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Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial.

Publication ,  Journal Article
Mack, MJ; Abraham, WT; Lindenfeld, J; Bolling, SF; Feldman, TE; Grayburn, PA; Kapadia, SR; McCarthy, PM; Lim, DS; Udelson, JE; Zile, MR ...
Published in: Am Heart J
November 2018

BACKGROUND: Patients with heart failure (HF) and symptomatic secondary mitral regurgitation (SMR) have a poor prognosis, with morbidity and mortality directly correlated with MR severity. Correction of isolated SMR with surgery is not well established in this population, and medical management remains the preferred approach in most patients. The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial was designed to determine whether transcatheter mitral valve (MV) repair with the MitraClip device is safe and effective in patients with symptomatic HF and clinically significant SMR. STUDY DESIGN: The COAPT trial is a prospective, randomized, parallel-controlled, open-label multicenter study of the MitraClip device for the treatment of moderate-to-severe (3+) or severe (4+) SMR (as verified by an independent echocardiographic core laboratory) in patients with New York Heart Association class II-IVa HF despite treatment with maximally tolerated guideline-directed medical therapy (GDMT) who have been determined by the site's local heart team as not appropriate for MV surgery. A total of 614 eligible subjects were randomized in a 1:1 ratio to MV repair with the MitraClip plus GDMT versus GDMT alone. The primary effectiveness end point is recurrent HF hospitalizations through 24 months, analyzed when the last subject completes 12-month follow-up, powered to demonstrate superiority of MitraClip therapy. The primary safety end point is a composite of device-related complications at 12 months compared to a performance goal. Follow-up is ongoing, and the principal results are expected in late 2018. CONCLUSIONS: HF patients with clinically significant SMR who continue to be symptomatic despite optimal GDMT have limited treatment options and a poor prognosis. The randomized COAPT trial was designed to determine the safety and effectiveness of transcatheter MV repair with the MitraClip in symptomatic HF patients with moderate-to-severe or severe SMR.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

November 2018

Volume

205

Start / End Page

1 / 11

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Survival Rate
  • Prosthesis Design
  • Prospective Studies
  • Outcome Assessment, Health Care
  • Morbidity
  • Mitral Valve Insufficiency
  • Mitral Valve Annuloplasty
  • Mitral Valve
 

Citation

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Mack, M. J., Abraham, W. T., Lindenfeld, J., Bolling, S. F., Feldman, T. E., Grayburn, P. A., … Stone, G. W. (2018). Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial. Am Heart J, 205, 1–11. https://doi.org/10.1016/j.ahj.2018.07.021
Mack, Michael J., William T. Abraham, JoAnn Lindenfeld, Steven F. Bolling, Ted E. Feldman, Paul A. Grayburn, Samir R. Kapadia, et al. “Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial.Am Heart J 205 (November 2018): 1–11. https://doi.org/10.1016/j.ahj.2018.07.021.
Mack MJ, Abraham WT, Lindenfeld J, Bolling SF, Feldman TE, Grayburn PA, et al. Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial. Am Heart J. 2018 Nov;205:1–11.
Mack, Michael J., et al. “Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial.Am Heart J, vol. 205, Nov. 2018, pp. 1–11. Pubmed, doi:10.1016/j.ahj.2018.07.021.
Mack MJ, Abraham WT, Lindenfeld J, Bolling SF, Feldman TE, Grayburn PA, Kapadia SR, McCarthy PM, Lim DS, Udelson JE, Zile MR, Gammie JS, Gillinov AM, Glower DD, Heimansohn DA, Suri RM, Ellis JT, Shu Y, Kar S, Weissman NJ, Stone GW. Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial. Am Heart J. 2018 Nov;205:1–11.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

November 2018

Volume

205

Start / End Page

1 / 11

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Survival Rate
  • Prosthesis Design
  • Prospective Studies
  • Outcome Assessment, Health Care
  • Morbidity
  • Mitral Valve Insufficiency
  • Mitral Valve Annuloplasty
  • Mitral Valve