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Brief Summary

GUIDELINE TITLE

Antithrombotic therapy in peripheral arterial occlusive disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Jackson MR, Clagett GP. Antithrombotic therapy in peripheral arterial occlusive disease. Chest 2001 Jan;119(1 Suppl):283S-299S.

** 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.

  • 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 rating scheme is defined at the end of the "Major Recommendations" field.

Chronic Limb Ischemia

Antiplatelet Therapy

Aspirin

  1. The guideline developers recommend lifelong aspirin therapy, 75 to 325 mg/day, in comparison to no antiplatelet therapy in patients with clinically manifest coronary or cerebrovascular disease (Grade 1A) and in those without clinically manifest coronary or cerebrovascular disease (Grade 1C+)

Ticlopidine

  1. The guideline developers recommend clopidogrel over ticlopidine (Grade 1C+).

Clopidogrel

  1. The guideline developers recommend clopidogrel in comparison to no antiplatelet therapy (Grade 1C+), but suggest that aspirin be used instead of clopidogrel (Grade 2A).

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

Cilostazol

  1. For patients with disabling intermittent claudication who do not respond to conservative measures (risk factor modification and exercise therapy) and who are not candidates for surgical or catheter-based intervention, the guideline developers suggest cilostazol (Grade 2A). The guideline developers suggest that clinicians not use cilostazol in those with less-disabling claudication (Grade 2A).

    Underlying values and preferences: The recommendation against cilostazol for those with less-disabling claudication places a relatively low value on small possible improvements in function in the absence of clear improvement in health-related quality of life.

Pentoxifylline

  1. The guideline developer recommend against the use of pentoxifylline (Grade 1B).

Prostaglandins

  1. For limb ischemia, the guideline developers suggest clinicians not use prostaglandins (Grade 2B).

    Underlying values and preferences: The recommendation places a low value on achieving small gains in walking distance in the absence of demonstrated improvement in quality of life.

Other Agents

  1. In patients with intermittent claudication, the guideline developers recommend against the use of anticoagulants (Grade 1A).

Acute Limb Ischemia

Heparin

  1. In patients with acute arterial emboli or thrombosis, the guideline developers recommend treatment with immediate systemic anticoagulation with unfractionated heparin (UFH) to prevent thrombotic propagation (Grade 1C). The guideline developers also recommend systemic anticoagulation with UFH followed by long-term vitamin K antagonist (VKA) to prevent recurrent embolism in patients undergoing embolectomy (Grade 1C).

Thrombolysis

  1. In patients with short-term (<14 days) thrombotic or embolic disease with low risk of myonecrosis and ischemic nerve damage developing during the time to achieve revascularization by this method, the guideline developers suggest intra-arterial thrombolytic therapy (Grade 2B).

    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 Grafts

Intraoperative Anticoagulation during Vascular Reconstruction

  1. For patients undergoing major vascular reconstructive procedures, the guideline developers recommend UFH at the time of application of vascular cross-clamps (Grade 1A).

Prolonging the Patency of Grafts

Antiplatelet Agents

  1. In patients undergoing prosthetic infrainguinal bypass, the guideline developers recommend aspirin (Grade 1A).

Vitamin K Antagonists (VKAs)

  1. The guideline developers suggest that VKA not be used routinely in patients undergoing infrainguinal femoropopliteal or distal vein bypass (Grade 2A).

    Underlying values and preferences: This recommendation attributes relatively little value to small increases in long-term patency and relatively high value to avoiding hemorrhagic complications.

VKA Plus Aspirin

  1. For routine patients undergoing infrainguinal bypass without special risk factors for occlusion, the guideline developers recommend against VKA plus aspirin (Grade 1A). 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 high value on the avoidance of bleeding complications but recognize that there are circumstances where the threat of limb loss and major disability may supercede the risk.

Carotid Endarterectomy

Aspirin

  1. The guideline developers recommend that aspirin, 75 to 325 mg/day, be given preoperatively and continued indefinitely in patients undergoing carotid endarterectomy (Grade 1A).

Asymptomatic and Recurrent Carotid Stenosis

  1. In nonoperative patients with asymptomatic or recurrent carotid stenosis, the guideline developers recommend lifelong aspirin, 75 to 162 mg/day (Grade 1C+).

Lower Extremity Endovascular Procedures

  1. For all patients undergoing lower-extremity balloon angioplasty (with or without stenting), the guideline developers recommend long-term aspirin, 75 to 162 mg/day (Grade 1C+).

Definitions

Grade of Recommendation Clarity of Risk/Benefit Methodological Strength of Supporting Evidence Implications
1A

Clear

Randomized controlled trials (RCTs) without important limitations

Strong recommendation; can apply to most patients in most circumstances without reservation

1C+

Clear

No RCTs, but strong RCT results can be unequivocally extrapolated, or overwhelming evidence from observational studies

Strong recommendation; can apply to most patients in most circumstances

1B

Clear

RCTs with important limitations (inconsistent results, methodological flaws*)

Strong recommendation; likely to apply to most patients

1C

Clear

Observational studies

Intermediate-strength recommendation; may change when stronger evidence is available

2A

Unclear

RCTs without important limitations

Intermediate-strength recommendation; best action may differ depending on circumstances or patients' or societal values

2C+

Unclear

No RCTs, but strong RCT results can be unequivocally extrapolated, or overwhelming evidence from observational studies

Weak recommendation; best action may differ depending on circumstances or patients' or societal values

2B

Unclear

RCTs with important limitations (inconsistent results, methodological flaws*)

Weak recommendation; alternative approaches likely to be better for some patients under some circumstances

2C

Unclear

Observational studies

Very weak recommendation; other alternatives may be equally reasonable

*These situations include RCTs with both lack of blinding and subjective outcomes, where the risk of bias in measurement of outcomes is high, or RCTs with large loss to follow-up.

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 2004 Sep)

GUIDELINE DEVELOPER(S)

American College of Chest Physicians - Medical Specialty Society

SOURCE(S) OF FUNDING

Funding was provided through an unrestricted educational grant by AstraZeneca LP, Aventis Pharmaceuticals, GlaxoSmithKline, Bristol-Myer Squibb/Sanofi-Synthelabo Partnership, and Organon Sanofi-Synthelabo LLC.

GUIDELINE COMMITTEE

American College of Chest Physicians Consensus Panel on Antithrombotic and Thrombolytic Therapy

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Primary Authors: G. Patrick Clagett, MD (Co-Chair); Michael Sobel, MD, Co-Chair; Mark R. Jackson, MD; Gregory Y. H. Lip, MD; Marco Tangelder, MD; Raymond Verhaeghe, MD

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

Participants: Giancarlo Agnelli, MD; Amin Al-Ahmad, MD; Pierre Amarenco, MD; Jack E. Ansell, MD; Shannon M. Bates, MD; Richard C. Becker, MD; Peter B. Berger, MD; David Bergqvist, MD, PhD, FRCS; Rebecca J. Beyth, MD, MSc; Stewart Brower, MLIS; Harry R. Buller, MD; Henry I. Bussey, PharmD, FCCP; Christopher P. Cannon, MD, FACC; Elizabeth A. Chalmers, MB, ChB, MD, MRCP(UK). FRCPath; Anthony K.C. Chan, MD; G. Patrick Clagett, MD; Barry Coller, MD; Clifford W. Colwell, MD; Deborah Cook, MD, MSc; James E. Dalen, MD, MPH, FCCP; J. Donald Easton, MD; Michael Ezekowitz, MD; Garret A. Fitzgerald, MD; William H. Geerts, MD, FCCP; Jeffrey S. Ginsberg, MD, FCCP; Alan S. Go, MD; Shaun D. Goodman, MD, FACC; Ian A. Greer, MD, FRCP, FRCOG; Andreas Greinacher, MD; Jeremy Grimshaw, MD, PhD; Cindy Grines, MD; Jonathan L. Halperin, MD; Robert A. Harrington, MD; John Heffner, MD, MPH; John A. Heit, MD; Judith S. Hochman, MD, FACC; Dieter Horstkotte, MD, FESC; Russell D. Hull, MBBS, MSc, FCCP; Elaine Hylek, MD; Thomas M. Hyers, MD, FCCP; Mark R. Jackson, MD; Alan Jacobson, MD; Roman Jaeschke, MD, MSc; Ajay Kakkar BSc, PhD; Clive Kearon, MD, PhD, FCCP; Matthew Kraay; Michael R. Lassen, MD; Mark N. Levine, MD, MSc; Alessandro Liberati, MD; Gregory YH Lip, MD, FESC, FACC; Warren J. Manning, MD; M. Patricia Massicotte, MD, MSc, FRCPC, MSc; Thomas W. Meade, MD; Venu Menon, MD, FACC; Alan D. Michelson, MD; Nancy Miller, RN; Paul Monagle, MBBS, MSc, MD, FRACP, FRCPA, FCCP; Heather Munger, MLS; Christopher M. O’Connor, MD; Martin O’Donnell, MD; E. Magnus Ohman, MD, FCCP; Carlo Patrono, MD; Stephen G. Pauker, MD; Graham F. Pineo, MD; Leon Poller, MD; Jeffrey J. Popma, MD; Martin H. Prins, MD; Robert Raschke, MD, MS; Gary Raskob, PhD; Joel G. Ray, MD, MSc; Gerald Roth, MD; Ralph L. Sacco, MD; Deeb N. Salem, MD, FCCP; Meyer M. Samama, MD; Andrew Schafer; Sam Schulman, MD, PhD; Daniel Singer, MD; Michael Sobel, MD; Paul D. Stein, MD, FCCP; Marco Tangelder, MD; Victor F. Tapson, MD, FCCP; Philip Teal, MD; Raymond Verhaeghe, MD; David A. Vorchheimer, MD; Theodore E. Warkentin, MD; Jeffrey Weitz, MD; Robert G. Wilcox, MD

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Dr. Sobel has received research funding from Commonwealth Biotechnologies Inc, and has received no honoraria or consulting fees from pharmaceutical or technology firms.

Dr. Jackson has not received industry funding for research and has not received honoraria during this time period.

Dr. Lip has received research funding from AstraZeneca, Merck, and Servier, and has received honoraria for his participation on advisory boards and/or as a speaker at educational events from AstraZeneca, Servier, Boehringer Ingelheim, Novartis, Mitsubishi, Pharma, Yamanuchi, Bristol-Myers Squibb, Sanofi-Synthelabo-Organon, GlaxoSmithKline, Sankyo and Merck.

Dr. Tangelder is at present an employee of Sanofi-Synthelabo. During the preparation of the text for this guideline, he had nothing to declare.

Dr. Verhaeghe has received research support from AstraZeneca AB and Sanofi-Organon.

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Jackson MR, Clagett GP. Antithrombotic therapy in peripheral arterial occlusive disease. Chest 2001 Jan;119(1 Suppl):283S-299S.

GUIDELINE AVAILABILITY

Electronic copies: Available from 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

The following are available:

  • The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Evidence-based guidelines. Northbrook, IL: ACCP, 2004 Sep.
  • Methodology for guideline development for the Seventh American College of Chest Physicians Conference on Antithrombotic and Thrombolytic Therapy. Northbrook, IL: ACCP, 2004 Sep.
  • Applying the grades of recommendation for antithrombotic and thrombolytic therapy: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Northbrook, IL: ACCP, 2004 Sep.
  • Hemorrhagic complications of anticoagulant treatment: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Northbrook, IL: ACCP, 2004 Sep.
  • Antithrombotic and thrombolytic therapy: from evidence to application: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Northbrook, IL: ACCP, 2004 Sep.
  • Platelet-active drugs: the relationships among dose, effectiveness, and side effects: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Northbrook, IL: ACCP, 2004 Sep.

Electronic copies: Available from the Chest - The Cardiopulmonary and Critical Care Journal Web site.

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

The following is also available:

  • Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence-based guidelines; quick reference guide. Northbrook, IL: ACCP, 2004 Sep. Personal Digital Assistant (PDA) download available at ACCP Web site.

Additional implementation tools are also available:

  • Clinical resource: antithrombotic and thrombolytic therapy. Northbrook, IL. ACCP, 2004. Ordering information: Available from the ACCP Web site.

PATIENT RESOURCES

The following is available:

  • A patient's guide to antithrombotic and thrombolytic therapy. In: Clinical resource: antithrombotic and thrombolytic therapy. Northbrook (IL): American College of Chest Physicians (ACCP). 2004.

Ordering information is available from the ACCP Web site.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

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.

COPYRIGHT STATEMENT

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

DISCLAIMER

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