2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (Updating the 2005 guideline)
PREAMBLE Keeping pace with the stream of new data and evolving evidence on which guideline recommendations are based is an ongoing challenge to timely development of clinical practice guidelines. In an effort to respond promptly to new evidence, the American College of Cardiology Foundation/ American Heart Association (ACCF/AHA) Task Force on Practice Guidelines (Task Force) has created a "focused update" process to revise the existing guideline recommendations that are affected by the evolving data or opinion. New evidence is reviewed in an ongoing fashion to more efficiently respond to important science and treatment trends that could have a major impact on patient outcomes and quality of care. Evidence is reviewed at least twice a year, and updates are initiated on an as-needed basis and completed as quickly as possible while maintaining the rigorous methodology that the ACCF and AHA have developed during their partnership of >20 years. publication in a peer-reviewed journal; large, randomized, placebo-controlled trial(s); nonrandomized data deemed important on the basis of results affecting current safety and efficacy assumptions, including observational studies and meta-analyses; strength/weakness of research methodology and findings; likelihood of additional studies influencing current findings; impact on current and/or likelihood of need to develop new performance measure(s); request(s) and requirement(s) for review and update from the practice community, key stakeholders, and other sources free of relationships with industry or other potential bias; number of previous trials showing consistent results; and need for consistency with a new guideline or guideline updates or revisions. Selected members of the previous writing committee as well as other experts in the subject under consideration are chosen by the ACCF and AHA to examine subject-specific data and to write guidelines in partnership with representatives from other medical organizations and specialty groups. Writing group members review the selected late-breaking clinical trials and other new data that have been vetted through the Task Force; weigh the strength of evidence for or against particular tests, treatments, or procedures; and include estimates of expected outcomes where such data exist. Patient-specific modifiers, comorbidities, and issues of patient preference that may influence the choice of tests or therapies are considered. When available, information from studies on cost is considered, but data on efficacy and outcomes constitute the primary basis for the recommendations contained herein. In analyzing the data and developing recommendations and supporting text, the writing group uses evidence-based methodologies developed by the Task Force.1 The Class of Recommendation (COR) is an estimate of the size of the treatment effect considering risks versus benefits in addition to evidence and/or agreement that a given treatment or procedure is or is not useful/effective or in some situations may cause harm. The Level of Evidence (LOE) is an estimate of the certainty or precision of the treatment effect. The writing group reviews and ranks evidence supporting each recommendation with the weight of evidence ranked as LOE A, B, or C according to specific definitions that are included in Table 1. Studies are identified as observational, retrospective, prospective, or randomized where appropriate. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and are ranked as LOE C. When recommendations at LOE C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. For issues for which sparse data are available, a survey of current practice among the clinicians on the writing group is the basis for LOE C recommendations, and no references are cited. The schema for COR and LOE is summarized in Table 1, which also provides suggested phrases for writing recommendations within each COR. A new addition to this methodology is a separation of the Class III recommendations to delineate whether the recommendation is determined to be of "no benefit" or is associated with "harm" to the patient. In addition, in view of the increasing number of comparative effectiveness studies, comparator verbs and suggested phrases for writing recommendations for the comparative effectiveness of one treatment or strategy versus another have been added for COR I and IIa, LOE A or B only. In view of the advances in medical therapy across the spectrum of cardiovascular diseases, the Task Force has designated the term guideline-directed medical therapy (GDMT) to represent optimal medical therapy as defined by ACCF/AHA guideline-recommended therapies (primarily Class I). This new term, GDMT, will be used herein and throughout all future guidelines. Because the ACCF/AHA practice guidelines address patient populations (and healthcare providers) residing in North America, drugs that are not currently available in North America are discussed in the text without a specific COR. For studies performed in large numbers of subjects outside North America, each writing group reviews the potential influence of different practice patterns and patient populations on the treatment effect and relevance to the ACCF/AHA target population to determine whether the findings should inform a specific recommendation. The ACCF/AHA practice guidelines are intended to assist healthcare providers in clinical decision making by describing a range of generally acceptable approaches to the diagnosis, management, and prevention of specific diseases or conditions. The guidelines attempt to define practices that meet the needs of most patients in most circumstances. The ultimate judgment regarding care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient. As a result, situations may arise for which deviations from these guidelines may be appropriate. Clinical decision making should involve consideration of the quality and availability of expertise in the area where care is provided. When these guidelines are used as the basis for regulatory or payer decisions, the goal should be improvement in quality of care. The Task Force recognizes that situations arise in which additional data are needed to inform patient care more effectively; these areas will be identified within each respective guideline when appropriate. Prescribed courses of treatment in accordance with these recommendations are effective only if followed. Because lack of patient understanding and adherence may adversely affect outcomes, physicians and other healthcare providers should make every effort to engage the patient's active participation in prescribed medical regimens and lifestyles. In addition, patients should be informed of the risks, benefits, and alternatives to a particular treatment and be involved in shared decision making whenever feasible, particularly for COR IIa and IIb, for which the benefit-to-risk ratio may be lower. The Task Force makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the members of the writing group. All writing group members and peer reviewers of the guideline are asked to disclose all such current relationships as well as those existing 12 months previously. In December 2009, the ACCF and AHA implemented a new policy for relationships with industry and other entities (RWI) that requires the writing group chair plus a minimum of 50% of the writing group to have no relevant RWI (Appendix 1 for the ACCF/AHA definition of relevance). These statements are reviewed by the Task Force and all members during each conference call and/or meeting of the writing group and are updated as changes occur. All guideline recommendations require a confidential vote by the writing group and must be approved by a consensus of the voting members. Members are not permitted to write, and must recuse themselves from voting on, any recommendation or section to which their RWI apply. Members who recused themselves from voting are indicated in the list of writing group members, and section recusals are noted in Appendix 1. Authors' and peer reviewers' RWI pertinent to this guideline are disclosed in Appendixes 1 and 2, respectively. Additionally, to ensure complete transparency, writing group members' comprehensive disclosure information—including RWI not pertinent to this document—is available as an online supplement. Comprehensive disclosure information for the Task Force is also available online at www.cardiosource.org/ACC/About-ACC/Leadership/Guidelines-and-Documents-Task-Forces.aspx. The work of the writing group was supported exclusively by the ACCF and AHA without commercial support. Writing group members volunteered their time for this activity. In an effort to maintain relevance at the point of care for practicing physicians, the Task Force continues to oversee an ongoing process improvement initiative. As a result, in response to pilot projects, several changes to these guidelines will be apparent, including limited narrative text and a focus on summary and evidence tables. The recommendations in this focused update will be considered current until they are superseded by another focused update or the full-text guideline is revised. Guidelines are official policy of both the ACCF and AHA. Alice K. Jacobs, MD, FACC, FAHA Chair ACCF/AHA Task Force on Practice Guidelines The results of late-breaking clinical trials presented at the annual scientific meetings of the ACC, AHA, European Society of Cardiology, Society for Vascular Surgery, Society of Interventional Radiology, and Society for Vascular Medicine, as well as selected other data/articles published through December 2010, were reviewed by the 2005 guideline writing committee along with the Task Force and other experts to identify those trials and other key data that may impact guideline recommendations. On the basis of the criteria/ considerations noted above, recent trial data and other clinical information were considered important enough to prompt a focused update of the "ACC/AHA 2005 Guidelines for the Management of Patients With Peripheral Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic)."2 Because clinical research and clinical care of vascular disease have a global investigative and international clinical care tradition, efforts were made to harmonize this update with the Trans-Atlantic Inter-Society Consensus document on Management of Peripheral Arterial Disease (TASC) and the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) Steering Committee guideline writing efforts.3 To provide clinicians with a comprehensive set of data, whenever deemed appropriate or when published, the absolute risk difference and number needed to treat or harm are provided in the guideline, along with confidence intervals (CIs) and data related to the relative treatment effects, such as odds ratio, relative risk, hazard ratio (HR), or incidence rate ratio. Consult the full-text version2 or executive summary4 of the "ACC/AHA 2005 Guidelines for the Management of Patients With Peripheral Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic)" for policy on clinical areas not covered by the focused update. Individual recommendations modified in this focused update will be incorporated into future revisions and/or updates of the full-text guideline. For this focused update, all eligible members of the 2005 writing committee were invited to participate; those who agreed (referred to as the 2011 focused update writing group) were required to disclose all RWI relevant to the data under consideration. In addition, new members were invited in order to preserve the required RWI balance. The writing group included representatives from the ACCF, AHA, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery. This document was reviewed by 2 official reviewers each nominated by the ACCF and the AHA, as well as 2 reviewers each from the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery; and 13 individual content reviewers (including members from the following groups: ACCF/AHA Task Force on Clinical Data Standards, ACCF Interventional Scientific Council, 2005 Peripheral Artery Disease Writing Committee, ACCF/AHA Task Force on Performance Measures, ACCF Prevention Committee, and ACCF Peripheral Vascular Disease Committee). All information on reviewers' RWI was distributed to the writing group and is published in this document (Appendix 2). This document was approved for publication by the governing bodies of the ACCF and AHA and endorsed by the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery. Medical therapy for renal disease: No new pivotal trials or studies were identified. Revascularization for renal disease: The writing group acknowledges that some new studies support a more limited role for renal revascularization. For example, the ASTRAL (Angioplasty and Stent for Renal Artery Lesions) investigators5 concluded that there were substantial risks but no clinical benefit from revascularization in patients with atherosclerotic renovascular disease. The writing group concurred that the criteria for patient selection in this randomized controlled trial (RCT) potentially excluded many patients who might have benefitted from intervention. It is anticipated that ongoing studies such as the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) trial6 will provide additional evidence relevant to these recommendations in the near future. Methods of revascularization for renal disease: The 2005 recommendations remain current. The 2011 focused update acknowledges the declining use of surgical revascularization and the increasing use of catheter-based revascularization for renal artery stenoses. The writing group determined that new data support the equivalency of surgical and endovascular treatment, with lower morbidity and mortality associated with endovascular treatment but higher patency rates with surgical treatment in those patients who survived for at least 2 years after randomization.5 The writing group also notes that new data suggest that 1) the efficacy of revascularization may be reduced in patients with branch artery stenoses7 and 2) patients undergoing renal artery bypass may do best when surgery is performed in high-volume centers.8 Table 2 contains recommendations for ankle-brachial index (ABI), toe-brachial index, and segmental pressure examination. See Appendix 3 for supplemental information. The German Epidemiologic Trial on Ankle Brachial Index Study Group included 6880 patients ≥65 years of age and demonstrated that 21% of the cohort had either asymptomatic or symptomatic PAD.11 On the basis of this large epidemiologic study, the 2011 writing group modified the age for consideration of ABI diagnostic testing to ≥65 years. The writing group considered the potential impact of lowering the PAD detection age to 65 years, acknowledging that the ABI test would be used in an incrementally larger "at-risk" population. This reflects the intent of both the original evidence-based document and this focused update to blunt the profound ongoing underdiagnosis and undertreatment of individuals with PAD until limb ischemic symptoms have become severe. This ABI recommendation is intended for office-based and vascular laboratory diagnostic use and is not intended to serve as a population screening tool. The writing group noted with confidence that no other cardiovascular disease diagnostic test can be applied in an age-defined clinical population with such a high detection rate, low to no risk, and low cost. We encourage expansion of the evidence base by design and completion of ABI screening studies. The definitions of normal and abnormal ABI values have been modified based on publication of the results of the Ankle Brachial Index Collaboration.24 This includes a normal ABI range of 1.00 to 1.40, and abnormal values continue to be defined as those ≤0.90. ABI values of 0.91 to 0.99 are considered "borderline" and values >1.40 indicate noncompressible arteries. The 2005 recommendations stated that segmental pressure measurements are useful in the diagnosis and anatomic localization of lower extremity PAD. The 2011 writing group recognized that vascular diagnostic laboratories could use segmental pressures, Doppler waveform analysis, pulse volume recordings, or ABI with duplex ultrasonography (or some combination of these methods) to document the presence and location of PAD in the lower extremity. Table 3 contains recommendations for smoking cessation. See Appendix 3 for supplemental information. No prospective RCTs have examined the effects of smoking cessation on cardiovascular events in patients with lower extremity PAD. Observational studies have found that the risk of death, myocardial infarction, and amputation is substantially greater, and lower extremity angioplasty and open surgical revascularization patency rates are lower in individuals with PAD who continue to smoke than in those who stop smoking.34-36 In some studies, exercise time is greater in patients who stop smoking than in current smokers.37, 38 Efforts to achieve smoking cessation are recommended for patients with lower extremity PAD. Physician advice coupled with frequent follow-up achieves 1-year smoking cessation rates of approximately 5% compared with only 0.1% in individuals who try to quit smoking without a physician's intervention.39 With pharmacological interventions such as nicotine replacement therapy and bupropion, 1-year smoking cessation rates of approximately 16% and 30%, respectively, are achieved in a general population of smokers.33 Varenicline, a nicotinic receptor partial agonist, has demonstrated superior quit rates when compared with nicotine replacement and bupropion in several RCTs.30-32 The superior smoking cessation may result from better reductions in craving and withdrawal symptoms.40 Despite its greater cost, is of its quit In 2009, the and a that both bupropion and have been associated with of changes in such as and or In patients with PAD comprehensive smoking cessation that included and pharmacological support the rate of smoking cessation at months compared with advice to quit smoking versus cessation interventions are particularly in individuals with is that of may be in the of this and use is associated with a particularly Table contains recommendations for and See Appendix 3 for supplemental information. The writing group reviewed RCTs and 1 related to therapy and PAD as of this focused the demonstrated a in cardiovascular events among symptomatic PAD patients randomized to therapy versus there was of criteria and regimens among the The results of 3 RCTs of use versus for cardiovascular risk among patients with PAD have been published the 2005 These trials with the 2 larger trials with of follow-up no benefit of both of these studies only asymptomatic patients from population screening clinical based on in ABI and The of of Arterial individuals with an ABI the for trial used a of ABI but the ABI the lower pressure at the This is in to clinical practice (and this of the higher pressure at the for These the of the results to patients with clinical PAD who are symptomatic and/or have lower ABI values and a greater risk of ischemic The Prevention which was the of the 3 therapy trials patients with more defined by both symptoms and/or ABI values and demonstrated a in cardiovascular ischemic events among subjects randomized to this trial was of with only of a patients The of therapy for patients with a risk for among but no in cardiovascular This included the and trials but not the for The recommended range of has been modified to to to the in the clinical trials and in use in clinical The 2005 recommendation of as an to therapy is No new clinical trials have compared therapy with the versus in Patients at of demonstrated an benefit of On the basis of the findings of the for and and may be to combination therapy with plus for certain patients with PAD who are not considered at risk of of an for the PAD patient should be on the basis of and other clinical along with cost and from regulatory The Vascular trial provided evidence against the use of therapy in addition to therapy for prevention of cardiovascular events among patients with and the of evidence is to B for this Class III The writing group that selection of the optimal therapy and of in populations of patients with PAD are scientific is a need for additional data from RCTs and observational studies to the efficacy and risk of across the spectrum of PAD defined according to versus and of ABI To no clinical trials have examined the efficacy of new such as or to ischemic events in patients with lower extremity PAD. Table contains recommendations for endovascular and open surgical treatment for limb in patients with limb See Appendix 3 for supplemental information. The writing group has reviewed the results of the in of the trial by the of and a patients with limb by and such as and and including patients defined by this PAD guideline term limb were to an treatment strategy of either open surgery or clinical outcomes in this trial were and The results published in 2005 indicated that in patients with limb to the clinical outcomes bypass and were These results that bypass was one more and was associated with higher morbidity than The trial also suggested that after 2 years, patients with had rates and this was based on a of a number of more follow-up was to or this The results of a follow-up have been and that there was no difference in and the 2 treatment a bypass was associated with a in of months to and a of months to for those patients who survived for at least 2 years after In for all patients in the there was no difference the 2 treatment in or these data suggest that is for a bypass to be considered for these selected patients to and This has also that the outcomes following bypass were when may be to bypass in patients with a of Table contains recommendations for of See Appendix 3 for supplemental information. the of treatment for and artery have the years, a greater understanding of the appropriate of these and has been open and endovascular have demonstrated clinical with rates of and mortality and For patients with an who are to years and who are risk surgical open or endovascular is is no to either of This was demonstrated in 2 large randomized, prospective studies. The trial the outcomes of patients years of age who were appropriate for either endovascular or open of that were at least in based on years, patients were and to either or open The primary outcomes were mortality and and data were on an was a minimum of years or until death, with a follow-up of years. The treatment which were with a age of years, were with to was a difference in mortality endovascular and open endovascular versus open odds to this benefit was not the of mortality in the endovascular group was compared with in the group to mortality was also with in the group compared with in the group to was required in of patients with an but in only of those who open surgery the need for of the These findings were consistent with those in another randomized, prospective The trial the outcomes of patients with who were randomized to either endovascular or open surgical The primary was were no in or the patients to open surgery and the patients to endovascular intervention. to the the of patients in the trial were with a age of years. The minimum follow-up was years, and the was years. this of time rate of the 2 was not The rate was in the group and among those undergoing to cardiovascular disease was the most cause of death, for only of the in the group and of the in the endovascular treatment group. from such as were more the follow-up from was more in the group compared with the endovascular treatment group to a trial has the results of the and The trial randomized with or an associated artery or an with to surgical or endovascular The primary was As with both the and there were no in The trial were and current or a follow-up of years, there was no difference in versus for endovascular and surgical there were no in the rates of or the in surgical the number of endovascular As with the the and trials that the benefits of endovascular including a lower are not the of that is deemed to be most appropriate for each individual patient should be treatment should not be used in patients who do not meet the criteria or who with the required follow-up Patients require either or of the of the at 1 and to that the has not and there are no that have in and/or of the patients be the indicated follow-up and treatment of the lack of to required or to treat when endovascular should not be considered the optimal treatment surgical is indicated for those patients who do not meet the criteria for endovascular A patient general is deemed for open may not benefit from endovascular This was suggested in a of the The 2 trial randomized patients with of at least with that open to either endovascular treatment or no patients were randomized to the endovascular treatment group and patients to the had The primary was from any The patients were for a minimum of years or until The follow-up was years. mortality was a difference in mortality the 2 was identified for endovascular therapy versus without treatment, to this was not associated with follow-up there was no difference in mortality the 2 in the endovascular group versus in the for endovascular to there was no benefit to the endovascular treatment of in patients was considered to open in this optimal of this patient population has not been studies are required to better define the role of endovascular in patients with who are considered to be at high surgical or American College of Cardiology MD, FACC, C. MD, MD, FACC, and and Clinical American College of Cardiology Heart Association and Clinical and Clinical American Heart Association MD, MD, of and of Scientific of