JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

VOL.

ª 2014 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

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ISSN 0735-1097/$36.00

PUBLISHED BY ELSEVIER INC.

http://dx.doi.org/10.1016/j.jacc.2014.08.041

Implications of the 2013 ACC/AHA Cholesterol Guidelines for Adults in Contemporary Cardiovascular Practice Insights From the NCDR PINNACLE Registry Thomas M. Maddox, MD, MSC,*y William B. Borden, MD,z Fengming Tang, MS,x Salim S. Virani, MD, PHD,k William J. Oetgen, MD, MBA,{ J. Brendan Mullen, BSFS,# Paul S. Chan, MD, MSC,x Paul N. Casale, MD,** Pamela S. Douglas, MD,yy Fredrick A. Masoudi, MD, MSPH,*y Steven A. Farmer, MD, PHD,z John S. Rumsfeld, MD, PHD*y

ABSTRACT BACKGROUND In a significant update, the 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol guidelines recommend fixed-dose statin therapy for those at risk and do not recommend nonstatin therapies or treatment to target low-density lipoprotein cholesterol (LDL-C) levels, limiting the need for repeated LDL-C testing. OBJECTIVES The goal of this study was to examine the impact of the 2013 ACC/AHA cholesterol guidelines on current U.S. cardiovascular practice. METHODS Using the NCDR PINNACLE (National Cardiovascular Data Registry Practice Innovation and Clinical Excellence) registry data from 2008 to 2012, we assessed current practice patterns as a function of the 2013 cholesterol guidelines. Lipid-lowering therapies and LDL-C testing patterns by patient risk group (atherosclerotic cardiovascular disease [ASCVD], diabetes, LDL-C $190 mg/dl, or an estimated 10-year ASCVD risk $7.5%) were described. RESULTS Among a cohort of 1,174,545 patients, 1,129,205 (96.1%) were statin-eligible (91.2% ASCVD, 6.6% diabetes, 0.3% off-treatment LDL-C $190 mg/dl, 1.9% estimated 10-year ASCVD risk $7.5%). There were 377,311 patients (32.4%) not receiving statin therapy and 259,143 (22.6%) receiving nonstatin therapies. During the study period, 20.8% of patients had 2 or more LDL-C assessments, and 7.0% had more than 4. CONCLUSIONS In U.S. cardiovascular practices, 32.4% of statin-eligible patients, as defined by the 2013 ACC/AHA cholesterol guidelines, were not currently receiving statins. In addition, 22.6% were receiving nonstatin lipid-lowering therapies and 20.8% had repeated LDL-C testing. Achieving concordance with the new cholesterol guidelines in patients treated in U.S. cardiovascular practices would result in significant increases in statin use, as well as significant reductions in nonstatin therapies and laboratory testing. (J Am Coll Cardiol 2014;-:-–-) © 2014 by the American College of Cardiology Foundation.

I

n 2013, at the request of the National Heart,

updated the guidelines on the treatment of blood

Lung, and Blood Institute of the National Insti-

cholesterol to reduce atherosclerotic cardiovascular

tutes of Health, the American College of Cardiol-

risk in adults (1–3). This update was a significant

ogy (ACC) and American Heart Association (AHA)

departure from the previous Third Report of the

From the *Cardiology Section, VA Eastern Colorado Health Care System, Denver, Colorado; yUniversity of Colorado School of Medicine, Aurora, Colorado; zGeorge Washington University, Washington, DC; xMid-America Heart Institute, Kansas City, Missouri; kMichael E. DeBakey VA Medical Center, Baylor College of Medicine, Houston, Texas; {American College of Cardiology, Washington, DC; #National Quality Forum, Washington, DC; **Lancaster General Health, Lancaster, Pennsylvania; and the yyDuke University Medical Center, Durham, North Carolina. Dr. Maddox is supported with a VA Health Services Research and Development career development award. Dr. Oetgen is the Executive Vice President for Science, Education, and Quality of the American College of Cardiology. Dr. Masoudi is the Senior Medical Officer for the National Cardiovascular Data Registry; and has a contract with the American College of Cardiology. Dr. Rumsfeld is the Chief Science Officer for the National Cardiovascular Data Registry. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Manuscript received May 20, 2014; revised manuscript received July 27, 2014, accepted August 3, 2014.

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Maddox et al.

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ABBREVIATIONS

National

AND ACRONYMS

Expert Panel on Detection, Evaluation, and

Cholesterol

Education

Program

Treatment of High Blood Cholesterol in

ACC = American College

Adults (Adult Treatment Panel [ATP] III)

of Cardiology

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Impact of 2013 Cholesterol Guidelines

10-year ASCVD risk $7.5%) and lipid-lowering therapies and LDL-C testing patterns were described.

METHODS

guidelines (4), and focused primarily on

AHA = American Heart Association

randomized

consistent

DATA SOURCE. The NCDR PINNACLE served as the

ASCVD = atherosclerotic

with the recent recommendations by the

study data source. Cardiology practices voluntarily

cardiovascular disease

Institute of Medicine for guideline develop-

participate in and submit data to PINNACLE as part

ATP = Adult Treatment Panel

ment (5,6). The new guidelines redefined

of a national office-based cardiovascular quality

LDL-C = low-density

patient populations for treatment, targeting

improvement program (8). Data are collected on all

those with confirmed atherosclerotic car-

patients with hypertension, coronary artery disease,

lipoprotein cholesterol

controlled

trials,

diovascular disease (ASCVD), diabetes, native low-

heart failure, and/or atrial fibrillation. The data are

density lipoprotein cholesterol (LDL-C) levels $190

collected at the point of care through a validated

mg/dl, or 10-year cardiovascular risk $7.5%. The

electronic medical record mapping algorithm de-

new guidelines recommended a “treat to risk” strat-

signed to comprehensively capture required data

egy using fixed-dose statin medications, rather

elements or, in rare cases when electronic health re-

than the previous “treat to LDL-C target” strategy;

cords are not in use, a paper chart abstraction form.

did not recommend use of nonstatin therapies; and

These data elements include demographics, insur-

did not recommend treatment to target LDL-C lipid

ance status, and detailed clinical information in-

levels, thus rendering repeated on-treatment testing

cluding symptoms, medical conditions, vital signs,

unnecessary.

medications, and laboratory values. Registry data

The potential impact of the new guidelines on

quality assurance is maintained through rigorous data

current U.S. cardiovascular practice is unknown.

definitions, standard data collection and trans-

Because cardiologists typically treat patients at the

mission, and periodic data quality checks (9,10).

highest risk for cardiac events, optimizing cholesterol

STUDY POPULATION. All patients aged 18 years

management in light of these new guidelines would

or older with clinical encounters in the PINNACLE

be expected to have a significant impact. Although

registry (version 1.2) between January 1, 2008, and

there has been work published on the population

December 31, 2012, were identified. Patients with

impact of these new guidelines (7), important ques-

insufficient data to determine their risk group, as

tions remain unanswered. In particular, little is

outlined in the 2013 cholesterol guidelines, were

known about current lipid-lowering therapies and

excluded. Patients were then categorized into 5

LDL-C testing patterns; this knowledge would help

mutually exclusive risk groups on the basis of the 2013

quantify expected shifts in care and subsequent im-

cholesterol guidelines: ASCVD; diabetes (without

plications for statin use, nonstatin use, and LDL-C

ASCVD); off-treatment LDL-C $190 mg/dl (without

testing among risk groups.

ASCVD or diabetes); 10-year ASCVD risk $7.5%

Accordingly, we examined the implications of the

(without ASCVD, diabetes, or off-treatment LDL-C

2013 ACC/AHA cholesterol guidelines on current

$190 mg/dl); or no risk criteria. ASCVD criteria

lipid-lowering therapy and testing patterns in con-

included: medical record documentation of coronary

temporary cardiology practices using data from the

artery disease; peripheral arterial disease; previous

NCDR PINNACLE (National Cardiovascular Data Reg-

stroke or transient ischemic attack; unstable angina;

istry Practice Innovation and Clinical Excellence).

stable angina; myocardial infarction; coronary artery

The PINNACLE registry collects continuous, real-

bypass grafting; and/or percutaneous coronary inter-

time, clinical information on all patients treated

vention. Next, patients without evidence of ASCVD,

in participating outpatient cardiology practices in

ages 40 to 75 years, and with medical record docu-

the Unites States. As such, current lipid-lowering

mentation of diabetes were identified. Patients

therapy and LDL-C testing patterns can be assessed,

without evidence of ASCVD or diabetes, on no lipid-

and the shifts expected under the new guidelines can

lowering

be predicted. This study sought to determine the

$190 mg/dl were then identified. Patients without

prevalence in the PINNACLE registry of patients

ASCVD or diabetes or an off-treatment LDL-C $190

meeting eligibility criteria for statin therapy under

mg/dl and ages 40 to 75 years were next identified and

the new guidelines and to assess their current therapy

had their estimated 10-year ASCVD risk calculated

and LDL-C testing patterns. Using registry data from

using the pooled risk calculator referenced in the 2013

2008 to 2012, patients were classified by risk group

cholesterol guidelines (1). Those with an estimated 10-

(ASCVD, diabetes, LDL-C $190 mg/dl, or an estimated

year risk $7.5% were included in the fourth group.

therapies,

and

with

$1

LDL-C

value

JACC VOL.

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Maddox et al.

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Impact of 2013 Cholesterol Guidelines

Finally, those patients who did not meet the criteria for any of the 4 risk groups were classified as “no risk criteria.” To determine the final risk group classification for patients with multiple risk group qualifica-

PINNACLE registry patients between 2008 and 2012 (n=1,711,326)

tions over time, all clinic visits recorded in PINNACLE for each patient were examined for each risk group classification in a sequential, hierarchical fashion. For

Excluded (n=536,781)

example, if 2 years after his or her diabetes diagnosis,

 Age