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CLINICAL STATEMENTS AND GUIDELINES

August 29, 2023 Circulation. 2023;148:e9–e119. DOI: 10.1161/CIR.0000000000001168

Virani et al 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Chronic Coronary Disease Guideline

is observed in those with the highest baseline LDL-C levels and at similar risk of events. Furthermore, percent reduction in LDL-C appears to provide additional prognostic value overachieved LDL-C levels.43 The expected percent reduction in LDL-C levels with high-intensity statin therapy is ≥50% and should be used to assess clinical efficacy. However, baseline LDL-C levels in patients before statin initiation are not always available in clinical practice. The threshold of LDL-C ≥70 mg/dL is then useful to determine whether to intensify lipid management. 2.	 Although high-intensity statin therapy is preferred,

high-intensity statin therapy may not be tolerated by some patients or may be contraindicated because of clinically significant drug-drug interactions.44 Statin intolerance is defined as adverse effects associated with statin therapy that improve or resolve with dose modification or discontinuation of statin therapy; and requires a trial of at least 2 statins with one at the lowest approved daily dose.45 Statin intolerance may also be complete or partial (tolerating less than the recommended statin intensity). Clinicians should also consider the possibility of a “nocebo effect”— patient expectation of harm resulting in perceived adverse effects.46 Multiple RCTs showed that moderate-intensity statin therapy also reduces cardiovascular events and death among patients with established ASCVD, including those >75 years of age; therefore, a moderate-intensity statin should be used in patients unable to tolerate a high-intensity statin.2,4–8 Additional strategies may also be used to identify a tolerable statin regimen (eg, low-intensity statin, alternative daily dosing) to reduce LDL-C but it is unclear if these strategies also reduce the risk of ASCVD events.47

3 The goal for LDL-C lowering is defined as percent-

age responses in LDL-C relative to baseline levels. Although reductions in LDL-C are expected with moderate- and high-intensity statins (Table 11), individual response can vary substantially.11 The maximum percentage change in LDL-C occurs within 4 to 12 weeks after initiation of or change in lipid-lowering therapy. The Friedewald equation is known to underestimate LDL-C in the setting of elevated TG levels, thus other approaches to LDL-C measurement (eg, Martin/Hopkins method) may be desirable.48,49 Obtaining lipid profile measurements every 3 to 12 months is associated with increased adherence to therapy and identification of patients requiring further intensification of treatment.9,10 See Sections 4.4.3 and 5 of the 2018 AHA/ACC multisociety cholesterol guideline50 for additional information regarding efficacy and safety monitoring. 4.	 The economic value of a lipid-lowering therapy depends on the absolute benefit (in terms of the number of cardiovascular events averted or quality-adjusted life years [QALY] gained) that patients derive from receiving the treatment relative to the comparator as well as the cost of the therapy being evaluated.13 Because of the very low annual cost of generic formulations of statins in the United States, the use of maximally tolerated statin therapy in patients with CCD is projected to be cost-saving (ie, the lifetime savings from averted cardiovascular events more than offset the lifetime cost of statin therapy and resulting adverse effects).12 Note that this value statement should not be extrapolated to higher-cost branded formulations of statins. 5.	 In IMPROVE-IT (Improved Reduction of Outcomes; Vytorin Efficacy International Trial), the addition of ezetimibe to moderate-intensity statin therapy among patients with ACS resulted in a significant ASCVD risk reduction (7% relative

Table 10.  Very High-Risk* of Future ASCVD Events Definition of Very High-Risk* History of multiple major ASCVD events OR One major ASCVD event AND ≥2 high-risk conditions Major ASCVD Events Recent ACS (within the past 12 mo) History of MI (other than recent ACS events listed above) History of ischemic stroke Symptomatic peripheral artery disease (history of claudication with ABI <0.85, or previous revascularization or amputation)51 High-Risk Conditions Age ≥65 y Familial hypercholesterolemia† History of previous coronary artery bypass graft surgery or percutaneous coronary intervention outside of the major ASCVD event(s) Diabetes Hypertension Chronic kidney disease (eGFR, 15–59 mL/min/1.73 m2)15,29 Current tobacco smoking Persistently elevated LDL-C ≥100 mg/dL despite maximally tolerated statin therapy and ezetimibe History of congestive heart failure *Very high-risk includes a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions. †Management of patients with familial hypercholesterolemia often requires combination lipid lowering therapy and referral to a lipid specialist, and possibly lipoprotein apheresis.58,59 ABI indicates ankle brachial index; ACS, acute coronary syndrome; ASCVD, atherosclerotic cardiovascular disease; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; LDL-C, low-density lipoprotein cholesterol; and MI, myocardial infarction. Modified with permission from Grundy SM, et al.42 Copyright 2019 American Heart Association, Inc., and American College of Cardiology Foundation.

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