Key result
Periprocedural MI drives ~19% of PCI composite events, with its exclusion flipping trial significance in 8%.
Why the study?
The clinical and prognostic significance of periprocedural myocardial infarction (PMI) in PCI trials remains uncertain, and data regarding contemporary PMI definitions and reporting practices are lacking.
Systematic Review
Periprocedural myocardial infarction reporting in contemporary PCI trials is inconsistent and heterogeneous, yet makes up a substantial proportion of composite endpoints that can reverse primary trial conclusions when excluded.
Answers are grounded in this paper and cite their sources.
Inconsistent PMI reporting and definitions in PCI trials can reverse primary endpoint significance; challenges composite endpoint standardization in cardiovascular research.
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.
No takes yet. Share an insight, caveat, or question.
Baillie et al. (2026) conducted a systematic review in Periprocedural myocardial infarction in percutaneous coronary intervention. Periprocedural myocardial infarction (PMI) reporting and exclusion in sensitivity analyses vs. Composite endpoint including PMI was evaluated on PMI reporting frequency, definitions, contribution to composite outcomes, and reversal of primary endpoint statistical significance upon PMI exclusion. Periprocedural MI was separately reported in 49% of PCI trials, comprising a median 19% of composite events, and its exclusion reversed primary endpoint significance in 8% of trials.
Synapse has enriched 10 related papers. Consider them for comparative context: