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ESC Presentation for HART PAD

Performance of Clinical/Proteomic panel to predict obstructive peripheral artery disease in patients with and without diabetes mellitus

European Society of Cardiology (ESC) Scientific Sessions, Munich, Germany

August 25, 2018

Highlights & Key Findings

  • Peripheral artery disease (PAD) is a global health problem associated with significant morbidity and mortality. Patients with diabetes mellitus (DM) are at substantial risk of developing PAD, however its diagnosis is often delayed until advanced stages when complications arise.

  • PAD affects more than 202 million people worldwide and is often underdiagnosed and undertreated until the disease has reached advanced stages. Patients with DM are at substantial risk of developing PAD. Patients with PAD have increased risk of coronary artery disease (CAD), heart attack, or stroke, and, if left untreated, PAD can lead to foot or leg amputation.

  • Using proteomics and machine learning (a subset of artificial intelligence), a biomarker clinical/proteomic panel was validated to predict prevalent obstructive PAD (HART PAD) in patients undergoing diagnostic peripheral angiography and/or coronary angiography.

  • The clinical/proteomic HART PAD panel consists of one clinical variable (history of hypertension) and concentrations of six biomarkers (midkine, kidney injury molecule-1, interleukin-23, follicle stimulating hormone, angiopoietin-1, and eotaxin-1).

  • In a prospective cohort of 354 patients referred for diagnostic peripheral angiography and/or coronary angiography enrolled in the Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA) Study (Clinical Trials.Gov NCT00842868), performance of this diagnostic panel was assessed in patients with (N=94) and without DM (N=260) using Monte Carlo cross validation.

  • In patients with DM, the HART PAD panel had excellent performance for diagnosis of PAD. Using a 5- point score, a score of 1 had a 100% Negative Predictive Value (NPV) and a score of 5 had a 95% Positive Predictive Value (PPV). Additionally, the HART PAD panel was highly accurate in predicting the need for revascularization in patients with PAD. These results were comparable to those patients without DM.


  • In a prospective cohort study, we describe a clinical/ biomarker score with high accuracy for predicting the presence of PAD and need for revascularization in patients with and without DM.

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The 2018 ESC Presentation for HART PAD

Clinical Cardiology

A Clinical and Biomarker Scoring System to Predict the Presence of Obstructive Peripheral Artery Disease:

Results from the Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA) Study

Accepted for Publication on March 4, 2018

Highlights & Key Findings

  • Peripheral artery disease (PAD) is an increasing global health problem with 202 million people diagnosed. A need exists for alternative means for evaluating Peripheral artery disease (PAD).


  • A prospective cohort of 355 patients referred for diagnostic peripheral angiography and/orcoronary angiography to Massachusetts General Hospital were enrolled in the CASABLANCA Study (Clinical Trials.Gov NCT00842868). Predictors of ≥50% stenosis in at least one peripheral vessel were identified from over fifty clinical variables and 109 biomarkers.


  • Machine Learning (Subset of AI) & Big Data. Candidate panels of biomarkers and clinical variables were generated and evaluated with machine learning statistical techniques, a subset of Artificial Intelligence (AI). The ultimate result of this process was a final test panel and scoring system.


  • Final score has 1 clinical variable (History of hypertension) and 6 biomarkers (Angiopoietin-1, Eotaxin-1, Follicle Stimulating Hormone, Interleukin-23, Kidney Injury Molecule-1, and Midkine).


  • Low risk patients (score = 1) had NPV of 98%; high risk patients (score = 5) had PPV of 86%.


  • In a prospective cohort study, we describe a novel method to predict angiographically significant PAD, also lending potential prognostic information regarding need for revascularization.

  • The biomarkers in this model all have plausible biologic links to atherosclerosis.

  • Clinically, use of a tool such as this could act as a gatekeeper prior to imaging or invasive testing, thus reducing cost and exposures to intravenous contrast and/or ionizing radiation.

  • The score may also be used to evaluate at-risk patients for risk of vascular complications. Enriching clinical trials for PAD-related events or identifying patients at risk for adverse effects of drug therapies could be effective.

  • Prevencio has also developed HART   AMP, a panel specifically for identifying patients at risk for amputation.

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The AHA 2017 Presentation

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