A novel approach to systematically implement the universal definition of myocardial infarction: insights from the CHAMPION PLATFORM trial
- Sergio Leonardi1,2,
- Adriano A M Truffa1,
- Megan L Neely1,
- Pierluigi Tricoci1,
- Harvey D White3,
- C Michael Gibson4,
- Matthew Wilson1,
- Gregg W Stone5,
- Robert A Harrington6,
- Deepak L Bhatt7,
- Kenneth W Mahaffey1
- 1Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA
- 2Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
- 3Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
- 4Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
- 5Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA
- 6Stanford University, Stanford, California, USA
- 7VA Boston Healthcare System, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts, USA
- Correspondence to Dr Sergio Leonardi, Duke Clinical Research Institute, 2400 Pratt Street, Room 0311 Terrace Level, Durham, NC 27705, USA;
- Received 2 October 2012
- Revised 23 January 2013
- Accepted 25 January 2013
- Published Online First 23 February 2013
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.