Welcome to NGC. Skip directly to: Search Box, Navigation, Content.


Brief Summary

GUIDELINE TITLE

Antithrombotic therapy for peripheral artery occlusive disease. American College of Chest Physicians evidence-based clinical practice guidelines (8th edition).

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Clagett GP, Sobel M, Jackson MR, Lip GY, Tangelder M, Verhaeghe R. Antithrombotic therapy in peripheral arterial occlusive disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004 Sep;126(3 Suppl):609S-26S.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • December 3, 2008, Innohep (tinzaparin): The U.S. Food and Drug Administration (FDA) has requested that the labeling for Innohep be revised to better describe overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and deep vein thrombosis (DVT), pulmonary embolism (PE), or both.
  • February 28, 2008, Heparin Sodium Injection: The U.S. Food and Drug Administration (FDA) informed the public that Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection and their heparin lock flush solutions. Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the U.S. market. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

The grades of recommendation (1A, 1B, 1C, 2A, 2B, 2C) are defined at the end of the "Major Recommendations" field.

Chronic Limb Ischemia and Intermittent Claudication

  1. In peripheral artery disease (PAD) patients with clinically manifest coronary or cerebrovascular disease, the guideline developers recommend lifelong antiplatelet therapy in comparison to no antiplatelet therapy (Grade 1A).
  2. In those without clinically manifest coronary or cerebrovascular disease, the guideline developers suggest aspirin (75–100 mg/day) over clopidogrel (Grade 2B). In patients who are aspirin intolerant, the guideline developers recommend clopidogrel over ticlopidine (Grade 1B).

    Underlying values and preferences: This recommendation places a relatively high value on avoiding large expenditures to achieve uncertain, small reductions in vascular events.

  3. In patients with PAD and intermittent claudication, the guideline developers recommend against the use of anticoagulants to prevent vascular mortality or cardiovascular events (Grade 1A).
  4. For patients with moderate-to-severe disabling intermittent claudication who do not respond to exercise therapy, and who are not candidates for surgical or catheter-based intervention, the guideline developers recommend cilostazol (Grade 1A). The guideline developers suggest that clinicians not use cilostazol in those with less disabling claudication (Grade 2A). The guideline developers recommend against the use of pentoxifylline (Grade 2B).

    Underlying values and preferences: Because of the cost of cilostazol therapy, and the safety and efficacy of an exercise program, the guideline developers recommend cilostazol treatment be reserved for patients with moderate-to-severe claudication who have tried and failed an exercise program, and are not candidates for vascular surgical or endovascular procedures.

  5. For patients with intermittent claudication, the guideline developers recommend against the use of anticoagulants (Grade 1A).
  6. For patients with limb ischemia, the guideline developers suggest clinicians do not use prostaglandins (Grade 2B).

Acute Limb Ischemia

  1. In patients who suffer from acute arterial emboli or thrombosis, the guideline developers recommend immediate systemic anticoagulation with UFH, over no anticoagulation (Grade 1C). In patients undergoing embolectomy, the guideline developers suggest following systemic anticoagulation with UFH with long-term anticoagulation with VKA (Grade 2C).
  2. In patients with short-term (< 14 days) thrombotic or embolic disease, the guideline developers suggest intra-arterial thrombolytic therapy (Grade 2B), provided patients are at low risk of myonecrosis and ischemic nerve damage developing during the time to achieve revascularization by this method.

    Underlying values and preferences: This recommendation places relatively little value on small reductions in the need for surgical intervention and relatively high value on avoiding large expenditures and possible major hemorrhagic complications.

Vascular Bypass Grafts

  1. For patients undergoing major vascular reconstructive procedures, the guideline developers recommend intravenous (IV) unfractionated heparin (UFH), prior to the application of vascular cross clamps (Grade 1A).
  2. For all patients undergoing infrainguinal arterial reconstruction, the guideline developers recommend aspirin (75–100 mg, begun preoperatively) (Grade 1A). The guideline developers recommend against the routine use of perioperative dextran, heparin, or long-term anticoagulation with vitamin K antagonist (VKA) for all extremity reconstructions (Grade 1B).
  3. For patients receiving routine autogenous vein infrainguinal bypass, the guideline developers recommend aspirin (75–100 mg, begun preoperatively) (Grade 1A). The guideline developers suggest that VKA not be used routinely in patients undergoing infrainguinal vein bypass (Grade 2B). For those at high risk of bypass occlusion and limb loss, the guideline developers suggest VKA plus aspirin (Grade 2B).

    Underlying values and preferences: These recommendations place relatively little value on small increases in long-term patency that may be statistically uncertain, and a relatively high value on avoiding hemorrhagic complications.

  4. For patients receiving routine prosthetic infrainguinal bypass, the guideline developers recommend aspirin (75–100 mg, begun preoperatively) (Grade 1A). The guideline developers suggest that VKA not be used routinely in patients undergoing prosthetic infrainguinal bypass (Grade 2A).

    Underlying values and preferences: These recommendations place relatively little value on small increases in long-term patency that may be statistically uncertain, and a relatively high value on avoiding hemorrhagic complications.

Carotid Endarterectomy

In patients undergoing carotid endarterectomy, the guideline developers recommend that aspirin, 75–100 mg, be given preoperatively to prevent perioperative ischemic neurologic events. The guideline developers recommend lifelong postoperative aspirin (75–100 mg/day) (Grade 1A).

Asymptomatic Carotid Stenosis

  1. In nonoperative patients with asymptomatic carotid stenosis (primary or recurrent), the guideline developers recommend lifelong aspirin, 75–100 mg/d (Grade 1C). In this patient group, the guideline developers recommend against dual antiplatelet therapy with aspirin and clopidogrel (Grade 1B).
  2. For patients undergoing lower-extremity balloon angioplasty (with or without stenting), the guideline developers recommend long-term aspirin (75–100 mg/day) (Grade 1C). For patients undergoing lower-extremity balloon angioplasty (with or without stenting), the guideline developers recommend against anticoagulation with heparin or VKA (Grade 1A).

Definitions:

Grading Recommendation
Grade of Recommendation* Benefit vs. Risk and Burdens Methodologic Quality of Supporting Evidence Implications
Strong recommendation, high-quality evidence, Grade 1A Desirable effects clearly outweigh undesirable effects, or vice versa Consistent evidence from RCTs without important limitations or exceptionally strong evidence from observational studies Recommendation can apply to most patients in most circumstances; further research is very unlikely to change our confidence in the estimate of effect
Strong recommendation, moderate-quality evidence, Grade 1B Desirable effects clearly outweigh undesirable effects, or vice versa Evidence from RCTs with important limitations (inconsistent results, methodologic flaws, indirect or imprecise), or very strong evidence from observational studies Recommendation can apply to most patients in most circumstances; higher quality research may well have an important impact on our confidence in the estimate of effect and may change the estimate
Strong recommendation, low or very low-quality evidence, Grade 1C Desirable effects clearly outweigh undesirable effects, or vice versa Evidence for at least one critical outcome from observational studies, case series, or from RCTs with serious flaws or indirect evidence Recommendation can apply to most patients in many circumstances; higher-quality research is likely to have an important impact on our confidence in the estimate of effect and may well change the estimate
Weak recommendation, high-quality evidence, Grade 2A Desirable effects closely balanced with undesirable effects Consistent evidence from RCTs without important limitations or exceptionally strong evidence from observational studies The best action may differ depending on circumstances or patient or society values; further research is very unlikely to change our confidence in the estimate of effect
Weak recommendation, moderate-quality evidence, Grade 2B Desirable effects closely balanced with undesirable effects Evidence from RCTs with important limitations (inconsistent results, methodologic flaws, indirect or imprecise), or very strong evidence from observational studies Best action may differ depending on circumstances or patient or society values; higher-quality research may well have an important impact on our confidence in the estimate of effect and may change the estimate
Weak recommendation, low or very low-quality evidence, Grade 2C Desirable effects closely balanced with undesirable effects Evidence for at least one critical outcome from observational studies, case series, or from RCTs with serious flaws or indirect evidence Other alternatives may be equally reasonable; higher-quality research is likely to have an important impact on our confidence in the estimate of effect and may well change the estimate

*The guideline developers use the wording recommend for strong (Grade 1) recommendations and suggest for weak (Grade 2) recommendations.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2001 Jan (revised 2008 Jun)

GUIDELINE DEVELOPER(S)

American College of Chest Physicians - Medical Specialty Society

SOURCE(S) OF FUNDING

American College of Chest Physicians

GUIDELINE COMMITTEE

American College of Chest Physicians (ACCP) Expert Panel on Antithrombotic and Thrombolytic Therapy

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Primary Authors: Michael Sobel, MD; Raymond Verhaeghe, MD

Committee Co-Chairs: Jack Hirsh, MD, FCCP (Chair); Gordon H. Guyatt, MD, FCCP; Gregory W. Albers, MD; Robert A. Harrington, MD, FCCP; Holger J. Schünemann, MD, PhD, FCCP

Participants: Giancarlo Agnelli, MD; Pierre Amarenco, MD; Jack E. Ansell, MD; Collin Baigent; Shannon M. Bates, MD; Kenneth A. Bauer, MD; Richard C. Becker, MD; Peter B. Berger, MD; David Bergqvist, MD, PhD; Rebecca J. Beyth, MD; Christopher P. Cannon, MD; Elizabeth A. Chalmers, MB, ChB, MD; Anthony K.C. Chan, MBBS; Clifford W. Colwell, Jr., MD; Anthony J. Comerota, MD; Deborah Cook, MD; Mark A. Crowther, MD; James E. Dalen, MD; Gabrielle deVeber, MD, MHSc; Maria Benedetta Donati, MD, PhD; James D. Douketis, MD; Andrew Dunn, MD; J. Donald Easton, MD; Michael Ezekowitz, MD; Margaret Fang; William H. Geerts, MD, FCCP; Alan S. Go, MD; Samuel Z. Goldhaber, MD, FCCP; Shaun D. Goodman, MD; Michael Gould, MD, FCCP; Ian A. Greer, MD; Andreas Greinacher, MD; David Gutterman, MD, FCCP, HSP; Jonathan L. Halperin, MD; John A. Heit, MD; Elaine M. Hylek, MD; Alan Jacobson, MD; Roman Jaeschke, MD, PhD; Amir K. Jaffer, MD; Susan Kahn; Clive Kearon, MBBCh, PhD; Fenella Kirkham, MBBC; Andreas Koster, MD, PhD; Michael R. Lassen, MD; Mark N. Levine, MD, MSc; Sandra Zelman Lewis, PhD; A. Michael Lincoff, MD; Gregory YH Lip, MD; Christopher Madias, MD; Warren J. Manning, MD; Daniel B. Mark, MD; M. Patricia Massicotte, MD, MSc; David Matchar, MD; Thomas W. Meade, DM, FCCP; Venu Menon, MD; Tracy Minichiello, MD; Paul Monagle, MBBS, MSc, MD, FCCP; Christopher M. O'Connor, MD; Patrick O'Gara, MD; E. Magnus Ohman, MD; Ingrid Pabinger, MD; Gualtiero Palareti, MD; Carlo Patrono, MD; Stephen G. Pauker, MD; Graham F. Pineo, MD; Jeffrey J. Popma, MD; Gary Raskob, PhD; Gerald Roth, MD; Ralph L. Sacco, MD; Deeb N. Salem, MD, FCCP; Charles-Marc Samama, MD, FCCP; Meyer Michel Samama, MD; Sam Schulman, MD, PhD; Daniel Singer, MD; Michael Sobel, MD; Shoshanna Sofaer, DrPH; Alex C. Spyropoulos, MD FCCP; Ph. Gabriel Steg, MD; Philip Teal, MD; Raymond Verhaeghe, MD; David A. Vorchheimer, MD; Theodore E. Warkentin, MD; Jeffrey Weitz, MD

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Dr. Sobel discloses that he has received grant monies from the National Institutes of Health and the Department of Veterans Affairs.

Professor Verhaeghe discloses that he has received grant monies from Bayer, LEO Pharma, and Sanofi-Aventis.

ENDORSER(S)

American College of Clinical Pharmacy - Medical Specialty Society
American Society of Health-System Pharmacists - Professional Association

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Clagett GP, Sobel M, Jackson MR, Lip GY, Tangelder M, Verhaeghe R. Antithrombotic therapy in peripheral arterial occlusive disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004 Sep;126(3 Suppl):609S-26S.

GUIDELINE AVAILABILITY

Electronic copies: Available to subscribers of the Chest - The Cardiopulmonary and Critical Care Journal.

Print copies: Available from the American College of Chest Physicians, Products and Registration Division, 3300 Dundee Road, Northbrook IL 60062-2348.

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This summary was completed by ECRI on July 30, 2001. The information was verified by the guideline developer on September 27, 2001. This NGC summary was updated by ECRI on December 9, 2004. The updated information was verified by the guideline developer on January 12, 2005. This summary was updated by ECRI Institute on June 22, 2007 following the U.S. Food and Drug Administration (FDA) advisory on heparin sodium injection. This summary was updated by ECRI Institute on March 14, 2008 following the updated FDA advisory on heparin sodium injection. This NGC summary was updated by ECRI Institute on December 2, 2008. The updated information was verified by the guideline developer on January 7, 2009.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .

NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
DHHS Logo