OCT vs Angiography for Guidance of Percutaneous Coronary Intervention of Calcified Lesions: The CALIPSO Randomized Clinical Trial.

Background

To determine if optical coherence tomography (OCT) is superior to angiography for calcified lesions PCI guidance.

确定光学相干断层扫描（OCT）是否比血管造影术更适合用于指导钙化病变的PCI。

DESIGN, SETTING, AND PARTICIPANTS: The CALIPSO (Calcified Lesion Intervention Planning Steered by OCT) trial was a prospective, multicenter, open-label, randomized clinical trial that included patients with stable moderate to severe calcified coronary lesions on coronary angiography scheduled for PCI.

设计、设置和参与者：CALIPSO（光学相干断层扫描引导的钙化病变干预计划）试验是一项前瞻性、多中心、开放标签的随机临床试验，包括了在冠状动脉造影上显示稳定中度至重度钙化病变并计划进行经皮冠状动脉介入治疗（PCI）的患者。

The trial was conducted at 12 sites in France between December 2021 and June 2023, and data were analyzed from December 2023 to April 2024.

该试验在2021年12月至2023年6月期间在法国的12个地点进行，并且数据在2023年12月至2024年4月期间进行了分析。

intervention

After diagnostic coronary angiography, eligible patients were randomly assigned in a 1:1 ratio to receive OCT-guided PCI or angiography-guided PCI.

在诊断性冠状动脉造影后，符合条件的患者以1:1的比例随机分配接受OCT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。

In the OCT group, the procedures were guided by OCT analysis and predefined standardized management algorithms.

在OCT组中，手术过程由OCT分析和预定义的标准管理算法指导。

Patients from both arms had control post-PCI OCT analysis after procedure completion for primary end point measurement.

两组患者在经皮冠状动脉介入治疗（PCI）后进行了光学相干断层扫描（OCT）分析，以评估主要终点。

main_outcomes_and_measures

The primary end point was the minimal stent area (MSA) measured by OCT in both groups.

主要终点是两组中通过OCT测量的最小支架面积（MSA）。

Secondary key safety end points included periprocedural myocardial infarction, radiation dose, contrast medium volume, and procedure duration.

次要安全性终点包括围手术期心肌梗死、辐射剂量、对比剂用量和手术持续时间。

Results

A total of 143 patients were randomized, and 134 were included in the final analysis (65 in the OCT group and 69 in the angiography group).

共有143名患者被随机分配，最终分析纳入了134名患者（OCT组65名，血管造影组69名）。

Median (IQR) patient age was 73.0 (66.0-78.0) years, and 25 patients (18.7%) were female.

患者的中位年龄为73.0（66.0-78.0）岁，其中25名患者（18.7%）为女性。

The baseline characteristics of the groups were comparable, but the use of intravascular lithotripsy was more frequent in the OCT arm (30 patients [46%] vs 8 patients [12%]; P < .001).

两组的基线特征可比，但在OCT组中，血管内碎石术的使用更为频繁（30名患者[46%]对比8名患者[12%]；P<.001）。

The final median (IQR) MSA was larger in the OCT group than in the angiography group (6.5 [5.5-8.1] mm2 vs 5.0 [4.1-6.1] mm2; P < .001).

OCT组的最终中位数（四分位数间距）MSA大于血管造影组（6.5 [5.5-8.1] mm2 vs 5.0 [4.1-6.1] mm2; P < .001）。

There was no difference in periprocedural complications incidence, contrast medium volume, or procedure duration between groups.

两组之间围手术期并发症发生率、对比剂用量或手术持续时间没有差异。

conclusions_and_relevance

The CALIPSO randomized clinical trial showed that OCT guidance associated with predefined algorithmic management achieved better stent implantation results than angiography guidance in patients with calcified lesions PCI, without any additional safety concern.

CALIPSO 随机临床试验显示，在钙化病变的经皮冠状动脉介入治疗（PCI）患者中，光学相干断层扫描（OCT）引导结合预定义算法管理相较于血管造影引导，实现了更好的支架植入结果，且没有增加任何额外的安全性问题。

trial_registration

ClinicalTrials.gov Identifier: NCT05301218.

ClinicalTrials.gov 注册号：NCT05301218。