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Randomized Controlled Trial Multicenter Study
Surgical treatment of moderate ischemic mitral regurgitation.
- Peter K Smith, John D Puskas, Deborah D Ascheim, Pierre Voisine, Annetine C Gelijns, Alan J Moskowitz, Judy W Hung, Michael K Parides, Gorav Ailawadi, Louis P Perrault, Michael A Acker, Michael Argenziano, Vinod Thourani, James S Gammie, Marissa A Miller, Pierre Pagé, Jessica R Overbey, Emilia Bagiella, François Dagenais, Eugene H Blackstone, Irving L Kron, Daniel J Goldstein, Eric A Rose, Ellen G Moquete, Neal Jeffries, Timothy J Gardner, Patrick T O'Gara, John H Alexander, Robert E Michler, and Cardiothoracic Surgical Trials Network Investigators.
- The authors' affiliations are listed in the Appendix.
- N. Engl. J. Med.. 2014 Dec 4;371(23):2178-88.
BackgroundIschemic 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.MethodsWe 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.ResultsAt 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.ConclusionsIn 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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