Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
Rivoli Infermi Hospital ASL TO3, Rivoli, Turin, Italy.
EuroIntervention. 2023 Feb 6;18(13):e1108-e1119. doi: 10.4244/EIJ-D-22-00454.
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.
Our study aimed to investigate the safety and efficacy of LM PCI with the latest-generation Resolute Onyx DES.
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.
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).
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.
经皮冠状动脉介入治疗（PCI）左主干（LM）的数据主要来自于使用药物洗脱支架（DES）平台的研究，这些研究没有专门的大血管设备，扩张能力有限。
本研究旨在探讨使用新一代 Resolute Onyx DES 进行 LM PCI 的安全性和疗效。
ROLEX（使用 Resolute Onyx 进行左主干血运重建）是一项前瞻性、多中心研究（ClinicalTrials.gov：NCT03316833），纳入了接受无保护左主干冠状动脉疾病和 SYNTAX 评分<33 的患者，这些患者接受了 Resolute Onyx 佐他莫司洗脱冠状动脉支架的 PCI，该支架包括专门的特大血管平台。主要终点（EP）是靶病变失败（TLF）：心脏死亡、靶血管心肌梗死（TVMI）和缺血驱动的靶病变血运重建（ID-TLR）的复合终点，随访时间为 1 年。所有事件均由独立临床事件委员会裁定。一个独立的核心实验室分析了所有的程序血管造影。
共纳入 26 个中心的 450 例患者（平均年龄 71.8 岁，SYNTAX 评分 24.5±7.2，急性冠脉综合征 53%）。其中，77%的患者接受了单支架 PCI，23%的患者接受了双支架技术（8%双吻压挤[DK]，6%克鲁特，9% T/T 和小突出[TAP]支架）。45%的患者接受了血管内影像学指导（42%血管内超声[IVUS]，3%光学相干断层扫描[OCT]）。1 年时，主要 EP 发生率为 5.1%（心脏死亡 2.7%，TVMI 2.7%，ID-TLR 2.0%）。明确/可能的支架血栓形成率为 1.1%。在一个预先指定的调整后的亚分析中，接受 IVUS/OCT 指导与血管造影指导的 PCI 的患者的主要 EP 发生率明显更低（2.0% vs 7.6%；风险比[HR]0.28，95%置信区间[CI]：0.13-0.58；p<0.001）。
在这项大型、多中心、前瞻性注册研究中，使用 Resolute Onyx DES 进行 LM PCI 在 1 年时显示出良好的安全性和疗效，尤其是在接受冠状动脉内影像学指导时。
