Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME, et al.
Circulation. Date of publication 2017 Mar 21;volume 135(12):e726-e779.
1. Circulation. 2017 Mar 21;135(12):e726-e779. doi: 10.1161/CIR.0000000000000471.
Epub 2016 Nov 13.
2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity
Peripheral Artery Disease: A Report of the American College of
Cardiology/American Heart Association Task Force on Clinical Practice
Guidelines.
Gerhard-Herman MD, Gornik HL(1), Barrett C(1), Barshes NR(1), Corriere MA(1),
Drachman DE(1), Fleisher LA(1), Fowkes FG(1), Hamburg NM(1), Kinlay S(1),
Lookstein R(1), Misra S(1), Mureebe L(1), Olin JW(1), Patel RA(1), Regensteiner
JG(1), Schanzer A(1), Shishehbor MH(1), Stewart KJ(1), Treat-Jacobson D(1),
Walsh ME(1).
Author information:
(1)Writing committee members are required to recuse themselves from voting on
sections to which their specific relationships with industry and other entities
may apply; see Appendix 1 for recusal information. Functioning as the lay
volunteer/patient representative. ACC/AHA Representative. Vascular and
Endovascular Surgery Society Representative. Society for Cardiovascular
Angiography and Interventions Representative. ACC/AHA Task Force on Clinical
Practice Guidelines Liaison. Inter-Society Consensus for the Management of
Peripheral Arterial Disease Representative. Society for Vascular Medicine
Representative. Society of Interventional Radiology Representative. Society for
Clinical Vascular Surgery Representative. Society for Vascular Surgery
Representative. American Association of Cardiovascular and Pulmonary
Rehabilitation Representative. Society for Vascular Nursing Representative.
Erratum in
Circulation. 2017 Mar 21;135(12 ):e791-e792.
Since 1980, the American College of Cardiology (ACC) and American Heart
Association (AHA) have translated scientific evidence into clinical practice
guidelines with recommendations to improve cardiovascular health. These
guidelines, based on systematic methods to evaluate and classify evidence,
provide a cornerstone of quality cardiovascular care. In response to reports
from the Institute of Medicine, and a mandate to evaluate new knowledge and
maintain relevance at the point of care, the ACC/AHA Task Force on Clinical
Practice Guidelines (Task Force) modified its methodology.– The relationships
among guidelines, data standards, appropriate use criteria, and performance
measures are addressed elsewhere.
INTENDED USE: Practice guidelines provide recommendations applicable to patients
with or at risk of developing cardiovascular disease. The focus is on medical
practice in the United States, but guidelines developed in collaboration with
other organizations may have a broader target. Although guidelines may be used
to inform regulatory or payer decisions, the intent is to improve quality of
care and align with patients' interests. Guidelines are intended to define
practices meeting the needs of patients in most, but not all, circumstances, and
should not replace clinical judgment. Guidelines are reviewed annually by the
Task Force and are official policy of the ACC and AHA. Each guideline is
considered current until it is updated, revised, or superseded by published
addenda, statements of clarification, focused updates, or revised full-text
guidelines. To ensure that guidelines remain current, new data are reviewed
biannually to determine whether recommendations should be modified. In general,
full revisions are posted in 5-year cycles.–
MODERNIZATION: Processes have evolved to support the evolution of guidelines as
“living documents” that can be dynamically updated. This process delineates a
recommendation to address a specific clinical question, followed by concise text
(ideally <250 words) and hyperlinked to supportive evidence. This approach
accommodates time constraints on busy clinicians and facilitates easier access
to recommendations via electronic search engines and other evolving technology.
EVIDENCE REVIEW: Writing committee members review the literature; weigh the
quality of evidence for or against particular tests, treatments, or procedures;
and estimate expected health outcomes. In developing recommendations, the
writing committee uses evidence-based methodologies that are based on all
available data.– Literature searches focus on randomized controlled trials
(RCTs) but also include registries, nonrandomized comparative and descriptive
studies, case series, cohort studies, systematic reviews, and expert opinion.
Only selected references are cited. The Task Force recognizes the need for
objective, independent Evidence Review Committees (ERCs) that include
methodologists, epidemiologists, clinicians, and biostatisticians who
systematically survey, abstract, and assess the evidence to address systematic
review questions posed in the PICOTS format (P=population, I=intervention,
C=comparator, O=outcome, T=timing, S=setting).,– Practical considerations,
including time and resource constraints, limit the ERCs to evidence that is
relevant to key clinical questions and lends itself to systematic review and
analysis that could affect the strength of corresponding recommendations.
GUIDELINE-DIRECTED MANAGEMENT AND TREATMENT: The term “guideline-directed
management and therapy” (GDMT) refers to care defined mainly by ACC/AHA Class I
recommendations. For these and all recommended drug treatment regimens, the
reader should confirm dosage with product insert material and carefully evaluate
for contraindications and interactions. Recommendations are limited to
treatments, drugs, and devices approved for clinical use in the United States.
CLASS OF RECOMMENDATION AND LEVEL OF EVIDENCE: The Class of Recommendation (COR;
ie, the strength of the recommendation) encompasses the anticipated magnitude
and certainty of benefit in proportion to risk. The Level of Evidence (LOE)
rates evidence supporting the effect of the intervention on the basis of the
type, quality, quantity, and consistency of data from clinical trials and other
reports (Table 1).– Unless otherwise stated, recommendations are sequenced by
COR and then by LOE. Where comparative data exist, preferred strategies take
precedence. When >1 drug, strategy, or therapy exists within the same COR and
LOE and no comparative data are available, options are listed alphabetically.
RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES: The ACC and AHA sponsor the
guidelines without commercial support, and members volunteer their time. The
Task Force zealously avoids actual, potential, or perceived conflicts of
interest that might arise through relationships with industry or other entities
(RWI). All writing committee members and reviewers are required to disclose
current industry relationships or personal interests, from 12 months before
initiation of the writing effort. Management of RWI involves selecting a
balanced writing committee and assuring that the chair and a majority of
committee members have no relevant RWI (Appendix 1). Members are restricted with
regard to writing or voting on sections to which their RWI apply. For
transparency, members' comprehensive disclosure information is available online.
Comprehensive disclosure information for the Task Force is also available
online. The Task Force strives to avoid bias by selecting experts from a broad
array of backgrounds representing different geographic regions, sexes,
ethnicities, intellectual perspectives/biases, and scopes of clinical practice,
and by inviting organizations and professional societies with related interests
and expertise to participate as partners or collaborators.
INDIVIDUALIZING CARE IN PATIENTS WITH ASSOCIATED CONDITIONS AND COMORBIDITIES:
Managing patients with multiple conditions can be complex, especially when
recommendations applicable to coexisting illnesses are discordant or
interacting. The guidelines are intended to define practices meeting the needs
of patients in most, but not all, circumstances. The recommendations should not
replace clinical judgment.
CLINICAL IMPLEMENTATION: Management in accordance with guideline recommendations
is effective only when followed. Adherence to recommendations can be enhanced by
shared decision making between clinicians and patients, with patient engagement
in selecting interventions on the basis of individual values, preferences, and
associated conditions and comorbidities. Consequently, circumstances may arise
in which deviations from these guidelines are appropriate.
DOI: 10.1161/CIR.0000000000000471
PMCID: PMC5477786
PMID: 27840333 [Indexed for MEDLINE]
