Severe aortic stenosis (AS) is often accompanied by coronary artery disease (CAD). While coronary computed tomography angiography (CCTA) is routinely used before aortic valve replacement (AVR) to evaluate coronary anatomy, it lacks physiological assessment of myocardial ischemia.
This prospective, single-center, randomized controlled trial aims to evaluate whether integrating functional assessment using CT-derived fractional flow reserve (CT-FFR) with CCTA can optimize revascularization decision-making and improve clinical outcomes. A total of 300 severe AS patients scheduled for transcatheter or surgical AVR will be randomly assigned to either the experimental group (revascularization decisions guided by both CCTA and CT-FFR) or the control group (decisions guided by CCTA alone). Participants will be followed up for 1 year to assess major adverse cardiovascular events and other clinical outcomes.
Age >18 years.
Severe aortic stenosis confirmed by echocardiography, defined as peak aortic jet velocity (Vmax) ≥4.0 m/s, mean transvalvular gradient ≥40 mmHg, or aortic valve area (AVA) ≤1.0 cm² [or indexed aortic valve area (AVAi) ≤0.6 cm²/m²].
New York Heart Association (NYHA) functional class II or higher.
Eligible for both transfemoral transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).
Allergy to prosthetic valve materials or iodinated contrast agents.
Contraindication or allergic reaction to anticoagulants or antiplatelet agents, or inability to tolerate required anticoagulant or antiplatelet therapy.
Active infective endocarditis or any other active infection.
Severe vascular disease precluding safe implantation of a prosthetic valve.
Parallel
CCTA plus CT-FFR-informed preoperative decision strategy
Other interventionPreoperative coronary evaluation and revascularization decision-making before aortic valve replacement are based on combined CCTA anatomical assessment and CT-FFR functional assessment. When anatomical and functional assessments are concordant, both are considered in treatment planning. When anatomical and functional assessments are discordant, the CT-FFR functional result serves as the primary basis for revascularization decision-making.
CCTA-guided preoperative decision strategy
Other interventionCCTA is performed as the standardized preoperative anatomic coronary assessment in patients with severe aortic stenosis scheduled for aortic valve replacement. Coronary stenosis is evaluated by 2 experienced radiologists using the 18-segment coronary model, visual diameter stenosis assessment, and CAD-RADS 2.0 classification. In the control strategy, coronary evaluation and revascularization planning are based on CCTA anatomic findings alone.
Major Adverse Cardiovascular Events (MACE)
The primary endpoint is a cardiovascular-focused composite including major adverse cardiovascular events (MACE, defined as cardiac death, nonfatal myocardial infarction, unstable angina, heart failure admission, clinically-driven target vessel revascularization, or valve re-intervention). This outcome will be reported as the percentage of participants experiencing at least one of these events.
Incidence of All-Cause Mortality at 1 Year
The rate of death from any cause, including both cardiac and non-cardiac deaths. Reported as the percentage of participants.
Incidence of All-Cause Mortality at 30 Days
The rate of early death from any cause (cardiac and non-cardiac). Reported as the percentage of participants.
Incidence of Patient-Oriented Composite Endpoint at 1 Year
The composite of MACE (nonfatal myocardial infarction, unstable angina, cardiac death, or heart failure admission), disabling stroke, clinically-driven target vessel revascularization, valve re-intervention, and life-threatening or disabling bleeding occurring within the early post-operative period.
Incidence of Patient-Oriented Composite Endpoint at 30 Days
The composite of MACE (nonfatal myocardial infarction, unstable angina, cardiac death, or heart failure admission), disabling stroke, clinically-driven target vessel revascularization, valve re-intervention, and life-threatening or disabling bleeding occurring within the early post-operative period .
Exploratory Outcome: Rate of Concomitant or Staged Coronary Revascularization
An exploratory procedural endpoint defined as the proportion of patients who undergo percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) concomitantly at the time of aortic valve replacement (AVR), and/or staged PCI/CABG performed within 30 days prior to AVR. This endpoint is included to capture the clinical decision-making pathway and the real-world impact of the preoperative assessment strategy. Reported as the percentage of participants.
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