REWRITE-CAD Protocol: Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease (REWRITE-CAD)

Inclusion Criteria:

1. History of PCI (1 year - 5 years prior to Day 0) and/or history of MI (Type I or II) (1 year - 5 years prior to Day 0)
2. Patients who do not exhibit symptoms suggestive of CAD
3. No other clinical CCTA subsequent to MI/PCI but prior to screening
4. eGFR >45 mL/min per most recent measurement within 90 days
5. Willingness to comply with all aspects of the protocol including research CCTAs, lab draws, medication adherence assessments, attending all study visits, and the ability to comply with prescribed medications
6. For a female participant of childbearing potential (those who have not been surgically sterilized), a pregnancy test must be performed with negative results known within 7 days prior to randomization
7. Ability to provide informed consent
8. Visible plaque in non-stented region on CCTA as assessed by CCTA core lab
9. Acceptable CCTA quality per Heartflow acceptance criteria

Exclusion Criteria:

Non-imaging based

1. Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion)

2. On PCSK9i and/or inclisiran at baseline

3. Reduced left ventricular ejection fraction (LVEF) <35%, if known

4. Prior coronary artery bypass graft (CABG)

5. Prior stents in 2+ vessel territories

6. Life expectancy less than 2 years due to non-CV comorbidities

7. Enrolled in an investigational trial that involves a non-approved cardiac drug or device

8. Previously evaluated with and/or in a trial which includes AI-CPA

9. Any condition that might interfere with trial procedures or follow up visits

10. LDL-C <70 mg/dL at baseline lab draw

11. Active chemotherapy and/or radiation

    Imaging Based (all to be assessed by CCTA core lab)

12. Left Main (LM) ≥50% stenosis on baseline CCTA

13. Proximal LAD FFRct <0.75

14. Total occlusions in major vessels and/or total occlusion in stent

15. No visible plaque in non-stented segments on CCTA

16. Incidental findings requiring immediate follow-up or management (e.g., Aortic dissection, findings suggestive of cancer, pulmonary embolism)

17. Findings that require further imaging follow-up within 1 year (e.g., pulmonary nodules ≥6 mm)