经导管修复与二尖瓣手术治疗继发性二尖瓣反流。
Transcatheter Repair versus Mitral-Valve Surgery for Secondary Mitral Regurgitation.
机构信息
From the Department of Internal Medicine III (S.B., R.P.), the Institute of Medical Statistics and Computational Biology (W.M., J.F., M.H.), and Cardiothoracic Surgery (T. Wahlers), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, the Department of Cardiothoracic Surgery (T.D.) and Cardiology (P.C.S.), Jena University Hospital, Friedrich-Schiller-University of Jena, Jena, Thoracic and Cardiovascular Surgery (J.G.) and General and Interventional Cardiology/Angiology (V.R.), Heart and Diabetes Center NRW, University Hospital of the Ruhr-University Bochum, Medical Faculty OWL, Bad Oeynhausen, the Department of Cardiology, Ulm University Heart Center, Ulm (M. Kessler, W.R.), the Faculty of Health, School of Medicine (P.B.), and Helios Klinikum Krefeld (A.B.), University Witten/Herdecke, Witten, Marienkrankenhaus (E.L.), the Department of Cardiology, University Hospital Eppendorf (E.L.), and the Department of Cardiothoracic Surgery, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf (H.R.), Hamburg, the Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen (J.S.), Cardiac Surgery (T.N.), Heart Center Leipzig at Leipzig University (H.T.), and Leipzig Heart Science (H.T.), Leipzig, the Department of Cardiovascular Surgery, University Hospital Frankfurt and Goethe University Frankfurt, Frankfurt (T. Walther), University Hospital Düsseldorf and CARID (Cardiovascular Research Institute Düsseldorf), Düsseldorf (M. Kelm), Medical Clinic and Polyclinic I (J.H.) and the Department of Cardiac Surgery (C.H.), Ludwig Maximilian University Munich, Munich, Medical Clinic II, University Heart Center Lübeck, and the German Center for Cardiovascular Research (DZHK), Lübeck (I.E.), the Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim (U.F.-R.), Otto-von-Guericke-University Magdeburg, Magdeburg (A.S.), the Department of Cardiology, University Medical Center Rostock, Rostock (H.I.), the Department of Cardiology, University Medical Center Mainz (P.L., R.S.B.), and the German Center for Cardiovascular Research (DZHK) partner site Rhine Main (P.L.), Mainz, St. Franziskus Hospital, Münster (S.R.), and the Department of Cardiology, Helios Klinikum Siegburg, Siegburg (H.B.) - all in Germany.
出版信息
N Engl J Med. 2024 Nov 14;391(19):1787-1798. doi: 10.1056/NEJMoa2408739. Epub 2024 Aug 31.
BACKGROUND
Current treatment recommendations for patients with heart failure and secondary mitral regurgitation include transcatheter edge-to-edge repair and mitral-valve surgery. Data from randomized trials comparing these therapies are lacking in this patient population.
METHODS
In this noninferiority trial conducted in Germany, patients with heart failure and secondary mitral regurgitation who continued to have symptoms despite guideline-directed medical therapy were randomly assigned, in a 1:1 ratio, to undergo either transcatheter edge-to-edge repair (intervention group) or surgical mitral-valve repair or replacement (surgery group). The primary efficacy end point was a composite of death, hospitalization for heart failure, mitral-valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure. The primary safety end point was a composite of major adverse events within 30 days after the procedure.
RESULTS
A total of 210 patients underwent randomization. The mean (±SD) age of the patients was 70.5±7.9 years, 39.9% were women, and the mean left ventricular ejection fraction was 43.0±11.7%. Within 1 year, at least one of the components of the primary efficacy end point occurred in 16 of the 96 patients with available data (16.7%) in the intervention group and in 20 of the 89 with available data (22.5%) in the surgery group (estimated mean difference, -6 percentage points; 95% confidence interval [CI], -17 to 6; P<0.001 for noninferiority). A primary safety end-point event occurred in 15 of the 101 patients with available data (14.9%) in the intervention group and in 51 of the 93 patients with available data (54.8%) in the surgery group (estimated mean difference, -40 percentage points; 95% CI, -51 to -27; P<0.001).
CONCLUSIONS
Among patients with heart failure and secondary mitral regurgitation, transcatheter edge-to-edge repair was noninferior to mitral-valve surgery with respect to a composite of death, rehospitalization for heart failure, stroke, reintervention, or implantation of an assist device in the left ventricle at 1 year. (Funded by Abbott Vascular; MATTERHORN ClinicalTrials.gov number, NCT02371512.).
背景
目前，针对心力衰竭合并继发性二尖瓣反流患者的治疗建议包括经导管缘对缘修复术和二尖瓣手术。在这一患者群体中，缺乏比较这些治疗方法的随机试验数据。
方法
本试验在德国开展，为非劣效性试验，纳入了继续接受指南指导的药物治疗但仍有症状的心力衰竭合并继发性二尖瓣反流患者，按 1:1 比例随机分配至行经导管缘对缘修复术（干预组）或二尖瓣手术修复或置换（手术组）。主要疗效终点是术后 1 年内死亡、心力衰竭再住院、二尖瓣再介入、辅助装置植入或卒中等复合终点。主要安全性终点是术后 30 天内主要不良事件的复合终点。
结果
共有 210 例患者接受了随机分组。患者的平均（±SD）年龄为 70.5±7.9 岁，39.9%为女性，左心室射血分数的平均水平为 43.0±11.7%。在 1 年内，干预组中 96 例有可用数据的患者（16.7%）和手术组中 89 例有可用数据的患者（22.5%）中至少有一个主要疗效终点组成部分发生，估计平均差值为-6 个百分点；95%置信区间为-17 至 6；非劣效性检验 P<0.001）。干预组中有 101 例有可用数据的患者（14.9%）和手术组中有 93 例有可用数据的患者（54.8%）发生了主要安全性终点事件，估计平均差值为-40 个百分点；95%置信区间为-51 至-27；P<0.001）。
结论
在心力衰竭合并继发性二尖瓣反流患者中，经导管缘对缘修复术在 1 年时与二尖瓣手术相比，在死亡、心力衰竭再住院、卒中等复合终点方面不劣效。（由 Abbott Vascular 资助；MATTERHORN ClinicalTrials.gov 编号，NCT02371512。）
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