Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial - 17/12/18
, William T. Abraham, MD b, JoAnn Lindenfeld, MD c, Steven F. Bolling, MD d, Ted E. Feldman, MD e, Paul A. Grayburn, MD f, Samir R. Kapadia, MD g, Patrick M. McCarthy, MD h, D. Scott Lim, MD i, James E. Udelson, MD j, Michael R. Zile, MD k, James S. Gammie, MD l, A. Marc Gillinov, MD m, Donald D. Glower, MD n, David A. Heimansohn, MD o, Rakesh M. Suri, MD p, Jeffrey T. Ellis, PhD q, Yu Shu, PhD q, Saibal Kar, MD r, Neil J. Weissman, MD s, Gregg W. Stone, MD tAbstract |
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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| RCT# NCT01626079. |
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| Conflicts of interest: Dr Abraham is a consultant to Abbott, St Jude, and Medtronic. Dr Lindenfeld is a consultant to Abbott, St Jude, Relypsa, RESMED, Vwave, and Novartis. Dr Feldman is a consultant to and has received research grants from Abbott, BSC, Edwards Lifesciences, and Gore. Dr Grayburn is a consultant to Abbott, Tendyne, and Bracco Diagnostics and has received grants from Abbott, Medtronic, Baxter, ValTech Cardio, and Guided Delivery Systems. Dr Lim is a consultant to Abbott. Dr Zile has received consultation fees from Abbott. Dr Gammie is a consultant to Edwards Lifesciences. Dr Gillinov is a consultant to Abbott, Medtronic, Edwards Lifesciences, CryoLife, and AtriCure. Dr Ellis and Dr Shu are employees of Abbott Vascular. Dr Kar is a consultant to Abbott Vascular and Boston Scientific, and has received research grants from Edwards Lifesciences and Mitralign. Dr Weissman has received research grants from Abbott, Edwards Lifesciences, Sorin, St Jude, Medtronic, Boston Scientific, Mitralign, and Direct Flow. Dr Stone is a consultant to Valfix and owns equity in Ancora Heart. |
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| The other authors have no relevant disclosures. |
Vol 205
P. 1-11 - novembre 2018 Retour au numéro
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