Ventricular shaping compared with standard surgery in patients with
functional mitral regurgitation requiring revascularization improved survival
and rates of major adverse outcomes, according to new data from RESTOR-MV.
The Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of
the Mitral Valve (RESTOR-MV) study was a randomized, prospective, multicenter
study featuring 165 patients with functional mitral regurgitation and coronary
disease. Patients treated with CABG and mitral repair were randomly assigned to
receive either CABG plus mitral ring annuloplasty (control; n=75) or CABG plus
Coapsys (Myocor Inc.; n=74), whereas patients receiving CABG alone were
randomly assigned to either CABG plus Coapsys (n=8) or CABG alone (control;
n=8). The study was terminated when the sponsor (Myocor) did not secure ongoing
According to study data, patients treated with Coapsys had a greater
decrease in left ventricular end-diastolic dimension (P=.021), as well
as improved survival rating (87% vs. 77%; HR=0.421; 95% CI, 0.200-0.886), when
compared with the control at 2 years.
Mitral regurgitation grades were decreased at least two
grades or was grade 1 or less in 92% of the control arm vs. 66.7% in the
treatment arm (P=.02).
Additionally, rates of complication-free survival — which included
death, MI, stroke and
valve reoperation — at 2 years were higher in the
Coapsys group (85% vs. 71%; HR=0.372; 95% CI, 0.185-0.749).
“On the basis of intention-to-treat analyses, the RESTOR-MV trial
found that patients with [functional mitral regurgitation] who required
revascularization and were treated with ventricular reshaping rather than the
standard surgical approach had HRs of less than one-half for both mortality and
major adverse outcomes,” Eugene A. Grossi, MD, and fellow
researchers wrote of their study’s findings. “This unique approach to
reshaping the left ventricle and treating the valve has effected a meaningful
impact on the clinical outcomes of patients with [functional mitral