High-Quality Statin Trials Support the 2013 American College of Cardiology/American Heart Association Cholesterol Guidelines After the HOPE-3 Trial (Heart Outcomes Prevention Evaluation-3): MESA (The Multiethnic Study of Atherosclerosis)
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- cardiovascular diseases
- hydroxymethylglutaryl-CoA reductase inhibitors
- primary prevention
The 2013 American College of Cardiology/American Heart Association (ACC/AHA) guideline on cholesterol treatment to prevent atherosclerotic cardiovascular disease (ASCVD)1 has been criticized for lowering the risk thresholds for primary prevention with statin therapy. Although the ≥7.5% (class I) and ≥5% (class IIa) 10-year ASCVD risk thresholds were identified as new indications for treatment by extrapolating results obtained in randomized controlled trials (RCTs) of statin therapy, results from population-based European cohorts indicate that >30% of individuals eligible for statin therapy by class I recommendations do not have RCT data supporting statin efficacy.2,3 Furthermore, when the US Preventive Services Task Force published its recommendations (based on review of trial evidence), it restricted the indication for statin therapy in comparison with the ACC/AHA guideline by recommending a higher treatment threshold (10%) combined with ≥1 ASCVD risk factor. However, the evidence base for statins in primary prevention grew substantially in 2016 with publication of the HOPE-3 trial (Heart Outcomes Prevention Evaluation-3) that enrolled intermediate-risk persons for whom a clear indication for statin therapy was still lacking.4 The implications of HOPE-3 for the evidence base supporting ACC/AHA risk-based statin allocation remain unknown. Therefore, using MESA (Multiethnic Study of Atherosclerosis), a population-based US cohort, we assessed the extent to which the ACC/AHA recommendations for statin therapy are supported by currently available high-quality RCT evidence: WOSCOPS (West of Scotland Coronary Prevention Study), AFCAPS/TexCAPS (Air Force/Texas Coronary Atherosclerosis Prevention Study), ASCOT-LLA (Anglo-Scandinavian Cardiac Outcomes …