title: A Simple Disease-Guided Approach to Personalize ACC/AHA-Recommended Statin Allocation in Elderly People: The BioImage Study.
abstract: The 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines recommend primary prevention with statins for individuals with ≥7.5% 10-year risk for atherosclerotic cardiovascular disease (ASCVD). Everyone living long enough will become eligible for risk-based statin therapy due to age alone.
  
  
  
  This study sought to personalize ACC/AHA risk-based statin eligibility using noninvasive assessment of subclinical atherosclerosis.
  
  
  
  In 5,805 BioImage participants without known ASCVD at baseline, those with ≥7.5% 10-year ASCVD risk were down-classified from statin eligible to ineligible if imaging revealed no coronary artery calcium (CAC) or carotid plaque burden (cPB). Intermediate-risk individuals were up-classified from optional to clear statin eligibility if CAC was ≥100 (or equivalent cPB).
  
  
  
  At a median follow-up of 2.7 years, 91 patients had coronary heart disease and 138 had experienced a cardiovascular disease event. Mean age of the participants was 69 years, and 86% qualified for ACC/AHA risk-based statin therapy, with high sensitivity (96%) but low specificity (15%). CAC or cPB scores of 0 were common (32% and 23%, respectively) and were associated with low event rates. With CAC-guided reclassification, specificity for coronary heart disease events improved 22% (p < 0.0001) without any significant loss in sensitivity, yielding a binary net reclassification index (NRI) of 0.20 (p < 0.0001). With cPB-guided reclassification, specificity improved 16% (p < 0.0001) with a minor loss in sensitivity (7%), yielding an NRI of 0.09 (p = 0.001). For cardiovascular disease events, the NRI was 0.14 (CAC-guided) and 0.06 (cPB-guided). The positive NRIs were driven primarily by down-classifying the large subpopulation with CAC = 0 or cPB = 0.
  
  
  
  Withholding statins in individuals without CAC or carotid plaque could spare a significant proportion of elderly people from taking a pill that would benefit only a few. This individualized disease-guided approach is simple and easy to implement in routine clinical practice.
authors: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors: Martin Bødtker
authors: MB
authors: Mortensen
authors: Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York.
authors: Valentin
authors: V
authors: Fuster
authors: scPharmaceuticals, Lexington, Massachusetts.
authors: Pieter
authors: P
authors: Muntendam
authors: Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York.
authors: Roxana
authors: R
authors: Mehran
authors: Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York.
authors: Usman
authors: U
authors: Baber
authors: Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York.
authors: Samantha
authors: S
authors: Sartori
authors: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. Electronic address: erling.falk@clin.au.dk.
authors: Erling
authors: E
authors: Falk
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000572:American Heart Association; D050197:Atherosclerosis / Q000453:epidemiology / Q000517:prevention & control*; D003324:Coronary Artery Disease / Q000453:epidemiology / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D011322:Primary Prevention; D011446:Prospective Studies; D012372:ROC Curve; D018570:Risk Assessment; D013997:Time Factors; D014481:United States / Q000453:epidemiology
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
keywords: cardiovascular disease; carotid plaque; coronary calcium; primary prevention; risk assessment