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Randomized Controlled Trial
. 2014 Dec 4;371(23):2178-88.
doi: 10.1056/NEJMoa1410490. Epub 2014 Nov 18.

Surgical treatment of moderate ischemic mitral regurgitation

Collaborators, Affiliations
Randomized Controlled Trial

Surgical treatment of moderate ischemic mitral regurgitation

Peter K Smith et al. N Engl J Med. .

Abstract

Background: Ischemic mitral regurgitation is associated with increased mortality and morbidity. For surgical patients with moderate regurgitation, the benefits of adding mitral-valve repair to coronary-artery bypass grafting (CABG) are uncertain.

Methods: We randomly assigned 301 patients with moderate ischemic mitral regurgitation to CABG alone or CABG plus mitral-valve repair (combined procedure). The primary end point was the left ventricular end-systolic volume index (LVESVI), a measure of left ventricular remodeling, at 1 year. This end point was assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized as the lowest LVESVI rank.

Results: At 1 year, the mean LVESVI among surviving patients was 46.1±22.4 ml per square meter of body-surface area in the CABG-alone group and 49.6±31.5 ml per square meter in the combined-procedure group (mean change from baseline, -9.4 and -9.3 ml per square meter, respectively). The rate of death was 6.7% in the combined-procedure group and 7.3% in the CABG-alone group (hazard ratio with mitral-valve repair, 0.90; 95% confidence interval, 0.38 to 2.12; P=0.81). The rank-based assessment of LVESVI at 1 year (incorporating deaths) showed no significant between-group difference (z score, 0.50; P=0.61). The addition of mitral-valve repair was associated with a longer bypass time (P<0.001), a longer hospital stay after surgery (P=0.002), and more neurologic events (P=0.03). Moderate or severe mitral regurgitation was less common in the combined-procedure group than in the CABG-alone group (11.2% vs. 31.0%, P<0.001). There were no significant between-group differences in major adverse cardiac or cerebrovascular events, deaths, readmissions, functional status, or quality of life at 1 year.

Conclusions: In patients with moderate ischemic mitral regurgitation, the addition of mitral-valve repair to CABG did not result in a higher degree of left ventricular reverse remodeling. Mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral regurgitation but an increased number of untoward events. Thus, at 1 year, this trial did not show a clinically meaningful advantage of adding mitral-valve repair to CABG. Longer-term follow-up may determine whether the lower prevalence of mitral regurgitation translates into a net clinical benefit. (Funded by the National Institutes of Health and the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00806988.).

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Figures

Figure 1
Figure 1. Time-to-Event Curves for the Composite End Point of Cardiac or Cerebrovascular Events and Death, According to Treatment Group
The composite end point of major adverse cardiac or cerebrovascular events included death, stroke, subsequent mitral-valve (MV) surgery, hospitalization for heart failure, and an increase of one or more classes in the New York Heart Association (NYHA) classification. Crosses indicate censoring of data at the indicated time point. CABG denotes coronary-artery bypass surgery.
Figure 2
Figure 2. NYHA Class and Death, According to Treatment Group
The proportions of patients in each NYHA class are shown at baseline and at 6 and 12 months; the proportions of patients who died are shown at 6 and 12 months.

Comment in

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