Abstract
Background and aims
Guideline-recommended use of risk calculators to select for statin therapy in primary prevention has never been tested in a randomized controlled trial (RCT). We determined the extent to which guideline-based statin recommendations from the American College of Cardiology/American Heart Association (ACC/AHA), Canadian Cardiovascular Society(CCS), UK National Institute for Health and Care Excellence (NICE), and European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) is supported by available evidence from RCTs.
Methods
79,171 individuals from the Copenhagen General Population Study who were free of ASCVD and statin use at baseline were included. RCT evidence supporting guideline-recommended statin allocation and the estimated number needed to treat (NNT) to prevent one ASCVD event were assessed.
Results
During 8.2 years of follow-up, 4031 ASCVD events occurred. Of individuals eligible for statin therapy with the ACC/AHA, CCS, NICE and ESC/EAS guidelines, 86%, 88%, 88% and 84% had direct RCT evidence of statin efficacy, respectively (guideline-positive&RCT-positive). This group represented 26–37% of all 79,171 individuals, while guideline-positive&RCT-negative individuals represented 5–7%, guideline-negative&RCT-positive individuals 28–39%, and guideline-negative&RCT-negative individuals represented 30–31%. The ASCVD events per 1000 person-years were 11.4–12.7 (guideline-positive&RCT-positive), 6.3–8.0 (guideline-positive&RCT-negative), 4.2–5.2 (guideline-negative&RCT-positive), and 2.3–2.5 (guideline-negative&RCT-negative), respectively, while the corresponding NNT to prevent one event in 10 years using high-intensity statin were 19–21, 30–32, 48–60, and 105–125, respectively.
Conclusion
The far majority of individuals eligible for guideline-recommended primary prevention with statins have direct RCT evidence supporting statin use. Allocating statins based on guideline-criteria is more efficient with lower NNT for preventing ASCVD events than allocating statin therapy based solely on RCT evidence.
Full Article