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evident
Original paper
2018NEJMCardiology

COAPT

Transcatheter Mitral-Valve Repair in Patients with Heart Failure

RCTSecondary mitral regurgitation / heart failure

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Overview

In selected HFrEF with severe secondary MR despite optimized GDMT, MitraClip reduced HF hospitalizations and mortality.

Clinical takeaway

COAPT supports transcatheter edge-to-edge repair for carefully selected symptomatic HFrEF patients with severe secondary MR despite optimized therapy. Its contrast with MITRA-FR makes patient selection central.

Key result

HF hospitalizations: 35.8% vs 67.9% per patient-year; HR 0.53. Mortality at 24 months: 29.1% vs 46.1%; HR 0.62.

Practice impact

Refer selected symptomatic HFrEF patients with severe secondary MR despite optimized GDMT for valve-team evaluation for TEER.

Evidence

Study design

Randomized, open-label, device strategy trial.

Enrollment

614

Follow-up

24 months.

Geography

United States, Canada

Clinical question

Does transcatheter mitral-valve repair improve outcomes in heart failure patients with severe secondary mitral regurgitation despite medical therapy?

Population

  • Symptomatic heart failure patients with moderate-to-severe or severe secondary mitral regurgitation despite maximally tolerated guideline-directed medical therapy.

Intervention

Transcatheter mitral-valve repair with MitraClip plus guideline-directed medical therapy.

Comparator

Guideline-directed medical therapy alone.

Primary outcome

All hospitalizations for heart failure within 24 months.

MitraClip plus GDMT reduced heart-failure hospitalizations compared with GDMT alone.

Hazard ratio / 0.53 / 95% CI 0.40-0.70 / p<0.001

Key results

  • Annualized HF hospitalization rate: 35.8% per patient-year with device vs 67.9% per patient-year with control; HR 0.53; 95% CI 0.40-0.70; p<0.001.
  • All-cause death at 24 months: 29.1% with device vs 46.1% with control; HR 0.62; 95% CI 0.46-0.82; p<0.001.
  • Freedom from device-related complications at 12 months was 96.6%.

Harms

  • Device-related complications occurred but freedom from device-related complications at 12 months was 96.6%.

Clinical Use

Practice impact

  • Supports TEER evaluation for selected symptomatic HFrEF patients with severe secondary MR despite optimized GDMT.

Applicability

  • Most applicable to COAPT-like patients with persistent symptoms, severe secondary MR, optimized GDMT, and suitable valve anatomy.

Limitations

  • Highly selected population with protocolized medical therapy optimization.
  • Results differ from MITRA-FR, making MR severity relative to LV size important.
  • Procedure expertise and anatomy affect real-world generalizability.

Common misinterpretations

  • Do not extrapolate COAPT to all functional MR or to patients not optimized on GDMT.

Citation

Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018;379(24):2307-2318. doi:10.1056/NEJMoa1806640

The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient-year in the device group as compared with 67.9% per patient-year in the control group (hazard ratio, 0.53; 95% confidence interval [CI], 0.40 to 0.70; P<0.001).