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The 2022 ACC Consensus Pathway Recommends

LOWER LDL-C LEVELS AND A GREATER ROLE FOR PCSK9i mAbs LIKE REPATHA^{® 1,}*

Key Updates of the 2022 ACC Expert Consensus Decision Pathway

The ACC developed the 2022 ACC Expert Consensus Decision Pathway^† (2022 Consensus Pathway) to address gaps in care for LDL-C lowering to reduce ASCVD risk. It relies on evidence established by the 2013 ACC/AHA and 2018 AHA/ACC/Multisociety cholesterol guidelines and provides further recommendations regarding the use of non-statin therapies.

In a retrospective cohort study of 16,344 patients with a history of major ASCVD events, 94% had additional risk factors that placed them in the very high-risk category.^2,‡

VERY HIGH RISK DEFINITION
Multiple major ASCVD events

Recent ACS (within the past 12 months)

History of MI (other than recent ACS event listed above)

History of ischemic stroke

Symptomatic PAD (claudication with ABI <0.85, or prior revascularization/amputation)
or
One major ASCVD event and multiple high-risk conditions

Age ≥65 years

Prior CABG or PCI outside major ASCVD event(s)

Diabetes mellitus

HeFH

CKD (eGFR 15-59 mL/min/1.73 m²)

Hypertension

Current smoking

History of CHF

Persistently elevated LDL-C (≥100 mg/dL [≥2.6 mmol/L] despite maximally tolerated statin therapy + ezetimibe)

When to Consider Adding a PCSK9i mAb to Your ASCVD Patients’ Lipid-Lowering Therapy¹

Use the chart below as a guide for suggested treatment options for your patients with high LDL-C and when a ≥50% reduction in LDL-C is needed¹

Optimal Reduction Not Achieved With Statins?^1,§

LDL-C ≥55 mg/dL and
VERY HIGH RISK**

Consider PCSK9i mAbs, like evolocumab, and/or ezetimibe.^{††,‡‡}

If still not achieved…

Consider bempedoic
acid or inclisiran^††

LDL-C ≥70 mg/dL and
NOT VERY HIGH RISK

Consider ezetimibe.

If still not achieved…

Consider adding or replacing with PCSK9i mAbs, like evolocumab.^‡‡

If still not achieved…

Consider bempedoic
acid or inclisiran^††

Adults in above categories with possible statin-associated side effects

Consider the below drug therapy options or referral to lipid specialists:

1st PCSK9i mAbs and/or ezetimibe. If still not achieved…
2nd Bempedoic acid or inclisiran. If still not achieved in adults with an LDL-C of ≥190 mg/dL…

PCSK9i mAbs such as Repatha^® are preferred by the 2022 ACC Expert Consensus Decision Pathway as the initial PCSK9i of choice for patients with ASCVD due to

PROVEN EFFICACY

And cardiovascular outcomes data from outcomes trials¹

DEMONSTRATED SAFETY PROFILE¹

IMPROVED COST-EFFECTIVENESS

Due to updated 2018 pricing of PCSK9i mAbs¹

Effective Strategies for Advanced Lipid Management White Paper Download

Discover effective strategies for advanced lipid management, and the role that non-statin therapies like Repatha^® (evolocumab) can play

GET INSIGHTS FROM YOUR PEERS

SEE THE EFFICACY OF REPATHA®

*2022 ACC Expert Consensus Decision Pathway on the role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Solution Set Oversight Committee | Journal of the American College of Cardiology.¹

^†Note that this process did not involve formal systematic reviews, grading of evidence, or synthesis of evidence. The goal was to provide practical guidance in situations not covered by the 2018 AHA/ACC/Multisociety cholesterol guideline until the next round of guidelines has the opportunity to formally review recent scientific evidence.

^‡A retrospective cohort study of 16,344 patients 19 years of age or older with a history of a major ASCVD event using data from MarketScan database. LDL-C values were available through linkage with the quest diagnostics laboratory database between January 1, 2015 and January 1, 2016. Patients were followed from January 1, 2016 through December 31, 2017, for recurrent ASCVD events. Major ASCVD events included a recent ACS, history of MI other than a recent ACS, history of ischemic stroke, and symptomatic PAD.

^§Non-statin pharmacologic options are considered after optimizing lifestyle, controlling ASCVD risk factors, adhering to guideline-recommended statin therapy (and increasing to high-intensity statin if not already taking), and evaluating for statin intolerance.

^**Includes age ≥65 years, hypertension, diabetes, heterozygous familial hypercholesterolemia, history of prior coronary artery bypass surgery, or percutaneous coronary intervention.¹

^††Strongly consider PCSK9i mAbs if fully statin intolerant and attempts to lower LDL-C with ezetimibe or bile acid sequestrants result in persistent <50% LDL-C reduction (or may consider if LDL ≥70 mg/dL or non–HDL-C ≥100 mg/dL). Consider PCSK9i mAbs only if on maximally tolerated statin therapy (and either ezetimibe or bile acid sequestrants if not very high-risk ASCVD), with persistent <50% LDL-C reduction (or may consider if LDL-C ≥70 mg/dL or non–HDL-C ≥100 mg/dL). No cardiovascular outcome studies exist for bempedoic acid or inclisiran.¹

^‡‡PCSK9i mAbs may be preferred by the 2022 ACC Consensus Pathway as the initial non-statin agent in patients who require >25% additional lowering of LDL-C or based on clinical-patient decision-making. Potential considerations in use of PCSK9i mAbs, compared to ezetimibe, include net risk reduction benefits of a PCSK9i mAbs, administration through subcutaneous injection, every 2 weeks or once monthly dosing schedule, storage requirements, and cost.¹

References: 1. Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2022 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022;80(14):1366-1418. doi:10.1016/j.jacc.2022.07.006 2. Muntner P, Orroth KK, Mues KE, et al. Evaluating a simple approach to identify adults meeting the 2018 AHA/ACC cholesterol guideline definition of very high risk for atherosclerotic cardiovascular disease. Cardiovasc Drugs Ther. 2022;36:475-481. doi:10.1007/s10557-021-07167-1 3. Data on file, Amgen; 2022.

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INDICATIONS

The 2022 ACC Consensus Pathway Recommends

LOWER LDL-C LEVELS AND A GREATER ROLE FOR PCSK9i mAbs LIKE REPATHA^{® 1,}*

Key Updates of the 2022 ACC Expert Consensus Decision Pathway

VERY HIGH RISK DEFINITION

or

When to Consider Adding a PCSK9i mAb to Your ASCVD Patients’ Lipid-Lowering Therapy¹