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

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 committeeadjudicated (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 PCIMI and may allow for more rigorous assessment of interventions in patients undergoing early PCI.