Author + information
- Received October 5, 2016
- Revision received December 7, 2016
- Accepted December 15, 2016
- Published online April 3, 2017.
- Ernest Spitzer, MDa,b,
- Ton de Vries, MSca,
- Rafael Cavalcante, MD, PhDb,
- Marieke Tuinman, MSca,
- Tessa Rademaker-Havinga, MSca,
- Maaike Alkema, MSca,
- Marie-Angele Morel, MSca,
- Osama I. Soliman, MD, PhDa,b,
- Yoshinobu Onuma, MD, PhDa,b,
- Gerrit-Anne van Es, PhDc,
- Jan G.P. Tijssen, PhDc,
- Eugene McFadden, MDa,d and
- Patrick W. Serruys, MD, PhDe,∗ ()
- aCardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands
- bDepartment of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands
- cEuropean Cardiovascular Research Institute, Rotterdam, the Netherlands
- dDepartment of Cardiology, Cork University Hospital, Cork, Ireland
- eInternational Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom
- ↵∗Address for correspondence:
Dr. Patrick W. Serruys, International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59 North Wharf Road, London W2 1LA, United Kingdom.
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.
The RESOLUTE all comers trial was funded by Medtronic CardioVascular. Dr. Onuma is a member of the Advisory Board of Abbott Vascular. Dr. McFadden has received honoraria for clinical event committee work for Abbott Vascular; and a travel grant from Menarini Ireland. Dr. Serruys is a consultant for Abbott Laboratories, AstraZeneca Pharmaceuticals, Biotronik, Medtronic, Volcano Europe BVBA, St. Jude Medical, Stentys France, Svelte Medical Systems, Inc., and Sino Medical Sciences Technology, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 5, 2016.
- Revision received December 7, 2016.
- Accepted December 15, 2016.
- 2017 American College of Cardiology Foundation