Clinical trial NCT06075160: Resting Full-cycle Ratio (RFR)-Guided Revascularization
Official title: Prospective Evaluation of Long-term Clinical Outcomes After Resting Full-cycle Ratio (RFR)-Guided Percutaneous Coronary Revascularization; A Multi-center, International, Single Arm Interventional, Comparing Registry (COMFORT Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: physiologic assessment
intermediate stenosis
Lead sponsor: Sejong General Hospital
Sponsor class: OTHER
Collaborators: name: Wonju Severance Christian Hospital
name: Hospital San Carlos, Madrid
name: Seoul St. Mary's Hospital
name: Dong-A University Hospital
name: Gyeongsang National University Hospital
name: Soon Chun Hyang University
name: Keimyung University Dongsan Medical Center
name: Ulsan University Hospital
name: Seoul National University Bundang Hospital
name: Kosin University Gospel Hospital
name: Pusan National University Hospital
First posted: 2023-10-10
Enrollment: 1167
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intermediate coronary artery stenosis, who need functional evaluation

Brief summary: The purpose of this study is to compare the clinical outcomes of a 2-year follow-up to determine whether RFR-guided coronary intervention is non-inferior to FFR-guided coronary intervention in patients with intermediate coronary stenosis.

Detailed description: Myocardial ischemia is a key determinant of clinical prognosis in patients with coronary artery disease. In this regard, functional assessment of intermediate coronary stenoses with transtenotic pressure ratios provides a more accurate measure of stenosis-derived myocardial ischemia in comparison to conventional coronary angiography (3-5). One of the major clinical benefit of fractional flow reserve (FFR) is that, by acting as a gatekeeper, non-ischemia-causing lesions suitable for optimal medical treatment can be accurately identified, avoiding unnecessary coronary stenting. However, despite being support with the highest level of recommendation by the current guidelines for guiding clinical-decision making, adoption of FFR in the real world practice is still very low, mainly due to the need of hyperemic agents like adenosine that frequently cause patient discomfort, and time consumption. To overcome such limitations of pressure-wire derived index from the need of adenosine, other alternatives have been looking for over the last years. Instantaneous wave-free ratio (iFR), a resting trans-stenotic pressure index obtained as the ratio of distal coronary pressure to aortic pressure during the diastolic wave-free period, demonstrated a good diagnostic accuracy to define functional significance of coronary lesions without need of adenosine, using FFR as reference. Recently, two large, randomized trials demonstrated that iFR-guided coronary revascularization is clinically non-inferior to FFR-guided revascularization with respect to one-year risk of major adverse cardiac events. Accordingly, like FFR, iFR is now receiving the highest level of recommendations to guide clinical decision making in patients with stable intermediate coronary stenosis. A new adenosine-free index, the resting full-cycle ratio (RFR), has recently emerged. RFR is defined as the lowest ratio of intracoronary distal pressure to aortic pressure under resting condition, irrespective of systole or diastole, and has demonstrated equivalent diagnostic performance to iFR. RFR has an advantage over iFR, because it is not limited by sensitive land marking of components of the pressure waveform unlike iFR.

This novel physiologic index without the need of adenosine has the potential to increase the worldwide adoption of coronary physiology in guiding coronary revascularization in daily clinical practice. However, there is a paucity of important data regarding clinical outcomes of RFR-guided revascularization strategy. We hypothesize long-term clinical outcome of RFR-guided revascularization is non-inferior to that of FFR-guided revascularization, and it reduce the rate of PCI than FFR-guided revascularization. Therefore, we sought to investigate the long-term effectiveness and safety of RFR-based decision making in patients with one or more intermediate coronary stenosis, and to assess whether it is non-inferior to FFR-guided revascularization.

Eligibility criteria: Inclusion Criteria:

* Patients with intermediate coronary artery stenosis (visually 50-90% diameter stenosis) who decided to undergoing a RFR-guided coronary intervention according to clinical necessity
* Patients who voluntarily decided to participate in this study and signed informed consent

Exclusion Criteria:

* Severe left ventricular systolic dysfunction (LVEF \<30%)
* Cardiogenic shock
* Culprit vessel in acute coronary syndrome
* Donor vessel to supply chronic total occlusion lesion of non-target vessel
* Symptomatic valvular heart disease or cardiomyopathy
* Hemodynamic instability at the time of intervention (heart rate \<50 beats per minute, systolic blood pressure \<90mmHg)
* Previous CABG with patent grafts to the interrogated vessel
* Pregnancy or breastfeeding
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance

Primary outcomes:
measure: A composite of death from any cause, non-fatal myocardial infarction, or unplanned revascularization
timeFrame: At 2-year
Secondary outcomes:
measure: Target lesion failure
timeFrame: At 2-year
measure: Target vessel failure
timeFrame: At 2-year
measure: Death from any cause
timeFrame: At 2-year
measure: Cardiovascular death
timeFrame: At 2-year
measure: Cardiac death or non-fatal MI
timeFrame: At 2-year
measure: Non-fatal MI
timeFrame: At 2-year
measure: Any unplanned revascularization
timeFrame: At 2-year
measure: Target vessel revascularization
timeFrame: At 2-year
measure: Target lesion revascularization
timeFrame: At 2-year
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
state: Gyeonggi-do
Study officials:
References: