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.).

中文翻译：

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经导管修复与二尖瓣手术治疗继发性二尖瓣反流。


背景 目前对心力衰竭和继发性二尖瓣反流患者的治疗建议包括经导管边缘对边缘修复和二尖瓣手术。在该患者群体中缺乏比较这些疗法的随机试验数据。方法 在德国进行的这项非劣效性试验中，尽管接受了指南指导的药物治疗，但仍有症状的心力衰竭和继发性二尖瓣反流患者以 1：1 的比例随机分配接受经导管边缘到边缘修复（干预组）或手术二尖瓣修复或置换（手术组）。主要疗效终点是术后 1 年内死亡、因心力衰竭住院、二尖瓣再介入、植入辅助装置或中风的复合终点。主要安全终点是手术后 30 天内主要不良事件的复合。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，平均左心室射血分数为 43.0±11.7%。在 1 年内，干预组 96 名有可用数据的患者中有 16 名 （16.7%） 和手术组 89 名有可用数据中的 20 名 （22.5%） 至少发生了主要疗效终点的一个组成部分（估计平均差，-6 个百分点;95% 置信区间 [CI]，-17 至 6;P<0.001 为非劣效性）。干预组 101 例有可用数据的患者中有 15 例 （14.9%） 发生主要安全性终点事件，手术组 93 例有可用数据的患者中有 51 例 （54.8%） 发生主要安全性终点事件（估计均数差，-40 个百分点;95% CI，-51 至 -27;P<0.001）。 结论 在心力衰竭和继发性二尖瓣反流患者中，经导管边对边修复术在死亡、心力衰竭再住院、中风、再干预或 1 年时左心室植入辅助装置的复合方面不劣于二尖瓣手术。（由 Abbott Vascular 资助;马特宏峰 ClinicalTrials.gov 号，NCT02371512.）。