Michael J Mack1, William T Abraham2, JoAnn Lindenfeld3, Steven F Bolling4, Ted E Feldman5, Paul A Grayburn6, Samir R Kapadia7, Patrick M McCarthy8, D Scott Lim9, James E Udelson10, Michael R Zile11, James S Gammie12, A Marc Gillinov13, Donald D Glower14, David A Heimansohn15, Rakesh M Suri16, Jeffrey T Ellis17, Yu Shu17, Saibal Kar18, Neil J Weissman19, Gregg W Stone20. 1. Heart Hospital Baylor Plano, Baylor HealthCare System, Dallas, TX. Electronic address: MichaeMa@BaylorHealth.edu. 2. Departments of Medicine, Physiology, and Cell Biology, Division of Cardiovascular Medicine, and the Davis Heart & Lung Research Institute, The Ohio State University, Columbus, OH. 3. Advanced Heart Failure, Vanderbilt Heart and Vascular Institute, Nashville, TN. 4. Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor, MI. 5. Evanston Hospital Cardiology Division, Northshore University Health System, Evanston, IL. 6. Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, TX. 7. Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH. 8. Division of Cardiac Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Northwestern University, Chicago, IL. 9. Division of Cardiology, University of Virginia, Charlottesville, VA. 10. Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, MA. 11. Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston, SC. 12. Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore, MD. 13. Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH. 14. Division of Cardiology, Duke University Medical Center, Durham, NC. 15. Department of Cardiothoracic Surgery, St Vincent Heart Center, Indianapolis, IN. 16. Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland, OH. 17. Abbott, Santa Clara, CA. 18. Cedars Sinai Heart Institute, Cedars Sinai Medical Center, Los Angeles, CA. 19. MedStar Health Research Institute, Hyattsville, MD. 20. New York Presbyterian Hospital, Columbia University Medical Center, and The Cardiovascular Research Foundation, New York, NY.
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.
RCT Entities:
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 FailurePatients 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.
Authors: Annetine C Gelijns; Alan J Moskowitz; Patrick T O'Gara; Gennaro Giustino; Michael J Mack; Donna M Mancini; Emilia Bagiella; Judy Hung; Gorav Ailawadi; Martin B Leon; Michael A Acker; John H Alexander; Neal W Dickert; Wendy C Taddei-Peters; Marissa A Miller Journal: J Thorac Cardiovasc Surg Date: 2020-03-21 Impact factor: 5.209
Authors: Suzanne V Arnold; Khaja M Chinnakondepalli; John A Spertus; Elizabeth A Magnuson; Suzanne J Baron; Saibal Kar; D Scott Lim; Jacob M Mishell; William T Abraham; JoAnn A Lindenfeld; Michael J Mack; Gregg W Stone; David J Cohen Journal: J Am Coll Cardiol Date: 2019-03-17 Impact factor: 24.094
Authors: Mahboob Ali; Satya S Shreenivas; David N Pratt; Donald R Lynch; Dean J Kereiakes Journal: Circ Cardiovasc Interv Date: 2020-08-06 Impact factor: 6.546
Authors: Łukasz Kuźma; Jolanta Małyszko; Hanna Bachórzewska-Gajewska; Marta Maria Niwińska; Anna Kurasz; Małgorzata Zalewska-Adamiec; Marcin Kożuch; Sławomir Dobrzycki Journal: Int Urol Nephrol Date: 2020-07-14 Impact factor: 2.370