Rebecca T Hahn1, Federico Asch2, Neil J Weissman2, Paul Grayburn3, Saibal Kar4, Scott Lim5, Ori Ben-Yehuda6, Bahira Shahim6, Shmuel Chen7, Mengdan Liu6, Bjorn Redfors6, Diego Medvedofsky2, Rishi Puri8, Samir Kapadia8, Anna Sannino3, JoAnn Lindenfeld9, William T Abraham10, Michael J Mack3, Gregg W Stone11. 1. Columbia University Medical Center, New York Presbyterian Hospital, New York, New York. Electronic address: rth2@columbia.edu. 2. Medstar Health Research Institute, Washington, DC. 3. Baylor Scott & White Health, Plano, Texas. 4. Cedars Sinai Medical Center, Los Angeles, California. 5. University of Virginia, Charlottesville, Virginia. 6. Cardiovascular Research Foundation, New York, New York. 7. Columbia University Medical Center, New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York. 8. Cleveland Clinic, Cleveland, Ohio. 9. Vanderbilt University Medical Center, Nashville, Tennessee. 10. Ohio State University Medical Center, Columbus, Ohio. 11. 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.
Abstract
BACKGROUND: The presence of tricuspid regurgitation (TR) may affect prognosis in patients with mitral regurgitation (MR). OBJECTIVES: This study sought to determine the impact of TR on outcomes in patients with heart failure and severe secondary MR randomized toguideline-directed medical therapy (GDMT) or edge-to-edge repair with the MitraClip in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial. METHODS: A total of 614 patients with symptomatic heart failure with moderate to severe (3+) or severe (4+) secondary MR were randomized to maximally tolerated GDMT plus MitraClip or GDMTalone; 599 had core laboratory evaluable echocardiograms. Patients were divided into 2 groups by baseline TR severity: none/trace/mild TR (≤Mild TR) (n = 501 [83.6%]) and moderate/severe TR (≥Mod TR) (n = 98 [16.4%]). Two-year composite endpoints of death or heart failure hospitalization (HFH) and the individual endpoints were analyzed. RESULTS: Patients with ≥Mod TR were more likely to be New York Heart Association functional class III/IV (p < 0.0001) and have a Society of Thoracic Surgeons score of ≥8 (p < 0.0001), anemia (p = 0.02), chronic kidney disease (p = 0.003), and higher N-terminal pro-B-type natriuretic peptide (p = 0.02) than those with ≤Mild TR. Patients with ≥Mod TR had more severe MR (p = 0.0005) despite smaller left ventricular volumes (p = 0.005) and higher right ventricular systolic pressure (p < 0.0001). At 2 years, the composite rate of death or HFH was higher in patients with ≥Mod TR compared with ≤Mild TR treated with GDMT alone (83.0% vs. 64.3%; hazard ratio: 1.74; 95% confidence interval: 1.24 to 2.45; p = 0.001) but not following MitraClip (48.2% vs. 44.0%; hazard ratio: 1.14; 95% confidence interval: 0.71 to 1.84; p = 0.59). Rates of death or HFH, as well as death and HFH alone, were reduced by MitraClip compared with GDMT, irrespective of baseline TR grade (pinteraction = 0.16, 0.29, and 0.21 respectively). CONCLUSIONS:Patients with severe secondary MR who also had ≥Mod TR had worse clinical and echocardiographic characteristics and worse clinical outcomes compared to those with ≤Mild TR. Within the COAPT trial, MitraClip improved outcomes in patients with and without ≥Mod TR severity compared with GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079).
RCT Entities:
BACKGROUND: The presence of tricuspid regurgitation (TR) may affect prognosis in patients with mitral regurgitation (MR). OBJECTIVES: This study sought to determine the impact of TR on outcomes in patients with heart failure and severe secondary MR randomized to guideline-directed medical therapy (GDMT) or edge-to-edge repair with the MitraClip in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial. METHODS: A total of 614 patients with symptomatic heart failure with moderate to severe (3+) or severe (4+) secondary MR were randomized to maximally tolerated GDMT plus MitraClip or GDMT alone; 599 had core laboratory evaluable echocardiograms. Patients were divided into 2 groups by baseline TR severity: none/trace/mild TR (≤Mild TR) (n = 501 [83.6%]) and moderate/severe TR (≥Mod TR) (n = 98 [16.4%]). Two-year composite endpoints of death or heart failure hospitalization (HFH) and the individual endpoints were analyzed. RESULTS:Patients with ≥Mod TR were more likely to be New York Heart Association functional class III/IV (p < 0.0001) and have a Society of Thoracic Surgeons score of ≥8 (p < 0.0001), anemia (p = 0.02), chronic kidney disease (p = 0.003), and higher N-terminal pro-B-type natriuretic peptide (p = 0.02) than those with ≤Mild TR. Patients with ≥Mod TR had more severe MR (p = 0.0005) despite smaller left ventricular volumes (p = 0.005) and higher right ventricular systolic pressure (p < 0.0001). At 2 years, the composite rate of death or HFH was higher in patients with ≥Mod TR compared with ≤Mild TR treated with GDMT alone (83.0% vs. 64.3%; hazard ratio: 1.74; 95% confidence interval: 1.24 to 2.45; p = 0.001) but not following MitraClip (48.2% vs. 44.0%; hazard ratio: 1.14; 95% confidence interval: 0.71 to 1.84; p = 0.59). Rates of death or HFH, as well as death and HFH alone, were reduced by MitraClip compared with GDMT, irrespective of baseline TR grade (pinteraction = 0.16, 0.29, and 0.21 respectively). CONCLUSIONS:Patients with severe secondary MR who also had ≥Mod TR had worse clinical and echocardiographic characteristics and worse clinical outcomes compared to those with ≤Mild TR. Within the COAPT trial, MitraClip improved outcomes in patients with and without ≥Mod TR severity compared with GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079).
Authors: Vien T Truong; Tam N M Ngo; Jan Mazur; Hoai T M Nguyen; Thuy T M Pham; Cassady Palmer; Khanh N P Pham; Hoang T Phan; Kwan S Lee; Marwin Bannehr; Christian Butter; Takayuki Gyoten; Eugene S Chung Journal: ESC Heart Fail Date: 2021-09-22
Authors: Harminder Gill; Heath S L Adams; Omar Chehab; Christopher Allen; Jane Hancock; Pablo Lamata; Gianluca Lucchese; Bernard Prendergast; Simon Redwood; Tiffany Patterson; Ronak Rajani Journal: Front Cardiovasc Med Date: 2022-04-15
Authors: Susanne Anna Schlossbauer; Francesco Fulvio Faletra; Vera Lucia Paiocchi; Laura Anna Leo; Giorgio Franciosi; Michela Bonanni; Gianmarco Angelini; Anna Giulia Pavon; Enrico Ferrari; Siew Yen Ho; Rebecca T Hahn Journal: J Cardiovasc Dev Dis Date: 2021-09-03