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临床试验/NCT04664140
NCT04664140已完成不适用

Angio-based Quantitative Flow Ratio Virtual PCI Versus Conventional Angio-guided PCI in the Achievement of an Optimal Post-PCI QFR

University Hospital of Ferrara4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年2月20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
300
试验地点
4
主要终点
post-PCI QFR

研究概览

简要总结

A significant portion of patients continue to experience both adverse events and symptoms after angiographically successful PCI. Beyond different underlying mechanisms non-related to epicardial disease (vasospasm, microcirculatory dysfunction), several recent studies have shown that in at least 15-20% of PCIs, a prognostically meaningful ischemia, detected with different coronary physiology tools, is present at the end of a successful angiography-guided PCI. In addition, physiology is able to discriminate the underlying reason causing the suboptimal functional result, namely: i) in-stent drop; ii) focal drop outside stent; iii) diffuse disease.

However, the use of post-PCI physiology is still very low, even when it is utilized pre-PCI to set the indication for stenting. Lack of dedicated randomized clinical trials and procedural lengthening and increase in side effects are at the basis of this underutilization.

In addition, the ideal tool should allow to plan the intervention in advance rather than to assess the results afterwards. To this hand, QFR is particularly appealing, among available physiology tools, because it does not need wire or adenosine and allows: i) identification of disease mechanism; ii) co-registration with angiography; iii) pre-PCI planning with residual vessel QFR value according to a pre-specified treatment.

Taken all this characteristics together, QFR is the ideal technology for virtual PCI.

The hypothesis of the present investigation is that a procedural planning based on QFR (virtual PCI) is able to reduce the rate of patients with post-PCI suboptimal functional result, that has been found to correlate with prognosis in our earlier study, if compared to the traditional angio-guided PCI.

详细描述

Post-percutaneous coronary intervention (PCI) physiology The results of functional assessment performed after percutaneous coronary intervention (PCI) taught us that a "successful" angiography-guided PCI is often suboptimal in terms of physiology and that physiology result after PCI is closely linked to outcome. Yet, post-PCI physiology is rarely utilized in clinical practice, being employed in less than 10% of lesions investigated with physiology pre-PCI. Reasons for the low use of functional assessment post-PCI and for subsequent intervention are manifold. First, physiology is actually used after PCI only in cases where it was utilized pre-PCI. Second, randomized clinical trials (RCT) addressing the use of physiology to assess PCI results have not been performed, therefore clear instructions and cutoffs for its use are lacking. Third, when fractional flow reserve (FFR) is measured, the need to administer adenosine several times during the same procedure results in increased procedure time, cost and adverse side effects. Fourth, in case of a post-PCI suboptimal functional result, it may be difficult to ascertain the underlying cause.

New indices and tools have been developed in an effort to overcome barriers to the widespread adoption of functional assessment. Non-hyperaemic pressure indices (NHPI) including, resting distal to aortic coronary pressure ratio (Pd/Pa), and other resting indices have enabled functional evaluation without pharmacological arteriolar vasodilation, while angiography-based functional assessment have eliminated the need for a dedicated pressure wire.

Importantly, these newer tools may allow operators to understand the mechanism underlying an abnormal physiology value after angiographically successful intervention. In fact, the real novelty related to their development is the shift from a binary interpretation of physiology (positive/negative) to a quantitative site-specific one. For these reasons, they are extremely appealing post-PCI and several studies have been recently conducted to validate them in this setting.

Quantitative flow ratio (QFR) In particular, quantitative flow ratio (QFR) is an angiographically-derived estimate of FFR developed as an alternative to wire-based intracoronary physiology. One advantage of angio-based FFR systems is allowing the generation of a pullback curve and discrimination of the physiological contribution of each single lesion as well as diagnosis of diffuse disease. The value of QFR to assess the functional results of PCI has been tested in the prospective Angio-Based Fractional Flow Reserve to Predict Adverse Events After Stent Implantation (HAWKEYE) study. Seven hundred fifty-one vessels in 602 patients undergoing angiographically satisfactory second-generation drug eluting stent (DES) implantation were analyzed. At the end of the procedure, the operator acquired projections for QFR computation performed offline by an independent core laboratory. Receiver operating characteristic (ROC) curve analysis identified a post-PCI QFR best cut-off of <0.90 (area under the curve 0.77; 95% confidence interval [CI]: 0.74-0.80; p< 0.001). After correction for potential confounding factors, post-PCI QFR<0.90 was associated with a 3-fold increase in risk for the vessel-oriented composite endpoint at 2 years (HR: 2.91; 95% CI 1.63-5.19; p< 0.001). Further, a very important finding of the HAWKEYE study was the demonstration that QFR could discriminate among different coronary artery disease (CAD) patterns. In vessels with suboptimal functional result, the site of the QFR drop was in-stent in 13% of the cases, while a focal drop outside the stent was identifiable in 32% of the cases. Thirty-four percent of vessels showed diffuse disease, while in 21% a combination of the aforementioned possibilities was present. It is important to note that QFR analyzability depends on quality of angiography and it is feasible in around 80% of the cases. Moreover, QFR is not applicable in specific lesion subsets such as left main, bifurcation and ostial lesions.

Virtual PCI The inherent limit of post-PCI physiology is to add measurement and consequent actions after the end of a procedure that has been deemed successful by the same operator who is performing it. In addition, it is associated with the increase in procedural time and costs. Thus, a broad application of post-PCI physiology, although clinically meaningful, is implausible.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The core-laboratory will be blinded to patients randomization during the adjudication of the endpoint

入排标准

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

入选标准

  • Indication to PCI for either acute or chronic coronary syndrome
  • Signed informed consent

排除标准

  • Planned surgical revascularization
  • Prior Coronary Artery Bypass Graft (CABG) Surgery
  • Culprit lesion of STEMI or NSTEMI
  • Clinical or angiographic features limiting QFR computation:
  • Left main or ostial right coronary artery
  • Atrial fibrillation
  • Ongoing ventricular arrhythmias
  • Significant and persistent tachycardia
  • Revascularization of a chronic total occlusion
  • Non-cardiovascular co-morbidity reducing life expectancy to < 1 year
  • Any factor precluding 1-year follow-up

结局指标

主要结局

post-PCI QFR

时间窗: end of the procedure

proportion of patients with a final post-PCI QFR result ≥0.90

次要结局

  • vessel-oriented composite endpoint (VOCE)(1 year)

研究者

发起方
University Hospital of Ferrara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianluca Campo

Full Professor of Cardiology

University Hospital of Ferrara

研究点 (4)

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