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

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.

• Authors: Sergio Leonardi, Adriano A M Truffa, Megan L Neely, Pierluigi Tricoci, Harvey D White, C Michael Gibson, Matthew Wilson, Gregg W Stone, Robert A Harrington, Deepak L Bhatt, Kenneth W Mahaffey
• Journal: Heart (British Cardiac Society) (Heart) Vol. 99 Issue 17 Pg. 1282-7 (Sep 2013) ISSN: 1468-201X [Electronic] England
• PMID: 23434768 (Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Biomarkers
• Purinergic P2Y Receptor Antagonists
• Troponin
• Adenosine Monophosphate
• cangrelor
• Creatine Kinase, MB Form

Topics

• Acute Coronary Syndrome (therapy)
• Adenosine Monophosphate (analogs & derivatives, therapeutic use)
• Aged
• Biomarkers (blood)
• Creatine Kinase, MB Form (analysis)
• Female
• Humans
• Logistic Models
• Male
• Middle Aged
• Myocardial Infarction (blood, diagnosis, therapy)
• Percutaneous Coronary Intervention (adverse effects)
• Purinergic P2Y Receptor Antagonists (therapeutic use)
• Randomized Controlled Trials as Topic
• Risk Assessment
• Sensitivity and Specificity
• Troponin (blood)