Non-ST Elevation Myocardial Infarction, Stable Angina, ST-segment Elevation Myocardial Infarction, Unstable Angina
Conditions
Keywords
fractional flow reserve, myocardial ischemia, coronary artery disease, coronary flow reserve, index of microcirculatory resistance, prognosis, percutaneous coronary intervention
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTFractional flow reserve, coronary flow reserve, and index of microcirculatory resistance
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).
Sponsors
Samsung Medical Center
Tsuchiura Kyodo General Hospital
Hospital San Carlos, Madrid
Imperial College Healthcare NHS Trust
Tokyo Medical and Dental University
Sungkyunkwan University
Inje University
Keimyung University Dongsan Medical Center
Ulsan University Hospital
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization | 5 year | Patient-oriented composite outcome |
| Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization | 5 year | Vessel-oriented composite outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of any death | 5 year | all-cause mortality |
| Cumulative incidence of cardiac death | 5 year | cardiac death |
| Cumulative incidence of myocardial infarction | 5 year | 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 |
| Cumulative incidence of ischemia-driven revascularization | 5 year | 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 |
Countries
Japan, South Korea, Spain
Outcome results
None listed