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A new approach to test validity and clinical usefulness of the 2013 ACC/AHA guideline on statin therapy: A
Davood Khalili1, Samaneh Asgari2, Farzad Hadaegh2
1Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Epidemiology, School of Public Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Insights
The ACC/AHA cholesterol guideline is useful but may lead to overtreatment in women. This study evaluated its clinical utility in a high-risk population, finding it beneficial overall.
Area of Science:
- Cardiology
- Public Health
- Clinical Risk Assessment
Background:
- Controversy exists regarding the clinical usefulness of the new ACC/AHA guideline for cardiovascular risk assessment and hypercholesterolemia management.
- This study aimed to evaluate the guideline's utility in a high-incidence population using novel metrics.
Purpose of the Study:
- To validate the ACC/AHA risk equation in a large cohort.
- To assess the guideline's ability to identify high-risk individuals for cardiovascular diseases (CVDs).
- To evaluate the net benefit and number needed to treat (NNT) for statin therapy.
Main Methods:
- Validated the ACC/AHA risk equation in 5153 individuals (40-75 years).
- Identified high-risk individuals at baseline and tracked CVD outcomes over 10 years.
- Quantified guideline discrimination and evaluated decision quality using Net Benefit Fraction and NNT.
Main Results:
- The equation overestimated CVD risk by 57% in men and 48% in women.
- 73% of men and 44% of women were eligible for statin therapy.
- The guideline showed significant net benefit, with NNTs ranging from 5-55, but intensive therapy's benefit was uncertain in non-diabetic women.
Conclusions:
- The ACC/AHA cholesterol guidelines demonstrate clinical usefulness in this population.
- Potential for overtreatment exists, particularly among women.
Background:
The ACC/AHA released a new guideline on the assessment of cardiovascular risk and management of hypercholesterolemia that some controversy exists concerning its usefulness. We examined the clinical usefulness of this guideline in a high incidence population using novel measures.
Methods:
First, we validated the new risk equation in a cohort of 2372 men and 2781 women aged 40-75 years. Then, high risk individuals for cardiovascular diseases (CVDs) were identified according to the ACC/AHA guideline at baseline (as a predictor) and CVD outcomes were detected during a 10-year follow-up. Discrimination of the guideline was quantified and the quality of decisions was evaluated by Net Benefit Fraction index considering the harm, for false-positive, and benefit, for true-positive predictions. Finally, net number needed to treat (NNT) for statin was estimated, using test tradeoff index, in diabetic and non-diabetic subjects.
Results:
During follow-up, 726 CVD events including 298 hard CVDs occurred. The equation overestimated the risk by 57% in men and 48% in women. Based on the guideline, 73% of men and 44% of women were eligible for statin therapy. The lowest sensitivity was detected for intensive treatment in non-diabetic subgroups (82% in men and 41% in women; corresponding specificity, 52% and 90% respectively). The guideline had a significant net benefit for both moderate and intensive treatment, which resulted in estimated NNTs ranged 5-55; however, net benefit of intensive therapy was uncertain in non-diabetic women.
Conclusions:
We objectively showed that the ACC/AHA recommendations could be useful in our population but with some overtreatment in women.
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