Does MitraClip Stand the Test of Time? A Look at the 5-Year COAPT Data

The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial demonstrated that transcatheter edge-to-edge repair of the mitral valve using the MitraClip device (Abbott Laboratories, Abbott Park, Illinois) significantly lowered the risk of heart failure (HF) hospitalization and all-cause mortality at 24 months in patients with systolic HF (left ventricular ejection fraction <50%) and moderate-to-severe or severe mitral regurgitation (MR).1 Five-year follow-up data from the COAPT trial were presented at ACC.23.2

Compared with optimal guideline-directed medical therapy (GDMT), the benefit of MitraClip persisted at 5 years, with a significant reduction in the annualized rate of HF hospitalization: 33.1% versus 57.2% (hazard ratio [HR], 0.53).2 All-cause mortality was also reduced (HR, 0.72).2 Device-specific safety events occurred in only four patients (1.4%).2 The five-year mortality rate was high in both the device arm (57.3%) and control arm (67.2%), reflecting the progressive nature of HF and importance of long-term follow-up.2

Although it is a positive-outcome trial, there are several aspects to note. After 2 years, 21% of patients in the control arm received MitraClip, which may have attenuated the positive results of the trial.2

Enrollment for the COAPT trial occurred before the widespread use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) for the treatment of HF, and only three patients were prescribed SGLT2i.2 Routine SGLT2i use may narrow the difference between the control and MitraClip groups. However, the COAPT trial enrolled patients with significant MR that persisted despite GDMT.1 Therefore, using MitraClip to repair MR that persists despite GDMT that includes SGLT2i would likely have similar benefit.

In summary, in the 5-year analysis of the COAPT trial, MitraClip continued to benefit patients with systolic HF and significant MR, improving survival and preventing HF hospitalizations.

References

  1. Stone GW, Lindenfeld J, Abraham WT, et al.; COAPT Investigators. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med 2018;379:2307-18.
  2. Stone GW, Abraham WT, Lindenfeld J, et al.; COAPT Investigators. Five-year follow-up after transcatheter repair of secondary mitral regurgitation. N Engl J Med 2023;388:2037-48.

Clinical Topics: Heart Failure and Cardiomyopathies, Valvular Heart Disease, Acute Heart Failure, Mitral Regurgitation

Keywords: ACC Annual Scientific Session, ACC23, Mitral Valve, Mitral Valve Insufficiency, Stroke Volume, Follow-Up Studies, Diabetes Mellitus, Type 2, Ventricular Function, Left, Sodium-Glucose Transporter 2 Inhibitors, Heart Failure, Hospitalization, Outcome Assessment, Health Care, Glucose, Sodium


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