IVUS-Guided versus Angiography-Guided PCI in Unprotected Left Main Coronary Disease.

Whether intravascular ultrasonographic (IVUS) guidance during PCI results in better clinical outcomes than conventional angiographic guidance alone is uncertain.

PCI期间是否使用血管内超声（IVUS）指导比单纯使用传统血管造影指导能带来更好的临床结果尚不确定。

Methods

In an international, multicenter, open-label trial, we randomly assigned patients with unprotected left main coronary artery disease in a 1:1 ratio to undergo either IVUS-guided PCI or angiography-guided PCI.

在一项国际多中心开放标签试验中，我们以1:1的比例随机分配了未受保护的左主冠状动脉疾病的患者，以接受IVUS引导的PCI或血管造影引导的PCI。

The primary end point was a patient-oriented composite of any stroke, any myocardial infarction, any revascularization, or death from any cause at the longest follow-up.

主要终点是任何中风、任何心肌梗死、任何血运重建或任何原因导致的死亡的患者导向的复合终点，在最长随访期间。

Results

A total of 806 patients underwent randomization; 401 were assigned to undergo IVUS-guided PCI and 405 to undergo angiography-guided PCI.

共有806名患者进行了随机分组；其中401名患者被分配接受IVUS引导的经皮冠状动脉介入治疗（PCI），另外405名患者被分配接受血管造影引导的PCI。

The mean (±SD) age of the patients was 71.4±10.7 years, 78.4% of the patients were men, and 34.7% had diabetes.

患者的平均年龄为71.4±10.7岁，78.4%的患者为男性，34.7%的患者患有糖尿病。

At a median follow-up of 2.9 years, a primary end-point event had occurred in 135 patients (33.7%) in the IVUS-guided PCI group and in 125 patients (30.9%) in the angiography-guided PCI group (hazard ratio, 1.11; 95% confidence interval, 0.87 to 1.42; P = 0.40).

在中位随访2.9年时，IVUS引导的PCI组中有135名患者（33.7%）和血管造影引导的PCI组中有125名患者（30.9%）发生了主要终点事件（风险比，1.11；95%置信区间，0.87至1.42；P = 0.40）。

The incidenceof death, myocardial infarction, or revascularization appeared to be similar in the two groups.

两组的死亡、心肌梗死或再血管化发生率似乎相似。

The percentages of patients with procedure-related and overall safety events also appeared to be similar in the two groups.

两组患者在手术相关和总体安全事件的百分比上似乎也相似。

Conclusions

Among patients with unprotected left main coronary artery disease, IVUS-guided PCI showed no additional benefit over angiography-guided PCI with respect to the incidenceof stroke, myocardial infarction, any revascularization, or death from any cause at a median follow-up of 2.9 years.

在未保护左主干冠状动脉疾病的患者中，与血管造影引导的经皮冠状动脉介入治疗（PCI）相比，IVUS引导的PCI在中位随访2.9年时，并未显示出对中风、心肌梗死、任何再血管化或任何原因死亡发生率的额外益处。

(Funded by Philips Image Guided Therapy Devices and Boston Scientific; OPTIMAL ClinicalTrials.gov number, NCT04111770.).

(由飞利浦图像引导治疗设备和波士顿科学公司资助; OPTIMAL ClinicalTrials.gov编号, NCT04111770。)