In an analysis of patients from the COAPT trial with severe mitral regurgitation (MR) who have heart failure and tricuspid regurgitation (TR), treatment with MitraClip plus guideline-directed medical therapy (GDMT) led to more favorable prognoses compared to GDMT alone.
The analysis of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial was published in the Sept. 15 issue of the Journal of the American College of Cardiology.
Administering percutaneous treatment of TR at time of transcatheter mitral repair has been a controversial subject for some time. Analyses of the TriValve and TRAMI registries suggest that treating TR could offer better outcomes, while other experts exercise more conservatism.
In the latest COAPT analysis, Rebecca Hahn, MD, of Columbia University Medical Center, New York, and co-investigators assessed 599 patients with symptomatic heart failure and moderate to severe or severe secondary MR, who were adequate for TR assessment. They found 98 patients who had at least moderate degrees of TR at baseline had worse clinical outcomes and echocardiographic characteristics, compared to 501 with mild or no TR, at baseline.
Following baseline measurement, the patients were randomized to receive either maximally tolerated GDMT plus MitraClip or GDMT alone. Treatment of TR with MitraClip – regardless of severity – led to better improvements on the 2-year composite endpoints of death or heart failure hospitalization (HFH) compared to GDMT alone.
Those given only GDMT and who had worse TR had an 83% rate of death or HFH, compared to 64.3% for those with milder or no TR (hazard ratio [HR], 1.74; 95% confidence interval [CI], 1.24 to 2.45; p = 0.001). Patients with more severe TR who were given MitraClip, on the other hand, had a lessened 48.2% death or HFH rate, with a 44% rate for those with milder or no TR, with no significant difference between those with more severe and milder TR (HR, 1.14; 95% CI, 0.71 to 1.84; p = 0.59).
Death rates or HFH, and death and HFH alone, were reduced with MitraClip compared with GDMT, irrespective of baseline TR severity (p-interaction = 0.16, 0.29, and 0.21 respectively).
Nevertheless, there were more deaths before discharge in MitraClip-treated patients with more severe TR at baseline than those with mild or no TR (5.1% vs. 0.8%; p = 0.03). Significantly fewer patients with moderate to severe TR compared to the milder TR cases achieved mild MR from the MitraClip at time of discharge, the researchers added.
More research is still needed to determine whether concomitant or sequential treatment of TR can improve outcomes further, they said.
In an accompanying editorial comment, Yee-Ping Sun, MD, of Brigham and Women's Hospital, Boston, said the study has key implications in an area in which evidence is limited, and where clinicians are attempting to optimally select patients to “recreate COAPT in the real world.”
Despite its “inherent limitations,” given that it is a secondary analysis, the study is also important as healthcare providers move forward with transcatheter management of tricuspid regurgitation, he noted. The fact that worse prognoses for those with moderate to severe TR was mitigated for patients treated with MitraClip “provides further evidence that the presence of significant TR is likely reflective of a different phenotype and should be considered in patient selection,” he said.
Sun went on to point to recent analyses demonstrating that patients with disproportionate MR is likely to be an important factor in achieving optimal results with the MitraClip in functional MR.
“The observation in this study that (moderate to severe) TR is associated with smaller (left ventricular])volumes and more severe MR, therefore, suggests that significant TR may be another important component of the disproportionate MR phenotype," he wrote.
Hahn R, Asch F, Weissman N, et al. Impact of Tricuspid Regurgitation on Clinical Outcomes: The COAPT Trial. J Am Coll Cardiol 2020;76:1305-14.
Sun YP. How much Tricuspid Regurgitation? J Am Coll Cardiol 2020;76:1315-7.