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Multicenter Study
. 2023 Feb 6;18(13):e1108-e1119.
doi: 10.4244/EIJ-D-22-00454.

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

Giuseppe Tarantini  1 , Luca Nai Fovino  1 , Ferdinando Varbella  2 , Daniela Trabattoni  3 , Giuseppe Caramanno  4 , Carlo Trani  5 , Nicoletta De Cesare  6 , Giovanni Esposito  7 , Matteo Montorfano  8 , Carmine Musto  9 , Andrea Picchi  10 , Imad Sheiban  11 , Valeria Gasparetto  11 , Flavio L Ribichini  12 , Francesco Cardaioli  1 , Salvatore Saccà  13 , Enrico Cerrato  14 , Massimo Napodano  1 , Matteo Martinato  15 , Danila Azzolina  15 , Giuseppe Andò  16 , Antonio Mugnolo  17 , Marco Caruso  18 , Roberta Rossini  19 , Enrico Passamonti  20 , Rui Campante Teles  21 , Stefano Rigattieri  22 , Dario Gregori  15 , Corrado Tamburino  23 , Francesco Burzotta  5
Affiliations
Multicenter Study

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

Giuseppe Tarantini et al. EuroIntervention. .

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.

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Conflict of interest statement

G. Tarantini reports honoraria for lectures/consulting from Medtronic, Edwards Lifesciences, Boston Scientific, GADA, and Abbott. L. Nai Fovino received a research grant from Medtronic. F. Burzotta reports speakers’ fees from Abbott, Abiomed, Medtronic, and Terumo. C. Trani reports speakers’ fees from Abbott, Abiomed, Medtronic, and Terumo. M. Montorfano reports consultant fees from Abbott, Boston Scientific, and Medtronic. The other authors have no conflicts of interest to declare. The Guest Editor reports lecture fees paid to his institution from Amgen, Bayer Healthcare, Biotronik, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, Ferrer, Pfizer, and Novartis; consultancy fees paid to his institution from Boehringer Ingelheim; and grant support from Bayer Healthcare, Boston Scientific, Biotronik, Edwards Lifesciences, GlaxoSmithKline, Medtronic, and Pfizer.

Figures

Figure 1
Figure 1. Primary endpoint incidence estimated using the cumulative incidence function accounting for death as a competing risk.
Figure 2
Figure 2. One-year outcomes of patients undergoing angiography-guided vs intravascular imaging-guided left main percutaneous coronary interventions.
Inverse probability treatment weighted Cox regression models. Propensity score has been estimated by considering as confounding factors age, gender, diabetes, 3-vessel CAD and ACS. ACS: acute coronary syndrome; CAD: coronary artery disease; EP: endpoint; HR: hazard ratio; ID-TLR: ischaemia-driven target lesion revascularisation; IVUS: intravascular ultrasound; OCT: optical coherence tomography; PCI: percutaneous coronary intervention; ST: stent thrombosis; TVMI: target vessel myocardial infarction
Figure 3
Figure 3. Incidence of the composite primary endpoint and its single components in patients treated for isolated left coronary artery disease (with or without involvement of the proximal segment of the bifurcation main branch).
Inverse probability treatment weighted Cox regression models. Propensity score has been estimated by considering as confounding factors age, gender, diabetes, ACS and use of intravascular imaging. ACS: acute coronary syndrome; DES: drug-eluting stent; EP: endpoint; HR: hazard ratio; ID-TLR: ischaemia driven target lesion revascularisation; LAD: left anterior descending; LCx: left circumflex; LM: left main; NS: nonsignificant; PCI: percutaneous coronary intervention; prox: proximal; TVMI: target vessel myocardial infarction
Central illustration
Central illustration. Summary of the ROLEX registry main results, including findings of the intravascular imaging-guided LM PCI subanalysis.
ACS: acute coronary syndrome; CABG: coronary artery bypass graft; CAD: coronary artery disease; DES: drug-eluting stent; EP: endpoint; HR: hazard ratio; ID-TLR: ischaemia-driven target lesion revascularisation; IVUS: intravascular ultrasound; LM: left main; OCT: optical coherence tomography; PCI: percutaneous coronary intervention; ST: stent thrombosis; TLF: target lesion failure; TVMI: target vessel myocardial infarction
See this image and copyright information in PMC

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