Karol E. Watson, MD, PhD, FACC reviewing Mortensen MB et al. J Am Coll Cardiol 2015 Dec 22. Bittner V. J Am Coll Cardiol 2015 Dec 22.

To compare the strengths of three approaches for deciding which primary­prevention patients should be treated with a statin, investigators analyzed data from the Copenhagen General Population Study on 37,892 subjects enrolled in 2003–2008 and free of atherosclerotic cardiovascular disease (ASCVD), diabetes, and statin use at baseline (age range, 40–75; mean age, 56; 57% women).

The three approaches to determine eligibility for a primary­prevention statin were:

• Risk­based, per the 2013 cholesterol guidelines from the American College of Cardiology/American Heart Association (ACC/AHA; NEJM JW Cardiol Jan 2014 and J Am Coll Cardiol 2014; 63:2889); patients aged 40 to 75 with 10­year ASCVD risk ≥7.5% or LDL­cholesterol ≥190 mg/dL were eligible.
• Trial­based (JAMA 2013; 310:1123); i.e., guided by various enrollment criteria used in five large primary­prevention statin trials (e.g., men aged 45–64 with total cholesterol ≥252 mg/dL plus LDL­cholesterol ≥155 mg/dL).
•  Hybrid approach (age range, 45–79; J Am Coll Cardiol 2015; 65:942), requiring both 10­year ASCVD risk >7.5% and trial­based inclusion criteria (LDL­cholesterol ≥160 mg/dL, orLDL­cholesterol 130–160 mg/dL and HDL­cholesterol ≤45 mg/dL, or LDL­cholesterol <130 mg/dL and high­sensitivity C­reactive protein ≥2 mg/L).

The investigators calculated the observed event rate per 1000 person­years among statin­eligible participants. In the 2013 ACC/AHA risk­based approach, 42% of the cohort were eligible for statin therapy; the ASCVD event rate was 9.8 per 1000 person­years. With the trial­based approach, 56% were eligible for statin therapy, but the observed event rate was only 6.8 per 1000 person­years. With the hybrid approach, a much smaller proportion was eligible for statin therapy (21%), but the observed event rate was the highest, 11.2 per 1000 person­years.

Comment

According to the investigators, the ACC/AHA guidelines approach for primary prevention of ASCVD with statins prevents more ASCVD events than the other two approaches and does so while treating fewer people than the trial-based approach. In addition, the ACC/AHA risk-based approach was well-calibrated at a 10-year ASCVD risk of >7.5% in this population. The study has several strengths including the large size of the sample and the use of a contemporary cohort with over 50% women. A limitation is that the cohort used was homogeneous (white and of Danish descent). The balance of these findings favors the ACC/AHA risk-based approach, at least in this population.

CITATION(S):

1.   Mortensen MB et al. Primary prevention with statins: ACC/AHA risk­based approach versus trial­based approaches to guide statin therapy. J Am Coll Cardiol ; :. (http://dx.doi.org/10.1016/j.jacc.2015.09.089 )

2.   Bittner V.Selecting patients for statin therapy in primary prevention: If we could only predict the future. J Am Coll Cardiol ; :. (http://dx.doi.org/10.1016/j.jacc.2015.10.015)