Outcomes of the RESTOR-MV Trial (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve)

被引:97
作者
Grossi, Eugene A. [1 ,2 ]
Patel, Nirav [3 ]
Woo, Y. Joseph [4 ]
Goldberg, Judith D. [2 ]
Schwartz, Charles F. [2 ]
Subramanian, Valavanur [3 ]
Feldman, Ted [5 ]
Bourge, Robert [6 ]
Baumgartner, Norbert [7 ]
Genco, Christopher [7 ]
Goldman, Scott [8 ]
Zenati, Marco [9 ]
Wolfe, J. Alan [10 ]
Mishra, Yugal K. [11 ]
Trehan, Naresh [13 ]
Mittal, Sanjay [13 ]
Shang, Shulian [2 ]
Mortier, Todd J. [12 ]
Schweich, Cyril J., Jr. [12 ]
机构
[1] NYU, Sch Med, NY Harbor Healthcare Syst, New York, NY 10028 USA
[2] New York Harbor Vet Healthcare Syst, New York, NY USA
[3] Lenox Hill Hosp, New York, NY 10021 USA
[4] Hosp Univ Penn, Philadelphia, PA 19104 USA
[5] Northwestern Univ, Evanston Hosp, Evanston, IL 60201 USA
[6] Univ Alabama Birmingham, Birmingham, AL USA
[7] Covenant Hlth Ctr, Saginaw, MI USA
[8] Lankenau Hosp, Lancaster, PA USA
[9] Vet Adm Hosp, Pittsburgh, PA USA
[10] St Josephs Hosp, Atlanta, GA USA
[11] Escorts Heart Inst, New Delhi, India
[12] Myocor Inc, Maple Grove, MN USA
[13] Indrapratha Apollo, New Delhi, India
关键词
functional mitral insufficiency; left ventricular reshaping; mitral valve repair; LONG-TERM SURVIVAL; CORONARY REVASCULARIZATION; RESTRICTIVE ANNULOPLASTY; REGURGITATION; MODERATE; IMPACT; SURGERY;
D O I
10.1016/j.jacc.2010.06.051
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
Objectives We sought to determine whether patients with functional mitral regurgitation (FMR) would benefit from ventricular reshaping by the Coapsys device (Myocor, Inc., Maple Grove, Minnesota). Background FMR occurs when ventricular remodeling impairs valve function. Coapsys is a ventricular shape change device placed without cardiopulmonary bypass to reduce FMR. It compresses the mitral annulus and reshapes the ventricle. We hypothesized that Coapsys for FMR would improve clinical outcomes compared with standard therapies. Methods RESTOR-MV (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve) was a randomized, prospective, multicenter study of patients with FMR and coronary disease with core laboratory analysis. After enrollment, patients were stratified to the standard indicated surgery: either coronary artery bypass graft alone or coronary artery bypass graft with mitral valve repair. In each stratum, randomization was to either control (indicated surgery) or treatment (coronary artery bypass graft with Coapsys ventricular reshaping). Results The study was terminated when the sponsor failed to secure ongoing funding; 165 patients were randomized. Control and Coapsys both produced decreases in left ventricular (LV) end-diastolic dimension and MR at 2 years (p < 0.001); Coapsys provided a greater decrease in LV end-diastolic dimension (p = 0.021). Control had lower MR grades during follow-up (p = 0.01). Coapsys showed a survival advantage compared with control at 2 years (87% vs. 77%) (hazard ratio: 0.421; 95% confidence interval: 0.200 to 0.886; stratified log-rank test; p = 0.038). Complication-free survival (including death, stroke, myocardial infarction, and valve reoperation) was significantly greater with Coapsys at 2 years (85% vs. 71%) (hazard ratio: 0.372; 95% confidence interval: 0.185 to 0.749; adjusted log-rank test; p = 0.019). Conclusions Analysis of RESTOR-MV indicates that patients with FMR requiring revascularization treated with ventricular reshaping rather than standard surgery had improved survival and a significant decrease in major adverse outcomes. This trial validates the concept of the ventricular reshaping strategy in this subset of patients with heart failure. (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve [RESTOR-MV]; NCT00120276) (J Am Coll Cardiol 2010; 56: 1984-93) (C) 2010 by the American College of Cardiology Foundation
引用
收藏
页码:1984 / 1993
页数:10
相关论文
共 29 条
[1]
Aklog L, 2001, CIRCULATION, V104, pI68
[2]
The potential of myocardial perfusion scintigraphy for risk stratification of asymptomatic patients with type 2 diabetes [J].
Bax, Jeroen J. ;
Bonow, Robert O. ;
Tschoepe, Diethelm ;
Inzucchi, Silvio E. ;
Barrett, Eugene .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2006, 48 (04) :754-760
[3]
Restrictive annuloplasty and coronary revascularization in ischemic mitral regurgitation results in reverse left ventricular remodeling [J].
Bax, JJ ;
Braun, J ;
Somer, ST ;
Klautz, R ;
Holman, ER ;
Versteegh, MIM ;
Boersma, E ;
Schalij, MJ ;
van der Wall, EE ;
Dion, RA .
CIRCULATION, 2004, 110 (11) :II103-II108
[4]
The STICH trial: Misguided conclusions [J].
Buckberg, Gerald D. ;
Athanasuleas, Constantine L. .
JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 2009, 138 (05) :1060-U35
[5]
Mitral valve procedure in dilated cardiomyopathy:: Repair or replacement? [J].
Calafiore, AM ;
Gallina, S ;
Di Mauro, M ;
Gaeta, F ;
Iacò, AL ;
D'Alessandro, S ;
Mazzei, V ;
Di Giammarco, G .
ANNALS OF THORACIC SURGERY, 2001, 71 (04) :1146-1152
[6]
Impact of mitral regurgitation on long-term survival after percutaneous coronary intervention [J].
Ellis, SG ;
Whitlow, PL ;
Raymond, RE ;
Schneider, JP .
AMERICAN JOURNAL OF CARDIOLOGY, 2002, 89 (03) :315-+
[7]
Optimal mitral annular and subvalvular shape change created by the coapsys device to treat functional mitral regurgitation [J].
Fukamachi, K ;
Inoue, M ;
Popovic, Z ;
Ootaki, Y ;
Kopcak, MW ;
Dessoffy, R ;
Thomas, JD ;
McCarthy, PM .
ASAIO JOURNAL, 2005, 51 (01) :17-21
[8]
Downsizing of the mitral valve and coronary revascularization in severe ischemic mitral regurgitation results in reverse left ventricular and left atrial remodeling [J].
Geidel, S ;
Lass, M ;
Schneider, C ;
Groth, G ;
Boczor, S ;
Kuck, KH ;
Ostermeyer, J .
EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY, 2005, 27 (06) :1011-1016
[9]
Ischemic versus degenerative mitral regurgitation: Does etiology affect survival? [J].
Gillinov, AM ;
Blackstone, EH ;
Rajeswaran, J ;
Mawad, M ;
McCarthy, PM ;
Sabik, JF ;
Shiota, T ;
Lytle, BW ;
Cosgrove, DM .
ANNALS OF THORACIC SURGERY, 2005, 80 (03) :811-819
[10]
Patient survival characteristics after routine mitral valve repair for ischemic mitral regurgitation [J].
Glower, DD ;
Tuttle, RH ;
Shaw, LK ;
Orozco, RE ;
Rankin, JS .
JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 2005, 129 (04) :860-866