Reporting of periprocedural myocardial infarctions in coronary intervention trials: a systematic review
C Baillie, E Szalkiewicz, I Merdler, D ShepshelovichAbstract
Background
Periprocedural myocardial infarction (PMI) is a standard yet controversial component of composite endpoints in percutaneous coronary intervention (PCI) trials. Despite its widespread inclusion in primary outcomes, the clinical and prognostic significance of PMI remains uncertain. Data regarding contemporary PMI definitions and reporting practices are lacking.
Methods
We systematically reviewed PCI randomised controlled trials published in six high-impact journals (New England Journal of Medicine, Lancet, JAMA, European Heart Journal, Circulation, JACC) between 2019 and 2023. We assessed PMI reporting frequency, definitions, and contribution to composite outcomes. For trials reporting PMI separately, we performed sensitivity analyses on cumulative event counts excluding PMI to determine whether primary endpoint statistical significance was altered.
Results
Forty-nine trials met inclusion criteria. Only 24 (49%) separately reported PMI. Definitional heterogeneity was substantial: 12 trials (50%) used the Universal Definition of Myocardial Infarction, 5 (21%) SCAI criteria, 4 (17%) ARC-2 definitions, and 3 (13%) protocol-specific criteria. As seen in the figure, PMI comprised a median of 19% (range 4–54%) of composite endpoint events and 41% (range 9–91%) of all reported MIs. Excluding PMI reversed primary endpoint significance in 2 of 24 trials (8%): in ISCHEMIA, the result changed from non-significant to significant (p=0.34 to p<0.001), while in OCTOBER, significance was lost (p=0.035 to p=0.073). Both trials with reversals reported PMI exclusively in supplementary materials.
Conclusions
PMI reporting in contemporary PCI trials is inconsistent and definitionally heterogeneous. PMI events constituted a substantial proportion of composite endpoints and, in some trials, materially altered primary conclusions. Standardised, separate PMI reporting with prespecified sensitivity analyses would enhance trial interpretability and reduce concerns about selective outcome reporting.Contribution of PMI to composite endpointsFor image description, please refer to the figure legend and surrounding text.