# Optimize Risk Assessment for Incident and Recurrent Atherosclerotic Cardiovascular Disease

> **NIH NIH R01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2022 · $711,827

## Abstract

Recent American Heart Association (AHA) and American College of Cardiology (ACC) cholesterol guidelines
put atherosclerotic cardiovascular disease (ASCVD) risk assessment at the center of decision-making for
initiating and dosing of lipid-lowering therapies including statins, ezetimibe, and PCSK9 inhibitors.
Nonetheless, there remains controversy regarding how efficiently this guideline directs medication to those
who will receive a large absolute ASCVD risk reduction benefit. For primary prevention, the 2018 AHA/ACC
guideline introduced the concept of risk-enhancing factors to identify individuals who have a risk higher than
predicted by the pooled cohort equations (PCE). The presence of risk-enhancing factors supports a decision to
initiate or intensify statin therapy in patients with borderline and intermediate risk. However, the guideline did
not quantify how much a risk-enhancing factor changes an individual's 10-year risk, making decisions to treat
or not to treat informed by the risk-enhancing factors ultimately subjective. Social determinants of health
(SDOH) are important ASCVD risk factors. The PCE systematically underestimates risk for individuals who are
socially deprived; however, SDOH are not included in the PCE or considered as risk-enhancing factors in the
current guidelines. Additionally, the PCE's performance is questionable in Hispanics and Asians, the two
fastest growing minority groups in the US. For secondary prevention, the 2018 guideline recommends high-
intensity statin therapy for the 24 million US adults with established ASCVD, with ezetimibe and PCSK9
inhibitors recommended for a subset with a very high risk for recurrent ASCVD, defined by a history of multiple
major ASCVD events or one major event with multiple high-risk conditions. However, recent evidence suggests
that this definition may classify too many individuals (>50%) as having very high risk. Additionally, women,
racial/ethnic minorities, and those with adverse SDOH may have a higher risk for recurrent ASCVD, but those
factors were not considered in the current guideline when defining very high risk of recurrent ASCVD.
To address these gaps in the literature and guidelines, our study proposes to 1) quantify how much the
presence or absence of each risk-enhancing factor (including SDOH and Hispanic and Asian subgroups) and
their combinations change 10-year ASCVD risk beyond PCE predictions; 2) determine the algorithm that
optimizes the discrimination of individuals at very high risk for a recurrent ASCVD event; and 3) compare the
health, economic, and health equity impact among US adults of selecting individuals for lipid-lowering
therapies according to approaches identified in Aims 1 and 2 vs. in the 2018 cholesterol guideline.
This study will develop approaches that improve the precision of cholesterol treatment guidelines in US adults,
and help direct treatment to ethnic subgroups and groups with a high burden of adverse SDOH who have a
high ASCVD risk but...

## Key facts

- **NIH application ID:** 10447646
- **Project number:** 5R01HL155081-02
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Jaejin An
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $711,827
- **Award type:** 5
- **Project period:** 2021-07-15 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10447646

## Citation

> US National Institutes of Health, RePORTER application 10447646, Optimize Risk Assessment for Incident and Recurrent Atherosclerotic Cardiovascular Disease (5R01HL155081-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10447646. Licensed CC0.

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