From ACC: A Consensus Approach to the Use of Non-Statin Therapy for Atherosclerotic Cardiovascular Disease Prevention

By Carl E. Orringer, MD, FACC; Pamela Bowe Morris, MD, FACC; Donald M. Lloyd-Jones, MD, FACC

Guideline-directed patient care recommendations are based upon studies that make observations on groups of subjects who have specific characteristics and exhibit variable degrees of benefit or harm in response to various interventions. While the data derived from clinical trials provide information on the mean response of those taking a specified treatment versus those on placebo or alternate therapy, the results may not necessarily apply to a specific patient with unique clinical characteristics. When the evidence base that would otherwise direct care falls beyond the scope of well-designed clinical trials, or when patients who have uncommon conditions are encountered in clinical practice, clinicians often seek guidance that requires an interpretation of how the best available data can be used to facilitate clinical decision-making.

As advocated by a 2014 ACC Presidential Task Force, a new focus was to be placed on the development of concise decision pathways and/or key points of care. Stakeholder input was to be considered via roundtables or think tank meetings and then writing groups were to be convened to provide "Expert Consensus Decision Pathways" (ECDP's), the purpose of which was to develop clinical policy based upon "expert opinion in areas in which important clinical decisions are not adequately addressed by the available existing trials." These ECDP's were developed to complement existing guidelines and provide clinical guidance between new versions of the Guidelines.

In accordance with the above plan of action, the ACC held the second "LDL: Address the Risk Think Tank" on September 16, 2015. This meeting included expert clinicians and stakeholders from key patient advocacy groups, health plans, pharmacy benefit managers, drug manufacturers, electronic health record vendors, and health systems to discuss the impact that newer data might have on the care of high risk patients with dyslipidemia. The National Lipid Association (NLA) was an invited stakeholder organization at this meeting, and NLA representation was requested on the Writing Group that was subsequently convened to create the2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk.1

The process employed in the creation of the ECDP document was supported by the ACC without external funding. All members of the Writing Group volunteered their time to create the document. The document was formulated based upon multiple conference calls among committee members and ACC staff. A formal review was completed based upon ACC policy, including expert reviewers nominated by the ACC. Two NLA reviewers were sought to provide input on behalf of the organization. A public comment period was also held to provide additional feedback. All comments were adjudicated by the Writing Committee, and then the final document was evaluated and approved for publication by the ACC governing bodies and the NLA Board of Directors.

The document began by endorsing the basic recommendations of the 2013 ACC/AHA Blood Cholesterol Guideline.2 The evidence base employed in that Guideline was randomized controlled trials (RCT's) with ASCVD outcomes and systematic reviews and meta-analyses of RCT's with ASCVD outcomes. As stated in the Guideline, "A limited number of expert opinion recommendations were made only when RCT evidence was not present and after a thorough consideration of what the Expert Panel had learned from the RCT's." The Guideline recommended that in individuals on maximally-tolerated statin therapy with a less-than-anticipated response to those agents, and in high-risk categories, including:

• clinical ASCVD <age 75 years;
• LDL-C ≥190 mg/dL; and
• age 40-75 years with diabetes,

consideration may be given to the use of non-statin cholesterol drugs if ASCVD risk-reduction benefits outweigh the potential for adverse effects. The Guideline also advised that preference should be given to cholesterol-lowering drugs shown to reduce ASCVD events in RCT's.

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