近日，意大利Vita Salute大学-圣拉斐尔医院Luca Testa团队比较了血管内超声引导下与血管造影引导下PCI治疗无保护左主干冠状动脉疾病的疗效。这一研究成果于2026年3月30日发表在《新英格兰医学杂志》上。

经皮冠状动脉介入治疗在无保护左主干冠脉疾病中的应用日益增多。在介入治疗过程中，采用血管内超声引导是否比单纯常规血管造影引导能带来更好的临床结局，目前尚不明确。

在一项国际多中心、开放标签试验中，研究组将无保护左主干冠脉疾病患者按1:1的比例随机分配，接受血管内超声引导下的经皮冠状动脉介入治疗或单纯血管造影引导下的经皮冠状动脉介入治疗。主要终点是在最长随访期内，以患者为导向的复合终点，包括任何卒中、任何心肌梗死、任何血运重建或全因死亡。

共有806例患者接受随机分组；401例被分配至血管内超声引导经皮冠状动脉介入治疗组，405例被分配至血管造影引导经皮冠状动脉介入治疗组。患者平均（±标准差）年龄为71.4±10.7岁，其中78.4%为男性，34.7%患有糖尿病。中位随访2.9年时，血管内超声引导组有135例患者（33.7%）发生了主要终点事件，血管造影引导组有125例患者（30.9%）发生了主要终点事件（风险比1.11；95%置信区间0.87~1.42；P=0.40）。两组在死亡、心肌梗死或血运重建的发生率方面似乎相似。两组中与操作相关的安全事件及总体安全事件的患者百分比也似乎相似。

研究结果表明，在无保护左主干冠脉疾病患者中，中位随访2.9年时，与单纯血管造影引导相比，血管内超声引导的经皮冠状动脉介入治疗在卒中、心肌梗死、任何血运重建或任何原因死亡的发生率方面并未显示出额外获益。

附：英文原文

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

Author: Luca Testa, Jose Maria De la Torre Hernandez, Giovanni Luigi De Maria, Daniel A. Jones, Pablo Pion-Esteban, Gianluca Campo, Bruno Garcia del Blanco, Manuel Pan, Tamara Garcia-Camarero, Gennaro Sardella, Peter O’Kane, John P. Greenwood, Flavio L. Ribichini, Irene Pescetelli, Alfonso Ielasi, Iigo Lozano, James Cockburn, Jacopo A. Oreglia, Azfar G. Zaman, Francesco Bedogni, Wietze Lindeboom, Jan G.P. Tijssen, Ernest Spitzer, Adrian P. Banning

Issue&Volume: 2026-03-30

Abstract:

Background

Percutaneous coronary intervention (PCI) is increasingly used for revascularization of unprotected left main coronary artery disease. Whether intravascular ultrasonographic (IVUS) guidance during PCI results in better clinical outcomes than conventional angiographic guidance alone is uncertain.

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. 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.

Results

A total of 806 patients underwent randomization; 401 were assigned to undergo IVUS-guided PCI and 405 to undergo angiography-guided 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. 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). The incidence of death, myocardial infarction, or revascularization appeared to be similar in the two groups. The percentages of patients with procedure-related and overall safety events also appeared to be similar in the two groups.

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 incidence of stroke, myocardial infarction, any revascularization, or death from any cause at a median follow-up of 2.9 years.

DOI: NJ202603300000024

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2600440