MITRA-FR vs. COAPT: lessons from two trials with diametrically opposed results

Eur Heart J Cardiovasc Imaging. 2019 Jun 1;20(6):620-624. doi: 10.1093/ehjci/jez073.

Abstract

Percutaneous mitral valve repair using the MitraClip device has been proposed to correct secondary mitral regurgitation (MR). Recently, the results of two randomized controlled trials, that is MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) and COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation), assessing the efficacy and safety of MitraClip in patients with systolic heart failure and severe secondary MR were published. A priori, these two trials targeted the same patient populations with the same disease using the same device but the results of these trials were diametrically opposed, MITRA-FR being neutral and COAPT being highly positive with respect to efficacy of the MitraClip procedure. The objectives of this viewpoint are: (i) to highlight not only the similarities but also the differences between MITRA-FR and COAPT, which may explain the strikingly different results and conclusions between these two trials and (ii) to derive from these results, implications with regards to the application of the MitraClip procedure in clinical practice.

Keywords: echocardiography; heart failure; mitral regurgitation; transcatheter.

Publication types

  • Comparative Study

MeSH terms

  • Cardiac Catheterization / methods*
  • Female
  • Follow-Up Studies
  • Heart Failure / diagnostic imaging
  • Heart Failure / mortality
  • Heart Failure / surgery*
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation / methods*
  • Humans
  • Male
  • Minimally Invasive Surgical Procedures / methods
  • Mitral Valve Insufficiency / diagnostic imaging
  • Mitral Valve Insufficiency / mortality
  • Mitral Valve Insufficiency / surgery*
  • Outcome Assessment, Health Care*
  • Prospective Studies
  • Prosthesis Design
  • Randomized Controlled Trials as Topic
  • Risk Assessment
  • Treatment Outcome