IVUS or Angiography Guidance for Percutaneous Coronary Intervention in Complex Coronary Bifurcation Lesions: The DKCRUSH VIII Randomized Clinical Trial.

Whether the use of IVUS guidance improves the outcomes as compared with angiography guidance in patients with complex coronary bifurcation lesion undergoing double kissing (DK) crush is uncertain.

在进行双吻合（DK）压榨术的复杂冠状动脉分叉病变患者中，使用IVUS引导是否比血管造影引导改善结果尚不确定。

This study aimed to investigate the treatment effect of IVUS-guided PCI, as compared with angiography-guided PCI, in patients with complex bifurcation lesions.

本研究旨在调查在复杂分叉病变患者中，与血管造影引导的经皮冠状动脉介入治疗（PCI）相比，血管内超声（IVUS）引导的PCI治疗效果。

Methods

We conducted a multicenter, randomized, open-label trial at 24 centers in China.

我们在中国的24个中心进行了一项多中心、随机、开放标签的试验。

Patients with clinical indications for PCI and a complex bifurcation lesion based on DEFINITION (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) criteria (particularly side branch lesion length ≥10 mm) from coronary angiography were randomly assigned in a 1:1 ratio to IVUS-guided PCI or angiography-guided PCI.

根据DEFINITION（定义和复杂分叉病变对药物洗脱支架经皮冠状动脉介入治疗后临床结果的影响）标准，具有临床PCI指征和复杂分叉病变（特别是分支病变长度≥10毫米）的患者，通过冠状动脉造影以1:1的比例随机分配至IVUS引导的PCI或血管造影引导的PCI。

The primary endpoint was a composite of target vessel failure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization at 1 year after randomization.

主要终点是靶血管失败的复合终点，定义为随机化后1年内的心脏死亡、靶血管心肌梗死或临床驱动的靶血管血运重建。

Results

We assigned 555 patients to IVUS-guided PCI (n = 277) or angiography-guided PCI (n = 278).

我们分配了555名患者接受IVUS引导的PCI（n = 277）或血管造影引导的PCI（n = 278）。

A total of 124 patients (44.8%) in the IVUS-guided PCI group and 122 (43.9%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery.

IVUS引导的PCI组共有124名患者（44.8%）和血管造影引导的PCI组共有122名患者（43.9%）涉及左主冠状动脉分叉病变。

DK crush was used in 96.8% of patients.

DK crush技术在96.8%的患者中得到应用。

At 1 year, a primary endpoint event occurred in 17 patients (6.1%) in the IVUS-guided PCI group and in 41 patients (14.7%) in the angiography-guided PCI group (HR: 0.40; 95% CI: 0.23-0.71; P = 0.002), driven mainly by reductions in target vessel myocardial infarction or target vessel revascularization.

在1年时，IVUS引导的PCI组有17名患者（6.1%）发生了主要终点事件，而血管造影引导的PCI组有41名患者（14.7%）发生了主要终点事件（HR: 0.40; 95% 置信区间: 0.23-0.71; P = 0.002），这主要归因于靶血管心肌梗死或靶血管血运重建的减少。

Conclusions

In the present randomized trial comparing IVUS-guided vs angiography-guided PCI for complex coronary bifurcation lesions treated with the 2-stent DK crush technique, the benefits of IVUS-guided PCI at 1 year was achieved largely through achievement of IVUS-defined optimization targets rather than IVUS use alone.

在当前的随机试验中，比较了使用IVUS指导与仅使用血管造影指导的PCI治疗复杂冠状动脉分叉病变，采用2支架DK Crush技术。在1年时，IVUS指导的PCI的益处主要是通过实现IVUS定义的优化目标实现的，而不仅仅是使用IVUS本身。

(IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions [DKCRUSH VIII]; NCT03770650).

(IVUS引导的DK Crush支架置入技术治疗复杂分叉病变患者 [DKCRUSH VIII]; NCT03770650).