Predictors and Long-term Incidence of In-stent Restenosis After Chronic Total Occlusion Percutaneous Coronary Intervention: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Cumulative incidence of long-term ISR after CTO PCI
研究概览
简要总结
The goal of this clinical trial is to describe the long-term (≥ 3 years) patency of coronary artery stents following chronic total occlusion percutaneous coronary intervention (CTO PCI). The main questions it aims to answer are:
- What is the incidence of in-stent restenosis after CTO PCI?
- What are patient-, lesion-, and procedure-related factors associated with an increased risk of in-stent restenosis after CTO PCI?
详细描述
This study was approved by the ethics committee of Helsinki University Central Hospital (approval number HUS/12527/2022) and complied with the Declaration of Helsinki.
Patient selection Study participants were selected from a registry that included stable coronary artery disease patients with a chronic total occlusion (CTO) treated with percutaneous coronary intervention (CTO PCI) in Helsinki University Central Hospital 2014-2021. Optimal medical therapy was prescribed to all patients at the time of CTO PCI. All patients, who received surveillance imaging, gave written, informed consent prior to the beginning of the study.
Definition Segments extending 5 mm proximal and 5 mm distal to the stent were included as part of the stent for the evaluation of in-stent restenosis (ISR). CTO stents consisted of one or more coronary artery stents, potentially involving different stent types. Stent overlap was taken into consideration in cases of multiple stents. In coronary computed tomography angiography (CCTA) radiological ISR was defined as luminal narrowing of ≥ 50 % within the CTO stent. In native coronary arteries, stenosis was classified as minimal (<25 %), mild (25-49 %), moderate (50-69 %), severe (70-99 %), and total occlusion (100 %).
In CCTA, a non-contrast calcium score was obtained initially. This was followed by third-generation dual-source CCTA (Somatom Force, Siemens) using contrast medium (Omnipaque 350, GE Healthcare). Sublingual nitroglycerin was administered prior to scanning. The imaging protocol was optimised according to the patient's heart rate and in cases where the heart rate exceeded > 70/min, intravenous metoprolol was administered.
Patients' symptomatic status at the time of surveillance imaging was assessed using the Canadian Cardiovascular Society (CCS) classification via a telephone interview. For patients without study-driven surveillance imaging, the CCS classification at clinical imaging follow-up was determined based on electronic medical records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study's cardiac radiologist was blinded for symptomatic data, stent type and stent quantity. The target vessel of implanted coronary artery stents was provided.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study inclusion criteria were the following:
- •Successful CTO PCI with a drug-eluting stent
- •Primary procedure minimum of 3 years prior to study date
- •Of the included patients, CTO stent patency surveillance imaging with CCTA was conducted according to the following criteria. Patients were consecutive and prospectively recruited.
- •Surveillance imaging inclusion criteria
- •Surviving patients ≤ 80 years old at the time of surveillance imaging
- •Communication in Finnish, Swedish or English
排除标准
- •Target lesion revascularisation or angiographically verified ISR after CTO PCI
- •Malignancy with ongoing diagnostics or poor prognosis
- •Considerable functional impairment in activities of daily living
- •Presence of a clinically significant psychiatric disorder
- •Ongoing alcohol or drug abuse
- •Presence of a memory disorder or other clinically significant cognitive impairment
- •Coronary artery bypass surgery (CABG) after CTO PCI
- •Estimated glomerular filtration rate ≤40 ml/min
- •invasive coronary angiography performed less than 6 months prior to the surveillance imaging date
- •CCTA results were reviewed by the interventional cardiologists of the study and ICA was offered to patients with:
- •ISR or an inconclusive finding within the CTO stent.
- •Anginal symptoms with either ≥ 50 % stenosis or an inconclusive finding in any native coronary artery or within a non-CTO stent.
研究组 & 干预措施
Study population
All patients included in the study
干预措施: chronic total occlusion percutaneous coronary intervention (CTO PCI) (Procedure)
Study population
All patients included in the study
干预措施: coronary computed tomography angiography (Diagnostic Test)
Study population
All patients included in the study
干预措施: invasive coronary angiography (Diagnostic Test)
结局指标
主要结局
Cumulative incidence of long-term ISR after CTO PCI
时间窗: Through study completion, up to 10.9 years, with an average follow-up of 7.1 years.
ISR was defined as a ≥ 50 % luminal diameter narrowing within the coronary artery stent.
次要结局
未报告次要终点
研究者
Lauri Mansikkaniemi
M.D.
Helsinki University Central Hospital