Analysis Backed by
Clinical Evidence
With 600+ peer-reviewed publications, Heartflow is committed to ongoing clinical research as we work to transform the diagnosis and management of coronary artery disease worldwide.
Explore the extensive research backing the use of Heartflow and its influence on patient care by clicking one of the studies below.
Coronary CTA
The PROMISE study showed that Coronary Computed Tomography Angiography (CCTA) provides superior prognostic value over functional testing for stable chest pain, with a hazard ratio of 2.7 for predicting major adverse cardiac events. CCTA also reduced normal test results by 31% and improved event prediction.
A meta-analysis of 22 trials (9,379 participants) highlighted the benefits of CCTA in acute chest pain evaluation. CCTA reduced hospital stays by 14% and immediate costs by 17%. It also increased revascularizations (RR 1.45) and medication adjustments (RR 1.33), demonstrating its effectiveness in guiding interventions for low-to-intermediate risk patients.
The CONFIRM Registry, involving 27,000 patients without known risk factors, showed that normal CCTA results predict a 7+ year “warranty period” with 95% event-free survival, while event rates were higher in obstructive and non-obstructive CAD.
The SCOT-HEART trial randomized 4,146 patients between standard care and CCTA to evaluate each pathway as a front-line test for stable chest pain. CCTA reduced the primary endpoint of coronary heart disease death or nonfatal myocardial infarction by 41% at 5 years compared to standard care. A post-hoc analysis on quantitative plaque assessment showed enhanced risk prediction capabilities, with high total plaque volume associated with a 7-fold greater risk of myocardial infarction.
SCOT-HEART Investigators, Newby DE, Adamson PD, et al. N Engl J Med. 2018
Platform
The EMERALD studies showed that AI-enabled FFRCT and and Plaque Analyses improved prediction of coronary lesions causing ACS. EMERALD II (351 patients) found that combining AI-enabled Plaque and FFRCT increased accuracy (AUC 0.84) compared to conventional CCTA alone (AUC 0.78), highlighting their value in identifying future culprit lesions.
The ADVANCE-DK Registry highlights the long-term value of FFRCT and Plaque Analysis in coronary artery disease. At 7 years, patients with normal FFRCT had a lower risk of adverse events (5.7%) than those with abnormal FFRCT (16.2%). Adding plaque quantification improved predictive accuracy (AUC 0.73 vs. 0.63 for CCTA alone). Over 3 years, abnormal FFRCT strongly predicted cardiovascular death and myocardial infarction (RR 8.8, p<.001) and maintained accuracy even in patients with CAC scores >400, reinforcing its role in risk stratification and management.
Madsen, et al. Radiology 2023., Meier, D. et al, 2024; In press.
Roadmap™
Analysis
The SMART-CT study evaluated the impact of Roadmap Analysis on CCTA interpretation. The study demonstrated a 25% reduction in read times, even among level 3 readers, and improved the accuracy of level 2 readers Additionally, Roadmap Analysis improved inter-reader agreement and increased reader confidence, while maintaining diagnostic accuracy compared to invasive coronary angiography.
The ACCURACY validation study evaluated the performance of Roadmap Analysis against invasive quantitative coronary angiography (QCA). The study demonstrated high diagnostic performance with a per-vessel NPV of 96%, sensitivity of 90%, and AUC of 0.92.
FFRCT
Analysis
Accuracy
The PACIFIC trial demonstrated the superior diagnostic performance of FFRCT compared to Coronary CTA, with 87% sensitivity, 81% specificity per vessel, and 86% accuracy per patient against invasive FFR. FFRCT achieved a higher AUC (0.93 vs. 0.82) and maintained strong predictive value for identifying hemodynamically significant coronary artery disease, particularly in intermediate stenoses. These findings establish FFRCT as a superior non-invasive method for functional coronary assessment.
Outcomes
The PRECISE randomized controlled trial evaluated 2,103 patients comparing CCTA + FFRCT against standard care (stress testing or catheterization) in patients with stable chest pain. Compared to the standard pathway, the CCTA + FFRCT pathway identified 78% more patients with disease (78% more effective) and reduced the rate of negative diagnostic-only catheterizations by 69% without any negative impacts on clinical outcomes.
The PLATFORM study evaluated the clinical and economic impact of using CCTA + FFRCT versus standard care in patients with suspected CAD. FFRCT-guided care dramatically reduced negative diagnostic catheterizations by 83%. Healthcare costs were reduced by 33% while maintaining good clinical outcomes through one year of follow-up.
Treatment Planning
The ADVANCE Registry enrolled 5,083 patients across 38 international sites examining the prognostic value of FFRCT. At one year follow-up, patients with normal FFRCT (>0.80) showed significantly lower rates of revascularization (5.6% vs 38.4%) and cardiovascular death/MI (0.2% vs 0.8%) compared to those with abnormal FFRCT (≤0.80). Additionally, when an FFRCT Analysis was provided with CCTA, 97% of patients had their optimal treatment plan identified from the single test
Patel MR, Nørgaard BL, Fairbairn TA, et al. JACC Cardiovasc Imaging. 2020
Plaque
Analysis
The REVEALPLAQUE study is the only published, prospective study to show 95% agreement between Heartflow’s Plaque Analysis and the invasive gold standard, intravascular ultrasound (IVUS). The study compared outputs across 432 lesions in 237 patients from US and Japan. This validation established Heartflow’s Plaque Analysis as a validated, non-invasive alternative to IVUS for comprehensive coronary plaque assessment.
The DECODE study evaluated the clinical impact of Heartflow Plaque Analysis on patient management. Three independent investigators, including cardiologists and trained CTA readers, assessed 100 patients. The study found that the addition of Plaque Analysis led to management changes in 66% of cases compared to CCTA alone, with 50% of patients with a zero-calcium score receiving revised treatment plans. Additionally, 63% of patients had medical therapy intensified based on Plaque Analysis findings, demonstrating its impact on clinical decision-making and refining risk assessment beyond conventional calcium scoring.
The DECIDE Registry is evaluating changes in medical management following Heartflow Plaque Analysis compared to CCTA alone in 20,000 patients across 40 sites. Clinical outcomes, including cardiovascular death, MI, revascularization, medication adjustments, and hospitalizations, will also be assessed. As of November 2024, ~6,400 patients have been enrolled, with planned follow-up at 90 days and 1 year. Initial findings are expected in late 2025.
AI Derived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management (DECIDE)
Using a large international cohort, Heartflow analyzed more than 11,000 CCTAs to stratify total coronary atherosclerotic plaque volumes by age and sex. Physicians can utilize this data to help manage and optimize patient care.