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Design and rationale of the WARRIOR ancillary study for coronary CT angiographic analysis
Balaji Tamarappoo1, Rafal Wolny2, Guadalupe Flores Tomasino3
1Division of Cardiology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ.
Insights
Intensive medical therapy (IMT) may improve coronary plaque in women with INOCA. This study quantifies IMT’s impact on plaque composition and chest pain, offering new insights for non-obstructive coronary artery disease management.
Area of Science:
- Cardiology
- Medical Imaging
- Translational Research
Background:
- Over 50% of women with suspected ischemia have INOCA, a condition where plaque impact is not well understood.
- Current treatments like statins and ACE inhibitors/ARBs show promise, but their effect on coronary plaque needs further characterization.
Purpose of the Study:
- To evaluate the impact of intensive medical therapy (IMT) versus usual care (UC) on coronary plaque composition and chest pain in women with INOCA.
- To hypothesize that IMT positively influences plaque characteristics, affecting flow reserve and clinical outcomes.
- To utilize coronary CT angiography (CCTA) for detailed plaque and symptom analysis.
Main Methods:
- The WARRIOR ancillary study will enroll 200 women with INOCA, randomized to IMT or UC.
- Baseline and exit CCTA will be used to quantify changes in plaque and pericoronary adipose tissue (PCAT) characteristics.
- AI-enabled quantification and PCAT density analysis will assess plaque inflammation and hemodynamic significance.
Main Results:
- Changes in coronary plaque characteristics and their hemodynamic significance will be analyzed using AI-enabled CCTA quantification.
- Plaque inflammatory characteristics will be assessed via PCAT density analysis.
- Plaque burden, composition, and PCAT density will be correlated with angina scores (SAQ).
- A machine learning risk score (MLRS) will be derived from CCTA variables to predict angina changes.
Conclusions:
- This study is the first to quantify the effects of IMT versus UC on plaque composition in women with INOCA.
- Findings will elucidate the impact of IMT on coronary plaque, potentially improving treatment strategies for INOCA patients.
Background:
Over 50% of women evaluated for suspected ischemia have no obstructive coronary artery disease (INOCA). Statins, angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are effective in intermediate outcome trials; however, impact on coronary plaque has not been well characterized.
Objectives:
The Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (WARRIOR NCT03417388) trial testing intensive medical therapy (IMT) (high intensity statin, ACEI or ARB and low dose aspirin) vs usual care (UC) in women with suspected INOCA offers the opportunity to evaluate the impact of IMT vs UC on plaque composition, and chest pain symptoms by coronary CT angiography (CCTA). We hypothesize that IMT provides beneficial data on plaque composition impacting flow reserve and trial outcomes.
Methods:
This WARRIOR ancillary study will consecutively enroll 200 eligible participants randomized to IMT vs UC by baseline and exit CCTA. Changes in plaque and peri‑coronary artery adipose tissue attenuation (PCAT) characteristics will be quantified.
Results:
Results will address: (1) Changes in coronary plaque characteristics and their hemodynamic significance using AI-enabled quantification of CCTA; (2) Changes in plaque inflammatory characteristics through pericoronary adipose tissue (PCAT) density analysis; (3) Plaque burden, composition and PCAT density changes related to angina score (Seattle Angina Questionnaire [SAQ]), (4) Derive a quantitative machine learning risk score (MLRS) using CCTA-derived variables for prediction of change in angina.
Conclusions:
The ancillary study will be the first to quantify the impact of IMT vs UC on plaque composition, and outcomes in women with suspected INOCA.
Trial Registration:
WARRIOR Ancillary Study for CCTA Analysis, NCT05035056.
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