Standardised versus visual assessment of device success after percutaneous coronary intervention.
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Oshima Asahi, Revaiah Pruthvi C, Kanehama Nozomu, Wlodarczak Adrian, Möllmann Helge, Moreno Raul, Dziarmaga Milosz, Sabaté Manel, Legutko Jacek, Silvestri Marc, Lemoine Julien, Choudhury Anirban, Ince Hüseyin, Öner Alper, Sharif Faisal, Biscaglia Simone, Kochman Janusz, Wykrzykowska Joanna, Lesiak Maciej, Amat-Santos Ignacio J, Kumar Abhishek, Meneveau Nicolas, Landt Martin, Magro Michael, Zaman Azfar, Veerasamy Murugapathy, Tarantini Giuseppe, Farah Bruno, O'kane Peter, Del Blanco Bruno Garcia, Gomez-Hospital Joan Antoni, Jozwa Robert, Schmitz Thomas, Anderson Richard, Achenbach Stephan, Hoye Angela, McNeice Andrew, Lauten Alexander, Van Belle Eric, Bartus Stanislaw, Wacinski Piotr, Devadathan Sen, Bednarek Adrian, Wlodarczak Szymon, Gurav Aishwarya, Farina Jacopo, Ferraz-Costa Gonçalo, Paluszkiewicz Jerzy, Miyashita Kotaro, Tobe Akihiro, Chinhenzva Albert, Garg Scot, Sunny Sofia, Ní Bheoláin Gráinne, Harte Emma, Tsai Tsung-Ying, Onuma Yoshinobu, Serruys Patrick W
Аннотация
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).