# Coronary Artery Calcium in the PRagmatic EValuation of evENTs And Benefits of Lipid lowering in the Elderly: CAC PREVENTABLE Ancillary Study

> **NIH NIH R01** · DUKE UNIVERSITY · 2022 · $2,921,424

## Abstract

ABSTRACT
Predicting risk is critical for effective primary prevention of atherosclerotic cardiovascular
disease (ASCVD), however classifying risk in adults ≥75 years of age remains extremely
challenging. Coronary artery calcium (CAC) scoring and high-sensitivity troponin (hs-Tn) are
promising tools for risk stratification in older adults because they provide singular and enduring
snapshots that directly quantify a composite of cumulative risk factor exposure and individual
resiliency or vulnerability. Used jointly, we have shown that low values of CAC and hs-Tn may
be useful for “de-risking” older populations, identifying individuals with highly favorable
prognosis in whom preventive therapy may not be beneficial. However, despite promising
observational data, the true clinical value of CAC and hs-Tn in older adults remains uncertain
due to lack of a dedicated, adequately powered randomized trial. The NIA/NHLBI-funded
PREVENTABLE (PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr
adults) pragmatic clinical trial, which is currently randomizing 20,000 adults ≥75 years of age to
atorvastatin 40mg or placebo and following for ASCVD events, provides the ideal setting to test
the critical hypothesis that CAC and hs-Tn jointly identify older adults who will benefit the most,
and the least, from statin therapy. In this proposal, we seek to perform baseline CAC scanning
and hs-Tn measurement in 10,000 PREVENTABLE participants. At trial conclusion, we will
conduct analyses stratified by CAC, and jointly by CAC and hs-Tn, with >85% power to
determine heterogeneity of statin effect by biomarker status. At the end of the trial, we will
develop a comprehensive ASCVD risk classification model using traditional risk factors, CAC,
and hs-Tn and validate this in MESA and ARIC. We will then construct an online tool similar to
the LIFE-CVD model for calculating estimated benefit of statin therapy in the age ≥75 primary
prevention population, after detailed accounting for non-CVD competing risks observed in
PREVENTABLE. In summary, we believe that CAC scanning and hs-Tn measurement in
PREVENTABLE is the most expeditious and instructive way to fill critical knowledge gaps about
subclinical ASCVD in an older primary prevention population and to determine the value of a
biomarker-guided precision medicine approach for informing individual benefit of preventive
statin therapy.

## Key facts

- **NIH application ID:** 10475872
- **Project number:** 5R01HL155396-02
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** MICHAEL J BLAHA
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $2,921,424
- **Award type:** 5
- **Project period:** 2021-09-01 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10475872

## Citation

> US National Institutes of Health, RePORTER application 10475872, Coronary Artery Calcium in the PRagmatic EValuation of evENTs And Benefits of Lipid lowering in the Elderly: CAC PREVENTABLE Ancillary Study (5R01HL155396-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10475872. Licensed CC0.

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