Impact of Tricuspid Regurgitation on Clinical Outcomes: The COAPT Trial.
Impact of Tricuspid Regurgitation on Clinical Outcomes: The COAPT Trial.
- 2020
Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007
BACKGROUND: The presence of tricuspid regurgitation (TR) may affect prognosis in patients with mitral regurgitation (MR). 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). Copyright (c) 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. 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. 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. 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).
English
0735-1097
10.1016/j.jacc.2020.07.035 [doi] S0735-1097(20)36034-4 [pii]
*Heart Failure/dg [Diagnostic Imaging]
*Heart Failure/su [Surgery]
*Mitral Valve Insufficiency/dg [Diagnostic Imaging]
*Mitral Valve Insufficiency/su [Surgery]
*Tricuspid Valve Insufficiency/dg [Diagnostic Imaging]
*Tricuspid Valve Insufficiency/su [Surgery]
Aged
Aged, 80 and over
Echocardiography/td [Trends]
Female
Follow-Up Studies
Heart Failure/ep [Epidemiology]
Humans
Male
Middle Aged
Mitral Valve Insufficiency/ep [Epidemiology]
Surgical Instruments/td [Trends]
Treatment Outcome
Tricuspid Valve Insufficiency/ep [Epidemiology]
MedStar Heart & Vascular Institute
Journal Article
Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007
BACKGROUND: The presence of tricuspid regurgitation (TR) may affect prognosis in patients with mitral regurgitation (MR). 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). Copyright (c) 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. 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. 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. 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).
English
0735-1097
10.1016/j.jacc.2020.07.035 [doi] S0735-1097(20)36034-4 [pii]
*Heart Failure/dg [Diagnostic Imaging]
*Heart Failure/su [Surgery]
*Mitral Valve Insufficiency/dg [Diagnostic Imaging]
*Mitral Valve Insufficiency/su [Surgery]
*Tricuspid Valve Insufficiency/dg [Diagnostic Imaging]
*Tricuspid Valve Insufficiency/su [Surgery]
Aged
Aged, 80 and over
Echocardiography/td [Trends]
Female
Follow-Up Studies
Heart Failure/ep [Epidemiology]
Humans
Male
Middle Aged
Mitral Valve Insufficiency/ep [Epidemiology]
Surgical Instruments/td [Trends]
Treatment Outcome
Tricuspid Valve Insufficiency/ep [Epidemiology]
MedStar Heart & Vascular Institute
Journal Article