Coronary interventions

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

EuroIntervention 2023;18:e1108-e1119. DOI: 10.4244/EIJ-D-22-00454

Giuseppe Tarantini
Giuseppe Tarantini1, MD, PhD; Luca Nai Fovino1, MD, PhD; Ferdinando Varbella2, MD; Daniela Trabattoni3, MD, PhD; Giuseppe Caramanno4, MD; Carlo Trani5, MD, PhD; Nicoletta De Cesare6, MD; Giovanni Esposito7, MD, PhD; Matteo Montorfano8, MD, PhD; Carmine Musto9, MD; Andrea Picchi10, MD; Imad Sheiban11, MD; Valeria Gasparetto11, MD; Flavio L. Ribichini12, MD; Francesco Cardaioli1, MD; Salvatore Saccà13, MD; Enrico Cerrato14, MD, PhD; Massimo Napodano1, MD, PhD; Matteo Martinato15, MSc, PhD; Danila Azzolina15, MSc, PhD; Giuseppe Andò16, MD; Antonio Mugnolo17, MD; Marco Caruso18, MD; Roberta Rossini19, MD, PhD; Enrico Passamonti20, MD; Rui Campante Teles21, MD; Stefano Rigattieri22, MD, PhD; Dario Gregori15, MSc, PhD; Corrado Tamburino23, MD, PhD; Francesco Burzotta5, MD
1. Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy; 2. Rivoli Infermi Hospital ASL TO3, Rivoli, Turin, Italy; 3. Centro Cardiologico Monzino, IRCCS, Milan, Italy; 4. Ospedale San Giovanni di Dio, Agrigento, Italy; 5. Fondazione Policlinico Universitario A. Gemelli ICCS, Università Cattolica del Sacro Cuore, Rome, Italy; 6. Policlinico San Marco, Zingonia, Italy; 7. University of Naples Federico II, Naples, Italy; 8. Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; 9. Department of Cardiosciences, A.O. San Camillo-Forlanini Hospital, Rome, Italy; 10. Cardiovascular Department, Azienda USL Toscana SudEst, Misericordia Hospital, Grosseto, Italy; 11. Division of Cardiology, Peschiera del Garda Hospital, Verona, Italy; 12. Division of Cardiovascular Medicine, Department of Medicine, University of Verona, Verona, Italy; 13. Ospedale Civile di Mirano, Mirano, Italy; 14. Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano, Italy; 15. Unit of Biostatistics, Epidemiology and Public Health, University of Padova, Padova, Italy; 16. Division of Cardiology, University of Messina, Messina, Italy; 17. Mater Salutis Hospital Legnago, Legnago, Italy; 18. Division of Cardiology, University of Palermo, Palermo, Italy; 19. Division of Cardiology, ASST Papa Giovanni XXIII Hospital, Cuneo, Italy; 20. Division of Cardiology, Azienda Socio-Sanitaria Territoriale di Cremona, Cremona, Italy; 21. Hospital de Santa Cruz, CHLO, Nova Medical School, CEDOC, Lisbon, Portugal; 22. Sandro Pertini Hospital, Rome, Italy; 23. Cardiology, CAST-Policlinico Hospital, Cardio-Thorax-Vascular and Transplant Department, University of Catania, Catania, Italy

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 ( 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.

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drug-eluting stentintracoronary imagingintravascular ultrasoundleft mainpercutaneous coronary intervention
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