TY - JOUR
T1 - A large, prospective, multicentre study of left main PCI using a latest-generation zotarolimus-eluting stent
T2 - the ROLEX study
AU - Tarantini, Giuseppe
AU - Fovino, Luca Nai
AU - Varbella, Ferdinando
AU - Trabattoni, Daniela
AU - Caramanno, Giuseppe
AU - Trani, Carlo
AU - De Cesare, Nicoletta
AU - Esposito, Giovanni
AU - Montorfano, Matteo
AU - Musto, Carmine
AU - Picchi, Andrea
AU - Sheiban, Imad
AU - Gasparetto, Valeria
AU - Ribichini, Flavio L.
AU - Cardaioli, Francesco
AU - Saccà, Salvatore
AU - Cerrato, Enrico
AU - Napodano, Massimo
AU - Martinato, Matteo
AU - Azzolina, Danila
AU - Andò, Giuseppe
AU - Mugnolo, Antonio
AU - Caruso, Marco
AU - Rossini, Roberta
AU - Passamonti, Enrico
AU - Teles, Rui Campante
AU - Rigattieri, Stefano
AU - Gregori, Dario
AU - Tamburino, Corrado
AU - Burzotta, Francesco
PY - 2023/2/6
Y1 - 2023/2/6
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85147834181&partnerID=8YFLogxK
U2 - 10.4244/EIJ-D-22-00454
DO - 10.4244/EIJ-D-22-00454
M3 - Article
C2 - 36043326
AN - SCOPUS:85147834181
SN - 1774-024X
VL - 18
SP - e1108-e1119
JO - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
JF - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
IS - 13
ER -