Diastolic Hyperemia-Free Ratio in Patients With CAD (ICE-HEAT)

Yonsei University

Status: Completed

Conditions: Coronary Artery Disease; Coronary Stenosis

Treatments: Diagnostic Test: diastolic hyperemia-free ratio (DFR)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05421169

9-2022-0047

Details and patient eligibility

About

The investigators aimed to identify the value of concordance between the diastolic hyperemia-free ratio (DFR) and fractional flow reserve (FFR) during pre-interventional and post-interventional period using a 0.014" COMET II Pressure Guidewire

Full description

The physiologic assessment of coronary artery disease and ischemia-guided percutaneous coronary intervention (PCI) has become a standard practice for patients with coronary artery disease. Fractional flow reserve (FFR) represents hyperemic flow limitation caused by an epicardial coronary stenosis and its clinical usefulness has been proven by many clinical studies. However, the FFR is limited to clinical use despite the fact that it is recommended by the guideline due to the inconvenience of patients using medications used to induce maximum hyperemia, and the need for additional procedure time. Recently, a physiologic index which does not require hyperemia, instantaneous wave free ratio (iFR), was introduced and recent trials showed non-inferiority of iFR-guided strategy for 1-year clinical outcome, compared with FFR-guided strategy. Recently, not only iFR but also various intravascular pressure measurement techniques have been developed, one of which is diastolic hyperemia-free ratio (DFR). DFR uses the mean Pd/Pa calculated over the period in diastole defined as that during which arterial pressure is negatively sloped and below the mean arterial pressure. DFR showed equivalence as compared to gold standard FFR in the discrimination of non-culprit lesions requiring revascularization in patients with NSTEMI. In the case of DFR, there is no issue in terms of safety because it is conducted in the same way as iFR, but there are not many studies on the validation between DFR and FFR. Therefore, the present study aimed to identify the quality of concordance between DFR and FFR, determine the features associated with discrepancies in DFR and FFR.

Enrollment: 300 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients, ≥ 19 years of age, who are diagnosed with stable angina pectoris including silent ischemic heart disease and 50~90% stenosis of the coronary artery.
• Acute coronary syndrome patients with multivessel disease who have 50~90% stenosis of a non-culprit vessel on coronary angiography.

Exclusion criteria

• Patients with acute coronary syndrome and single vessel disease.
• Patients with hypersensitivity or contraindication to antiplatelet treatment.
• Female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
• Patients with a life expectancy shorter than 1 year.