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Valve Disease2018New England Journal of Medicine

MITRA-FR

Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation

Sample Size
304
Study Design
Multicenter, randomized, open-label, controlled trial
Year Published
2018
Category
Valve Disease

Clinical Question

Does percutaneous mitral valve repair with MitraClip reduce mortality and heart failure hospitalization in patients with severe secondary mitral regurgitation and heart failure?

Population

Patients with severe secondary mitral regurgitation (EROA ≥20 mm² or regurgitant volume ≥30 mL), symptomatic heart failure (NYHA class II-IV), and LVEF 15-40% at 37 centers in France.

Intervention

Percutaneous mitral valve repair with MitraClip plus medical therapy

Control

Medical therapy alone

Primary Endpoint

Composite of all-cause death or unplanned hospitalization for heart failure at 12 months

Key Findings

1

The primary endpoint occurred in 54.6% of MitraClip patients vs 51.3% of medical therapy patients at 12 months (OR 1.16; 95% CI, 0.73-1.84; p=0.53).

2

All-cause mortality at 12 months was 24.3% with MitraClip vs 22.4% with medical therapy (p=0.69).

3

Heart failure rehospitalization was 48.7% with MitraClip vs 47.4% with medical therapy (p=0.53).

4

MR severity was reduced to grade 2 or less in 91.9% of MitraClip patients at discharge, but residual MR ≥3+ persisted in some patients at follow-up.

5

Left ventricular volumes did not change significantly in the MitraClip group, suggesting limited reverse remodeling.

Impact on Clinical Practice

MITRA-FR provided a critically important counterpoint to COAPT, published in the same year with seemingly contradictory results. While COAPT showed dramatic mortality benefit, MITRA-FR found no benefit of MitraClip for secondary MR. Understanding the reasons for these divergent findings became one of the most important exercises in modern cardiology. The key differences between the trials centered on patient selection. MITRA-FR enrolled patients with more dilated ventricles and relatively less severe MR (proportionate MR), where the regurgitation was a consequence of advanced cardiomyopathy rather than a driver of symptoms. In contrast, COAPT enrolled patients with disproportionate MR, where the severity of regurgitation exceeded what would be expected for the degree of ventricular dilation. MITRA-FR taught the field that fixing the valve alone is insufficient when the underlying cardiomyopathy is the primary problem. The trial was instrumental in refining patient selection criteria for TEER and establishing the principle that anatomic correction without physiologic benefit does not improve outcomes.

Guideline Impact

MITRA-FR, in conjunction with COAPT, shaped guidelines to emphasize strict patient selection for TEER. ACC/AHA and ESC guidelines now specify that patients must have severe MR despite optimized GDMT, with anatomy suitable for clip therapy and without excessively dilated ventricles.

Limitations

Smaller sample size (304 vs 614 in COAPT) may have limited statistical power to detect modest treatment effects.

Less stringent MR severity criteria (EROA ≥20 mm²) compared to COAPT (EROA ≥30 mm²) may have included patients with less severe MR.

Residual MR after MitraClip was more common than in COAPT, potentially reflecting procedural or patient selection differences.

Farhan Ayubi, MD
Reviewed by Farhan Ayubi, MD
Vascular & Endovascular Surgeon

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2018 · New England Journal of Medicine
mitral regurgitationheart failuremitraclip vs medical therapy
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