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Vectra Cardiovascular (CV) Risk Prediction Using Vectra® Technical Specifications
Crescendo Biosciences, Inc., Effective Date: January 2021

TEST RESULTS SHOULD BE USED ONLY AFTER REVIEW OF THE FOLLOWING SPECIFICATIONS:

Indications and Use
Intended Use
Rheumatoid arthritis (RA) patients have increased risk for cardiovascular disease (CVD). Accurate CVD risk prediction could improve care for RA patients. This biomarker-based CVD risk prediction result (Vectra Cardiovascular Risk) may improve RA patient care by offering rheumatologists a feasible tool for assessing CVD risk to inform the management of traditional CVD risk factors and RA inflammation.

Description of Methods
Methods:
Vectra Cardiovascular Risk is a model that has been internally validated in patients with RA for predicting risk of having a cardiovascular (CV) event (myocardial infarction [MI], stroke or CV related death) within the next 3 years.

Vectra Cardiovascular Risk uses the Vectra test score, 3 biomarkers from the Vectra test, age, and patient-specific clinical CV risk factors to provide a more accurate risk assessment than models developed for comparison using only clinical data.

To develop Vectra Cardiovascular Risk, Medicare claims data were linked to multi-biomarker disease activity (Vectra) test results to select an RA patient cohort with age ≥40 years that was split 2:1 for training and internal validation. Clinical and RA-related variables, Vectra score and its 12 biomarkers were evaluated as predictors of a composite CVD outcome as outlined above.

Biomarkers and Vectra Score
The Vectra score assesses RA disease activity by combining the concentration of 12 biomarkers in patient serum into an algorithm that has been validated against the DAS28-CRP in seropositive and seronegative RA patients treated with a variety of RA therapies. For more details, please refer to the technical specifications of the Vectra score (PB 246)

Variables Included in Model Building
The variables included in model building were the Vectra Score (adjusted for age, sex and leptin), the 12 biomarkers of the Vectra test, race, tobacco use (past or present), patient sex, history of CVD other than MI or stroke, and diagnosis of diabetes, hypertension and hyperlipidemia. A history of CVD or other diagnoses was counted as present if any of the respective diagnostic codes were found for the patient.

Information on the following cardiovascular conditions was included in the result as a part of CVD history if applicable to the patient:

  • Coronary Artery Disease [including Angina Pectoris] (I20, I24, I25),
  • Peripheral Artery Disease or Atherosclerosis (I70, I74),
  • Transient Cerebral Ischemia or TIA (G45), Heart Failure (I50),
  • Atrial Fibrillation (I48), Aortic Aneurysm or Dissection (I71),
  • Nontraumatic Intracranial Hemorrhage [not leading to stroke] (I62)

Results
30,751 RA patients (904 CVD events) were analyzed. Covariates in the final Vectra Cardiovascular Risk Result were age, diabetes, hypertension, tobacco use, history of CVD (excluding MI/stroke), Vectra DA score, leptin, MMP-3 and TNF-R1:

Biomarker-related Vectra DA score, Leptin, MMP-3, TNF-R1 (Measured in Vectra DA)
Demographic Age
Clinical CV risk factors Diabetes, hypertension, tobacco use, history of CVD (excluding MI/stroke)

In internal validation, Vectra Cardiovascular Risk was a strong predictor of 3-year risk for a CV event, with a hazard ratio (95% CI) of 2.89 (2.46-3.41).

Percentage Risk and Categories of Risk
Vectra CV Risk scores are entered into a separate formula to obtain the risk of a CVD event over the next 3 years, expressed as a percentage value. Categories of 3-year risk were derived from the 10-year risk categories in the 2019 guidelines of the American College of Cardiology/American Heart Association Primary Prevention of CVD. The resulting 3-year risk categories are: Low (0 to <1.3%), borderline (≥1.3% to <1.8%), intermediate (≥1.8 to <5.2%), and high (≥5.2%) risk. In the validation dataset (N=10,275), the predicted 3-year Vectra CV Risk was low for 9.4% of patients, borderline for 10.2%, intermediate for 52.2% and high for 28.2%.

Goodness of Fit
Model fit was good, with mean predicted versus observed 3-year CVD risks of 4.5% versus 4.4%, respectively. Vectra Cardiovascular Risk significantly improved risk discrimination by the likelihood ratio test, compared to four clinical models.

Result reporting
The Vectra CV Risk Result will report information about the patients predicted level of CVD risk depending on the category of risk indicated by their Vectra CV Score.

Limitations of the test (exclusion criteria)
The test is not validated for:

  • Patients who do not qualify for Vectra test
  • Use with biomarker results that are independent of the Vectra test
  • Patients under the age of 40
  • Patients with known history of MI or stroke
  • Patients on anti-IL-6R treatment in the prior 90 days
  • Patients diagnosed with cancer in the past year (excluding non-melanoma skin cancer)

References

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Vectra Cardiovascular Risk Clinical Data
Vectra Clinical Data