Intravascular Ultrasound and Optical Coherence Tomography-Defined Optimal Criteria and Plaque Characteristics for Defining the Functional Significance of Coronary Stenoses Using Resting and Hyperemic Physiologic Indices
试验速览
- 阶段
- 不适用
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR
研究概览
简要总结
- to evaluate diagnostic accuracy and performance of IVUS and OCT-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices.
- to explores the association between intravascular imaging-derived plaque characteristics and invasive physiologic indices.
详细描述
Given the inherent limitations of coronary angiography to depict the presence of functionally significant epicardial coronary stenosis and discrepancy between angiographic stenosis severity and the presence of myocardial ischemia, invasive physiologic indices such as fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) has been a standard method to guide decision of revascularization.
Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are an intracoronary imaging method able to provide information about lumen area, vessel area, plaque burden, and plaque characteristics that can be used for the guidance of revascularization procedure. Several previous studies explored the diagnostic performance of intravascular imaging-defined quantitative parameters to predict functional significance defined by FFR, however, quantitative parameter derived from intravascular imaging showed only moderate diagnostic accuracy and the optimal cut-off value of intravascular imaging-derived minimal lumen area (MLA) or minimal lumen diameter (MLD) were varied according to the patient population, interrogated vessels, and the location of target lesions, suggesting limited clinical relevance of judging functional significance of target stenosis using intravascular imaging alone. Nevertheless, the adoption rate of FFR-guided decision has been limited due to various reasons and intravascular image-guided decision has been still used in substantial proportion of the patients.
Recently, new resting pressure-derived indices including resting full-cycle ratio (RFR) or diastolic pressure ratio (dPR) have been introduced as other substitutes for iFR, which does not require administration of hyperemic agents, therefore, possess more convenient in daily practice. Recent study with the largest sample size demonstrated identical diagnostic property and prognostic implication among iFR, RFR, and dPR. As those resting pressure-derived indices might have more generalizability for daily practice, it is expected to raise the adoption rate of physiologic interrogation. Therefore, understanding the association between all the available physiologic indices and intravascular imaging-derived quantitative and qualitative parameters might be important in clinical decision for patient who underwent invasive coronary angiography.
In this regard, the investigators sought to evaluate diagnostic accuracy and performance of intravascular imaging-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices and further explores the association between IVUS and OCT-derived plaque characteristics and invasive physiologic indices.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who suspected ischemic heart disease, and underwent invasive physiologic assessment and intravascular ultrasound
排除标准
- •Cardiogenic shock
- •Graft vessel
- •In-stent restenosis
结局指标
主要结局
Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR
时间窗: During Cardiac Cath
Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by instantaneous wave-free ratio (iFR)
时间窗: During Cardiac Cath
Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR
时间窗: During Cardiac Cath
Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR
时间窗: During Cardiac Cath
Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by fractional flow reserve (FFR)
时间窗: During Cardiac Cath
Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR
时间窗: During Cardiac Cath
Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR
时间窗: During Cardiac Cath
Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by diastolic pressure ratio (dPR)
时间窗: During Cardiac Cath
Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89
Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by resting full-cycle ratio (RFR)
时间窗: During Cardiac Cath
Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR
时间窗: During Cardiac Cath
Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR
时间窗: During Cardiac Cath
Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by dPR
时间窗: During Cardiac Cath
Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by dPR ≤0.89
Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR
时间窗: During Cardiac Cath
Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89
Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR
时间窗: During Cardiac Cath
Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80
Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by iFR
时间窗: During Cardiac Cath
Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by iFR ≤0.89
Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR
时间窗: During Cardiac Cath
Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89
次要结局
- Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR(During Cardiac Cath)
- Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR(During Cardiac Cath)
- Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR(During Cardiac Cath)
- Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR(During Cardiac Cath)
- Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR(During Cardiac Cath)
- Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR(During Cardiac Cath)
- Linear correlation between percent diameter stenosis and FFR(During Cardiac Cath)
- Linear correlation between percent diameter stenosis and dPR(During Cardiac Cath)
- Linear correlation between percent diameter stenosis and RFR(During Cardiac Cath)
- Linear correlation between minimal lumen diameter and FFR(During Cardiac Cath)
- Linear correlation between minimal lumen diameter and dPR(During Cardiac Cath)
- Linear correlation between minimal lumen area and FFR(During Cardiac Cath)
- Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR(During Cardiac Cath)
- Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR(During Cardiac Cath)
- Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR(During Cardiac Cath)
- Linear correlation between minimal lumen area and iFR(During Cardiac Cath)
- Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR(During Cardiac Cath)
- Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR(During Cardiac Cath)
- Linear correlation between plaque burden and RFR(During Cardiac Cath)
- Discriminatory function of percent diameter stenosis to predict functional significance assessed by FFR(During Cardiac Cath)
- Discriminatory function of percent diameter stenosis to predict functional significance assessed by dPR(During Cardiac Cath)
- Discriminatory function of minimal lumen diameter to predict functional significance assessed by dPR(During Cardiac Cath)
- Discriminatory function of minimal lumen diameter to predict functional significance assessed by RFR(During Cardiac Cath)
- Discriminatory function of plaque burden to predict functional significance assessed by dPR(During Cardiac Cath)
- Discriminatory function of plaque burden to predict functional significance assessed by RFR(During Cardiac Cath)
- Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR(During Cardiac Cath)
- Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR(During Cardiac Cath)
- Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR(During Cardiac Cath)
- Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR(During Cardiac Cath)
- Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR(During Cardiac Cath)
- Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR(During Cardiac Cath)
- Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR(During Cardiac Cath)
- Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR(During Cardiac Cath)
- Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR(During Cardiac Cath)
- Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR(During Cardiac Cath)
- Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR(During Cardiac Cath)
- Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR(During Cardiac Cath)
- Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR(During Cardiac Cath)
- Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR(During Cardiac Cath)
- Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR(During Cardiac Cath)
- Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR(During Cardiac Cath)
- Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR(During Cardiac Cath)
- Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR(During Cardiac Cath)
- Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR(During Cardiac Cath)
- Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR(During Cardiac Cath)
- Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR(During Cardiac Cath)
- Linear correlation between percent diameter stenosis and iFR(During Cardiac Cath)
- Linear correlation between plaque burden and FFR(During Cardiac Cath)
- Linear correlation between plaque burden and iFR(During Cardiac Cath)
- Discriminatory function of percent diameter stenosis to predict functional significance assessed by iFR(During Cardiac Cath)
- Discriminatory function of minimal lumen diameter to predict functional significance assessed by iFR(During Cardiac Cath)
- Discriminatory function of minimal lumen area to predict functional significance assessed by FFR(During Cardiac Cath)
- Discriminatory function of percent diameter stenosis to predict functional significance assessed by RFR(During Cardiac Cath)
- Linear correlation between minimal lumen diameter and iFR(During Cardiac Cath)
- Linear correlation between minimal lumen diameter and RFR(During Cardiac Cath)
- Linear correlation between plaque burden and dPR(During Cardiac Cath)
- Discriminatory function of minimal lumen diameter to predict functional significance assessed by FFR(During Cardiac Cath)
- Discriminatory function of minimal lumen area to predict functional significance assessed by iFR(During Cardiac Cath)
- Discriminatory function of minimal lumen area to predict functional significance assessed by dPR(During Cardiac Cath)
- Discriminatory function of minimal lumen area to predict functional significance assessed by RFR(During Cardiac Cath)
- Linear correlation between minimal lumen area and dPR(During Cardiac Cath)
- Linear correlation between minimal lumen area and RFR(During Cardiac Cath)
- Discriminatory function of plaque burden to predict functional significance assessed by FFR(During Cardiac Cath)
- Discriminatory function of plaque burden to predict functional significance assessed by iFR(During Cardiac Cath)
研究者
Bon-Kwon Koo
Professor
Seoul National University Hospital