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3-Year Outcomes of Transcatheter Mitral Valve Repair in Heart Failure
Quick Takes
- The COAPT trial found that treatment with edge-to-edge TMVr in addition to GDMT compared to GDMT alone was associated with a lower rate of HF hospitalizations and lower all-cause mortality at 24 months among patients with ischemic or nonischemic cardiomyopathy with LVEF 20%-50%, grade 3+ or 4+ functional mitral regurgitation (FMR), and symptomatic (functional class II, III, or IVa [ambulatory]) HF despite the use of GDMT.
- This study extends those findings to 36 months, with continued divergence of the curves through 36 months in the composite endpoint of death or HF hospitalization, and demonstrated benefit associated with TMVr among patients in the COAPT trial who underwent TMVr only after 24 months.
- This study provides further evidence that edge-to-edge TMVr may be beneficial among selected patients with ischemic or nonischemic cardiomyopathy, 3+ or 4+ FMR, and persistent symptoms despite maximized GDMT.
Study Questions:
1) Do the benefits associated with transcatheter mitral valve repair (TMVr) among patients with heart failure (HF) and functional mitral regurgitation (FMR) in the COAPT trial persist at 36 months, and 2) was there similar benefit among control subjects allowed to cross over to intervention at 24 months?
Methods:
The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial randomized 614 patients with HF with moderate-to-severe or severe FMR who remained symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT) to TMVr GDMT versus GDMT alone. The primary effectiveness endpoint was all HF hospitalizations (HFHs) through 24-month follow-up; this study reports follow-up through 36 months.
Results:
The annualized rates of HFHs per patient-year were 35.5% with TMVr and 68.8% with GDMT alone (hazard ratio [HR], 0.49; 95% confidence interval [CI], 0.37-0.63; p < 0.001; number needed to treat [NNT] = 3.0, 95% CI, 2.4-4.0). Mortality occurred in 42.8% of the device group versus 55.5% of the control group (HR, 0.67; 95% CI, 0.52-0.85; p = 0.001; NNT = 7.9, 95% CI, 4.6-26.1). Patients who underwent TMVr also had sustained 3-year improvements in MR severity, quality-of-life measures, and functional capacity. Among 58 patients assigned to GDMT alone who crossed over and were treated with TMVr, the subsequent composite rate of mortality or HFH was reduced compared with those who continued on GDMT alone (adjusted HR, 0.43; 95% CI, 0.24-0.78; p = 0.006).
Conclusions:
Among patients with HF and moderate-to-severe or severe FMR who remained symptomatic despite GDMT, TMVr was safe; provided a durable reduction in MR; reduced the rate of HFH; and improved survival, quality of life, and functional capacity compared with GDMT alone through 36 months. Surviving patients who crossed over to device treatment had a prognosis comparable to those originally assigned to transcatheter therapy.
Perspective:
The COAPT trial enrolled patients with ischemic or nonischemic cardiomyopathy with left ventricular ejection fraction (LVEF) 20%-50%, grade 3+ or 4+ FMR, and symptomatic (functional class II, III, or IVa [ambulatory]) HF despite the use of GDMT and cardiac resynchronization therapy when appropriate. The trial found that treatment with edge-to-edge TMVr in addition to GDMT compared to GDMT alone was associated with a lower rate of HFHs and lower all-cause mortality at 24 months. This study extends those findings to 36 months, with continued divergence of the curves through 36 months in the composite endpoint of death or HFH; and also demonstrated benefit associated with TMVr among patients in the COAPT trial who crossed over to TMVr after 24 months. The COAPT trial stands in contrast to findings in the MITRA-FR (Multicenter Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation) trial, which found no benefit associated with TMVr in a cohort of patients with relatively larger LVs and relatively less FMR. Although reconciling the disparate outcomes of the two studies still is ongoing, this study provides further evidence that edge-to-edge TMVr may be beneficial among selected patients with ischemic or nonischemic cardiomyopathy, 3+ or 4+ FMR, and persistent symptoms despite maximized GDMT.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease, Mitral Regurgitation
Keywords: Cardiac Surgical Procedures, Cardiomyopathies, Heart Failure, Heart Valve Diseases, Mitral Valve Insufficiency, Outcome Assessment, Health Care, Quality of Life, Stroke Volume, Transcatheter Aortic Valve Replacement, Ventricular Function, Left
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