A large, prospective, multicentre study of left main PCI using a latest-generation zotarolimus-eluting stent: the ROLEX study

Giuseppe Tarantini, Luca Nai Fovino, Ferdinando Varbella, Daniela Trabattoni, Giuseppe Caramanno, Carlo Trani, Nicoletta De Cesare, Giovanni Esposito, Matteo Montorfano, Carmine Musto, Andrea Picchi, Imad Sheiban, Valeria Gasparetto, Flavio L. Ribichini, Francesco Cardaioli, Salvatore Saccà, Enrico Cerrato, Massimo Napodano, Matteo Martinato, Danila AzzolinaGiuseppe Andò, Antonio Mugnolo, Marco Caruso, Roberta Rossini, Enrico Passamonti, Rui Campante Teles, Stefano Rigattieri, Dario Gregori, Corrado Tamburino, Francesco Burzotta

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14 Citations (Scopus)

Abstract

BACKGROUND: Data on left main (LM) percutaneous coronary interventions (PCI) have mostly been obtained in studies using drug-eluting stent (DES) platforms without dedicated large-vessel devices and with limited expansion capability. AIMS: Our study aimed to investigate the safety and efficacy of LM PCI with the latest-generation Resolute Onyx DES. METHODS: ROLEX (Revascularization Of LEft main with resolute onyX) is a prospective, multicentre study (ClinicalTrials.gov: NCT03316833) enrolling patients with unprotected LM coronary artery disease and a SYNTAX score <33 undergoing PCI with the Resolute Onyx zotarolimus-eluting coronary stent, that includes dedicated extra-large vessel platforms. The primary endpoint (EP) was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction (TVMI) and ischaemia-driven target lesion revascularisation (ID-TLR), at 1 year. All events were adjudicated by an independent clinical event committee. An independent core lab analysed all procedural angiograms. RESULTS: A total of 450 patients (mean age 71.8 years, SYNTAX score 24.5±7.2, acute coronary syndrome in 53%) were enrolled in 26 centres. Of these, 77% of subjects underwent PCI with a single-stent and 23% with a 2-stent technique (8% double kissing [DK] crush, 6% culotte, 9% T/T and small protrusion [TAP] stenting). Intravascular imaging guidance was used in 45% (42% intravascular ultrasound [IVUS], 3% optical coherence tomography [OCT]). At 1 year, the primary EP incidence was 5.1% (cardiac death 2.7%, TVMI 2.7%, ID-TLR 2.0%). The definite/probable stent thrombosis rate was 1.1%. In a prespecified adjusted subanalysis, the primary EP incidence was significantly lower in patients undergoing IVUS/OCT-guided versus angio-guided PCI (2.0 vs 7.6%; hazard ratio [HR] 0.28, 95% confidence interval [CI]: 0.13-0.58; p<0.001). CONCLUSIONS: In this large, multicentre, prospective registry, LM PCI with the Resolute Onyx DES showed good safety and efficacy at 1 year, particularly when guided by intracoronary imaging.

Original languageEnglish
Pages (from-to)e1108-e1119
JournalEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Volume18
Issue number13
DOIs
Publication statusPublished - 6 Feb 2023

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