Suzanne V Arnold1, Gregg W Stone2, Michael J Mack3, Adnan K Chhatriwalla4, Bethany A Austin4, Zixuan Zhang5, Ori Ben-Yehuda6, Saibal Kar7, D Scott Lim8, JoAnn Lindenfeld9, William T Abraham10, David J Cohen11. 1. Saint Luke's Mid America Heart Institute, Kansas City, Missouri; University of Missouri-Kansas City, Kansas City, Missouri. Electronic address: suz.v.arnold@gmail.com. 2. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 3. Baylor Scott & White Health, Plano, Texas. 4. Saint Luke's Mid America Heart Institute, Kansas City, Missouri; University of Missouri-Kansas City, Kansas City, Missouri. 5. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. 6. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. 7. Cedars-Sinai Medical Center, Los Angeles, California. 8. Division of Cardiology, University of Virginia, Charlottesville, Virginia. 9. Vanderbilt Heart and Vascular Institute, Nashville, Tennessee. 10. Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio. 11. University of Missouri-Kansas City, Kansas City, Missouri.
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) with the MitraClip rapidly improved health status and reduced the long-term risks for death and heart failure (HF) hospitalization in patients with HF and severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT). OBJECTIVES: The aim of this study was to examine if early health status changes were associated with long-term clinical outcomes in the COAPT population. METHODS: The association between change in health status (Kansas City CardiomyopathyQuestionnaire overall summary score [KCCQ-OS]) from baseline to 1 month and the composite rate of death or HF hospitalization between 1 month and 2 years in the COAPT trial were evaluated, and whether treatment (TMVr or GDMT alone) modified this association was tested. RESULTS: Among 551 patients with HF and severe secondary mitral regurgitation who were alive at 1 month, those randomized to TMVr were more likely than those randomized to GDMT alone to achieve a ≥10-point improvement in KCCQ-OS from baseline to 1 month (TMVr, 58%; GDMT alone, 26%). Early improvement in KCCQ-OS was inversely associated with the risk for death or HF hospitalization between 1 month and 2 years (p < 0.001). When analyzed as a continuous variable, a 10-point increase in KCCQ-OS was associated with a 14% lower risk for death or HF hospitalization (hazard ratio: 0.86; 95% confidence interval: 0.81 to 0.92; p < 0.001), with no significant interaction with treatment group (pinteraction = 0.17). After adjusting for demographic and clinical factors, the association between change in KCCQ-OS and outcomes was strengthened (hazard ratio: 0.79; 95% confidence interval: 0.73 to 0.86; p < 0.001). CONCLUSIONS: In patients with HF and severe secondary mitral regurgitation, a short-term change in disease-specific health status was strongly associated with the subsequent long-term risk for death or HF hospitalization. These findings reinforce the prognostic utility of serial KCCQ-OS assessments to identify patients at risk for poor long-term clinical outcomes in this population. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial]; 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) with the MitraClip rapidly improved health status and reduced the long-term risks for death and heart failure (HF) hospitalization in patients with HF and severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT). OBJECTIVES: The aim of this study was to examine if early health status changes were associated with long-term clinical outcomes in the COAPT population. METHODS: The association between change in health status (Kansas City Cardiomyopathy Questionnaire overall summary score [KCCQ-OS]) from baseline to 1 month and the composite rate of death or HF hospitalization between 1 month and 2 years in the COAPT trial were evaluated, and whether treatment (TMVr or GDMT alone) modified this association was tested. RESULTS: Among 551 patients with HF and severe secondary mitral regurgitation who were alive at 1 month, those randomized to TMVr were more likely than those randomized to GDMT alone to achieve a ≥10-point improvement in KCCQ-OS from baseline to 1 month (TMVr, 58%; GDMT alone, 26%). Early improvement in KCCQ-OS was inversely associated with the risk for death or HF hospitalization between 1 month and 2 years (p < 0.001). When analyzed as a continuous variable, a 10-point increase in KCCQ-OS was associated with a 14% lower risk for death or HF hospitalization (hazard ratio: 0.86; 95% confidence interval: 0.81 to 0.92; p < 0.001), with no significant interaction with treatment group (pinteraction = 0.17). After adjusting for demographic and clinical factors, the association between change in KCCQ-OS and outcomes was strengthened (hazard ratio: 0.79; 95% confidence interval: 0.73 to 0.86; p < 0.001). CONCLUSIONS: In patients with HF and severe secondary mitral regurgitation, a short-term change in disease-specific health status was strongly associated with the subsequent long-term risk for death or HF hospitalization. These findings reinforce the prognostic utility of serial KCCQ-OS assessments to identify patients at risk for poor long-term clinical outcomes in this population. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial]; NCT01626079).
Authors: Ali O Malik; Adnan K Chhatriwalla; John Saxon; Vittal Hejjaji; Amanda Stebbins; Philip G Jones; David J Cohen; Suzanne V Arnold; Sreekanth Vemulapalli; Zachary K Wegermann; Andrzej Kosinski; John A Spertus Journal: Circ Cardiovasc Qual Outcomes Date: 2020-12-07
Authors: Vittal Hejjaji; David J Cohen; John D Carroll; Zhuokai Li; Pratik Manandhar; Sreekanth Vemulapalli; Adam J Nelson; Ali O Malik; Michael J Mack; John A Spertus; Suzanne V Arnold Journal: Circ Cardiovasc Qual Outcomes Date: 2021-02-18
Authors: Muhammad Shahzeb Khan; Tariq Jamal Siddiqi; Javed Butler; Tim Friede; Wayne C Levy; Klaus K Witte; Janusz Lipiecki; Horst Sievert; Andrew J Stewart Coats Journal: ESC Heart Fail Date: 2021-02-22