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Heart doi:10.1136/heartjnl-2012-303103
  • Cardiovascular pharmacology
  • Original article

A novel approach to systematically implement the universal definition of myocardial infarction: insights from the CHAMPION PLATFORM trial

  1. Kenneth W Mahaffey1
  1. 1Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA
  2. 2Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
  3. 3Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
  4. 4Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
  5. 5Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA
  6. 6Stanford University, Stanford, California, USA
  7. 7VA Boston Healthcare System, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts, USA
  1. Correspondence to Dr Sergio Leonardi, Duke Clinical Research Institute, 2400 Pratt Street, Room 0311 Terrace Level, Durham, NC 27705, USA; sergio.leonardi{at}duke.edu
  • Received 2 October 2012
  • Revised 23 January 2013
  • Accepted 25 January 2013
  • Published Online First 23 February 2013

Abstract

Objective To reassess the efficacy of cangrelor efficacy using the universal definition of myocardial infarction (MI).

Design We adopted a novel approach to systematically implement the universal definition of MI. Two physicians blinded to treatment allocation reviewed plots of CK-MB and troponin values in relation to time of randomisation and percutaneous coronary intervention (PCI) to identify patients with stable or falling biomarkers pre-PCI (ie, primary cohort), and those with post-PCI CK-MB elevations.

Setting The CHAMPION PLATFORM trial.

Patients Non-ST-elevation acute coronary syndromes (95%) and stable angina patients (5%).

Interventions Cangrelor versus placebo.

Main outcome measures The efficacy of cangrelor compared with placebo using the reclassified events (type 4a MI) and the original clinical events committee-adjudicated (CEC PCI-MI) results was investigated.

Results Of 5295 patients, 3406 (64.4%) were in the primary cohort. Type 4a MI occurred in 4.3% (226 events/5295 patients) while original CEC PCI-MI occurred in 6.5% (344 events/5295 patients), a significant difference (p<0.0001). Using the reclassified MI events, the primary composite endpoint of death, MI, or ischaemia-driven revascularisation through 48 h occurred in 5.4% of patients (4.9% cangrelor, 6.0% placebo; OR 0.80; 95% CI 0.63 to 1.02) as opposed to 7.5% of the primary analyses (7.0% cangrelor, 8.0% placebo; OR 0.87; 95% CI 0.71 to 1.07).

Conclusions Systematic, strict implementation of the universal MI definition with emphasis on baseline assessment may enhance discrimination in detecting PCI-MI and may allow for more rigorous assessment of interventions in patients undergoing early PCI.