经导管修复二尖瓣反流后的 5 年随访。
Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation.
机构信息
From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S.), Columbia University Medical Center (S.O.M.), and the Cardiovascular Research Foundation (D.J.C.), New York, and St. Francis Hospital and Heart Center, Roslyn (D.J.C.) - all in New York; 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 Lindner Clinical Research Center and the Christ Hospital, Cincinnati (I.J.S.); Advanced Heart Failure, Vanderbilt Heart and Vascular Institute, Nashville (J.A.L.); the Division of Cardiology, HCA Healthcare, Los Angeles (S.K.), and Kaiser Permanente-San Francisco Hospital, San Francisco (J.M.M.); 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; the Division of Cardiology, University of Virginia, Charlottesville (D.S.L.); Intermountain Medical Center, Murray, UT (B.W.); Carolinas Medical Center, Charlotte, NC (M.R.); Piedmont Hospital, Atlanta (V.R.); University of Colorado Hospital, Aurora (A.B.); and MedStar Health Research Institute, Hyattsville, MD (F.M.A.).
出版信息
N Engl J Med. 2023 Jun 1;388(22):2037-2048. doi: 10.1056/NEJMoa2300213. Epub 2023 Mar 5.
BACKGROUND
Data from a 5-year follow-up of outcomes after transcatheter edge-to-edge repair of severe mitral regurgitation, as compared with outcomes after maximal doses of guideline-directed medical therapy alone, in patients with heart failure are now available.
METHODS
We randomly assigned 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 to undergo transcatheter edge-to-edge repair plus receive medical therapy (device group) or to receive medical therapy alone (control group) at 78 sites in the United States and Canada. The primary effectiveness end point was all hospitalizations for heart failure through 2 years of follow-up. The annualized rate of all hospitalizations for heart failure, all-cause mortality, the risk of death or hospitalization for heart failure, and safety, among other outcomes, were assessed through 5 years.
RESULTS
Of the 614 patients enrolled in the trial, 302 were assigned to the device group and 312 to the control group. The annualized rate of hospitalization for heart failure through 5 years was 33.1% per year in the device group and 57.2% per year in the control group (hazard ratio, 0.53; 95% confidence interval [CI], 0.41 to 0.68). All-cause mortality through 5 years was 57.3% in the device group and 67.2% in the control group (hazard ratio, 0.72; 95% CI, 0.58 to 0.89). Death or hospitalization for heart failure within 5 years occurred in 73.6% of the patients in the device group and in 91.5% of those in the control group (hazard ratio, 0.53; 95% CI, 0.44 to 0.64). Device-specific safety events within 5 years occurred in 4 of 293 treated patients (1.4%), with all the events occurring within 30 days after the procedure.
CONCLUSIONS
Among patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite guideline-directed medical therapy, transcatheter edge-to-edge repair of the mitral valve was safe and led to a lower rate of hospitalization for heart failure and lower all-cause mortality through 5 years of follow-up than medical therapy alone. (Funded by Abbott; COAPT ClinicalTrials.gov number, NCT01626079.).
背景
现在已经获得了经导管缘对缘修复术治疗重度二尖瓣反流患者 5 年随访结果的数据，与单独接受最大剂量指南指导的药物治疗的患者相比，这些结果与心力衰竭患者的药物治疗结果进行了比较。
方法
我们将心力衰竭且伴有中度至重度或重度继发性二尖瓣反流的患者随机分为两组，一组接受经导管缘对缘修复术加药物治疗（器械组），另一组接受单纯药物治疗（对照组）。在 78 个美国和加拿大的研究中心进行了研究。主要有效性终点是所有因心力衰竭住院的患者在 2 年的随访期内。在 5 年的时间里，评估了其他结果，包括心力衰竭再住院的年发生率、全因死亡率、心力衰竭死亡或住院的风险以及安全性。
结果
在参加试验的 614 名患者中，302 名被分配到器械组，312 名被分配到对照组。在 5 年内，器械组心力衰竭再住院的年发生率为 33.1%，对照组为 57.2%（风险比，0.53；95%置信区间[CI]，0.41 至 0.68）。5 年内全因死亡率在器械组为 57.3%，对照组为 67.2%（风险比，0.72；95%置信区间[CI]，0.58 至 0.89）。在 5 年内，器械组有 73.6%的患者发生心力衰竭死亡或住院，对照组有 91.5%的患者发生心力衰竭死亡或住院（风险比，0.53；95%置信区间[CI]，0.44 至 0.64）。在 5 年内，293 名接受治疗的患者中有 4 名（1.4%）发生了与器械相关的安全事件，所有事件均发生在手术后 30 天内。
结论
在接受指南指导的药物治疗后仍有症状的心力衰竭伴中度至重度或重度继发性二尖瓣反流患者中，二尖瓣经导管缘对缘修复术是安全的，与单纯药物治疗相比，可降低心力衰竭住院率和全因死亡率，随访 5 年。（由 Abbott 资助；COAPT ClinicalTrials.gov 编号，NCT01626079。）
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