Detecting Periprocedural Myocardial Infarction in Contemporary Percutaneous Coronary Intervention Trials
Ernest Spitzer1, Ton de Vries2, Rafael Cavalcante3
1Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands; Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
Objectives:
This study sought to investigate the differences in detecting (e.g., triggering) periprocedural myocardial infarction (PMI) among 3 current definitions.
Background:
PMI is a frequent component of primary endpoints in coronary device trials. Identification of all potential suspected events is critical for accurate event ascertainment. Automatic triggers based on study databases prevent underreporting of events.
Methods:
We generated automated algorithms to trigger PMI based on each definition and compared results using data from the RESOLUTE all comers trial.
Results:
The operationalization of current PMI definitions was achieved by defining programmable algorithms used to interrogate the study database. From a total of 636 PMI triggers, we identified 234 for the World Health Organization extended definition, 382 for the Third Universal definition, and 216 for the Society for Cardiovascular Angiography and Interventions definition. Differences among the biomarkers used, different cutoff values, and in the hierarchy among biomarkers within definitions, yielded a different number of triggers, and identified unique triggers for each definition. Only 38 triggers were consistently identified by all definitions. Availability of ECG data, eCRF data on clinical presentation, and the reporting of >2 post-procedural values of the same biomarker influenced considerably the number of PMI triggers identified.
Conclusions:
PMI definitions are not interchangeable. The number of triggers identified and consequently the potential number of events varies significantly, highlighting the importance of rigorous methodology when PMI is a component of a powered endpoint. Emphasis on collection of biomarkers, ECG data, and clinical status at baseline may improve the correct identification of PMI triggers.
Insights
Different definitions for periprocedural myocardial infarction (PMI) significantly alter event detection in coronary device trials. Rigorous methodology and comprehensive data collection are crucial for accurate PMI identification and event ascertainment.
Area of Science:
- Cardiology
- Biomarkers
- Clinical Trials
Background:
- Periprocedural myocardial infarction (PMI) is a critical endpoint in coronary device trials.
- Accurate identification of PMI events is essential for reliable trial outcomes.
- Automated triggers can prevent underreporting of potential PMI events.
Purpose of the Study:
- To compare the performance of three current definitions in detecting periprocedural myocardial infarction (PMI).
- To assess the impact of different PMI definitions on event ascertainment in coronary device trials.
Main Methods:
- Automated algorithms were developed to trigger PMI based on three distinct definitions.
- These algorithms were applied to data from the RESOLUTE all comers trial.
- The number of identified PMI triggers was compared across definitions.
Main Results:
- Significant variations in PMI trigger counts were observed among the World Health Organization, Third Universal, and Society for Cardiovascular Angiography and Interventions definitions.
- Differences in biomarker utilization, cutoff values, and hierarchical structures contributed to unique triggers for each definition.
- Only 38 PMI triggers were consistently identified across all three definitions, highlighting substantial discrepancies.
Conclusions:
- Current periprocedural myocardial infarction (PMI) definitions are not interchangeable, leading to significant variability in identified events.
- The choice of PMI definition critically impacts trial results, emphasizing the need for rigorous methodological standards.
- Optimizing the collection of biomarker data, ECGs, and clinical information is vital for improving PMI trigger identification.
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