Transcatheter Mitral-Valve Repair in Patients with Heart Failure
Transcatheter Mitral-Valve Repair in Patients with Heart Failure
复制标题
DOI：
10.1056/nejmoa1806640
复制
发表时间：
2018-12-13
影响因子：
158.5
通讯作者：
Mack, M. J.
中科院分区：
文献类型：
--
作者：
Stone, G. W.;Lindenfeld, J. A.;Mack, M. J.
背景：在心力衰竭患者中，由于左心室功能不全导致二尖瓣返流，预后很差。经导管二尖瓣修复术可能会改善他们的临床outcomes.METHODSAt 78网站在美国和加拿大，我们招募心力衰竭和中度至重度或重度继发性二尖瓣返流谁仍然有症状，尽管使用最大剂量的指南导向的药物治疗的患者。患者被随机分配到经导管二尖瓣修复术加药物治疗（器械组）或单纯药物治疗（对照组）。主要有效性终点是随访24个月内所有因心力衰竭住院的患者。主要安全性终点是12个月时无器械相关并发症;将该终点的发生率与预先规定的客观性能目标88.0%进行比较。在614例入组试验的患者中，302例被分配到器械组，312例被分配到对照组。器械组24个月内因心力衰竭住院的年化率为35.8%/患者年，对照组为67.9%/患者年（风险比为0.53; 95%置信区间[CI]为0.40 - 0.70; P
BACKGROUNDAmong patients with heart failure who have mitral regurgitation due to left ventricular dysfunction, the prognosis is poor. Transcatheter mitral-valve repair may improve their clinical outcomes.METHODSAt 78 sites in the United States and Canada, we enrolled patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy. Patients were randomly assigned to transcatheter mitral-valve repair plus medical therapy (device group) or medical therapy alone (control group). The primary effectiveness end point was all hospitalizations for heart failure within 24 months of follow- up. The primary safety end point was freedom from device-related complications at 12 months; the rate for this end point was compared with a prespecified objective performance goal of 88.0%.RESULTSOf the 614 patients who were enrolled in the trial, 302 were assigned to the device group and 312 to the control group. The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient-year in the device group as compared with 67.9% per patient-year in the control group (hazard ratio, 0.53; 95% confidence interval [CI], 0.40 to 0.70; P