The 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines for determining statin eligibility have been found to be more accurate and efficient in identifying increased risk of cardiovascular disease (CVD) events and presence of subclinical coronary artery disease compared to the 2004 guidelines. Findings from the analysis are published in the Journal of the American Medical Association.
The 2013 guidelines shifted from the treatment of traditional risk factors to absolute cardiovascular risk estimated by the 10-year atherosclerotic CVD (ASCVD) score for statin treatment. Researchers from the Massachusetts General Hospital and Harvard Medical School set out to determine whether the ACC/AHA guidelines improved the detection of individuals who develop incident CVD and/or have coronary artery calcification (CAC) vs. the National Cholesterol Education Program’s Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) guidelines. The study included patients (n=2,435) from the offspring and third generation cohorts of the Framingham Heart Study. Patients underwent multi-detector computed tomography for CAC between 2002–2005 with a median nine-year followup for new CVD.
Overall, more patients were eligible for statin treatment under the 2013 ACC/AHA guidelines vs. the 2004 ATP III guidelines (39% vs.14%). Of those eligible for statin treatment by the ATP III guidelines, 7% developed incident CVD vs. 2% among noneligible patients. Under the ACC/AHA guidelines, 6% developed incident CVD vs. 1% among noneligible patients. The risk of having incident CVD among statin eligible vs. noneligible patients was higher when applying the ACC/AHA guidelines’ statin eligibility criteria vs. ATP III guidelines. Researchers estimated that about 41,000–63,000 incident CVD events could be prevented over 10 years by adopting the ACC/AHA guidelines.
The researchers note that the absolute cardiovascular event risk of statin-noneligible adults is not much lower with the ACC/AHA guidelines (1%) compared with the ATP III guidelines (2.4%), and the larger benefit may be that the ACC/AHA guidelines identify many more statin-eligible participants with a similarly high event rate as the ATP III guidelines (6.3% vs 6.9%).
The current ASCVD threshold of ≥7.5%, which was associated with about 48% of adults treated with statins, had an incremental cost-effectiveness ratio (ICER) of $37,000/quality-adjusted life-year (QALY) vs. a ≥10% threshold. ASCVD thresholds of ≥4% and 3% resulted in ICERs of $81,000/QALY and $140,000 QALY, respectively.
A risk-benefit analysis of costs and potential adverse effects of statins, especially in patient with prediabetes and lower-risk patients is needed to better assess the effects of the change in statin eligibility guidelines on the healthcare system.
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