经导管二尖瓣修复术治疗心力衰竭患者。
Transcatheter Mitral-Valve Repair in Patients with Heart Failure.
机构信息
From New York-Presbyterian Hospital and the Cardiovascular Research Foundation (G.W.S.) and Columbia University Medical Center (G.W.S., S.O.M.), New York; Advanced Heart Failure, Vanderbilt Heart and Vascular Institute, Nashville (J.L.); the Departments of Medicine, Physiology, and Cell Biology, Division of Cardiovascular Medicine, and the Davis Heart and Lung Research Institute, Ohio State University, Columbus (W.T.A.), the Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland (S.R.K.), and Christ Hospital, Cincinnati (I.J.S.) - all in Ohio; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (S.K.), and Kaiser Permanente-San Francisco Hospital, San Francisco (J.M.M.) - both in California; the Division of Cardiology, University of Virginia, Charlottesville (D.S.L.); Intermountain Medical Center, Murray, UT (B.W.); Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas (P.A.G.), and Baylor Scott and White Heart Hospital Plano, Plano (M.J.M.) - both in Texas; Carolinas Medical Center, Charlotte, NC (M.R.); Piedmont Hospital, Atlanta (V.R.); University of Colorado Hospital, Aurora (A.B.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City (D.J.C.); and MedStar Health Research Institute, Hyattsville, MD (N.J.W.).
出版信息
N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.
BACKGROUND
Among 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.
METHODS
At 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%.
RESULTS
Of 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<0.001). The rate of freedom from device-related complications at 12 months was 96.6% (lower 95% confidence limit, 94.8%; P<0.001 for comparison with the performance goal). Death from any cause within 24 months occurred in 29.1% of the patients in the device group as compared with 46.1% in the control group (hazard ratio, 0.62; 95% CI, 0.46 to 0.82; P<0.001).
CONCLUSIONS
Among 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, transcatheter mitral-valve repair resulted in a lower rate of hospitalization for heart failure and lower all-cause mortality within 24 months of follow-up than medical therapy alone. The rate of freedom from device-related complications exceeded a prespecified safety threshold. (Funded by Abbott; COAPT ClinicalTrials.gov number, NCT01626079 .).
背景
在因左心室功能障碍导致二尖瓣反流的心力衰竭患者中，预后较差。经导管二尖瓣修复术可能改善他们的临床结果。
方法
在美国和加拿大的 78 个地点，我们招募了心力衰竭和中度至重度或重度继发性二尖瓣反流的患者，这些患者尽管使用了最大剂量的指南导向的药物治疗，但仍有症状。患者被随机分配接受经导管二尖瓣修复术加药物治疗（器械组）或单独药物治疗（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情况。主要安全性终点是 12 个月时无器械相关并发症；该终点的发生率与预先指定的 88.0%目标性能目标进行了比较。
结果
在这项试验中，共有 614 名患者入选，其中 302 名被分配到器械组，312 名被分配到对照组。在器械组中，24 个月内每例患者每年因心力衰竭住院的年化率为 35.8%，而对照组为 67.9%（风险比，0.53；95%置信区间[CI]，0.40 至 0.70；P<0.001）。在 12 个月时无器械相关并发症的发生率为 96.6%（置信区间下限为 94.8%；与目标性能相比，P<0.001）。在器械组中，24 个月内任何原因导致的死亡有 29.1%，而对照组为 46.1%（风险比，0.62；95%CI，0.46 至 0.82；P<0.001）。
结论
在因最大剂量指南导向药物治疗仍有症状的心力衰竭和中度至重度或重度继发性二尖瓣反流患者中，经导管二尖瓣修复术可降低 24 个月内因心力衰竭住院的发生率和全因死亡率，优于单独药物治疗。无器械相关并发症的发生率超过了预定的安全阈值。（由雅培资助；COAPT 临床试验.gov 编号，NCT01626079）。
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