Intravascular Ultrasound-Guided or Angiography-Guided Complex High-Risk PCI.

Although practice guidelines recommend intracoronary imaging for anatomically complex lesions, evidence from current European practice is limited.

尽管实践指南推荐对解剖结构复杂的病变进行冠状动脉内成像，但目前来自欧洲实践的证据有限。

Methods

In this investigator-initiated, international, open-label, randomized, controlled trial, we assigned patients undergoing complex PCI to either IVUS-guided PCI, performed with the use of prespecified stent-optimization criteria, or angiography-guided PCI.

在这项由研究者发起的国际、开放标签、随机对照试验中，我们将接受复杂经皮冠状动脉介入治疗（PCI）的患者分配到IVUS指导下的PCI组，该组使用预先设定的支架优化标准进行操作，或分配到血管造影指导下的PCI组。

The primary end point was target-vessel failure, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-vessel revascularization.

主要终点是靶血管失败，定义为心脏原因死亡、靶血管心肌梗死或临床指示的靶血管血运重建的复合终点。

Results

Of the 2020 patients who underwent randomization, 1010 in the IVUS-guided PCI group and 1009 in the angiography-guided PCI group were included in the primary analysis.

在2020名接受随机分组的患者中，有1010名接受IVUS引导的PCI治疗组和1009名接受血管造影引导的PCI治疗组的患者被纳入主要分析。

The mean age of the patients was 69 years, 79.4% were men, and 27.4% presented with an acute coronary syndrome.

患者的平均年龄为69岁，79.4%为男性，27.4%表现为急性冠状动脉综合征。

The mean procedure duration was 88.8 minutes with IVUS-guided PCI and 66.2 minutes with angiography-guided PCI.

IVUS引导的PCI手术平均耗时为88.8分钟，而血管造影引导的PCI手术平均耗时为66.2分钟。

Dilation with balloon angioplasty after stent implantation was performed in 91.3% of the IVUS-guided PCI procedures and in 84.5% of the angiography-guided PCI procedures.

在IVUS引导的PCI手术中，91.3%的病例在支架植入后进行了球囊扩张血管成形术，在血管造影引导的PCI手术中，84.5%的病例进行了球囊扩张血管成形术。

At a median follow-up of 19.0 months (interquartile range, 15.2 to 23.4), target-vessel failure had occurred in 140 patients (13.9%) in the IVUS-guided PCI group and in 112 patients (11.1%) in the angiography-guided PCI group (hazard ratio, 1.25; 95% confidence interval, 0.97 to 1.60; P = 0.08).

在中位随访19.0个月（四分位数范围，15.2至23.4）时，IVUS引导的PCI组中有140名患者（13.9%）发生了靶血管失败，而血管造影引导的PCI组中有112名患者（11.1%）发生了靶血管失败（风险比，1.25；95%置信区间，0.97至1.60；P = 0.08）。

Procedural complications occurred in 11.3% of the IVUS-guided PCI procedures and in 10.2% of the angiography-guided PCI procedures.

IVUS引导的PCI手术中，有11.3%发生了手术并发症，而血管造影引导的PCI手术中有10.2%发生了手术并发症。

The frequency of adverse events appeared to be similar in the two groups.

两组不良事件的发生频率似乎相似。

Conclusions

Among patients undergoing complex high-risk PCI, a strategy of routine IVUS-guided PCI performed with the use of prespecified stent-optimization criteria was not associated with a lower risk of target-vessel failure than angiography-guided PCI alone.

在进行复杂高风险经皮冠状动脉介入治疗（PCI）的患者中，使用预设的支架优化标准进行常规血管内超声（IVUS）引导的PCI策略，并未显示出比单独使用血管造影引导的PCI更低的目标血管失败风险。

(Funded by Boston Scientific; IVUS-CHIP ClinicalTrials.gov number, NCT04854070.).

(由波士顿科学公司资助; IVUS-CHIP ClinicalTrials.gov编号, NCT04854070。)