Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 60, Issue 22, Pages 2296-2304Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2012.09.005
Keywords
angioplasty; cardiovascular; clinical trial; creatine kinase; diagnostic techniques; endpoint determination; myocardial infarction; surrogate endpoint
Categories
Funding
- Schering-Plough
- Sanofi-Aventis
- Merck, Inc.
- Bristol-Myers Squibb
- Schering-Plough Research Institute
- Eli Lilly Company
- Daiichi Sankyo
- Amylin
- JJ-Scios
- Merck/Schering Plough
- Novartis
- Bristol-Myers Squibb Foundation
- AstraZeneca
- diaDexus
- Eli Lilly Co.
- GlaxoSmithKline
- Murdock Study
- NHLBI
- Regado Biosciences, Inc.
- Roche
- Abbott Vascular
- Amgen Inc.
- Amylin Inc.
- Baxter
- Edwards Lifesciences
- Guidant Corp.
- Ikaria
- Johnson Johnson
- KAI
- Luitpold Pharmaceuticals
- Medtronic
- Portola Pharmaceuticals
- POZEN Pharmaceuticals
- Regado Biosciences
- Roche Diagnostic
- The Medicines Co.
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Objectives This study compared prognoses of myocardial infarction related to percutaneous coronary intervention (PCI, procedural MI) using increasing creatine kinase-myocardial band (CK-MB) thresholds with spontaneous MI. Background Procedural MI usually is defined by a CK-MB elevation of more than 3 times the upper limit of normal (ULN), but higher thresholds have been proposed. Methods Patients from the EARLY-ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome) study and the SYNERGY (Superior Yield of the New strategy of Enoxaparin, Revascularization and GIYcoprotein IIb/IIIa inhibitors) study treated with PCI were included. The primary end point was 1-year all-cause mortality from 24 h after PCI. To determine an enzymatic threshold for procedural MI with a prognosis similar to that of spontaneous MI, we redefined procedural MI using increasing CK-MB thresholds and compared corresponding hazard ratios with those of spontaneous MI (CK-MB more than twice the ULN). Hazard ratios for mortality for procedural and spontaneous MI were calculated using Cox proportional hazards regression and Global Registry of Acute Cardiac Events covariates for risk adjustment. Results Nine thousand eighty-seven patients who underwent PCI (46.8%) were included; 773 procedural MI and 239 spontaneous MI occurred within 30 days. Adjusted hazard ratios for 1-year death were 1.39 (95% confidence interval [CI]: 1.01 to 1.89) for procedural MI and 5.37 (95% CI: 3.90 to 7.38) for spontaneous MI. The CK-MB threshold for procedural MI that achieved the same prognosis as spontaneous MI was 27.7 times the ULN (95% CI: 13.9 to 58.4), but this differed between the SYNERGY study (57.9 times the ULN, 95% CI: 17.9 to 63.6) and the EARLY-ACS study (20.4 times the ULN, 95% CI: 5.16 to 24.2). Of all procedural MI, 49 (6%) had CK-MB elevations of 27.7 or more times the ULN. Conclusions The current enzymatic definition of procedural MI (CK-MB more than 3 times the ULN) used in clinical trials is less strongly associated with death than that of spontaneous MI. Procedural MI achieves similar prognosis for 1-year mortality when much higher CK-MB thresholds are applied. (J Am Coll Cardiol 2012;60:2296-304) (C) 2012 by the American College of Cardiology Foundation
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