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J Thorac Cardiovasc Surg 2007;133:1604-1611
© 2007 The American Association for Thoracic Surgery

Cardiopulmonary Support and Physiology

Effects of pyridoxal-5'-phosphate (MC-1) in patients undergoing high-risk coronary artery bypass surgery: Results of the MEND-CABG randomized study

Jean-Claude Tardif, MDa,*, Michel Carrier, MDa, David E. Kandzari, MDc, Robert Emery, MDd, Robert Cote, MDe, Therese Heinonen, DVMb, Marjorie Zettler, PhDf, Vic Hasselblad, PhDc, Marie-Claude Guertin, PhDb,e, Robert A. Harrington, MDc MEND-CABG Investigators

a Montreal Heart Institute, Montreal, Canada
b Université de Montréal, the Montreal Heart Institute Coordinating Center, Montreal, Canada
c Duke Clinical Research Institute, Durham, NC
d Minnesota Heart and Vascular Center, Edina, Minn
f Montreal General Hospital, Montreal, Canada
e Medicure, Winnipeg, Canada.

Received for publication July 7, 2006; revisions received December 21, 2006; accepted for publication January 2, 2007.

* Address for reprints: Jean–Claude Tardif, MD, Montreal Heart Institute, 5000 Belanger Street, Montreal, H1T 1C8, Canada. (Email: jean-claude.tardif{at}icm-mhi.org).

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 ≥50 ng/mL (prespecified primary end point); 32.3% (P = .0349) with peak creatinine kinase–myocardial band ≥70 ng/mL; and 37.2% (P = .0283) with peak creatinine kinase–myocardial band ≥100 ng/mL. Myocardial infarctions with peak creatinine kinase–myocardial band≥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 ≥100 ng/mL. A larger, well-powered trial is needed to evaluate the cardioprotective effects of MC-1.

Abbreviations and Acronyms ATP = adenosine triphosphate; CABG = coronary artery bypass graft; CEC = Clinical Endpoint Committee; CK-MB = creatinine kinase–myocardial band; ECG = electrocardiogram; MI = myocardial infarction; P-5'-P = pyridoxal-5'-phosphate monohydrate; PCI = percutaneous coronary intervention; POD = postoperative day


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