Heart Centre, John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust, Oxford, United Kingdom.
Coronary Revascularisation Unit, IRCCS Policlinico S. Donato, San Donato Milanese, Milan, Italy.
PLoS One. 2022 Jan 7;17(1):e0260770. doi: 10.1371/journal.pone.0260770. eCollection 2022.
Percutaneous coronary intervention (PCI) is used increasingly for revascularization of unprotected left main coronary artery (LMCA) disease. Observational studies and subgroup analyses from clinical trials, have suggested a possible benefit from the use of intravascular ultrasound (IVUS) guidance when performing unprotected LMCA PCI. However, the value of imaging with IVUS has never been proven in an appropriately powered randomized clinical trial. The OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound (OPTIMAL) trial has been designed to establish whether IVUS-guided PCI optimization on LMCA is associated with superior clinical outcomes when compared with standard qualitative angiography-guided PCI.
The OPTIMAL trial is a randomized, multicenter, international study designed to enroll a total of 800 patients undergoing PCI for unprotected LMCA disease. Patients will be randomized in a 1:1 fashion to IVUS-guided PCI versus angiogram-guided PCI. In patients allocated to the angiogram-guided arm, use of IVUS is discouraged, unless there are safety concerns. In patients allocated to the IVUS guidance arm, pre-procedural IVUS assessment is highly recommended, whilst post-procedural IVUS assessment is mandatory to confirm appropriate stenting result and/or to guide stent result optimization, according to predefined criteria. Patients will be followed up to 2 years after the index procedure. The primary outcome measure is the Academic Research Consortium (ARC) patient-oriented composite endpoint (PoCE) which includes all-cause death, any stroke, any myocardial infarction and any repeat revascularization at 2 years follow-up.
The OPTIMAL trial aims to provide definitive evidence about the clinical impact of IVUS-guidance during PCI to an unprotected LMCA. It is anticipated by the investigators, that an IVUS-guided strategy will be associated with less clinical events compared to a strategy guided by angiogram alone.
ClinicalTrials.gov: NCT04111770. Registered on October 1, 2019.
经皮冠状动脉介入治疗（PCI）越来越多地用于治疗无保护左主干冠状动脉（LMCA）疾病的血运重建。观察性研究和临床试验的亚组分析表明，在进行无保护 LMCA PCI 时，使用血管内超声（IVUS）指导可能有益。然而，IVUS 成像的价值从未在一项适当功率的随机临床试验中得到证实。OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound（OPTIMAL）试验旨在确定与标准定性血管造影指导 PCI 相比，LMCA 上的 IVUS 指导 PCI 优化是否与更好的临床结果相关。
OPTIMAL 试验是一项随机、多中心、国际研究，旨在招募 800 名接受 PCI 治疗的无保护 LMCA 疾病患者。患者将以 1:1 的比例随机分为 IVUS 指导 PCI 与血管造影指导 PCI。在分配给血管造影指导组的患者中，除非存在安全问题，否则不鼓励使用 IVUS。在分配到 IVUS 指导臂的患者中，强烈建议进行术前 IVUS 评估，而术后 IVUS 评估是强制性的，以根据预设标准确认适当的支架置入结果和/或指导支架结果优化。患者将在指数手术后 2 年内进行随访。主要终点是学术研究联合会（ARC）以患者为导向的复合终点（PoCE），包括 2 年随访时的全因死亡、任何卒中和任何心肌梗死和任何再次血运重建。
OPTIMAL 试验旨在提供关于在无保护 LMCA 中进行 PCI 时 IVUS 指导的临床影响的明确证据。研究人员预计，与仅接受血管造影指导的策略相比，IVUS 指导策略将与更少的临床事件相关。
ClinicalTrials.gov：NCT04111770。于 2019 年 10 月 1 日注册。
