Coronary Artery Disease
Conditions
Keywords
CT-derived fractional flow reserve, Angiography-derived quantitative flow ratio
Brief summary
This is a multi-center, randomized controlled trial to compare the clinical outcomes between CT-derived fractional flow reserve (CT-FFR) guided strategy and angiography-derived quantitative flow ratio (QFR) guided strategy among patients with coronary artery disease (CAD). Participants who have at least one coronary stenosis of 70%-90% (vessel diameter ≥2.5 mm) detected by coronary CT angiography will be enrolled and are randomly assigned in a 1:1 ratio to CT-FFR guided group or QFR guided group. In CT-FFR group, the decisions of invasive angiography and revascularization will be guided by CT-FFR. In QFR group, the decision of invasive angiography will be made as usual care, and revascularization will be guided by QFR. The primary endpoint is the 1-year incidence of major adverse cardiac events (MACEs), including death, myocardial infarction, and unplanned revascularization.
Interventions
DIAGNOSTIC_TESTCT-FFR guided strategy
Patients in this group will undergo CT-derived fractional flow reserve (CT-FFR) analysis. If the CT-FFR value is ≤0.80, patients will subsequently undergo invasive coronary angiography (ICA) and receive coronary revascularization. If the CT-FFR values of all vessels are \>0.80, patients will not undergo invasive angiography.
DIAGNOSTIC_TESTQFR guided strategy
Patients in this group will undergo invasive coronary angiography (ICA) according to routine clinical indications. During the procedure, quantitative flow ratio (QFR) analysis will be performed. If the QFR value is ≤0.80, coronary revascularization will be performed. If the QFR value is \>0.80, coronary revascularization will be forwent.
Sponsors
China National Center for Cardiovascular Diseases
Fuwai Yunnan Cardiovascular Hospital
Central China Fuwai Hospital of Zhengzhou University
Shenzhen Sun Yat-sen Cardiovascular Hospital
Ruijin Hospital
Nanjing First Hospital, Nanjing Medical University
The First Affiliated Hospital with Nanjing Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The First Affiliated Hospital of Dalian Medical University
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient-level inclusion criteria: 1. Adults aged ≥18 years. 2. Patients with stable angina, unstable angina, or post-myocardial infarction ≥72 hours. 3. Patients are able and willing to provide written informed consent. Lesion-level inclusion criteria: (1) Coronary CT angiography (CCTA) shows at least one coronary artery with 70%-90% diameter stenosis and vessel diameter ≥2.5 mm. Patient-level
Exclusion criteria
1. Previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). 2. Suspected acute myocardial infarction (ECG or biomarkers indicating acute phase). 3. Moderate to severe chronic kidney disease, defined as serum creatinine \>150 μmol/L or estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m². 4. Severe valvular heart disease, aortic disease, or large ventricular aneurysm requiring surgery. 5. Atrial fibrillation or other severe cardiac arrhythmias. 6. Refusal or inability to sign informed consent. Lesion-level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Major Adverse Cardiac Events (MACEs) within 12 Months Post-Procedure | 12 Months Post-Procedural Follow-Up | MACEs is defined as a composite of all-cause death, myocardial infarction, and unplanned revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death | 12 Months After Randomization | Death from any cause during the follow-up period. |
| Cardiac death | 12 Months After Randomization | Death due to myocardial infarction, heart failure, or other cardiac causes. |
| Myocardial infarction (MI) | 12 Months After Randomization | Defined according to the Fourth Universal Definition of Myocardial Infarction. |
| Repeat revascularization | 12 Months After Randomization | Any planned or unplanned revascularization of the target vessel or graft. |
| Rehospitalization | 12 Months After Randomization | Any hospital readmission for cardiac causes, recurrent angina, or other medical reasons. |
| Rate of invasive coronary angiography avoidance | 12 Months After Randomization | The proportion of patients who avoided invasive coronary angiography after CT-FFR-based evaluation without adverse clinical outcomes. |
| Revascularization rate | 12 Months After Randomization | The proportion of patients undergoing any coronary revascularization (PCI or CABG). |
| Number of stents implanted or bypass grafts performed | 12 Months After Randomization | to assess procedural extent and resource utilization |
| Rate of optimal medical therapy | 12 Months After Randomization | The proportion of patients treated conservatively without revascularization. |
| PCI rate | 12 Months After Randomization | The proportion of patients receiving percutaneous coronary intervention. |
| CABG rate | 12 Months After Randomization | The proportion of patients undergoing coronary artery bypass grafting. |
| Total cost | 12 Months After Randomization | Including outpatient and inpatient diagnostic and treatment expenses, index hospitalization cost. |
Contacts
CONTACTZhe Zheng, MD, PhD
Outcome results
None listed