clinical outcomes of ct-ffr versus qfr-guided strategy for decision-making in patients with stable chest pain

Conditions: Angina, Stable; Coronary Artery Disease

Summary: this study is a multicenter, prospective, blinded (blinding of clinical evaluators), randomized controlled, event-driven non-inferiority clinical trial. eligible subjects who meet the inclusion criteria will be registered in the central randomization system and randomized in a 1:1 ratio to either the experimental group (ct-ffr guided group) or the control group (qfr guided group).

this study is a multicenter, prospective, blinded, randomized controlled trial with event-driven non-inferiority design (blinding of clinical evaluators). a total of 4,648 participants will be recruited and randomly assigned to the ct-ffr guided group or the qfr guided group in a 1:1 ratio. patients in the experimental group (ct-ffr guided group) will undergo three-dimensional reconstruction of coronary arteries and ct-ffr calculation using coronary ct angiography (ccta) images and the ruixin-ffr software. the ct-ffr results will be interpreted and analyzed by the researchers. if the ct-ffr value is \>0.8, patients will receive medical therapy only, while if the ct-ffr value is ≤0.8, patients will undergo further coronary angiography to determine the appropriate treatment strategy (pci, cabg, or medical therapy), based on the anatomical features of the lesion and ct-ffr results. patients in the control group (qfr guided group) will undergo invasive coronary angiography (ica) and qfr calculation based on ica images. if the qfr value is ≤0.8 and the lesion is suitable for intervention, patients will receive pci, while if the qfr value is \>0.8, medical therapy will be recommended. both groups will be followed up for clinical outcomes, health economics indicators, and quality of life at 1 month, 6 months, 1 year, 2 years, and 3 years. the occurrence of major adverse cardiovascular events (mace) will be compared between the two groups. the study will also assess the effectiveness, safety, and economic value of ct-ffr in guiding diagnosis and treatment decisions for patients with stable angina, using qfr guided pci as a control, with a non-inferiority comparison.

Eligibility criteria:
inclusion criteria: * age ≥18 years * with stable chest pain who underwent ccta and have at least 1 lesion with a percent diameter stenosis (ds%) between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment.these patients plan to undergo further non-invasive or invasive diagnosis and treatment. * able to undergo invasive coronary angiography (ica) * capable of complying with the study procedures and fully understand the informed consent form approved by the ethics committee, and provide voluntary consent. exclusion criteria: general exclusion criteria: * patients with acute coronary syndrome requiring urgent revascularization. * patients with unstable angina, including those with first-onset chest pain within 48 hours, ccs iii or higher first-onset angina, those whose angina has worsened to ccs iii or iv within a short period of time, or those with rest angina lasting more than 20 minutes. * patients with iodine contrast agent allergy. * pregnant or lactating women. * patients with severe congestive heart failure (nyha iii-iv or lvef \<30%) or acute pulmonary edema. * patients with severe renal insufficiency (creatinine \>150μmol/l or estimated - -glomerular filtration rate calculated by the cockcroft-gault formula \<45ml/kg/1.73 m2). * patients with other comorbidities and an expected survival time of less than 1 year. * patients who, for any other reason, are considered by the investigators to be unsuitable for inclusion in the study or unable to complete the study and follow-up. coronary cta and coronary angiography exclusion criteria: * patients with a body mass index \>35 when undergoing coronary ct testing, resulting in poor ct image quality due to motion artifacts, severe calcification, or inadequate iodine contrast agent filling. * patients with a history of coronary artery bypass grafting (cabg). * target lesions related to acute myocardial infarction. * target lesions involving left main stem disease. * target lesions involving myocardial bridging. * target lesions involving in-stent restenosis. * low-quality angiography due to poor visualization of vascular boundaries or poor iodine contrast agent filling. * excessive overlap of the stenotic segment or severe tortuosity of the target vessel, making qfr calculation impossible. regen