Severe Aortic Stenosis
Conditions
Brief summary
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.
Detailed description
Patients with severe aortic stenosis (AS) frequently have concomitant coronary artery disease (CAD), which complicates pre-operative evaluation and clinical decision-making for transcatheter (TAVR) or surgical aortic valve replacement (SAVR). Although coronary computed tomography angiography (CCTA) provides excellent anatomical evaluation and has become a standard pre-AVR workflow, it is insufficient for determining the functional and hemodynamic significance of coronary lesions. CT-derived fractional flow reserve (CT-FFR) offers a novel, non-invasive method to evaluate the ischemic burden. The objective of this prospective, single-center, randomized, parallel-controlled trial is to determine whether a "functional + anatomical" assessment strategy using CT-FFR provides incremental value over an "anatomical-only" strategy. A total of 300 eligible patients with severe AS planned for AVR will be randomized in a 1:1 ratio into two groups: 1. Experimental Group (CCTA + CT-FFR): The Heart Team will formulate the revascularization strategy (e.g., concomitant or staged PCI/CABG) based on both CCTA anatomical stenosis and CT-FFR physiological data (using a threshold of CT-FFR ≤0.80 to define hemodynamically significant ischemia). 2. Active Comparator Group (CCTA alone): The Heart Team will formulate the revascularization strategy based solely on CCTA anatomical grading according to the CAD-RADS classification. All participants will be followed for 365 days post-AVR. The primary endpoint is a patient-oriented composite of major adverse cardiovascular events (MACE, including 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. The study hypothesizes that incorporating CT-FFR into routine pre-AVR evaluation will optimize concomitant revascularization decisions, avoid unnecessary invasive procedures, and ultimately reduce the risk of post-operative adverse events.
Interventions
OTHERCCTA plus CT-FFR-informed preoperative decision strategy
Preoperative 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.
OTHERCCTA-guided preoperative decision strategy
CCTA 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.
Sponsors
Yan'an Affiliated Hospital of Kunming Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to treatment allocation. Participants and treating clinicians will not be blinded because CT-FFR results are used for preoperative decision-making in the intervention arm. Unblinding will occur after completion of 1-year follow-up and database lock.
Intervention model description
Participants with severe aortic stenosis scheduled for aortic valve replacement will be randomized 1:1 to a CCTA+CT-FFR-guided preoperative decision strategy or a CCTA-only preoperative decision strategy and followed for 365 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years. 2. 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 \[or indexed aortic valve area (AVAi) ≤0.6 cm²/m²\]. 3. New York Heart Association (NYHA) functional class II or higher. 4. Eligible for both transfemoral transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). 5. Undergoing preoperative coronary computed tomography angiography (CCTA). 6. Willing to participate in the study and able to provide written informed consent.
Exclusion criteria
1. Allergy to prosthetic valve materials or iodinated contrast agents. 2. Contraindication or allergic reaction to anticoagulants or antiplatelet agents, or inability to tolerate required anticoagulant or antiplatelet therapy. 3. Active infective endocarditis or any other active infection. 4. Severe vascular disease precluding safe implantation of a prosthetic valve. 5. Ascending aortic diameter ≥50 mm. 6. Prior prosthetic valve implantation in any cardiac position or prior coronary artery bypass grafting (CABG). 7. Preoperative imaging confirming aortic root anatomy unsuitable for transcatheter aortic valve implantation. 8. Intracardiac mass, left ventricular or left atrial thrombus, or vegetation confirmed by preoperative echocardiography. 9. Acute myocardial infarction within 30 days before surgery. 10. Clinically diagnosed stroke or transient ischemic attack within 3 months before surgery. 11. Bleeding or coagulation disorders within 3 months before surgery that required hospitalization or blood transfusion or were otherwise clinically significant and would preclude the antiplatelet therapy required in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events (MACE) | At 1 year (365 days) post-AVR | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of All-Cause Mortality at 1 Year | At 1 year (365 days) post-AVR | 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 | At 30 days post-AVR | 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 | At 1 year (365 days) post-AVR | 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 | At 30 days post-AVR | 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 . |
Countries
China
Contacts
CONTACTXirui Duan
PRINCIPAL_INVESTIGATORChengde Liao
Yan'an Affiliated Hospital of Kunming Medical University
Outcome results
None listed