Gennaro Giustino1, JoAnn Lindenfeld2, William T Abraham3, Saibal Kar4, D Scott Lim5, Paul A Grayburn6, Samir R Kapadia7, David J Cohen8, Lak N Kotinkaduwa9, Neil J Weissman10, Michael J Mack11, Gregg W Stone12. 1. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 2. Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee. 3. Division of Cardiovascular Medicine, The Ohio State University College of Medicine, Columbus, Ohio. 4. Los Robles Regional Medical Center, Thousand Oaks, California; Bakersfield Heart Hospital, Bakersfield, California. 5. Division of Cardiology, University of Virginia, Charlottesville, Virginia. 6. Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas. 7. Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. 8. University of Missouri-Kansas City School of Medicine, Kansas City, Missouri. 9. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. 10. MedStar Health Research Institute, Washington, DC; Georgetown University, Washington, DC. 11. Baylor Scott and White Heart Hospital Plano, Plano, Texas. 12. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address: gregg.stone@mountsinai.org.
Abstract
OBJECTIVES: The aim of this study was to evaluate the outcomes of MitraClip implantation versus guideline-directed medical therapy (GDMT) in patients with secondary mitral regurgitation (SMR) according to baseline functional status as assessed by the widely used New York Heart Association (NYHA) functional classification. BACKGROUND:Patients with heart failure (HF) and impaired functional status at baseline have poor prognosis. Whether the effects of transcatheter repair of secondary SMR in patients with HF are influenced by baseline functional status is unknown. METHODS: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, patients with HF with moderate to severe or severe SMR who remained symptomatic despite maximally tolerated GDMT were randomized to MitraClip implantation versus GDMT alone. Outcomes were evaluated according to baseline functional status as assessed using the NYHA functional classification. The primary endpoint of interest was the rate of death or HF-related hospitalization (HFH) at 2 years in time-to-first-event analyses. RESULTS: Among 613 randomized patients, 240 were in NYHA functional class II (39.2%), 322 were in NYHA functional class III (52.5%), and 51 were in ambulatory NYHA functional class IV (8.3%). Rates of death or HFH were progressively higher with increasing NYHA functional class. Compared with GDMT alone, MitraClip implantation resulted in lower 2-year rates of death or HFH consistently in patients in NYHA functional class II (39.7% vs. 63.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.37 to 0.77), NYHA functional class III (46.6% vs. 65.5%; HR: 0.60; 95% CI: 0.45 to 0.82), and NYHA functional class IV (66.7% vs. 85.2%; HR: 0.55; 95% CI: 0.28 to 1.10; pinteraction = 0.86). Greater improvements in quality of life at 2 years were observed in patients treated with the MitraClip compared with GDMT irrespective of baseline functional status. CONCLUSIONS: The NYHA functional classification provides prognostic utility in patients with HF and moderate to severe or severe SMR. In the COAPT trial, the benefits of MitraClip implantation were consistent in patients with better or worse functional status as assessed by NYHA functional class. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).
RCT Entities:
OBJECTIVES: The aim of this study was to evaluate the outcomes of MitraClip implantation versus guideline-directed medical therapy (GDMT) in patients with secondary mitral regurgitation (SMR) according to baseline functional status as assessed by the widely used New York Heart Association (NYHA) functional classification. BACKGROUND:Patients with heart failure (HF) and impaired functional status at baseline have poor prognosis. Whether the effects of transcatheter repair of secondary SMR in patients with HF are influenced by baseline functional status is unknown. METHODS: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, patients with HF with moderate to severe or severe SMR who remained symptomatic despite maximally tolerated GDMT were randomized to MitraClip implantation versus GDMT alone. Outcomes were evaluated according to baseline functional status as assessed using the NYHA functional classification. The primary endpoint of interest was the rate of death or HF-related hospitalization (HFH) at 2 years in time-to-first-event analyses. RESULTS: Among 613 randomized patients, 240 were in NYHA functional class II (39.2%), 322 were in NYHA functional class III (52.5%), and 51 were in ambulatory NYHA functional class IV (8.3%). Rates of death or HFH were progressively higher with increasing NYHA functional class. Compared with GDMT alone, MitraClip implantation resulted in lower 2-year rates of death or HFH consistently in patients in NYHA functional class II (39.7% vs. 63.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.37 to 0.77), NYHA functional class III (46.6% vs. 65.5%; HR: 0.60; 95% CI: 0.45 to 0.82), and NYHA functional class IV (66.7% vs. 85.2%; HR: 0.55; 95% CI: 0.28 to 1.10; pinteraction = 0.86). Greater improvements in quality of life at 2 years were observed in patients treated with the MitraClip compared with GDMT irrespective of baseline functional status. CONCLUSIONS: The NYHA functional classification provides prognostic utility in patients with HF and moderate to severe or severe SMR. In the COAPT trial, the benefits of MitraClip implantation were consistent in patients with better or worse functional status as assessed by NYHA functional class. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).
Authors: Andrew J S Coats; Stefan D Anker; Andreas Baumbach; Ottavio Alfieri; Ralph Stephan von Bardeleben; Johann Bauersachs; Jeroen J Bax; Serge Boveda; Jelena Čelutkienė; John G Cleland; Nikolaos Dagres; Thomas Deneke; Dimitrios Farmakis; Gerasimos Filippatos; Jörg Hausleiter; Gerhard Hindricks; Ewa A Jankowska; Mitja Lainscak; Christoph Leclercq; Lars H Lund; Theresa McDonagh; Mandeep R Mehra; Marco Metra; Nathan Mewton; Christian Mueller; Wilfried Mullens; Claudio Muneretto; Jean-Francois Obadia; Piotr Ponikowski; Fabien Praz; Volker Rudolph; Frank Ruschitzka; Alec Vahanian; Stephan Windecker; Jose Luis Zamorano; Thor Edvardsen; Hein Heidbuchel; Petar M Seferovic; Bernard Prendergast Journal: Eur Heart J Date: 2021-03-18 Impact factor: 29.983
Authors: Matteo Pagnesi; Marianna Adamo; Iziah E Sama; Stefan D Anker; John G Cleland; Kenneth Dickstein; Gerasimos S Filippatos; Chim C Lang; Leong L Ng; Piotr Ponikowski; Alice Ravera; Nilesh J Samani; Faiez Zannad; Dirk J van Veldhuisen; Adriaan A Voors; Marco Metra Journal: Eur J Heart Fail Date: 2021-08-01 Impact factor: 17.349