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June 18/25, 2019 Circulation. 2019;139:e1082–e1143. DOI: 10.1161/CIR.0000000000000625 e1092 CLINICAL STATEMENTS AND GUIDELINES Value Statement: Low Value (LOE: B-NR) 6. At mid-2018 list prices, PCSK9 inhibitors have a low cost value (>$150 000 per QALY) compared to good cost value (<$50 000 per QALY) (Section 7 provides a full discussion of the dynamic interaction of different prices and clinical benefit).S4.1-20–S4.1-22 IIa B-R 7. In patients older than 75 years of age with clinical ASCVD, it is reasonable to initiate moderate- or high-intensity statin therapy after evaluation of the potential for ASCVD risk reduction, adverse effects, and drug– drug interactions, as well as patient frailty and patient preferences.S4.1-23–S4.1-31 IIa C-LD 8. In patients older than 75 years of age who are tolerating high-intensity statin therapy, it is reasonable to continue high-intensity statin therapy after evaluation of the potential for ASCVD risk reduction, adverse effects, and drug-drug interactions, as well as patient frailty and patient preferences.S4.1-3,S4.1-10,S4.1-23,S4.1-26,S4.1-31–S4.1-36 IIb B-R 9. In patients with clinical ASCVD who are receiving maximally tolerated statin therapy and whose LDL-C level remains 70 mg/dL or higher (≥1.8 mmol/L), it may be reasonable to add ezetimibe.S4.1-15 IIb B-R 10. In patients with heart failure (HF) with reduced ejection fraction attributable to ischemic heart disease who have a reasonable life expectancy (3 to 5 years) and are not already on a statin because of ASCVD, clinicians may consider initiation of moderate-intensity statin therapy to reduce the occurrence of ASCVD events.S4.1-37 *Clinical atherosclerotic cardiovascular disease (ASCVD) includes acute coronary syndrome (ACS), those with history of myocardial infarction (MI), stable or unstable angina or coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or peripheral artery disease (PAD) including aortic aneurysm, all of atherosclerotic origin. Synopsis Clinical ASCVD encompasses ACS, those with history of MI, stable or unstable angina or coronary or other arterial revascularization, stroke, TIA or PAD including aortic aneurysm, all of atherosclerotic origin. The writing group used primarily the Cholesterol Treatment Trialists’ (CTT) meta-analysisS4.1-3,S4.1-4 of statin RCTs plus 4 other RCTs.S4.1-1,S4.1-2,S4.1-38,S4.1-45 Additional RCTs have used nonstatin drugs as add-ons to statin therapy and are included here. As a primary recommendation, highintensity statin therapy is indicated for clinical ASCVD, but if this cannot be used, moderate-intensity statin therapy can be initiated (Figure 1). The first goal is to achieve a ≥50% reduction in LDL-C levels, but if LDL-C levels remains ≥70 mg/dL (≥1.8 mmol/L) on maximally tolerated statin therapy, adding ezetimibe may be reasonable. In patients >75 years of age with ASCVD, potential benefits versus adverse effects of statin therapy should be considered before initiation of statin therapy. Finally, in very high-risk patients with multiple high-risk clinical factors, ezetimibe can be added to maximally tolerated statin therapy. Furthermore, if LDL-C levels remain ≥70 mg/dL (≥1.8 mmol/L), adding a PCSK9 inhibitor is reasonable if the cost/benefit ratio is favorable. In patients with HF due to ischemic heart disease, moderate-intensity statins may be considered. Recommendation-Specific Supportive Text 1. CTT meta-analysisS4.1-3,S4.1-4 showed that LDL-C lowering with statins reduces major ASCVD events. Patients with strokeS4.1-1 or peripheral artery diseaseS4.1-5 also derive these benefits. In a meta-analysis of 5 RCTs,S4.1-3 high-intensity statins compared with moderate-intensity statin therapy, significantly reduced major vascular events by 15% with no significant reduction in coronary deaths. Large absolute LDL-C reduction was associated with a larger proportional reduction in major vascular events.S4.1-4 High-intensity statin therapy generally reduces LDL-C levels by ≥50%. This percentage can be used to judge clinical efficacy. Absolute benefit from statin therapy depends on baseline LDL-C levels; the greatest absolute benefit accrues to patients with the highest baseline LDL-C levels. Percentage reduction of LDL-C levels is the most efficient means to estimate expected efficacy. An alternative to evaluating adequacy of therapy is to examine LDL-C on maximum-intensity statins. In a patient with ASCVD, if LDL-C level is ≥70 mg/dL (≥1.8 mmol/L), adding ezetimibe may be reasonable (see Recommendation 3). 2. Moderate-intensity statin therapy also reduces major vascular events and coronary heart disease (CHD) deaths in patients with ASCVD.S4.1-6,S4.1-7, S4.1-9–S4.1-13,S4.1-40 In RCTs, most of which included moderate-intensity statin therapy, there was a significant reduction in major vascular events even among those >75 years of age. Therefore, an upper age cutoff for moderate-intensity statin therapy was not identified in patients with ASCVD. 3. Patients with clinical ASCVD who are judged to be very high risk include those with a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions (Table 4). In these patients, additional net benefit from further LDL-C lowering when LDL-C is ≥70 mg/dL (≥1.8 mmol/L) or non–HDL-C ≥100 mg/dL (≥2.6 mmol/L) by ezetimibe and 2 PCSK9 inhibitors (evolocumab and alirocumab) has been demonstrated by 3 RCTs.S4.1-15,S4.1-17,S4.1-18 This guideline makes a strong recommendation (COR I) Recommendations for Statin Therapy Use in Patients With ASCVD (Continued) COR LOE Recommendations Downloaded from http://ahajournals.org by on October 7, 2026