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RESTOR-MV: Patients with functional mitral regurgitation benefited with ventricular shaping

Grossi EA. J Am Coll Cardiol. 2010;56:1984-1993.

Issue: January 2011

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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 funding.

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 regurgitation].”

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