TCT-651 The EAPCI Device Success Algorithm Prospectively Adjudicated by Imaging Core Lab in the PIONEER IV Trial: Insights with Angiography-Derived FFR
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Authors
Tsai T.
Oshima A.
Wykrzykowska J.
Rosseel L.
Sharif F.
Alkhalil M.
Curzen N.
De Wilder K.
Amoroso G.
Hofma S.
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2025
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Background: Device success (DS) is key in drug-eluting stent trials, but inconsistent definitions resulted in varied DS rates (91.2%-100%), hindering cross comparisons. Thus, EAPCI has endorsed a standardised DS algorithm, but it has not been prospectively implemented by a core lab. Suboptimal post-PCI angiography-derived fractional flow reserve (angio-FFR) is linked to poor outcomes. We applied the EAPCI algorithm with core-lab quantitative coronary angiography (QCA) and angiography-derived FFR. Method(s): We prospectively applied the EAPCI algorithm in the ongoing PIONEER IV trial (NCT04923191), a multicenter, all-comers RCT comparing PCI outcomes guided by angio-FFR vs. usual care, with both arms utilizing Healing-Targeted Supreme stents (HT Supreme). DS refers to lesions where the 1st stent implantation attempt was successful, with a residual stenosis 0.05 across the stent is proposed as an additional criterion of DS. The DS rate was compared against a performance index from 45 DES trials. Result(s): In the first 1270 patients, stent implantation was attempted in 1090 lesions, with 16 unsuccessful first attempts. Out of the 1074 lesions with a successful first attempt, 41 lesions had an operator-reported residual stenosis >=20% (visual/QCA), resulting in a DS rate of 94.8%; while core lab QCA analysis revealed 101 lesions with residual stenosis >=20%, reducing the DS rate to 88.5%. Out of the 1074 lesions with a successful first attempt, post-PCI angio-FFR could be calculated in 1053. Of these, 1025 lesions (97.3%) achieved a post-PCI DELTAangio-FFR<=0.05. In total, 957 lesions (87.8%) satisfied both core lab residual stenosis<20% and post-PCI DELTAangio-FFR<=0.05. Conclusion(s): The operator-reported DS rate for HT Supreme was 94.8%, while the core lab QCA adjudicated DS was modest at 88.5%. To ensure unbiased comparisons, core lab QCA should be mandatory, and post-PCI angio-FFR should be integrated into future DS algorithms. Categories: IMAGING AND PHYSIOLOGY: Physiologic Lesion Assessment Copyright © 2025
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Journal of the American College of Cardiology