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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Tsuchiura Kyodo General Hospital | OTHER |
| Hospital San Carlos, Madrid | OTHER |
| Imperial College Healthcare NHS Trust |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient and Vessels underwent physiologic evaluation | The total 1397 patients (1694 vessels) which evaluated using pressure-temperature sensor wire and measured FFR, CFR, and IMR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance | Diagnostic Test | 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). |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of any death | all-cause mortality | 5 year |
| Cumulative incidence of cardiac death | cardiac death | 5 year |
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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:
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patients who underwent clinically indicated invasive coronary angiography and measurements of FFR, CFR, and IMR for at least 1 coronary artery
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| Name | Affiliation | Role |
|---|---|---|
| Bon-Kwon Koo, MD, PhD | Seoul National University Hospital | Study Chair |
| Javier Escaned, MD, PhD | Hospital Clinico San Carlos, Madrid, Spain | Study Chair |
| Tsunekazu Kakuta, MD, PhD | Tokyo Medical and Dental University, Tokyo, Japan | Study Chair |
| Joo Myung Lee, MD, MPH, PhD | Samsung Medical Center, Seoul, Korea | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Medical and Dental University | Tokyo | Japan | ||||
| Samsung Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33911143 | Derived | Shin D, Lee JM, Lee SH, Hwang D, Choi KH, Kim HK, Doh JH, Nam CW, Shin ES, Hoshino M, Murai T, Yonetsu T, Mejia-Renteria H, Kakuta T, Escaned J, Koo BK. Non-randomized comparison between revascularization and deferral for intermediate coronary stenosis with abnormal fractional flow reserve and preserved coronary flow reserve. Sci Rep. 2021 Apr 28;11(1):9126. doi: 10.1038/s41598-021-88732-4. | |
| 32725991 |
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Anonymized patient level data will be made available by the corresponding author for reasonable requests. Consent was not obtained for data sharing but the presented data are anonymized and risk of identification is minimal.
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| OTHER |
| Tokyo Medical and Dental University | OTHER |
| Sungkyunkwan University | OTHER |
| Inje University | OTHER |
| Keimyung University Dongsan Medical Center | OTHER |
| Ulsan University Hospital | OTHER |
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|
| 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 |
| Seoul |
| South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Hospital Clinico San Carlos, Madrid, Spain | Madrid | Spain |
| Derived |
| Lee JM, Choi KH, Doh JH, Nam CW, Shin ES, Hoshino M, Murai T, Yonetsu T, Mejia-Renteria H, Kakuta T, Escaned J, Koo BK. Long-term Patient Prognostication by Coronary Flow Reserve and Index of Microcirculatory Resistance: International Registry of Comprehensive Physiologic Assessment. Korean Circ J. 2020 Oct;50(10):890-903. doi: 10.4070/kcj.2020.0083. Epub 2020 May 27. |
| 32624458 | Derived | Hamaya R, Lee JM, Hoshino M, Yonetsu T, Koo BK, Escaned J, Kakuta T; Collaborators. Clinical outcomes of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention By Coronary Flow Capacity Status in Stable Lesions. EuroIntervention. 2021 Jul 20;17(4):e301-e308. doi: 10.4244/EIJ-D-20-00401. |
| 32506182 | Derived | Hamaya R, Hoshino M, Yonetsu T, Lee JM, Koo BK, Escaned J, Kakuta T. Defining heterogeneity of epicardial functional stenosis with low coronary flow reserve by unsupervised machine learning. Heart Vessels. 2020 Nov;35(11):1527-1536. doi: 10.1007/s00380-020-01640-x. Epub 2020 Jun 6. |
| 32306809 | Derived | Lee SH, Lee JM, Park J, Choi KH, Hwang D, Doh JH, Nam CW, Shin ES, Hoshino M, Murai T, Yonetsu T, Mejia-Renteria H, Kakuta T, Escaned J; International Collaboration of Comprehensive Physiologic Assessment Investigators. Prognostic Implications of Resistive Reserve Ratio in Patients With Coronary Artery Disease. J Am Heart Assoc. 2020 Apr 21;9(8):e015846. doi: 10.1161/JAHA.119.015846. Epub 2020 Apr 18. |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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