Background

The few randomized controlled trials (RCTs) on chronic total occlusion (CTO) percutaneous coronary intervention (PCI) are subject to selection bias.

Objectives

The purpose of this study was to evaluate the differences between real-world CTO patients and those enrolled in RCTs.

Methods

This study performed a meta-analysis of national and dedicated CTO PCI registries and compared patient characteristics and outcomes with those of RCTs that randomized patients to CTO PCI versus medical therapy. Given the large sample size differences between RCTs and registries, the study focused on the absolute numbers and their clinical significance. The study considered a 5% relative difference between groups to be potentially clinically relevant.

Results

From 2012 to 2022, 6 RCTs compared CTO PCI versus medical therapy (n = 1,047) and were compared with 15 registries (5 national and 10 dedicated CTO PCI registries). Compared with registry patients, RCT patients had fewer comorbidities, including diabetes, hypertension, previous myocardial infarction, and prior coronary artery bypass graft surgery. RCT patients had shorter CTO length (29.6 ± 19.7 mm vs 32.6 ± 23.0 mm, a relative difference of 9.2%) and lower Japan–Chronic Total Occlusion Score scores (2.0 ± 1.1 vs 2.3 ± 1.2, a relative difference of 13%) compared with those enrolled in dedicated CTO registries. Procedural success was similar between RCTs (84.5%) and dedicated CTO registries (81.4%) but was lower in national registries (63.9%).

Conclusions

There is a paucity of randomized data on CTO PCI outcomes (6 RCTs, n = 1,047). These patients have lower risk profiles and less complex CTOs than those in real-world registries. Current evidence from RCTs may not be representative of real-world patients and should be interpreted within its limitation.

中文翻译：

---

慢性全闭塞血运重建研究中患者特征的比较分析

背景

少数关于慢性完全闭塞 (CTO) 经皮冠状动脉介入治疗 (PCI) 的随机对照试验 (RCT) 存在选择偏倚。

目标

本研究的目的是评估现实世界的 CTO 患者与参加 RCT 的患者之间的差异。

方法

本研究对国家和专门的 CTO PCI 登记处进行了荟萃分析，并将患者特征和结果与随机对照试验（将患者随机接受 CTO PCI 与药物治疗）进行比较。鉴于 RCT 和注册中心之间的样本量差异很大，该研究侧重于绝对数量及其临床意义。该研究认为组间 5% 的相对差异具有潜在的临床相关性。

结果

从 2012 年到 2022 年，6 项 RCT 比较了 CTO PCI 与药物治疗（n = 1,047），并与 15 个注册中心（5 个国家注册中心和 10 个专门的 CTO PCI 注册中心）进行了比较。与登记患者相比，RCT 患者的合并症较少，包括糖尿病、高血压、既往心肌梗死和既往冠状动脉旁路移植术。与 RCT 患者相比，RCT 患者的 CTO 长度更短（29.6 ± 19.7 mm vs 32.6 ± 23.0 mm，相对差异为 9.2%），Japan-Chronic Total Occlusion Score 评分更低（2.0 ± 1.1 vs 2.3 ± 1.2，相对差异为 13%）与那些在专门的 CTO 注册表中注册的人一起。RCT (84.5%) 和专门的 CTO 注册中心 (81.4%) 的程序成功率相似，但在国家注册中心 (63.9%) 的成功率较低。

结论

缺乏关于 CTO PCI 结果的随机数据（6 项 RCT，n = 1,047）。与真实世界登记中的患者相比，这些患者的风险概况和 CTO 的复杂性较低。目前来自 RCT 的证据可能不能代表真实世界的患者，应在其局限性范围内进行解释。