The SHAPE Trial Advisory Meeting – Part II

GoToMeeting Session Monday Nov 9th, 12PM EST

https://global.gotomeeting.com/join/580198429

Dial +1 (312) 757-3121 Access Code: 580-198-429 Meeting Password: SHAPE11

Followed by Focus Group Meeting as a satellite event in conjunction with

Annual Scientific Sessions of American Heart Associations November 9, 7-9PM (Dinner), Rosen Plaza Hotel, Salon 12

Orlando, Florida

Comparative Effectiveness Trial Designs of

Coronary Artery Calcium Screening vs.

Risk Estimation

Presenter:

David Maron, M.D.Professor and Director, Preventive Cardiology Stanford University School of

Medicine, Stanford, CA

Trial Designs

• VIEW• ROBINSCA original www.robinsca.nl • Modified ROBINSCA with a CAC zero• PRECISION • SCORE 1• SCORE 2

VIEWN=30,000

ROBINSCAN=39,000 at high risk for CAD based on a questionnaire and

self-measured waist circumference

N=13,000 N=13,000 N=13,000

MD discretion ACEi + statin

What about CAC =0?

Asymptomatic Smokers* Undergoing Low Dose CT for Early Lung Cancer

Screening and CAC >400

Primary Prevention Strategy

(“Usual Care”)

Secondary Prevention Strategy

(“Directed Care”)

MD Discretion

PRECISION

Follow-up for outcomes

MD Discretion

*55-74 years old with Hx cigarette smoking >30 pack-years;if former smoker, must have quit within the previous 15 years

Asymptomatic Smokers Undergoing Low Dose CT for Early Lung Cancer

Screening and CAC >400 or 0

Blinded to ScoreASCVD Risk Estimate

Unblinded Score

MD Discretion

Usual Care

High-intensity statin and aspirin

Nostatin or aspirin

SCORE 1Screening Calcium or Risk Estimation

CAC >400 CAC = 0

Follow-up for outcomes

Consent all asymptomatic smokers undergoing low dose CT for early lung cancer screening and randomize only

CAC >400 to aggressive Rx

No Score, use ASCVD Risk Estimate

Unblinded Score >400

Usual Care, annual assessment (email)

High-Intensity Statin and

aspirin

SCORE 2 (Berman)Screening Calcium or Risk Estimation

Follow-up for outcomes

Perform CAC scoring at end of trial, assess >400 group

David Maron’s Questions to ROBINSCA Investigators:

1) Is statin recommended or provided? If provided, only for group B, or for A and B?

2) Is statin dose the same regardless of calcium score?

3) Could statin be changed from simvastatin to atorvastatin (because of greater efficacy, fewer drug-drug interactions)?

4) How do you manage CAC = 0? Rx statin or withhold statin?

5) Is low dose aspirin recommended to everyone with CAC >0?

Questions for brainstorming at SHAPE Trial Advisory Meeting Part-2:

A) if ROBINSCA is completed today and shows superiority of CAC-based risk assessment, will it be sufficient to change (AHA/ACC/ESC) guidelines, get FDA/CMS/USPTFS endorsement, and convince the payers, or will we need additional studies?

B) if ROBINSCA is completed today and shows lack of superiority for CAC-based risk assessment, will it be sufficient to negate other evidence gathered so far, including HRP, MESA, HNR, etc.? C) How do we go about testing carotid and possibly femoral plaque measurement with ultrasound in these trials? is the combination of CAC and US useful as shown by HRP/BioImage? How about functional testing and monitoring response to therapy? Other questions are welcomed.

View discussions of SHAPE Trial Advisory Meetings Part 1 and 2

www.shapesociety.org