Intravascular Imaging- vs Angiography-Guided Complex PCI: 5-Year Outcomes From a Randomized Trial.

The authors sought to present long-term clinical outcomes of intravascular imaging-guided PCI compared with angiography-guided PCI in patients with complex coronary artery lesions.

作者试图呈现血管内成像引导的PCI与血管造影引导的PCI在复杂冠状动脉病变患者中的长期临床结果对比。

Methods

Eligible patients with complex coronary artery lesions were randomly assigned 2:1 to undergo intravascular imaging-guided PCI or angiography-guided PCI in this prospective multicenter open-label superiority trial performed in South Korea.

在这项在韩国进行的前瞻性多中心开放标签优势试验中，符合条件的复杂冠状动脉病变患者被随机分配为2:1，接受血管内影像引导的经皮冠状动脉介入治疗（PCI）或仅由血管造影引导的PCI。

The primary endpoint was a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization.

主要终点是心脏死亡、靶血管相关心肌梗死或临床驱动的靶血管血运重建的复合终点。

Results

A total of 1,639 patients underwent randomization with 1,092 assigned to imaging-guided PCI and 547 assigned to angiography-guided PCI.

共有1,639名患者进行了随机分组，其中1,092名被分配到影像引导的经皮冠状动脉介入治疗（PCI），547名被分配到造影引导的PCI。

At a median follow-up of 5.3 years (Q1-Q3: 4.4-6.2 years), the primary endpoint occurred in 109 of 1,092 patients (10.5%) in the intravascular imaging-guided PCI group and 78 of 547 patients (14.9%) in the angiography-guided PCI group (HR: 0.68; 95% CI: 0.51-0.91; P = 0.009).

在中位随访5.3年（四分位数间距：4.4-6.2年）时，影像引导的PCI组中有109名患者（占10.5%）和造影引导的PCI组中有78名患者（占14.9%）达到了主要终点事件（HR: 0.68; 95% 置信区间: 0.51-0.91; P = 0.009）。

Cardiac death or target vessel-related myocardial infarction occurred in 78 patients (7.6%) in the intravascular imaging-guided PCI group and in 56 patients (10.7%) in the angiography-guided PCI group, clinically driven target vessel revascularization in 45 (4.4%) and 32 (6.2%), and definite stent thrombosis in 1 (0.1%) and 4 (0.7%), respectively.

在血管内影像引导的PCI组中，有78名患者（7.6%）发生了心脏死亡或靶血管相关的心肌梗死，而在仅接受血管造影引导的PCI组中，有56名患者（10.7%）发生此类事件。临床驱动的靶血管血运重建在45名患者（4.4%）和32名患者（6.2%）中发生，而明确的支架血栓形成分别在1名患者（0.1%）和4名患者（0.7%）中发生。

There were no apparent differences in procedure-related safety events between the groups.

两组之间在程序相关安全事件方面没有明显的差异。

Conclusions

In patients with complex coronary artery lesions undergoing PCI, intravascular imaging guidance reduced the risk of a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization at median follow-up of 5.3 years, compared to angiography guidance.

在接受经皮冠状动脉介入治疗（PCI）的复杂冠状动脉病变患者中，与血管造影引导相比，血管内成像引导在中位随访5.3年时，降低了心脏死亡、靶血管相关心肌梗死或临床驱动的靶血管血运重建复合终点的风险。

(Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention for Complex Coronary Artery Disease [RENOVATE-COMPLEX-PCI]; NCT03381872).

(血管内成像与血管造影引导的经皮冠状动脉介入治疗复杂冠状动脉疾病[RENOVATE-COMPLEX-PCI]; NCT03381872)。