Comparison of Site-Reported and Core Laboratory-Reported Creatine Kinase-MB Values in Non–ST-Segment Elevation Acute Coronary Syndrome (from the International Trial SYNERGY)

• Published in: The American journal of cardiology 2009-11, Vol.104 (10), p.1330-1335
• Main Authors: Linefsky, Jason P., MD, Lin, Min, PhD, Pieper, Karen S., MS, Reist, Craig J., PhD, Berdan, Lisa G., PA-C, Antman, Elliott M., MD, Goodman, Shaun G., MD, French, John K., MB, ChB, PhD, Guneri, Sema, MD, Roe, Matthew T., MD, MHS, Newby, L. Kristin, MD, MHS, Harrington, Robert A., MD, Ferguson, James J., MD, Califf, Robert M., MD, Mahaffey, Kenneth W., MD
• Format: Article
• Language: English
• Subjects: Acute Coronary Syndrome - blood; Acute Coronary Syndrome - mortality; Acute Coronary Syndrome - therapy; Acute coronary syndromes; Amino acids; Angioplasty, Balloon, Coronary; Biological and medical sciences; Biomarkers - blood; Cardiology; Cardiology. Vascular system; Cardiovascular; Clinical trials; Comparative analysis; Coronary Artery Bypass; Coronary heart disease; Creatine Kinase, MB Form - blood; Heart; Heart attacks; Humans; Inhibitor drugs; Kinases; Laboratories; Medical sciences; Myocardial Infarction - blood; Myocardial Infarction - mortality; Myocardial Infarction - therapy; Myocarditis. Cardiomyopathies
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2009.06.056

The effect of nonstandardized creatine kinase (CK)-MB assays on the assessment of myocardial infarction (MI) end points in multicenter international trials has not been evaluated. We compared the site-reported and corresponding core laboratory CK-MB measures from 5 countries participating in the Superior Yield of the New Strategy of Enoxaparin, Revascularization, and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial. Samples for CK-MB were collected locally, with corresponding samples sent to a core laboratory at enrollment and after recurrent ischemic events, percutaneous coronary intervention, or coronary artery bypass grafting. The measured values were compared to the reported assay upper limits of normal (ULN) used at the site (or core laboratory for the core laboratory samples). The CK-MB results were available locally and from the core laboratory for 913 patients, constituting 4,693 time-matched laboratory values. The agreement between the core and site laboratory CK-MB/ULN ratio was moderate (concordance correlation coefficient 0.45) and varied considerably by geographic location and site. The CK-MB values were elevated (≥2 times the ULN) by the core laboratory but normal (