Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention (PERSPECTIVE-PCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 588
- 试验地点
- 5
- 主要终点
- Target Vessel Failure
研究概览
简要总结
Coronary physiologic assessments by the pressure-derived fractional flow reserve (FFR) have become standard methods for identifying hemodynamic deprivation in coronary arterial stenosis for evidence-based percutaneous coronary intervention (PCI). Invasive physiologic indices-guidance enables on-site real time assessment for functional significance of epicardial coronary stenosis and the use of those indices has shown to be effective to guide treatment decision. Several studies further support the role of post-PCI FFR measurement as a functional marker of residual disease after PCI and prognostic indicator of patients. Although optimal cut-off values of post-PCI FFR varied across studies, an inverse relationship between post-PCI FFR and the risk of future clinical events have been reported consistently.
Recently, non-hyperemic pressure ratios (NHPRs) have been introduced in clinical practice. Although there are several different NHPRs, previous studies consistently indicated that those NHPRs shares similar diagnostic performance and prognostic implications. Nevertheless, few reports were available for clinical relevance of NHPRs in evaluation of post-PCI status.
In this context, we will evaluate the physiologic characteristics and prognostic implication of post-PCI NHPRs and compare with those of post-PCI FFR in patients who underwent angiographically successful PCI with 2nd generation drug-eluting stent implantation (DES).
详细描述
Patients who diagnosed significant coronary artery disease and treated by 2nd generation DES with post-PCI physiologic evaluation would be enrolled.
Invasive physiologic assessment including recording of resting pressure trecing would be required at the baseline and at the end of index PCI procedure. PCI procedure would be performed upon local routine. Any available 2nd generation DES could be used. Web-based electronic-case record form (CRF) system will be used for collecting data. All data will be handled and analyzed by blind fashion at independent core lab. 2-year clinical outcome after index procedure will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any patient meets eligible criteria who underwent PCI with DES followed by invasive physiologic assessment at the index procedure
- •available both post-PCI resting pressure tracing and FFR
排除标准
- •culprit vessel of acute coronary syndrome
- •failed achieving TIMI 3 flow at the end of PCI
- •left ventricular ejection fraction <30%
- •graft vessel
- •collateral feeder
- •in-stent restenosis
- •primary myocardial or valvular heart disease
- •in patient whose life expectancy less than 2 years
- •visible thrombus of target vessel segment
- •unmeasured post-PCI resting pressure tracings
结局指标
主要结局
Target Vessel Failure
时间窗: 2 years after index procedure
a composite of cardiac death, clinically-driven target vessel-related myocardial infarction, and clinically-driven target vessel revascularization. The target vessel will be defined as the treated vessel with 2nd generation DES which was assessed by post stent fractional flow reserve.
次要结局
- independent predictors for target-vessel failure(2 years after index procedure)
- delta FFR per unit time(At the time of index procedure)
- Relative percent increase of physiologic indices(At the time of index procedure)
研究者
Joo Myung Lee
Assistant Professor
Samsung Medical Center