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J Thorac Cardiovasc Surg 2007;133:1409-1411
© 2007 The American Association for Thoracic Surgery

Editorial

Translational research: Is there a future?

Division of Cardiothoracic Surgery, University of Washington, Seattle, Wash.

Received for publication January 12, 2007; accepted for publication January 25, 2007.

^_* Address for reprints: Edward Donald Verrier, MD, University of Washington, Surgery, 1959 NE Pacific St, Box 356310, Seattle, WA 98195.

The first 300 words of the full text of this article appear below.

In this issue of the Journal, Tardif and associates¹ from the Montreal Heart Institute report the results of the double-blind, placebo-controlled MC-1 (cardoxal) to Eliminate Necrosis Damage in Coronary Artery Bypass Grafting (MEND-CABG) trial conducted at 40 centers in the United States and Canada between April 2004 and July 2005. The MEND-CABG trial is a phase II study intended to evaluate the potential cardioprotective and neuroprotective effects of pyridoxal-5'-phosphate (cardoxal) in patients undergoing high-risk coronary artery bypass grafting (CABG). Pyridoxal-5'-phosphate monohydrate (P-5'-P, or MC-1) is a naturally occurring metabolite of pyridoxine that acts as a purinergic receptor antagonist that blocks intracellular influx of calcium, thereby theoretically reducing cell damage during episodes of ischemia and reperfusion.

It is important to realize that in the study design the authors and their statistical colleagues decided on the primary and secondary end points on the basis of a careful account of predictable event rates that would balance enrollment (number and associated costs) with need to achieve believable statistical significance. The primary efficacy end point was the combined incidence of cardiovascular death, nonfatal myocardial infarction, and nonfatal cerebral infarction to day 30. Secondary efficacy end points included individual components of the combined end point, area under the curve of creatine kinase isoenzyme MB (CK-MB) within the first 24 hours after CABG, mortality from all causes, and composite and component end points to postoperative day 90. Myocardial infarction was defined in the independent central core electrocardiographic laboratory as follows: (1) peak CK-MB value greater than 50 ng/mL, or greater than 35 ng/mL with electrocardiographic evidence of Q waves through postoperative day 4; (2) peak CK-MB greater than 25 ng/mL or new Q waves occurring after postoperative day 4; and (3) Q-wave or non–Q wave myocardial infarction identified by investigator and confirmed by central core laboratory.

. . . [Full Text of this Article]

Related Article

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, Michel Carrier, David E. Kandzari, Robert Emery, Robert Cote, Therese Heinonen, Marjorie Zettler, Vic Hasselblad, Marie-Claude Guertin, Robert A. Harrington MEND-CABG Investigators
J. Thorac. Cardiovasc. Surg. 2007 133: 1604-1611. [Abstract] [Full Text] [PDF]