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.
Objectives
This study sought to personalize ACC/AHA risk-based statin eligibility using noninvasive assessment of subclinical atherosclerosis.
Methods
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).
Results
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.
Conclusions
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.
Key Words
cardiovascular disease
carotid plaque
coronary calcium
primary prevention
risk assessment
Abbreviations and Acronyms
ACC
American College of Cardiology
AHA
American Heart Association
ASCVD
atherosclerotic cardiovascular disease
CAC
coronary artery calcium
CHD
coronary heart disease
cPB
carotid plaque burden
CVD
cardiovascular disease
MI
myocardial infarction
PCE
Pooled Cohort Equations
Cited by (0)
The BioImage Study was designed by the High-Risk Plaque Initiative, a pre-competitive industry collaboration funded by BG Medicine, Abbott Vascular, AstraZeneca, Merck & Co., Philips, and Takeda. Dr. Mehran has received research grant support from Eli Lilly/Daiichi-Sankyo, Bristol-Myers Squibb, AstraZeneca, The Medicines Company, and OrbusNeich; has served as a consultant for Janssen Pharmaceuticals, Osprey Medical, Watermark Research Partners, and Medscape; and has served on the scientific advisory board of Abbott Laboratories. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Tasneem Naqvi, MD, served as Guest Editor for this paper.
