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Published on: October 16, 2021
Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation
Gregg W Stone1, William T Abraham1, JoAnn Lindenfeld1
1From 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.).
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.).
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