Percutaneous Repair With the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation - MITRA-FR

Sep 02, 2019
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
French Ministry of Health and Research National Program; Abbott Vascular
Date Presented:
09/02/2019
Date Published:
12/13/2018
Date Updated:
09/02/2019
Original Posted Date:
08/27/2018
References

Contribution To Literature:

The MITRA-FR trial failed to show that percutaneous mitral valve repair was superior to medical therapy at preventing adverse events.

Description:

The goal of the trial was to evaluate percutaneous mitral valve repair (MitraClip) compared with medical therapy among patients with severe functional mitral regurgitation.

Study Design

  • Randomized
  • Parallel

Patients with severe secondary mitral regurgitation were randomized to percutaneous mitral valve repair (n = 152) versus medical therapy (n = 152). The results were the same among all tested subgroups.

  • Total number of enrollees: 304
  • Duration of follow-up: 12 months
  • Mean patient age: 70 years
  • Percentage female: 21%

Inclusion criteria:

  • Symptomatic heart failure
  • Severe secondary mitral regurgitation defined as effective regurgitant orifice >20 mm2 or regurgitant volume >30 cc/beat
  • Left ventricular ejection fraction 15-40%

Exclusion criteria:

  • Candidates for mitral valve surgery

 Other salient features/characteristics:

  • Reduction in mitral regurgitation of ≥2 grades: 92%
  • Mean effective regurgitant orifice area (EROA): 31 mm2
  • Mean left ventricular end-diastolic volume (LVEDV): 272 cc

Principal Findings:

The primary outcome, death or hospitalization for heart failure, occurred in 54.6% of the percutaneous mitral valve repair group compared with 51.3% of the medical therapy group (p = 0.53).

Secondary outcomes:

  • Death: 24.3% of the percutaneous mitral valve repair group versus 22.4% of the medical therapy group (p = not significant)
  • Hospitalization for heart failure: 48.7% of the percutaneous mitral valve repair group versus 47.4% of the medical therapy group (p = not significant)
  • Death or hospitalization at 24 months: 64.2% of the percutaneous mitral valve repair group versus 68.6% of the medical therapy group (p = not significant)

Interpretation:

Among patients with severe secondary mitral regurgitation, percutaneous mitral regurgitation repair (MitraClip) was not beneficial. The MitraClip device was not associated with a reduction in the composite (or individual components) of death or hospitalization for heart failure. The MitraClip device was effective since 92% of patients experienced a reduction in mitral regurgitation of at least 2 grades; however, follow-up echocardiographic data were incompletely reported. The lack of benefit was likely due to the poor prognosis of the severe underlying cardiomyopathy.

This trial contrasts with the COAPT trial, which documented benefit from MitraClip therapy for secondary mitral regurgitation. One reason postulated for this difference is that patients in COAPT had more mitral regurgitation per unit of ventricular volume (i.e., disproportionate mitral regurgitation). In COAPT, the mean EROA was 41 mm2 and the mean LVEDV was 194 cc versus MITRA-FR, where the mean EROA was 31 mm2 and the mean LVEDV was 272 cc.

References:

Presented by Dr. Jean-Francois Obadia at the European Society of Cardiology Congress, Paris, France, September 2, 2019.

Obadia JF, Messika-Zeitoun D, Leurent G, et al., on behalf of the MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med 2018;379:2297-2306.

Editorial: Nishimura RA, Bonow RO. Percutaneous Repair of Secondary Mitral Regurgitation — A Tale of Two Trials. N Engl J Med 2018;379:2374-6.

Presented by Dr. Jean-Francois Obadia at the European Society of Cardiology Congress, Munich, Germany, August 27, 2018.

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Keywords: ESC Congress, ESC 19, Cardiac Surgical Procedures, Cardiomyopathies, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Mitral Valve Insufficiency, Primary Prevention, Stroke Volume


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