Randomized, Placebo-Controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention in Stable Angina: The ORBITA-CTO Trial.

The aim of this study was to assess the efficacy of CTO PCI in the first randomized, placebo-controlledtrial of CTO PCI.

本研究旨在评估CTO PCI在首个CTO PCI的随机、安慰剂对照试验中的疗效。

Methods

ORBITA-CTO is a multicenter, randomized, blinded trial comparing CTO PCI with a placebo procedure.

ORBITA-CTO 是一项多中心、随机、盲法试验，比较了CTO PCI与安慰剂程序。

Patients had angina attributable to a single-vessel CTO, without bystander coronary disease.

患者有单支血管CTO引起的胸痛，没有旁观者冠状动脉疾病。

Angina symptoms were recorded daily using the ORBITA app.

使用ORBITA应用程序每日记录心绞痛症状。

After dual-injection coronary angiography, patients were randomized to either CTO PCI or placebo.

在双注射冠状动脉造影后，患者被随机分配到CTO PCI或安慰剂组。

Blinding was maintained using auditory isolation and deep conscious sedation.

通过听觉隔离和深度意识镇静来维持盲法。

Antianginal medications were stopped at randomization and reintroduced on a patient-initiated protocol.

在随机分组时停止使用抗心绞痛药物，并根据患者启动的协议重新引入。

At the 6-month follow-up, assessments were repeated.

在6个月的随访时，评估被重复进行。

The primary efficacy outcome was the angina symptom score, an ordinal scale combining the daily symptom burden assessed by the ORBITA app, antianginal use, and over-ride events.

主要疗效结果是心绞痛症状评分，这是一个序数量表，结合了通过ORBITA应用程序评估的每日症状负担、抗心绞痛药物使用和覆盖事件。

Secondary outcomes were symptom and quality of life questionnaires and blinding fidelity.

次要结果包括症状和生活质量问卷以及盲法的忠实度。

Results

Between October 19, 2021 and October 21, 2025, 50 patients were randomly assigned to CTO PCI (n = 25) or placebo (n = 25).

在2021年10月19日至2025年10月21日期间，共有50名患者被随机分配接受CTO PCI（n = 25）或安慰剂（n = 25）。

One patient randomized to PCI was withdrawn during the procedure because of a complication.

一名被随机分配至经皮冠状动脉介入治疗（PCI）的患者在手术过程中因并发症被撤出。

All 50 patients were included in the primary analysis.

所有50名患者均被纳入主要分析。

Compared with placebo, CTO PCI resulted in an immediate and sustained improvement in the angina symptom score (OR: 4.38; 95% credible interval [CrI]: 1.57-12.69; probability of benefit [Pr{Benefit}] = 0.996), arising from a clear reduction in the number of episodes of angina (OR: 4.38; 95% CrI: 1.55-11.78; Pr[Benefit] = 0.997).

与安慰剂相比，CTO PCI 导致心绞痛症状评分立即且持续改善（OR: 4.38; 95% 可信区间 [CrI]: 1.57-12.69; 益处概率 [Pr{Benefit}] = 0.996），这源于心绞痛发作次数的明显减少（OR: 4.38; 95% CrI: 1.55-11.78; Pr[Benefit] = 0.997）。

This resulted in an additional 30.6 days free of angina (95% CrI: 11.1-50.7; Pr[Benefit] >0.999).

这导致了额外的30.6天无心绞痛发作（95% CrI: 11.1-50.7; Pr[Benefit] >0.999）。

Improvements were also observed with the Seattle Angina Questionnaire in angina frequency (+10.7; 95% CrI: 1.4-20.2; Pr[Benefit] = 0.988), physical limitation, quality of life, and summary score and Canadian Cardiovascular Society class.

使用西雅图心绞痛问卷也观察到心绞痛频率(+10.7; 95% CrI: 1.4-20.2; Pr[Benefit] = 0.988)、身体限制、生活质量以及总评分和加拿大心血管病学会等级的改善。

Blinding of patients, staff, and researchers was maintained.

患者、工作人员和研究人员的盲法得到了保持。

Conclusions

In patients with symptomatic single-vessel CTO, CTO PCI improves angina beyond placebo.

在有症状的单血管慢性完全闭塞（CTO）患者中，CTO经皮冠状动脉介入治疗（PCI）在缓解心绞痛方面的效果超过安慰剂。

(A Placebo-controlledTrial of Chronic Total Occlusion Percutaneous Coronary Intervention for the Relief of Stable Angina [ORBITA-CTO]; NCT05142215).

（一项安慰剂对照试验，研究慢性完全闭塞经皮冠状动脉介入治疗对稳定型心绞痛的缓解效果[ORBITA-CTO]; NCT05142215）。