Abstract

Background: The European Association of Percutaneous Cardiovascular Interventions (EAPCI)-endorsed algorithm for defining device success has not yet been prospectively tested against standardised quantitative coronary angiography (QCA) by a core lab.

Aims: We sought to assess whether visually evaluated device success by the operator at the end of percutaneous coronary intervention (PCI) aligns with the EAPCI-endorsed standardised definition adjudicated by the core lab and to evaluate its association with clinical outcomes.

Methods: This prespecified analysis of the Multivessel TALENT trial included 1,548 patients with three-vessel disease randomised to treatment with either Supraflex Cruz or SYNERGY stents. PCI was attempted in 4,052 lesions. The core lab assessed post-PCI residual in-stent percentage diameter stenosis (%DS) by QCA (target <20%) and exploratory delta (Δ) angiography-derived fractional flow reserve (angio-FFR) across the stent(s) (target <0.05). Device success was evaluated using the site-reported data (visual evaluation of in-stent %DS), core lab QCA, core lab angio-FFR, and combined core lab QCA+angio-FFR. The lesion-oriented composite endpoint (LOCE; comprising cardiovascular death, target vessel myocardial infarction, or target lesion revascularisation) was assessed at 1 year.

Results: Site-reported device success was 97.4%. Core lab definitions yielded lower rates: 93.8% for Δangio-FFR <0.05, 88.0% for residual %DS <20%, and 83.2% for QCA+angio-FFR (all p<0.001 vs site report after Bonferroni correction). Lesions not meeting QCA-based device success had a higher incidence of LOCE than those meeting the definition (12.0% vs 9.1%; log-rank p=0.041). Device success and LOCE rates did not differ between the two stents for any definition.

Conclusions: In this prespecified lesion-level substudy, standardised assessment using the EAPCI device success algorithm with core lab QCA reclassified a substantial proportion of operator-adjudicated successes and identified lesions at higher 1-year LOCE risk. (ClinicalTrials.gov: NCT04390672)