跳至主要内容
临床试验/NCT05672862
NCT05672862已完成不适用

International Post-PCI FFR Registry for Extended Follow up Outcomes After Coronary Stenting

Bon-Kwon Koo1 个研究点 分布在 1 个国家目标入组 2,128 人开始时间: 2021年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,128
试验地点
1
主要终点
The cumulative incidence (percent) of target vessel failure

研究概览

简要总结

Percutaneous coronary intervention (PCI) is a standard treatment strategy for coronary artery disease (CAD). With the presence of myocardial ischemia, PCI reduces the risks of death, myocardial infarction (MI), and revascularization compared to medical therapy. However, the risk of future clinical events remains high, and about 10% of patients experienced further cardiovascular events after PCI. Several factors are associated with these poor outcomes. Well-known patient-related risk factors are diabetes mellitus, chronic kidney disease, left ventricular dysfunction, previous MI, and presentation with acute coronary syndrome. Procedure-related factors, such as stent under expansion, malposition, edge dissection, the number of the used stent, and total stent length, are also related to poor prognosis after PCI. Recent studies reported that fractional flow reserve (FFR) after coronary stenting, or post-PCI FFR, was associated with future clinical outcomes after PCI, and low post-PCI FFR value was associated with procedural factors. However, optimal cut-off values of post-PCI FFR ranged widely, from 0.86 to 0.96, and some studies reported the limited prognostic value of post-PCI FFR. This might result from differences in study populations, the definition of outcomes, type of stent used, and distribution of included vessels among previous studies. Previously, the investigators incorporated previous data into the International Post-PCI FFR registry and demonstrated the prognostic value of post-PCI FFR using the machine learning technique. However, the results were based on the two years follow-up of patients after PCI, and the prognostic value of post-PCI FFR in long-term outcomes is still uncertain. Therefore, the investigators planned to extend the International Post-PCI FFR registry to define the long-term prognostic implication of post-PCI FFR.

详细描述

The investigators planned to extend the International Post-PCI FFR registry (NCT04684043) to explore the long-term prognostic value of post-PCI FFR. The International Post-PCI FFR registry (NCT04684043) already included the 2,200 patients who underwent PCI and measured post-PCI FFR between June 2011 and May 2018. As the clinical, angiographic, and physiologic data are already collected in the International Post PCI FFR registry, the investigators will further collect the most recent clinical outcome data until 2021.5 and incorporate them into the International Post-PCI FFR Extended registry. As the current study will evaluate clinical outcomes at 5 years, 2,128 patients who underwent PCI and measured post-PCI FFR between June 2011 and Nov 2016 will be included and studied. The investigators will request further clinical outcome data from 10 hospitals that provided the data for the International Post-PCI FFR registry before.

A standardized form of a spreadsheet, including standardized definitions of variables, was used to collect the individual patient data from the principal investigators of each qualified registry. Patient clinical, angiographic, and physiologic data at the time of index PCI were recorded and already collected at Seoul National University Hospital. As clinical outcome data of 2 years of follow-up after index PCI are already collected in the International Post-PCI FFR registry (NCT04684043), clinical outcome data after 2 years of index PCI will be collected by medical records until 2021.5 of each hospital. All submitted data were double-checked by a central monitoring team in Seoul National University Hospital. All patients' identifying numbers are anonymized as "Subject_No" and the investigators will request the patients' clinical outcome data using these anonymized identifying numbers of the patients. Also, the investigators will share collected data with collaborators, using these numbers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
19 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent PCI and post-PCI FFR measurements after angiographically successful stent implantation (residual stenosis < 20% by visual estimation)

排除标准

  • Post-PCI TIMI (The Thrombolysis In Myocardial Infarction) flow of < 3
  • Depressed left ventricular systolic function (ejection fraction < 30%)
  • Culprit lesion for the acute coronary syndrome
  • Graft vessel
  • Collateral feeder
  • In-stent stenosis
  • Primary myocardial or valvular heart disease
  • Patients with life expectancy < 2 years.

结局指标

主要结局

The cumulative incidence (percent) of target vessel failure

时间窗: 5 years

Target vessel failure is a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization. The cumulative incidence will be calculated as Kaplan-Mier estimates at 5 years.

次要结局

  • The cumulative incidence (percent) of cardiac death or myocardial infarction(5 years)
  • The cumulative incidence (percent) of target vessel myocardial infarction(5 years)
  • The cumulative incidence (percent) of target vessel revascularization(5 years)

研究者

发起方
Bon-Kwon Koo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bon-Kwon Koo

Professor

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验