Michael J Mack1, JoAnn Lindenfeld2, William T Abraham3, Saibal Kar4, D Scott Lim5, Jacob M Mishell6, Brian K Whisenant7, Paul A Grayburn8, Michael J Rinaldi9, Samir R Kapadia10, Vivek Rajagopal11, Ian J Sarembock12, Andreas Brieke13, Jason H Rogers14, Steven O Marx15, David J Cohen16, Neil J Weissman17, Gregg W Stone18. 1. Baylor Scott & White Heart Hospital Plano, Plano, Texas, USA. Electronic address: michael.mack@bswhealth.org. 2. Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee, USA. 3. Departments of Medicine, Physiology, and Cell Biology, Division of Cardiovascular Medicine, and the Davis Heart & Lung Research Institute, The Ohio State University, Columbus, Ohio, USA. 4. Los Robles Regional Medical Center, Thousand Oaks, California, USA; Bakersfield Heart Hospital, Bakersfield, California, USA. 5. Division of Cardiology, University of Virginia, Charlottesville, Virginia, USA. 6. Kaiser Permanente-San Francisco Hospital, San Francisco, California, USA. 7. Intermountain Medical Center, Murray, Utah, USA. 8. Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas, USA. 9. Sanger Heart & Vascular Institute/Atrium Health, Charlotte, North Carolina, USA. 10. Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA. 11. Piedmont Hospital, Atlanta, Georgia, USA. 12. The Christ Hospital and Lindner Clinical Research Center, Cincinnati, Ohio, USA. 13. University of Colorado Hospital, Aurora, Colorado, USA. 14. University of California Davis Medical Center, Sacramento, California, USA. 15. Columbia University Irving Medical Center, New York, New York, USA. 16. University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, USA. 17. MedStar Health Research Institute, Washington, DC, USA; Georgetown University, Washington, DC, USA. 18. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai and Cardiovascular Research Foundation, New York, New York, USA. Electronic address: https://twitter.com/GreggWStone.
Abstract
BACKGROUND: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) resulted in fewer heart failure hospitalizations (HFHs) and lower mortality at 24 months in patients with heart failure (HF) with mitral regurgitation (MR) secondary to left ventricular dysfunction compared with guideline-directed medical therapy (GDMT) alone. OBJECTIVES: This study determined if these benefits persisted to 36 months and if control subjects who were allowed to cross over at 24 months derived similar benefit. METHODS: This study randomized 614 patients with HF with moderate-to-severe or severe secondary MR, who remained symptomatic despite maximally tolerated GDMT, to TMVr plus GDMT versus GDMT alone. The primary effectiveness endpoint was all HFHs through 24-month follow-up. Patients have now been followed for 36 months. RESULTS: The annualized rates of HFHs per patient-year were 35.5% with TMVr and 68.8% with GDMT alone (hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.37 to 0.63; p < 0.001; number needed to treat (NNT) = 3.0; 95% CI: 2.4 to 4.0). Mortality occurred in 42.8% of the device group versus 55.5% of control group (HR: 0.67; 95% CI: 0.52 to 0.85; p = 0.001; NNT = 7.9; 95% CI: 4.6 to 26.1). Patients who underwent TMVr also had sustained 3-year improvements in MR severity, quality-of-life measures, and functional capacity. Among 58 patients assigned toGDMT alone who crossed over and were treated with TMVr, the subsequent composite rate of mortality or HFH was reduced compared with those who continued on GDMT alone (adjusted HR: 0.43; 95% CI: 0.24 to 0.78; p = 0.006). CONCLUSIONS: Among patients with HF and moderate-to-severe or severe secondary MR who remained symptomatic despite GDMT, TMVr was safe, provided a durable reduction in MR, reduced the rate of HFH, and improved survival, quality of life, and functional capacity compared with GDMT alone through 36 months. Surviving patients who crossed over to device treatment had a prognosis comparable to those originally assigned to transcatheter therapy. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation [COAPT]; NCT01626079).
RCT Entities:
BACKGROUND: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) resulted in fewer heart failure hospitalizations (HFHs) and lower mortality at 24 months in patients with heart failure (HF) with mitral regurgitation (MR) secondary to left ventricular dysfunction compared with guideline-directed medical therapy (GDMT) alone. OBJECTIVES: This study determined if these benefits persisted to 36 months and if control subjects who were allowed to cross over at 24 months derived similar benefit. METHODS: This study randomized 614 patients with HF with moderate-to-severe or severe secondary MR, who remained symptomatic despite maximally tolerated GDMT, to TMVr plus GDMT versus GDMT alone. The primary effectiveness endpoint was all HFHs through 24-month follow-up. Patients have now been followed for 36 months. RESULTS: The annualized rates of HFHs per patient-year were 35.5% with TMVr and 68.8% with GDMT alone (hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.37 to 0.63; p < 0.001; number needed to treat (NNT) = 3.0; 95% CI: 2.4 to 4.0). Mortality occurred in 42.8% of the device group versus 55.5% of control group (HR: 0.67; 95% CI: 0.52 to 0.85; p = 0.001; NNT = 7.9; 95% CI: 4.6 to 26.1). Patients who underwent TMVr also had sustained 3-year improvements in MR severity, quality-of-life measures, and functional capacity. Among 58 patients assigned to GDMT alone who crossed over and were treated with TMVr, the subsequent composite rate of mortality or HFH was reduced compared with those who continued on GDMT alone (adjusted HR: 0.43; 95% CI: 0.24 to 0.78; p = 0.006). CONCLUSIONS: Among patients with HF and moderate-to-severe or severe secondary MR who remained symptomatic despite GDMT, TMVr was safe, provided a durable reduction in MR, reduced the rate of HFH, and improved survival, quality of life, and functional capacity compared with GDMT alone through 36 months. Surviving patients who crossed over to device treatment had a prognosis comparable to those originally assigned to transcatheter therapy. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation [COAPT]; NCT01626079).
Authors: Angela McInerney; Luis Marroquin-Donday; Gabriela Tirado-Conte; Breda Hennessey; Carolina Espejo; Eduardo Pozo; Alberto de Agustín; Nieves Gonzalo; Pablo Salinas; Iván Núñez-Gil; Antonio Fernández-Ortiz; Hernan Mejía-Rentería; Fernando Macaya; Javier Escaned; Luis Nombela-Franco; Pilar Jiménez-Quevedo Journal: J Clin Med Date: 2022-05-22 Impact factor: 4.964
Authors: Matthias Koschutnik; Varius Dannenberg; Carolina Donà; Christian Nitsche; Andreas A Kammerlander; Sophia Koschatko; Daniel Zimpfer; Martin Hülsmann; Stefan Aschauer; Matthias Schneider; Philipp E Bartko; Georg Goliasch; Christian Hengstenberg; Julia Mascherbauer Journal: J Pers Med Date: 2022-01-11