FAST III Trial Shows Non-Invasive vFFR Technology Matches Gold Standard FFR for Coronary Revascularization Guidance
核心洞察
The FAST III trial demonstrated that vessel fractional flow reserve (搜索) (vFFR) guided revascularization was non-inferior to traditional pressure wire-based FFR in 2,211 patients with intermediate coronary lesions (搜索) across 37 European centers.
Both treatment groups showed identical 7.5% rates of major adverse cardiac events at one year, with vFFR offering procedural advantages including shorter procedure times and fewer complications.
The angiography-based vFFR technology eliminates the need for pressure wires and hyperemic agents, potentially expanding access to physiologic lesion assessment while maintaining safety and efficacy.
The FAST III trial has demonstrated that vessel fractional flow reserve (搜索) (vFFR)-guided revascularization achieves outcomes comparable to the current gold standard pressure wire-based fractional flow reserve (搜索) (FFR) in patients with intermediate coronary lesions (搜索). The landmark study, presented at the American College of Cardiology Congress 2026 and simultaneously published in the New England Journal of Medicine, validates angiography-based physiology as a safe and effective alternative for guiding coronary interventions.
Trial Design and Patient Population
The investigator-initiated, open-label, multicenter randomized trial enrolled 2,211 patients across 37 sites in seven European countries. Patients had either acute (19%) or chronic coronary syndromes (搜索) (81%) with intermediate coronary lesions (搜索) defined as 30-80% diameter stenosis. The study population had a mean age of 67 years, with 24% being women. Comorbidities were common, including diabetes (搜索) in 27%, hypertension (搜索) in 72%, dyslipidemia (搜索) in 71%, prior myocardial infarction (搜索) in 23%, and prior revascularization in 35%.
Participants were randomized to either vFFR-guided revascularization (n=1,116) or FFR-guided revascularization (n=1,095). The mean number of lesions was similar between groups at 1.27 and 1.28, respectively. Complete physiological assessment was successful in 97% of the vFFR group and 99% of the FFR group, with revascularization performed in 45% and 36% of patients, respectively.
Primary Endpoint Achievement
The trial met its primary endpoint, demonstrating non-inferiority of vFFR to FFR. At one year, 7.5% of patients in both groups experienced the primary composite endpoint of all-cause death, any myocardial infarction (搜索), or any revascularization. The risk difference was −0.02 percentage points, well within the prespecified noninferiority margin of 3.0 percentage points (p=0.004).
For the key secondary endpoint of study-vessel failure examined by vFFR or FFR—a composite of cardiac death, MI, or any revascularization—the incidence remained similar at 4% in the vFFR group and 4.6% in the FFR group.
Procedural Advantages of vFFR Technology
The vFFR technology demonstrated several procedural benefits over traditional FFR. Mean procedure time was shorter with vFFR compared to FFR (55.8 minutes vs. 60.9 minutes). Notably, vFFR eliminated the need for pressure wires and adenosine administration, resulting in fewer intraprocedural complications (3.7% vs. 6.0%). The technology uses 3D quantitative coronary angiography without requiring hyperemic agents, making it less invasive for patients.
"The results of FAST III confirm the safety and feasibility of the online use of vFFR as an easy to use minimally invasive tool to guide revascularization in patients with intermediate coronary artery lesions in need of physiological lesion assessment," said Dr. Joost Daemen, principal investigator and cardiologist at the Thoraxcenter, Erasmus University Medical Center in Rotterdam.
Clinical Implications and Future Impact
The trial results have significant implications for clinical practice. vFFR identified a higher percentage of functionally significant lesions compared to FFR, which investigators noted as an area for future study. The technology's ease of use and reduced invasiveness could potentially increase the adoption of physiology-guided decision-making in coronary interventions.
"The technology has the potential to boost the use of physiology, which may increase the prognosis of patients in whom the decision to revascularize intermediate coronary artery lesions is still largely based on eye-balling," Dr. Daemen explained.
In an accompanying editorial comment, Yiannis S. Chatzizisis, MD, PhD, FACC, described the FAST III trial as "an important step toward a new standard of care," noting that it "provides meaningful support for a less-invasive physiology-guided strategy that may simplify decision making in treating the majority of patients with stable or unstable intermediate coronary lesions (搜索)."
Study Limitations and Industry Support
The trial had several limitations, including its open-label design, small percentage of patients with acute coronary syndrome, lack of investigator experience with vFFR compared to FFR, and a solely European patient population. Despite these limitations, adverse events were similar between the two groups.
The study was sponsored by the European Cardiovascular Research Institute (搜索) and supported by research grants from Siemens Healthineers (搜索) and Pie Medical Imaging (搜索). Bas Kuppens, CEO at Pie Medical Imaging, noted that the trial "has demonstrated benefits for care givers and patients by requiring less dose, less contrast agent, and reducing procedure lead time."