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Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation

Stone, Gregg W., Abraham, William T., Lindenfeld, JoAnn, Kar, Saibal, Grayburn, Paul A., Lim, D. Scott, Mishell, Jacob M., Whisenant, Brian, Rinaldi, Michael, Kapadia, Samir R., Rajagopal, Vivek, Sarembock, Ian J., Brieke, Andreas, Marx, Steven O., Cohen, David J., Asch, Federico M., Mack, Michael J.·2023·New England Journal of Medicine

Abstract

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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Metadata

Authors
Stone, G. W., Abraham, W. T., Lindenfeld, J., Kar, S., Grayburn, P. A., Lim, D. S., Mishell, J. M., Whisenant, B., Rinaldi, M., Kapadia, S. R., Rajagopal, V., Sarembock, I. J., Brieke, A., Marx, S. O., Cohen, D. J., Asch, F. M., & Mack, M. J.
Venue
New England Journal of Medicine
Published
2023-06
Volume
388
Issue
22
Pages
2037-2048
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W4323262080
Cited by
369
References
22
FWCI
64.91
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. https://app.cochat.ai/papers/10.1056/nejmoa2300213
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Stone, G. W., Abraham, W. T., Lindenfeld, J., Kar, S., Grayburn, P. A., Lim, D. S., Mishell, J. M., Whisenant, B., Rinaldi, M., Kapadia, S. R., Rajagopal, V., Sarembock, I. J., Brieke, A., Marx, S. O., Cohen, D. J., Asch, F. M., & Mack, M. J. (2023). Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2300213

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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