A new analysis of the COAPT trial found that acute and sustained reductions in mitral regurgitation (MR) of 0-2+ grades were related to anatomic, clinical and functional factors, which physicians should consider when deciding whether to perform transcatheter mitral valve repair (TMVr) in heart failure (HF) patients with severe secondary MR despite guideline-directed medical therapy (GDMT).
- Scott Lim, MD, of the University of Virginia, presented this analysis Tuesday on behalf of the COAPT investigators as a late-breaking trial Tuesday at Transcatheter Valve Therapies 2021 in Miami Beach, Florida.
The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) was an open-label, multicenter, randomized trial that studied the outcomes of TMVr with the MitraClip (Abbott Vascular) in 614 symptomatic patients with HF and moderate-to-severe MR from December 2012 through June 2017. Eligible patients were randomized to either TMVr with MitraClip and GDMT (n=302) or continued standalone GDMT (n=312). Results after 36 months showed that patients who underwent TMVr with the MitraClip continued to see sustained health benefits over those on GDMT alone.
Based on echo core lab assessments, endpoints were defined as follows: successful and durable MR reduction was a residual MR of 0-2+ achieved by 30 days that persisted through 2 years post-procedure; transient MR reduction was a residual MR of 0-2+ at 30 days that subsequently worsened to 3-4+ during 2-year follow-up; and a failure in MR reduction was a 3-4+ MR at 30 days.
Overall, successful and sustained MR reduction was achieved in 212 patients while transient MR reduction occurred in 41 patients. Twenty patients failed to experience any MR reduction.
According to Lim, a higher baseline 6-minute walk test distinguished those who experienced durable MR reduction from those with transient MR and those without any MR reduction (durable MR = 268±123 meters; transient MR = 228±126 meters; no MR reduction = 197±115 meters; p=0.01).
Lim noted that renal dysfunction, hypertension, and elevated surgical risk were predictive factors of transient MR reduction.
There were no baseline clinical or functional factors associated in patients who failed to experience any MR reduction, nor were there any common echocardiographic indices associated in patients who achieved durable MR reduction.
There were, however, echocardiographic indices associated in patients with no MR reduction, namely a greater degree of baseline MR, a higher inflow gradient, and P3 tethering.
The main COAPT trial was funded by Abbott.