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.
Study Type
OBSERVATIONAL
Enrollment
1,397
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).
Tokyo Medical and Dental University
Tokyo, Japan
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Hospital Clinico San Carlos, Madrid, Spain
Madrid, Spain
Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization
Patient-oriented composite outcome
Time frame: 5 year
Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization
Vessel-oriented composite outcome
Time frame: 5 year
Cumulative incidence of any death
all-cause mortality
Time frame: 5 year
Cumulative incidence of cardiac death
cardiac death
Time frame: 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
Time frame: 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
Time frame: 5 year
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