Journal of the American College of Cardiology Vol. 63, No.

24, 2014
 2014 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00
Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jacc.2014.02.578

VIEWPOINT

2013 ACC/AHA Cholesterol Treatment Guideline

What Was Done Well and What Could Be Done Better
Seth S. Martin, MD, Thura T. Abd, MD, MPH, Steven R. Jones, MD, Erin D. Michos, MD, MHS,
Roger S. Blumenthal, MD, Michael J. Blaha, MD, MPH
Baltimore, Maryland

Five years after convening the expert panel, the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to
Reduce Atherosclerotic Cardiovascular Risk in Adults was released. The American College of Cardiology and
American Heart Association issued the guideline on the basis of a systematic review of cholesterol treatment trials
performed by the National Heart, Lung, and Blood Institute. This report critically appraises the guideline and provides
our view of what was done well and what could be done better. In particular, we propose that the guideline succeeds
in prioritizing statin therapy, expanding the focus to atherosclerotic cardiovascular disease (including stroke), and
emphasizing absolute cardiovascular risk to determine eligibility for statin therapy. We contend that the guideline
could be enhanced by rening the use of lipid goals rather than removing them, enhancing guidance on evaluation
of cholesterol, and broadening the concept of age underpinning risk-based decision making to include vascular and
physiological age. We further suggest that the next guideline panel could comprehensively review current best
evidence, build on existing guidelines, and cultivate broader national and international consensus. Overall, we aim to
continue discussions about the important contributions and shortfalls of the guideline and create momentum for
effective implementation and timely updates. (J Am Coll Cardiol 2014;63:26748) 2014 by the American
College of Cardiology Foundation

Five years after it was commissioned, the document previ- the original publication of the Adult Treatment Panel
ously known as ATP IV was issued on November 12, 2013, (ATP) III guideline, the Cholesterol Treatment Trialists
under a revised name, 2013 ACC/AHA Guideline on the Collaboration has further expanded the extraordinary wealth
Treatment of Blood Cholesterol to Reduce Atherosclerotic of information on statin therapy (4,5). This class of medi-
Cardiovascular Risk in Adults (henceforth abbreviated as cations is 1 of the best validated to reduce the morbidity
CTG for Cholesterol Treatment Guideline) (1). The and mortality from atherosclerotic cardiovascular disease
American College of Cardiology and American Heart Asso- (ASCVD) and has an excellent safety prole (1,2,4). More-
ciation (ACC/AHA) issued the CTG on the basis of a sys- over, generic options for moderate- and high-intensity statin
tematic review of cholesterol treatment trials. This report formulations are now available. We anticipate that priori-
critically appraises the CTG and provides our view of what was tizing statins will lead to much less use of nonstatin therapy
done well and what could be done better in future iterations. in patients not yet on maximally tolerated statin therapy.
Expanding the focus to ASCVD. Cerebrovascular disease
What Was Done Well and coronary heart disease (CHD) share risk factors and the
underlying disease process of atherosclerosis. Lipid-lowering
Prioritizing statin therapy. The CTG succeeds in priori- interventions reduce clinical events related to ASCVD, not
tizing statin therapy, which is in line with recommendations only CHD. Therefore, addressing the broader disease
from our group (2) and others (3). Over the decade since construct is justied and more efcient.
There are complexities to this expanded paradigm, not
From the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, limited to the fact that 1 of multiple underlying patho-
Baltimore, Maryland. Dr. Martin is supported by the Pollin Cardiovascular Prevention physiological mechanisms can cause a stroke, and the
Fellowship, Marie-Jose and Henry R. Kravis endowed fellowship, and a National
Institutes of Health training grant (T32HL07024). Drs. Martin and Jones are listed as distinction can be challenging to adjudicate. Although we
coinventors on a pending patent led by Johns Hopkins University for a method of must carefully scrutinize and understand how to manage
low-density lipoprotein cholesterol estimation. Dr. Jones is a member of the scientic such complexities, on balance, expanding the framework
advisory board for and has received grant support from Atherotech Diagnostic Lab.
Dr. Blumenthal is supported by the Kenneth Jay Pollin Professorship in Cardiology.
from CHD to ASCVD is an important and welcome
Dr. Blaha is supported by National Institutes of Health grant L30HL110027. All change (6).
other authors have reported that they have no relationships relevant to the contents of Emphasizing absolute cardiovascular risk. The CTG
this paper to disclose.
Manuscript received December 3, 2013; revised manuscript received January 28,
emphasizes absolute risk in the allocation of statin therapy.
2014, accepted February 25, 2014. The CTG recommends moderate- to high-intensity statin
JACC Vol. 63, No. 24, 2014 Martin et al. 2675
June 24, 2014:26748 Analysis of the 2013 Cholesterol Guideline

therapy in groups with high absolute risk, including patients does not need to trigger auto- Abbreviations
with clinical ASCVD, those 40 to 75 years of age with matic addition of drug therapy. and Acronyms
diabetes mellitus, and those with low-density lipoprotein Rather, it could prompt a dis-
ACC/AHA = American
cholesterol (LDL-C) levels 190 mg/dl. The CTG prior- cussion of residual risk and op- College of Cardiology and
itizes these 3 groups on the basis of prevailing evidence from tions for further intensication of American Heart Association
randomized controlled trials. lifestyle improvements and add- AACE = American
For those not in one of these groups, if the patient has an on drug therapy, particularly in Association of Clinical
LDL-C level of 70 to 189 mg/dl and is 40 to 75 years of age, the setting of an elevated tri- Endocrinologists

then the CTG advises calculation of 10-year risk of ASCVD glyceride level and a low HDL-C ASCVD = atherosclerotic
on the basis of traditional risk factors using new sex- and level. Because the anticipated net cardiovascular disease

race-stratied pooled cohort equations developed by the benets of further lipid lowering ATP III = Adult Treatment
Panel III
ACC/AHA Risk Assessment Working Group (7). Concern are clearest in those with the
about overestimation of risk by these equations is being most clearly established risk, we CHD = coronary heart
disease
debated (8,9), and further validation studies are necessary. believe that lipid goals are best
CTG = Cholesterol
Nevertheless, we appreciate the intention to address absolute justied in high-risk secondary
Treatment Guideline
risk in primary prevention. In the CTG, the risk calculator prevention.
HDL-C = high-density
does not mandate drug prescription but rather serves as a It is true that there has not been lipoprotein cholesterol
starting point for a discussion about risk between the patient a denitive randomized clinical
LDL-C = low-density
and the clinician. This discussion may lead to additional trial of the addition of a second lipoprotein cholesterol
testing to rene the estimate of absolute risk. The CTG lipid-lowering agent in secondary
NLA = National Lipid
identies the intermediate-risk group as people with a 5% to prevention patients with residu- Association
7.5% 10-year risk of ASCVD and recommends a discussion ally elevated atherogenic choles-
about risk in people with 7.5% risk. terol levels. There are many clinical situations, including
in the management of hypertension, in which there are no
randomized trials of ASCVD outcomes with the addition
What Could Be Done Better
of drug A to drug B or the addition of drug C to drugs A
Rene the use of lipid goals rather than remove and B. However, we could learn from landmark strategy
them. There are potential downsides to lipid goals. They trials such as the COURAGE (Clinical Outcomes Uti-
could lead to overuse of nonstatin agents and combination lizing Revascularization and Aggressive Drug Evaluation)
regimens instead of maximizing statin therapy. This could trial, in which statins and nonstatins were titrated to an
increase the propensity for adverse effects, which could be LDL-C goal of 60 to 85 mg/dl. The central test of the
problematic specically in primary prevention patients with trial was optimal medical therapy with or without percu-
less certain absolute ASCVD risk and, therefore, less certain taneous coronary intervention, and it forms part of the
benets. Moreover, lipid goals could conceivably result in foundation for management of patients with stable CHD.
withholding of efcacious treatment in a person with an A COURAGE-like strategy to medical management in-
LDL-C level <100 mg/dl. Prior guidelines may not have cludes an LDL-C goal.
recommended intensive statin therapy, or a statin at all, in As previously reviewed (11,12), complementary lines of
higher-risk patients with low or average off-treatment levels evidence support the low LDL-C goal used in the COURAGE
of LDL-C (100 to 130 mg/dl), yet this group has a similar trial (or similar goals such as <80 or <70 mg/dl). First, LDL-C
proportional risk reduction from lowering of LDL-C levels levels in this range appear to be evolutionarily or biologically
(4). Therefore, applying a lipid goal at baseline could lead normal. Second, those with genetically determined low
to underuse of statins in higher-risk patients. LDL-C levels are strongly protected from ASCVD. Third,
We could address these issues without abandoning lipid trials and observational studies have consistently shown a
goals. To do so, we could refocus the use of lipid goals as an log-linear association of lower LDL-C level with lower risk
option to guide residual risk discussions on follow-up among of ASCVD. Fourth, populations treated to low LDL-C
those with a clearly established risk of ASCVD while levels in trials were more likely to have stabilization or
making it explicitly clear that maximizing the statin dose is regression of atherosclerosis. Fifth, the Cholesterol Treat-
the rst priority. Even in secondary prevention trial pop- ment Trialists Collaboration has shown that the benet of
ulations carefully selected to adhere to high-intensity statin statin therapy is tied not only to absolute ASCVD risk but
therapy, many patients did not attain optimal levels of also to the absolute lowering of LDL-C levels, with each
atherogenic cholesterol. In statin-treated patients, LDL-C, 39-mg/dl (1-mmol/l) reduction in LDL-C level decreas-
nonhigh-density lipoprotein cholesterol (nonHDL-C), ing the incidence of ASCVD by approximately one-fth.
and apolipoprotein B are markers of residual risk (10). Finally, subgroups of patients attaining the lowest LDL-C
Considering LDL-C and nonHDL-C on follow-up in levels in these trials had the best outcomes without any
relation to explicit goals, as was done in ATP III, could alert signicant increases in major adverse effects. Therefore, like
the patient and provider that levels are still suboptimal. This COURAGE, ATP III, and guidelines in Europe and
2676 Martin et al. JACC Vol. 63, No. 24, 2014
Analysis of the 2013 Cholesterol Guideline June 24, 2014:26748

Canada, we could use this information to manage residually However, people age differently. We submit that a broader
elevated LDL-C levels. construct of age may enhance risk discussions and treatment
Because LDL-C will not capture triglyceride-rich decisions. Heart age and vascular age could help patients
remnant lipoproteins, we could also consider nonHDL-C better understand how their risk compares with their chro-
or apolipoprotein B. A previous meta-analysis of statin and nological age. Moreover, the concepts of health age or
nonstatin lipid-lowering drugs used as monotherapy found a physiological age could be used to assess our patients
w1:1 percent lowering between nonHDL-C level and risk noncardiovascular comorbidities or competing risks, which
of CHD (13). Pre-specied subgroup analyses of trial par- could affect the net benets from intervention. If the patient
ticipants with high triglyceride and low HDL-C levels is free of competing risks, then we would suggest that the
(markers for remnants) are informative on the potential CTG could be less cautious in those older than 75 years of
benet of adding a brate (14) or niacin (14,15) to statin age. The meta-analysis by the Cholesterol Treatment Tria-
therapy. These studies have shown a consistent trend for lists Collaboration included 1,872 events in subjects older
benet. than 75 years of age, and there was no evidence of hetero-
Therefore, treating risk and treating lipids are not geneity of treatment effect by age (4). A meta-analysis
mutually exclusive and are actually complementary. Absolute focused on elderly patients without ASCVD at baseline, in-
risk places the lipids in context and can guide discussions volving 24,674 subjects with a mean age of 73.0  2.9 years
weighing potential benets and harms. However, lipid goals and 3.5  1.5 years of follow-up, found a signicant
provide a marker for adequacy of lipid lowering. They not reduction in ASCVD outcomes with statin therapy (18).
only help ensure adherence to lifestyle improvements and We would also like to prevent signicant accumulation of
statin therapy but also help guide therapy in high-risk atherosclerosis earlier in life. A risk score dominated by
patients in whom these treatments are exhausted. chronological age favors late treatment. Once atherosclerosis
Enhance guidance on evaluation of cholesterol. The progresses to an advanced stage, there may be an associated
CTG does not include evaluation in its title, as it was in degree of unmodiable risk. Although speculative, pre-
ATP III. However, new information has become available venting signicant progression of atherosclerosis in the rst
on the evaluation of cholesterol since ATP III. Although the place may help avoid at least part of this residual risk. It is
risk assessment guideline examines this information to some striking that the relative risk reduction associated with a
extent, evaluation of cholesterol is not purely an issue of risk genetically low LDL-C level is larger than that with later-
assessment. stage drug therapy (19).
For example, at baseline, the CTG recommends treat- We submit the following for debate: if you are stuck on a
ment if the LDL-C level is 70 mg/dl but not if it deserted island, have signicant subclinical atherosclerosis or
is <70 mg/dl. Therefore, accurate measurement in the in- heterozygous familial hyperlipidemia with an LDL-C level
dividual patient is critical to management. Expanding prior of 189 mg/dl, and have only enough statin to take for 20
evidence, we have shown that of patients who have a years, would you take it from 30 to 50 years of age or 50 to
Friedewald-estimated LDL-C level <70 mg/dl, 23% have a 70 years of age?
directly measured LDL-C level 70 mg/dl (39% if the Comprehensively review current best evidence, build
triglyceride level is 150 to 199 mg/dl and 59% if the on existing guidelines, and rene the CTG during
triglyceride level is 200 to 399 mg/dl) (16). If externally implementation. Evidence-based medicine is the con-
validated, a novel method for estimation of LDL-C levels scientious, explicit, and judicious use of current best evidence
could resolve much of the underestimation of LDL-C levels in making decisions about the care of individual patients
by accounting for variation in the relationship of triglycerides (20). Aimed at supporting evidence-based medicine, the
to very-low-density lipoprotein cholesterol (17). CTG conducted a systematic search of randomized
The next guideline could translate new knowledge on controlled trials through December 2009, and was also
cholesterol evaluation. It could take a leadership role in guiding allowed to consider trials through July 2013. The phrase no
clinicians on not only LDL-C but also nonHDL-C, apoli- evidence could be a dangerous claim (21), especially when
poprotein B, and LDL particle concentration. Along with the all current best evidence has not been considered.
science, there are historical, nancial, and logistical consider- A search on PubMed for cholesterol on the day the
ations, and an expert panel is well suited to weigh these factors. CTG was released yielded 219,290 published scientic
Broaden the concept of age. The CTG emphasizes reports. In answering Critical Question 1 about lipid goals,
chronological age in treatment decisions. For example, the the CTG screened 2,224 titles and abstracts, that is, w1%
CTG explicitly recommends statin therapy only in patients of the published literature.
who are 40 to 75 years of age. This same age range also To construct a comprehensive guideline, the writing group
determines who undergoes 10-year ASCVD risk calculation did not necessarily need to re-review >200,000 published
to guide treatment decisions. Age dominates the risk scientic reports. The ATP III critically appraised and syn-
calculator, with the 7.5% risk threshold exceeded by nearly thesized the relevant literature through 2004 (22). In addi-
all men in their mid to late 60s and nearly all women in their tion, specialty societies such as the National Lipid Association
70s despite an optimal risk factor prole. (NLA) (23) and the American Association of Clinical
JACC Vol. 63, No. 24, 2014 Martin et al. 2677
June 24, 2014:26748 Analysis of the 2013 Cholesterol Guideline

Endocrinologists (AACE) (24) have recently issued recom- guideline was not released for public comment before its
mendations for the management of cholesterol disorders. publication, we hope that a careful discussion about its
The NLA and the AACE each provided input to the content will continue, involving patients, health pro-
National Heart, Lung, and Blood Institute and ACC/AHA fessionals, scientists, health systems, and payers. We offer
during the development of the CTG but ultimately did not our initial reactions, aimed at creating momentum for
endorse the document. The reasons why the NLA and the effective guideline implementation and timely updates that
AACE each did not endorse the CTG were explained in will support the application of current best evidence to the
public statements (25,26). Each group cited the highly care of individual patients.
restrictive consideration of evidence, removal of lipid targets,
too little guidance on nonstatin options, and insufcient Reprint requests and correspondence: Dr. Michael J. Blaha,
consideration of special populations of patients. Blalock 524CJohns Hopkins Hospital, 1800 Orleans Street,
Outside of the United States, while the United Kingdom Baltimore, Maryland 21287. E-mail: [email protected].
just released a provisional guideline for stakeholder
comment (27), experts in Europe (28) and Canada (29,30)
have already completed updated guidelines. The Interna- REFERENCES

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178. Key Words: atherosclerosis - cardiovascular disease - cholesterol -
25. NLA Statement on the 2013 ACC/AHA Guideline on the Treatment coronary heart disease - dyslipidemia - guidelines - lipids -
of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in lipoproteins - myocardial infarction - statins - stroke - treatment.