Document Detail


Effects of pyridoxal-5'-phosphate (MC-1) in patients undergoing high-risk coronary artery bypass surgery: results of the MEND-CABG randomized study.
MedLine Citation:
PMID:  17532963     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Coronary artery bypass graft surgery remains associated with significant postoperative cardiovascular morbidity and mortality in high-risk patients. MC-1 (pyridoxal-5'-phosphate monohydrate) inhibits purinergic receptors and intracellular influx of Ca2+, thereby reducing cellular injury during experimental ischemia and reperfusion. The MEND-CABG trial tested the hypothesis that MC-1 reduces cardiovascular morbidity and mortality after coronary artery bypass graft. METHODS: In a phase 2, double-blinded, placebo-controlled study, 901 patients scheduled for coronary artery bypass graft surgery with cardiopulmonary bypass and at high risk for subsequent cardiac or neurologic complications were randomly assigned to receive oral MC-1 (250 mg or 750 mg/d once daily) or placebo beginning 3 to 10 hours prior to surgery and continued to postoperative day 30. RESULTS: At 30 days, MC-1 250 mg (compared with placebo) reduced the composite of death, nonfatal cerebral infarction, and nonfatal myocardial infarction by 14.0% (P = .3124) with peak creatinine kinase-myocardial band > or =50 ng/mL (prespecified primary end point); 32.3% (P = .0349) with peak creatinine kinase-myocardial band > or =70 ng/mL; and 37.2% (P = .0283) with peak creatinine kinase-myocardial band > or =100 ng/mL. Myocardial infarctions with peak creatinine kinase-myocardial band> or =100 ng/mL were reduced by 47.2% in the MC-1 250-mg group versus placebo (P = .0083). Greater efficacy was demonstrated with 250 mg than with the 750-mg dose of MC-1. CONCLUSIONS: In high-risk patients undergoing coronary artery bypass graft, treatment with MC-1 did not significantly affect the prespecified primary end point but was associated with a significant reduction in perioperative myocardial infarction with creatinine kinase-myocardial band > or =100 ng/mL. A larger, well-powered trial is needed to evaluate the cardioprotective effects of MC-1.
Authors:
Jean-Claude Tardif; Michel Carrier; David E Kandzari; Robert Emery; Robert Cote; Therese Heinonen; Marjorie Zettler; Vic Hasselblad; Marie-Claude Guertin; Robert A Harrington;
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of thoracic and cardiovascular surgery     Volume:  133     ISSN:  1097-685X     ISO Abbreviation:  J. Thorac. Cardiovasc. Surg.     Publication Date:  2007 Jun 
Date Detail:
Created Date:  2007-05-29     Completed Date:  2007-06-27     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0376343     Medline TA:  J Thorac Cardiovasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1604-11     Citation Subset:  AIM; IM    
Affiliation:
Montreal Heart Institute, Montreal, Canada. jean-claude.tardif@icm-mhi.org
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Aged
Aged, 80 and over
Area Under Curve
Canada
Cardiopulmonary Bypass
Cardiovascular Diseases / mortality,  surgery*
Chi-Square Distribution
Coronary Artery Bypass* / adverse effects
Creatine Kinase, MB Form / blood
Double-Blind Method
Female
Humans
Male
Middle Aged
Myocardial Infarction / etiology,  prevention & control*
Pyridoxal Phosphate / administration & dosage,  therapeutic use*
Stroke / etiology,  prevention & control*
Treatment Outcome
United States
Chemical
Reg. No./Substance:
54-47-7/Pyridoxal Phosphate; EC 2.7.3.2/Creatine Kinase, MB Form
Comments/Corrections
Comment In:
J Thorac Cardiovasc Surg. 2007 Jun;133(6):1409-11   [PMID:  17532929 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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