TY - JOUR
T1 - Detecting Periprocedural Myocardial Infarction in Contemporary Percutaneous Coronary Intervention Trials
AU - Spitzer, Ernest
AU - de Vries, Ton
AU - Cavalcante, Rafael
AU - Tuinman, Marieke
AU - Rademaker-Havinga, Tessa
AU - Alkema, Maaike
AU - Morel, Marie-Angele
AU - Soliman, Osama I.
AU - Onuma, Yoshinobu
AU - van Es, Gerrit-Anne
AU - Tijssen, Jan G. P.
AU - McFadden, Eugene
AU - Serruys, Patrick W.
PY - 2017
Y1 - 2017
N2 - This study sought to investigate the differences in detecting (e.g., triggering) periprocedural myocardial infarction (PMI) among 3 current definitions. 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. We generated automated algorithms to trigger PMI based on each definition and compared results using data from the RESOLUTE all comers trial. 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. 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
AB - This study sought to investigate the differences in detecting (e.g., triggering) periprocedural myocardial infarction (PMI) among 3 current definitions. 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. We generated automated algorithms to trigger PMI based on each definition and compared results using data from the RESOLUTE all comers trial. 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. 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
U2 - https://doi.org/10.1016/j.jcin.2016.12.016
DO - https://doi.org/10.1016/j.jcin.2016.12.016
M3 - Article
C2 - 28385402
SN - 1936-8798
VL - 10
SP - 658
EP - 666
JO - JACC. Cardiovascular interventions
JF - JACC. Cardiovascular interventions
IS - 7
ER -