Medical Versus Surgical Management of Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention
Medical Versus Surgical Management of Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention
The pilot prospective randomized trial is designed to determine the safety and feasibility of
 enrolling patients to surgically correct residual Mitral Regurgitation (MR) following
 Percutaneous Coronary Intervention (PCI) for Myocardial Infarction (MI) verses ongoing
 medical management of MR. The investigators hypothesize that if moderate MR is corrected in
 this patient subset, the patients will have improved outcomes as measured by decreased number
 of major adverse cardiac events, including death, congestive heart failure requiring
 hospitalization, atrial fibrillation, deterioration of New York Heart Association (NYHA)
 functional status and improved quality of life.
Mitral regurgitation (MR) is a frequent complication of myocardial infarction. Ischemic MR
 portends a poor prognosis on long term follow up. This pilot prospective randomized trial is
 a safety and feasibility trial to evaluate mitral valve repair versus surgical management in
 patients with residual MR after primary percutaneous coronary intervention (PCI). Patients
 will be screened for possible inclusion to identify those that have first MI treated with
 primary PCI. Patients with moderate MR at 6 or more weeks following first primary PCI will be
 randomized to continued medical management versus surgical mitral valve repair. Patients with
 previous or subsequent coronary artery bypass surgery and patients with severe ventricular
 dysfunction will be excluded. Patients will be followed for one year from the time of
 randomization. The safety and feasibility data will be used to design a large trial powered
 to detect a difference in mortality between treatment arms.

 Results of this study could lead to a radical change in the treatment paradigm for patients
 with ischemic MR following PCI for acute MI. In addition, insight gained from this study
 could advance our understanding of the interrelationship between LV remodeling and MR and
 shed some light into the mechanism of ventricular function deterioration following MI.
 Moreover, it may provide a framework for the development of further recommendations with
 respect to the indications for surgical intervention in this patient population.
Inclusion Criteria:

 -  Patients who have undergone PCI for first acute MI (index MI) since 7/1/09 at MMC and
 STJ

 -  documented moderate mitral regurgitation on follow up echocardiography six or more
 weeks after PCI procedure

 -  English speaking

 Exclusion Criteria:

 -  CABG after PCI for acute MI

 -  History of previous MI prior to index MI

 -  History of previous PCI or CABG prior to index PCI

 -  EF <30 % on the echocardiogram at 6 weeks after PCI for MI