Guideline Quiz: ACC Update on Non-Statin Therapy for ASCVD

What do the most current guidelines recommend for use of non-statin therapies in management of atherosclerotic cardiovascular disease (ASCVD)? Find out what you already know and what you may need to brush up on with this short quiz based on the 2017 update to the ACC Expert Consensus Decision Pathway (ECDP) on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk.¹

1. According to the 2013 ACC/AHA Guideline for Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults,² which of the following is NOT a statin benefit group?

A.  Adults aged ≥ 21 years with clinical ASCVD.

B.  Adults aged ≥ 21 years with LDL-C ≥ 170 mg/dL.

C.  Adults aged 40-75 years without ASCVD but with diabetes and with LDL-C between 70-189 mg/dL.

D.  Adults aged 40-75 years without ASCVD or diabetes and with LDL-C 79-189 mg/dL and estimated 10-year risk for ASCVD ≥ 7.5%.

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The correct answer is B. Adults aged ≥ 21 years with LDL-C ≥ 170 mg/dL is NOT recognized as a statin benefit group.

All of the above are designated as statin benefit groups except option B. The guidelines do identify adults aged ≥21 years with LDL-C ≥ 190 mg/dL as a group that would benefit from statin therapy, a parameter meant to carve out an adult group with hyperlipidemia or heterozygous FH. The ASCVD pooled cohorts risk calculator is used to assess the 10-year risk for ASCVD and statin therapy is recommended for anyone considered “high risk” (ASCVD risk ≥ 7.5%). Statin therapy can also be considered for “intermediate” risk (ASCVD risk between 5-7.5%) if other ASCVD risk factors are present (ie, LDL-C ≥ 160 mg/dL, family history of premature ASCVD, hs-CRP ≥ 2.0 mg/L, CAC ≥ 300 Agatston units, ABI < 0.9, high lifetime ASCVD risk).² The 2017 update to the Expert Consensus Decision Pathway did not make any changes to these major statin groups as defined in the 2013 guidelines.

2. Which of the following options accurately summarizes the results of the IMPROVE-IT trial?

A.  There was no benefit of niacin on a background of statin therapy in patients with ASCVD and LDL-C < 70 md/dL despite an increase in HDL-C.

B.  Inhibition of PCSK9 with evolocumab on a background of statin therapy lowered LDL-C levels to a median of 30 mg/dL and reduced the risk of cardiovascular events.

C.  Among participants with ASCVD, the addition of extended-release niacin–laropiprant to statin-based LDL-C–lowering therapy did not significantly reduce the risk of major vascular events but did increase the risk of serious adverse events.

D.  When added to statin therapy, ezetimibe resulted in incremental lowering of LDL-C levels and improved cardiovascular outcomes over 7 years of follow-up. Lowering LDL-C to levels below previous targets provided additional benefit without significant adverse events.

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The correct answer is D. Ezetimibe added to statin therapy reduced LDL-C and improved CV outcomes over 7 years.

Option A is the AIM-HIGH³ study of niacin on a background of statin therapy. Option B summarizes the result of the FOURIER trial.⁴ Option C describes results of the HPS-2 Thrive trial.⁵ Option D summarizes the results of IMPROVE-IT,⁶ which enrolled 18,144 patients within 10 days of a preceding acute coronary syndrome and randomized patients to either simvastatin 40 mg monotherapy or the combination of simvastatin 40 mg and 10 mg ezetemibe.

3. Which of the following are FDA-approved fully human monoclonal antibodies to PCSK9?

A.  Alirocumab

B.  Evolocumab

C.  Bococizumab

D.  A and B

E.   B and C

F.   None of the above

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The correct answer is D. A (alirocumab) and B (evolocumab) are FDA-approved PCSK9 inhibitors.

Both alirocumab (Praluent) and evolocumab (Repatha) have been approved by the FDA as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous FH (HeFH) or clinical ASCVD who require additional lowering of LDL-C. Evolocumab has also been approved in combination with other therapies for homozygous FH.

 4. Which of the following are additions/changes to the 2017 Focused Update to the 2016 ACC Expert Consensus Decision Pathway?

A.  A downgrading of bile acid sequestrant use, recommending the class only as optional secondary agents for those intolerant to ezetemibe.

B.  Incorporation of cardiovascular outcome data on PCSK9 inhibitors.

C.  Addition of multiple factors that may be considered for the identification of higher-risk patients with the addition of non-statin therapies to maximally tolerated statin: age ≥ 65 years, prior MI or non-hemorrhagic stroke, current daily cigarette smoking, symptomatic PAD, history of non-MI related coronary revascularization, residual CAD with ≥ 40% stenosis in ≥ 2 large vessels, HDL-C < 40 mg/dL for men, < 50 mg/dL for women, hs-CRP > 2 mg/L, or metabolic syndrome.

D.  All of the above

E.  None of the above

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The correct answer is D. All of the above

Options A, B and C are all changes/additions incorporated into the focused 2017 update.

5. True or False. The expert committee does not recommend the routine use of niacin as an adjunctive non-statin therapy.

A.  True

B.  False

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The correct answer is A. True.

Based on the results of the AIM-HIGH study³ and a meta-analysis on the use of niacin for primary and secondary prevention of CV events,7 no definitive benefit of niacin is observed and therapy is associated with side effects, therefore routine use is not recommended.

References

1. Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2017 Focused Update of the 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol. 2017 Aug 30. pii: S0735-1097(17)38898-8. doi: 10.1016/j.jacc.2017.07.745. [Epub ahead of print]
2. Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice. Circulation. 2013;01.cir.0000437738.63853.7a
3. The AIM-HIGH Investigators. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. N Engl J Med 2011; 365:2255-2267December 15, 2011.
4. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med 2017;376:1713-1722.
5. HPS2-THRIVE Collaborative Group. Effects of extended-release niacin with laropiprant in high-risk patients.N Engl J Med 2014; 371:203-212.
6. Cannon CP, Blazing MA, Giugliano RP,et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med 2015; 372:2387-2397.
7. Schandelmaier S, Briel M, Saccilotto R, et al. Niacin for primary and secondary prevention of cardiovascular events. Cochrane Database Syst Rev. 2017 6:CD009744.