International Collaboration of Comprehensive Physiologic Assessment

Study Overview
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Brief Summary
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The current study evaluated prognostic implication of comprehensive physiologic assessment using fractional flow reserve, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR).

Detailed Description
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The patient-level data was gathered from 3 nations (Korea, Japan, Spain). The total 1397 patients (1694 vessels) data was collected from 5 university hospitals in Korea (Seoul National University Hospital, Samsung Medical Centre, Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Centre, and Ulsan University Hospital, Korea) and Tsuchiura Kyodo General Hospital, Ibaraki, Japan, and Hospital Clinico San Carlos, Madrid, Spain. Standardized form of data collection sheet was used and all study adopted standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data. In case of acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction), only non-culprit vessel was included in the data. Primary outcome is patient- and vessel-oriented composite outcome at 5 years.

Official Title
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International Patient-level Pooled Analysis of Comprehensive Physiologic Assessment: Collaborating Project of Korea, Japan, and Spain

Conditions
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Stable Angina, Unstable Angina, Non-ST Elevation Myocardial Infarction, ST-segment Elevation Myocardial Infarction

Intervention / Treatment
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* Diagnostic Test: Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - patients who underwent clinically indicated invasive coronary angiography and measurements of FFR, CFR, and IMR for at least 1 coronary artery Exclusion Criteria: Patients with hemodynamic instability left ventricular dysfunction culprit vessel of acute coronary syndrome

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient and Vessels underwent physiologic evaluation<br>The total 1397 patients (1694 vessels) which evaluated using pressure-temperature sensor wire and measured FFR, CFR, and IMR. | Diagnostic Test: Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance<br>* The pressure sensor was positioned at the distal segment of a target vessel, and intracoronary nitrate was administered before each physiologic measurement. To derive resting mean transit time (Tmn), a thermodilution curve was obtained by using 3 injections (3-4 mL each) of room-temperature saline. Hyperemic proximal aortic pressure (Pa), distal arterial pressure (Pd), and hyperemic Tmn were measured during sustained hyperemia. CFR was calculated as resting Tmn/hyperemic Tmn. FFR was calculated as the lowest average of 3 consecutive beats during hyperemia. The uncorrected IMR was calculated by Pd × Tmn during hyperaemia. All IMR values were corrected by Yong's formula (Pa × Tmn × ([1.35 × Pd/Pa] - 0.32).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization | Patient-oriented composite outcome | 5 year | 
| Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization | Vessel-oriented composite outcome | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of any death | all-cause mortality | 5 year | 
| Cumulative incidence of cardiac death | cardiac death | 5 year | 
| Cumulative incidence of myocardial infarction | MI was defined as elevated cardiac enzyme levels greater than the upper limit of the normal range with either ischemic symptoms or electrocardiography changes indicating ischemia after index procedure. Periprocedural MI was not included as a clinical outcome | 5 year | 
| Cumulative incidence of ischemia-driven revascularization | Ischemia-driven revascularization was defined as a revascularization procedure with at least one of the following: (1) recurrence of angina; (2) positive non-invasive test; and (3) positive invasive physiologic test | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fractional flow reserve, myocardial ischemia, coronary artery disease, coronary flow reserve, index of microcirculatory resistance, prognosis, percutaneous coronary intervention