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Brief Summary

GUIDELINE TITLE

Antithrombotic therapy in atrial fibrillation: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

This guideline is updates a previous version: Albers GW, Dalen JE, Laupacis A, Manning WJ, Petersen P, Singer DE. Antithrombotic therapy in atrial fibrillation. Chest 2001 Jan;119(1 Suppl):194S-206S.

** 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.
  • August 16, 2007, Coumadin (Warfarin): Updates to the labeling for Coumadin to include pharmacogenomics information to explain that people's genetic makeup may influence how they respond to the drug.

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.

Long-term Antithrombotic Therapy for Chronic Atrial Fibrillation (AF) or Atrial Flutter, Anticoagulants and Antiplatelet Agents

Atrial Fibrillation

  1. In patients with persistent (also known as "sustained," and including patients categorized as "permanent" in certain classification schemes) or paroxysmal (intermittent) AF (PAF) at high risk of stroke (i.e., having any of the following features: prior ischemic stroke, transient ischemic attack (TIA), or systemic embolism, age >75 years, moderately or severely impaired left ventricular systolic function and/or congestive heart failure, history of hypertension, or diabetes mellitus), the guideline developers recommend anticoagulation with an oral vitamin K antagonist (VKA), such as warfarin (target international normalized ratio [INR], 2.5; range 2.0 to 3.0) (Grade 1A).
  2. In patients with persistent AF or PAF, age 65 to 75 years, in the absence of other risk factors, the guideline developers recommend antithrombotic therapy (Grade 1A). Either an oral VKA, such as warfarin (target INR, 2.5; range 2.0 to 3.0), or aspirin, 325 mg/d, are acceptable alternatives in this group of patients who are at intermediate risk of stroke.
  3. In patients with persistent AF or PAF <65 years old and with no other risk factors, the guideline developers recommend aspirin, 325 mg/d (Grade 1B).

    Underlying values and preferences: Anticoagulation with an oral VKA, such as warfarin, has far greater efficacy than aspirin in preventing stroke, and particularly in preventing severe ischemic stroke, in AF. The guideline developers recommend the option of aspirin therapy for lower-risk groups (see above); estimating the absolute expected benefit of anticoagulant therapy may not be worth the increased hemorrhagic risk and burden of anticoagulation. Individual lower-risk patients may rationally choose anticoagulation over aspirin therapy to gain greater protection against ischemic stroke if they value protection against stroke much more highly than reducing risk of hemorrhage and burden of managing anticoagulation.

Atrial Flutter

  1. For patients with atrial flutter, the guideline developers suggest that antithrombotic therapy decisions follow the same risk-based recommendations as for AF (Grade 2C).

Valvular Heart Disease and Atrial Flutter

  1. For patients with AF and mitral stenosis, the guideline developers recommend anticoagulation with an oral VKA, such as warfarin (target INR, 2.5; range 2.0 to 3.0) (Grade 1C+).
  2. For patients with AF and prosthetic heart valves, the guideline developers recommend anticoagulation with an oral VKA, such as warfarin (Grade 1C+).

    Remark: The target intensity of anticoagulation may be INR 3.0 (range, 2.5 to 3.5), i.e., higher than the usual target INR of 2.5 (range 2.0 to 3.0), and it may be appropriate to add aspirin, depending on type of prosthesis, its position, and other risk factors (See the National Guideline Clearinghouse summary of the ACCP guideline Antithrombotic Therapy in Valvular Heart Disease - Native and Prosthetic).

AF Following Cardiac Surgery

  1. For AF occurring shortly after open-heart surgery and lasting >48 hours, the guideline developers suggest anticoagulation with an oral VKA, such as warfarin, if bleeding risks are acceptable (Grade 2C). The target INR is 2.5 (range, 2.0 to 3.0). The guideline developers suggest continuing anticoagulation for several weeks following reversion to normal sinus rhythm (NSR), particularly if patients have risk factors for thromboembolism (Grade 2C).

Anticoagulation for Elective Cardioversion of AF or Atrial Flutter Patients

  1. For patients with AF of >48 hours or of unknown duration for whom pharmacologic or electrical cardioversion is planned, the guideline developers recommend anticoagulation with an oral VKA, such as warfarin (target INR, 2.5; range, 2.0 to 3.0), for 3 weeks before elective cardioversion and for at least 4 weeks after successful cardioversion (Grade 1C+).

    Remark: This recommendation applies regardless of a patient’s risk factor status. Continuation of anticoagulation beyond 4 weeks is based on whether the patient has experienced more than one episode of AF and on their risk factor status. Patients experiencing more than one episode of AF should be considered as having PAF (See recommendations above under "Atrial Fibrillation").

  2. For patients with AF of >48 hours or of unknown duration undergoing pharmacologic or electrical cardioversion, an alternative to the strategy outlined above is anticoagulation (immediate unfractionated intravenous (IV) heparin with target partial thromboplastin time [PTT] of 60 s [range, 50 to 70 s], or at least 5 days of warfarin with target INR of 2.5 [range, 2.0 to 3.0] at the time of cardioversion) and a screening multiplane transesophageal echocardiography (TEE) be performed. If no thrombus is seen and cardioversion is successful, the guideline developers recommend anticoagulation (target INR, 2.5; range 2.0 to 3.0) for at least 4 weeks. If a thrombus is seen on TEE, then cardioversion should be postponed and anticoagulation should be continued indefinitely. The guideline developers recommend obtaining a repeat TEE before attempting later cardioversion (all Grade 1B).

    Remark: The utility of the conventional and TEE-guided approaches is likely comparable. These recommendations apply regardless of a patient’s risk factor status. Continuation of anticoagulation beyond 4 weeks is based on whether the patient has experienced more than one episode of AF and on their risk factor status. Patients experiencing more than one episode of AF should be considered as having PAF (see recommendations above under "Atrial Fibrillation").

  3. For patients with AF of known duration <48 hours, the guideline developers suggest that cardioversion be performed without anticoagulation (Grade 2C). However, in patients without contraindications to anticoagulation, the guideline developers suggest beginning IV heparin (target PTT, 60 s; range, 50 to 70 s) or low-molecular-weight heparin (LMWH) (at full deep vein thrombosis [DVT] doses) at presentation (Grade 2C).

    Remark: For patients with risk factors for stroke, it is particularly important to be confident that the duration of AF is <48 hours. In such patients with risk factors, a TEE-guided approach (see recommendation #2 above under "Anticoagulation for elective cardioversion of AF or atrial flutter patients") is a reasonable alternative strategy. Postcardioversion anticoagulation is based on whether the patient has experienced more than one episode of AF and on their risk factor status. Patients experiencing more than one episode of AF should be considered as having PAF (see recommendations above under "Atrial Fibrillation").

  4. For emergency cardioversion where a TEE-guided approach is not possible, the guideline developers suggest IV unfractionated heparin (target PTT, 60 s; range, 50 to 70 s) be started as soon as possible, followed by 4 weeks of anticoagulation with an oral VKA, such as warfarin (target INR, 2.5; range 2.0 to 3.0) if NSR persists after cardioversion (Grade 2C).

    Remark: Continuation of anticoagulation beyond 4 weeks is based on whether the patient has experienced more than one episode of AF and on their risk factor status. Patients experiencing more than one episode of AF should be considered as having PAF (see recommendations above under "Atrial Fibrillation").

  5. For cardioversion of patients with atrial flutter, the guideline developers suggest use of anticoagulants in the same way as for cardioversion of patients with AF (Grade 2C).

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

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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").

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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: Daniel E. Singer, MD (Chair); Gregory W. Albers, MD; James E. Dalen, MD, MPH, Master FCCP; Alan S. Go, MD; Jonathan L. Halperin, MD; Warren J. Manning, 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. Singer has received research support from DuPont Pharma, now Bristol-Myers Squibb, and is a consultant for AstraZeneca.

Dr. Albers has received research support and honoraria as a consultant from AstraZeneca, Bristol- Myers Squibb, Boehringer Ingelheim, Genentech and Sanofi-Arganon.

Dr. Dalen is a consultant for DuPont Pharma, now Bristol-Myers Squibb, AstraZeneca, and Sanofi-Organon.

Dr. Go has nothing to declare.

Dr. Halperin has received research support from AstraZeneca and is a consultant for AstraZeneca. He is on the speaker's bureau for Bristol-Myers Squibb and Sanofi.

Dr. Manning is a consultant for AstraZeneca, Bristol-Myers Squibb, and Phillips Medical Systems.

GUIDELINE STATUS

This is the current release of the guideline.

This guideline is updates a previous version: Albers GW, Dalen JE, Laupacis A, Manning WJ, Petersen P, Singer DE. Antithrombotic therapy in atrial fibrillation. Chest 2001 Jan;119(1 Suppl):194S-206S.

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 as of October 31, 2001. This NGC summary was updated by ECRI on December 8, 2004. The updated information was verified by the guideline developer on January 12, 2005. This summary was updated by ECRI on March 6, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Coumadin (warfarin sodium). 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 September 7, 2007 following the revised U.S. Food and Drug Administration (FDA) advisory on Coumadin (warfarin). 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.

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