Evidence behind deeper insight from CCTA.
Clinical validation of DEEPVESSEL FFR and DEEPVESSEL Plaque for complementary physiological and anatomical assessment.
Clinical validation. Complementary insights.
ADAPT Study
A multicenter U.S. and European study evaluated DEEPVESSEL FFR for detecting ischemia, using invasive FFR as the reference standard.
86.9%
Sensitivity86.7%
Specificity
86.8%
Accuracy
91.9%
Negative predictive value
Primary endpoints met.
Sensitivity and specificity exceeded the prespecified performance targets based on their 95% confidence interval lower bounds.
Multi-national multi-center clinical validation study ADAPT [1] 2021
- DVFFR analysis was conducted on a total of 269 patients with 358 target vessels from 10 clinical sites (5 from US and 5 from EU)
- Primary endpoint: per-vessel sensitivity and specificity of DVFFR to detect ischemic condition comparing with invasive FFR measurement
- Study demonstrated that DVFFR yielded good diagnostic performance and met pre-specified criteria for study success
ADAPT: Per-vessel results
| Measure | Estimate | 95% confidence interval |
|---|---|---|
| Sensitivity | 86.9% | Lower bound: 80.6% |
| Specificity | 86.7% | Lower bound: 82.0% |
| Accuracy | 86.8% | 83.0–90.4% |
| Positive predictive value (PPV) | 79.4% | 71.8–86.2% |
| Negative predictive value (NPV) | 91.9% | 87.7–95.6% |
Reference standard: invasive FFR. Sensitivity and specificity show the
lower bounds of two-sided 95% confidence intervals. The prespecified
targets were 75% and 70%, respectively; both were met.
ADAPT: Per-patient results
| Measure | Estimate | 95% confidence interval |
|---|---|---|
| Sensitivity | 87.4% | 79.4–93.1% |
| Specificity | 83.7% | 76.5–89.4% |
| Accuracy | 85.2% | 80.2–89.4% |
| Positive predictive value (PPV) | 79.6% | 71.0–86.6% |
| Negative predictive value (NPV) | 90.1% | 83.6–94.6% |
Reference standard: invasive FFR. Results are reported at the patient level.
Additional DVFFR validation: 2017 and 2019 trials
Keya Medical conducted prospective[1] and retrospective multicenter, self-controlled studies in 2017 and 2019. In these trials, FFR measured invasively using a pressure wire was used as the gold standard to evaluate the sensitivity and specificity of DeepVessel FFR in evaluating functional myocardial ischemia in patients with stable coronary artery disease.
| Measure | 2017 prospective trial | 2019 retrospective trial |
|---|---|---|
| Accuracy | 89.2% | 90.8% |
| Sensitivity | 94.2% | 94.7% |
| Specificity | 84.3% | 88.6% |
| Positive predictive value (PPV) | 86.9% | 83.0% |
| Negative predictive value (NPV) | 92.2% | 96.7% |
Separate multicenter studies using pressure-wire invasive FFR as the
reference standard. These results are not pooled with ADAPT.
COMPOSE-CT Study
A multicenter U.S. study evaluated DEEPVESSEL Plaque against consensus from three Level III expert readers for plaque quantification and stenosis categorization.
r = 0.976
Total plaque volume
r = 0.994
Calcified plaque volume
r = 0.945
Non-calcified plaque volume
0.810
CAD-RADS® weighted kappa
Reference standard
Adjudicated expert consensus; the study did not use IVUS or histology.
COMPOSE-CT: Plaque volume correlation
| Measure | Pearson correlation (r) |
|---|---|
| Total plaque volume | 0.976 |
| Calcified plaque volume | 0.994 |
| Non-calcified plaque volume | 0.945 |
Reference standard: adjudicated consensus of three Level III expert readers. Values describe correlation in plaque volume measurements.
COMPOSE-CT: CAD-RADS® agreement
| Measure | Result |
|---|---|
| Exact category agreement | 75.5% |
| Agreement within one category | 95.9% |
| Weighted kappa | 0.810 |
Agreement with expert consensus for CAD-RADS stenosis categorization.
These results are separate from plaque volume correlation.
For healthcare professionals in the United States