Transcatheter Mitral Valve Repair in Patients With and Without Cardiac Resynchronization Therapy: The COAPT Trial

Circ Heart Fail. 2020 Nov;13(11):e007293. doi: 10.1161/CIRCHEARTFAILURE.120.007293. Epub 2020 Nov 12.

Abstract

Background: In the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), treatment of heart failure (HF) patients with moderate-severe or severe secondary mitral regurgitation with transcatheter mitral valve repair (TMVr) using the MitraClip plus guideline-directed medical therapy (GDMT) reduced 2-year rates of HF hospitalization and all-cause mortality compared with GDMT alone. Whether the benefits of the MitraClip extend to patients with previously implanted cardiac resynchronization therapy (CRT) is unknown. We sought to examine the effect of prior CRT in patients enrolled in COAPT.

Methods: Patients (N=614) with moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated doses of GDMT were randomized 1:1 to the MitraClip (TMVr arm) versus GDMT only (control arm). Outcomes were assessed according to prior CRT use.

Results: Among 614 patients, 224 (36.5%) had prior CRT (115 and 109 randomized to TMVr and control, respectively) and 390 (63.5%) had no CRT (187 and 203 randomized to TMVr and control, respectively). Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%, P=0.32). Death or HF hospitalization at 2 years was lower with TMVr versus control treatment in patients with prior CRT (48.6% versus 67.2%, hazard ratio, 0.60 [95% CI, 0.42-0.86]) and without CRT (42.5% versus 66.9%, hazard ratio, 0.52 [95% CI, 0.39-0.69]; adjusted Pinteraction=0.23). The effects of TMVr with the MitraClip on reducing the 2-year rates of all-cause death (adjusted Pinteraction=0.14) and HF hospitalization (adjusted Pinteraction=0.82) were also consistent in patients with and without CRT as were improvements in quality-of-life and exercise capacity.

Conclusions: In the COAPT trial, TMVr with the MitraClip improved the 2-year prognosis of patients with HF and moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated GDMT, regardless of prior CRT implantation. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.

Keywords: cardiac resynchronization therapy; heart failure; mitral valve; mortality; prognosis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cardiac Catheterization* / adverse effects
  • Cardiac Catheterization* / instrumentation
  • Cardiac Resynchronization Therapy* / adverse effects
  • Cardiac Resynchronization Therapy* / mortality
  • Female
  • Heart Failure / diagnosis
  • Heart Failure / mortality
  • Heart Failure / physiopathology
  • Heart Failure / therapy*
  • Heart Valve Prosthesis Implantation* / adverse effects
  • Heart Valve Prosthesis Implantation* / instrumentation
  • Heart Valve Prosthesis Implantation* / mortality
  • Hospitalization
  • Humans
  • Male
  • Middle Aged
  • Mitral Valve / physiopathology
  • Mitral Valve / surgery*
  • Mitral Valve Insufficiency / diagnosis
  • Mitral Valve Insufficiency / mortality
  • Mitral Valve Insufficiency / physiopathology
  • Mitral Valve Insufficiency / surgery*
  • Quality of Life
  • Recovery of Function
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • United States

Associated data

  • ClinicalTrials.gov/NCT01626079