicine III (D.F.), University Hospital of Schleswig-Holstein, Kiel, Clinic for Cardiovascular Surgery, University Heart Center Freiburg-Bad Krozingen, University Clinic Freiburg, and the Faculty of Medicine, Albert Ludwigs University Freiburg (M.C.), and the Department of Cardiology and Angiology, University Heart Center Freiburg-Bad Krozingen, Faculty of Medicine, University of Freiburg (F.-J.N., D.W.), Freiburg, the Department of Cardiology, Angiology, and Pneumology, Heidelberg University Hospital (N.F.), DZHK partner site Heidelberg-Mannheim (N.F., M. Karck), and the Department of Cardiac Surgery, University Hospital Heidelberg (M. Karck), Heidelberg, the Departments of Cardiac Surgery (C. Hagl) and Cardiology (S.M.), University Hospital Munich, Ludwig Maximilians University Munich, DZHK partner site Munich Heart Alliance (C. Hagl, M. Krane, S.M., E.X.), and the Department of Cardiovascular Surgery, Institute Insure, German Heart Center Munich, School of Medicine and Health (M. Krane), and the Department of Cardiology, German Heart Center Munich, Technical University of Munich (E.X.), Munich, DZHK partner site Rhine-Main, Rhine-Main (C. Hamm, W.-K.K., T.W.), the Departments of Cardiac Surgery (U.K.) and Internal Medicine and Cardiology (A.L.), Heart Center Dresden, University of Technology Dresden, Dresden, the Departments of Cardiology, Angiology, and Intensive Care Medicine (U.L.) and Cardiothoracic and Vascular Surgery (V.F.), Deutsches Herzzentrum der Charité, Charité University Medicine Berlin (U.L., V.F.), and DZHK partner site Berlin (U.L., V.F.), Berlin, the Departments of Internal Medicine II (L.S.M.) and Cardiothoracic Surgery (C.S.), University Medical Center Regensburg, Regensburg, and the Department of Cardiac and Vascular Surgery, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main (T.W.) - all in Germany; the Division of Cardiac Surgery, Department of Surgery, Yale School of Medicine, New Haven, CT (M. Krane); Cardio-CARE, Medizincampus Davos, Davos (A.Z., S. Blankenberg), and the Department of Health Sciences and Technology, ETH Zurich, Translational Cardiovascular Technology, Zurich (V.F.) - both in Switzerland; and the School of Mathematics, Statistics, and Computer Science, University of KwaZulu-Natal, Pietermaritzburg, South Africa (A.Z.).
在低风险的严重大动脉狭窄患者中,透气管大动脉植入 (TAVI) 证明与外科大动脉置换 (SAVR) 无差. 这一发现影响了这组患者的治疗策略.
科学领域:
- 心脏病学 心脏病学
- 干预心脏病学 干预心脏病学
- 心脏外科手术 心脏外科手术
背景情况:
- 严重的,有症状的大动脉狭窄症对那些符合跨导管大动脉植入 (TAVI) 和外科大动脉置换 (SAVR) 的低风险患者来说是一个治疗困境.
- 对于这个特定的患者队列,在常规临床实践中,关于最佳治疗策略的数据有限.
研究的目的:
- 为了比较TAVI与SAVR的疗效和安全性,在患有严重大动脉狭窄的患者中,低或中等的外科风险.
- 为了确定TAVI是否与SAVR在1年内死亡或中风的复合结果方面不劣.
主要方法:
- 一个随机的非劣势性试验,涉及38个德国站点的1414名患者 (701名TAVI,713名SAVR).
- 患者患有严重的大动脉狭窄,手术风险低至中等.
- 主要结局是1年后所有原因死亡或致命/非致命性中风的复合.
主要成果:
- 主要结局发生在TAVI组的5.4%与SAVR组的10.0%之间 (危险比,0.53;P<0.001非劣势).
- 与SAVR (6.2%) 相比,TAVI组 (2.6%) 的全因死亡率较低.
- 脑卒中发生率为TAVI的2.9%,SAVR的4.7%. 在这两组中,程序性并发症的发生率都很低.
结论:
- 通过导管的大动脉植入 (TAVI) 对低或中等外科风险的严重大动脉狭窄患者的外科大动脉置换 (SAVR) 没有劣势.
- 与SAVR相比,TAVI在该人群中显示,在一年内死亡或中风风险降低.
- 这些发现支持TAVI作为严重的大动脉狭窄症低风险患者的可行治疗选择.
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