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

Michael J. Mack*, William T. Abraham, Jo Ann Lindenfeld, Steven F. Bolling, Ted E. Feldman, Paul A. Grayburn, Samir R. Kapadia, Patrick M McCarthy, D. Scott Lim, James E. Udelson, Michael R. Zile, James S. Gammie, A. Marc Gillinov, Donald D. Glower, David A. Heimansohn, Rakesh M. Suri, Jeffrey T. Ellis, Yu Shu, Saibal Kar, Neil J. WeissmanGregg W. Stone

*Corresponding author for this work

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1-11
Number of pages11
JournalAmerican heart journal
Volume205
DOIs
StatePublished - Nov 1 2018

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Mitral Valve Insufficiency
Heart Failure
Outcome Assessment (Health Care)
Mitral Valve
Guidelines
Therapeutics
Equipment and Supplies
Safety
Multicenter Studies
Hospitalization
Morbidity
Mortality

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Mack, Michael J. ; Abraham, William T. ; Lindenfeld, Jo Ann ; Bolling, Steven F. ; Feldman, Ted E. ; Grayburn, Paul A. ; Kapadia, Samir R. ; McCarthy, Patrick M ; Lim, D. Scott ; Udelson, James E. ; Zile, Michael R. ; Gammie, James S. ; Gillinov, A. Marc ; Glower, Donald D. ; Heimansohn, David A. ; Suri, Rakesh M. ; Ellis, Jeffrey T. ; Shu, Yu ; Kar, Saibal ; Weissman, Neil J. ; Stone, Gregg W. / Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation : Design and rationale of the COAPT trial. In: American heart journal. 2018 ; Vol. 205. pp. 1-11.
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title = "Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial",
abstract = "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.",
author = "Mack, {Michael J.} and Abraham, {William T.} and Lindenfeld, {Jo Ann} and Bolling, {Steven F.} and Feldman, {Ted E.} and Grayburn, {Paul A.} and Kapadia, {Samir R.} and McCarthy, {Patrick M} and Lim, {D. Scott} and Udelson, {James E.} and Zile, {Michael R.} and Gammie, {James S.} and Gillinov, {A. Marc} and Glower, {Donald D.} and Heimansohn, {David A.} and Suri, {Rakesh M.} and Ellis, {Jeffrey T.} and Yu Shu and Saibal Kar and Weissman, {Neil J.} and Stone, {Gregg W.}",
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doi = "10.1016/j.ahj.2018.07.021",
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Mack, MJ, Abraham, WT, Lindenfeld, JA, 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 2018, 'Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial', American heart journal, vol. 205, pp. 1-11. https://doi.org/10.1016/j.ahj.2018.07.021

Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation : Design and rationale of the COAPT trial. / Mack, Michael J.; Abraham, William T.; Lindenfeld, Jo Ann; Bolling, Steven F.; Feldman, Ted E.; Grayburn, Paul A.; Kapadia, Samir R.; McCarthy, Patrick M; Lim, D. Scott; Udelson, James E.; Zile, Michael R.; Gammie, James S.; Gillinov, A. Marc; Glower, Donald D.; Heimansohn, David A.; Suri, Rakesh M.; Ellis, Jeffrey T.; Shu, Yu; Kar, Saibal; Weissman, Neil J.; Stone, Gregg W.

In: American heart journal, Vol. 205, 01.11.2018, p. 1-11.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation

T2 - Design and rationale of the COAPT trial

AU - Mack, Michael J.

AU - Abraham, William T.

AU - Lindenfeld, Jo Ann

AU - Bolling, Steven F.

AU - Feldman, Ted E.

AU - Grayburn, Paul A.

AU - Kapadia, Samir R.

AU - McCarthy, Patrick M

AU - Lim, D. Scott

AU - Udelson, James E.

AU - Zile, Michael R.

AU - Gammie, James S.

AU - Gillinov, A. Marc

AU - Glower, Donald D.

AU - Heimansohn, David A.

AU - Suri, Rakesh M.

AU - Ellis, Jeffrey T.

AU - Shu, Yu

AU - Kar, Saibal

AU - Weissman, Neil J.

AU - Stone, Gregg W.

PY - 2018/11/1

Y1 - 2018/11/1

N2 - 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.

AB - 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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U2 - 10.1016/j.ahj.2018.07.021

DO - 10.1016/j.ahj.2018.07.021

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