TY  - BOOK
AU  - Weissman, Neil J
TI  - Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial
SN  - 0002-8703
PY  - 2018///
KW  - *Heart Failure/co [Complications]
KW  - *Heart Valve Prosthesis Implantation/mt [Methods]
KW  - *Mitral Valve Annuloplasty/mt [Methods]
KW  - *Mitral Valve Insufficiency/su [Surgery]
KW  - *Mitral Valve/su [Surgery]
KW  - *Outcome Assessment (Health Care)
KW  - Aged
KW  - Aged, 80 and over
KW  - Echocardiography
KW  - Female
KW  - Heart Failure/ep [Epidemiology]
KW  - Heart Failure/pp [Physiopathology]
KW  - Humans
KW  - Male
KW  - Mitral Valve Insufficiency/co [Complications]
KW  - Mitral Valve Insufficiency/mo [Mortality]
KW  - Mitral Valve/dg [Diagnostic Imaging]
KW  - Morbidity/td [Trends]
KW  - Prospective Studies
KW  - Prosthesis Design
KW  - Survival Rate/td [Trends]
KW  - Treatment Outcome
KW  - United States/ep [Epidemiology]
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
N1  - Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
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; 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; Copyright (c) 2018 Elsevier Inc. All rights reserved; 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
UR  - https://dx.doi.org/10.1016/j.ahj.2018.07.021
ER  -