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Brief Summary

GUIDELINE TITLE

Antithrombotic therapy in atrial fibrillation. 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 is updates a previous version: Singer DE, Albers GW, Dalen JE, Go AS, Halperin JL, Manning WJ. Antithrombotic therapy in atrial fibrillation: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004 Sep;126(3 Suppl):429S-56S.

** 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.

Atrial Fibrillation

  1. In patients with Atrial Fibrillation (AF), including those with paroxysmal AF, who have had a prior ischemic stroke, transient ischemic attack (TIA), or systemic embolism, the guideline developers recommend long-term anticoagulation with an oral vitamin K antagonist (VKA), such as warfarin, targeted at an international normalized ratio (INR) of 2.5 (range, 2.0 to 3.0) because of the high risk of future ischemic stroke faced by this set of patients (Grade 1A). Timing of the initiation of VKA therapy after an acute ischemic stroke involves balancing the risk of hemorrhagic conversion with short-term risk of recurrent ischemic stroke and is addressed in the "Ischemic Stroke" chapter of the original guideline document (see the National Guideline Clearinghouse (NGC) summary of the American College of Chest Physicians (ACCP) guideline Antithrombotic and Thrombolytic Therapy for Ischemic Stroke).
  2. In patients with AF, including those with paroxysmal AF, who have two or more of the following risk factors for future ischemic stroke, the guideline developers recommend long-term anticoagulation with an oral VKA, such as warfarin, targeted at an INR of 2.5 (range, 2.0 to 3.0) because of the increased risk of future ischemic stroke faced by this set of patients (Grade 1A). Two or more of the following risk factors apply: (1) age > 75 years, (2) history of hypertension, (3) diabetes mellitus, and (4) moderately or severely impaired left ventricular systolic function and/or heart failure.

    Remark: Recommendations 1 and 2 above correspond to a recommendation of oral VKA therapy for individuals with a score > 2 using the Congestive heart failure, Hypertension, Age, Diabetes, Stroke (doubled) risk scoring system (CHADS2) classification. For these and all other recommendations of long-term therapy in this chapter, "long-term" means lifelong unless a contraindication emerges.

  3. In patients with AF, including those with paroxysmal AF, with only one of the risk factors listed below, the guideline developers recommend long-term anti-thrombotic therapy (Grade 1A), either as anticoagulation with an oral VKA, such as warfarin, targeted at an INR of 2.5 (range, 2.0 to 3.0) (Grade 1A), or as aspirin, at a dose of 75 to 325 mg/d (Grade 1B). For these patients at intermediate risk of ischemic stroke, the guideline developers suggest a VKA rather than aspirin (Grade 2A). This set of patients with AF is defined by having one of the following risk factors: (1) age > 75 years, (2) history of hypertension, (3) diabetes mellitus, or (4) moderately or severely impaired left ventricular systolic function and/or heart failure.
  4. In patients with AF, including those with paroxysmal AF, aged < 75 years and with none of the other risk factors listed above, the guideline developers recommend long-term aspirin therapy at a dose of 75 to 325 mg/d (Grade 1B) because of their low risk of ischemic stroke.

    Underlying values and preferences: Anticoagulation with oral VKAs, 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 in recommendations 3 and 4, 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 the burden of managing anticoagulation. Our recommendations assume that the patient is not at high risk for bleeding and that good control of anticoagulation will occur.

    Remarks: These recommendations apply to patients with persistent or paroxysmal AF and not to patients with a single brief episode of AF due to a reversible cause, such as an acute pulmonary infection. The optimal dose of aspirin for patients with AF is unclear. The largest effect of aspirin was seen in the first Stroke Prevention in AF (SPAF I) trial, which used aspirin at 325 mg/d. However, generalizing from trials of aspirin for all antithrombotic indications and from physiologic studies, the guideline developers feel the best balance of efficacy and safety is achieved at low doses of aspirin, i.e., 75 to 100 mg/d (see the "Antiplatelet Drugs" chapter of the original guideline document [listed in "Availability of Companion Documents" field.])

Atrial Flutter

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

Valvular Heart Disease and AF

  1. For patients with AF and mitral stenosis, the guideline developers recommend long-term anticoagulation with an oral VKA, such as warfarin (target INR 2.5; range, 2.0 to 3.0) (Grade 1B).
  2. For patients with AF and prosthetic heart valves, the guideline developers recommend long-term anticoagulation with an oral VKA, such as warfarin, at an intensity appropriate for the specific type of prosthesis (Grade 1B). See the "Valvular and Structural Heart Disease" chapter in the original guideline document or the NGC summary Valvular and Structural Heart Disease.

AF Following Cardiac Surgery

For patients with 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 4 weeks following reversion to and maintenance of normal sinus rhythm, particularly if patients have risk factors for thromboembolism (Grade 2C).

Anticoagulation for Elective Cardioversion of AF

  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, at a target INR of 2.5 (range, 2.0 to 3.0) for 3 weeks before elective cardioversion and for at least 4 weeks after sinus rhythm has been maintained (Grade 1C).

    Remark: This recommendation applies to all patients with AF, including those whose risk factor status would otherwise indicate a low risk for stroke. Patients with risk factors for thromboembolism should continue anticoagulation beyond 4 weeks unless there is convincing evidence that sinus rhythm is maintained. For patients with recurrent episodes of AF, recommendations 1, 2, 3, and 4 under the "Atrial Fibrillation" section above, apply.

  2. For patients with AF of > 48 hours or of unknown duration who are undergoing pharmacologic or electrical cardioversion, the guideline developers recommend either immediate anticoagulation with intravenous (IV) unfractionated heparin (UFH) (target partial thromboplastin Time (PTT), 60 s; range, 50 to 70 s), or low-molecular-weight heparin (LMWH) (at full deep vein thrombosis (DVT) treatment doses), or at least 5 days of warfarin (target INR of 2.5; range, 2.0 to 3.0) at the time of cardioversion and performance of a screening multiplane transesophageal echocardiography (TEE). If no thrombus is seen, cardioversion is successful, and sinus rhythm is maintained, 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 addressing the equivalence of TEE-guided vs. non–TEE-guided cardioversion; see recommendation 1 above).

    Remark: The utility of the conventional and TEE-guided approaches is likely comparable. This recommendation applies to all patients with AF, including those whose risk factor status would otherwise indicate a low risk for stroke. Patients with risk factors for thromboembolism should continue anticoagulation beyond 4 weeks unless there is convincing evidence that sinus rhythm is maintained. For patients with recurrent episodes of AF, recommendations 1, 2, 3, and 4 under the "Atrial Fibrillation" section above, apply.

  3. For patients with AF of known duration < 48 hours, the guideline developers suggest that cardioversion be performed without prolonged 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 LMWH (at full DVT treatment 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) is a reasonable alternative strategy. Postcardioversion anticoagulation is based on whether the patient has experienced more than one episode of AF and on his or her risk factor status. For patients with recurrent episodes of AF, recommendations 1, 2, 3, and 4 under the "Atrial Fibrillation" section above, apply.

  4. For emergency cardioversion in the hemodynamically unstable patient, the guideline developers suggest that IV UFH (target PTT of 60 s with a target range of 50 to 70 s) or LMWH (at full DVT treatment doses) be started as soon as possible, followed by at least 4 weeks of anticoagulation with an oral VKA, such as warfarin (target INR of 2.5; range, 2.0 to 3.0) if cardioversion is successful and sinus rhythm is maintained (Grade 2C).

    Remark: Long-term continuation of anticoagulation is based on whether the patient has experienced more than one episode of AF and on his or her risk factor status. For patients experiencing more than one episode of AF, recommendations 1, 2, 3, and 4 under the "Atrial Fibrillation" section above, apply.

  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:

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

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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 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: Daniel E. Singer, MD; Gregory W. Albers, MD; James E. Dalen, MD, MPH, FCCP; Margaret C. Fang, MD, MPH; Alan S. Go, MD; Jonathan L. Halperin, MD; Gregory Y. H. Lip, MD; Warren J. Manning, 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. Singer discloses that he has received grant monies from the US Public Health Service (research grant No. AB15478), the National Institute on Aging, the National Institutes of Health, and the Eliot B. and Edith C. Shoolman Fund of the Massachusetts General Hospital. He has served as a consultant to Medtronic, Boehringer Ingelheim, Bayer HealthCare, Johnson & Johnson, Sanofi-Aventis, and Daiichi Sankyo Inc.

Dr. Albers discloses that he has received grant monies from the National Institutes of Health, Astra, Genentech, Bristol-Myers Squibb, Sanofi, Boehringer Ingelheim, NMT Medical, and Aventis. He is also on the speakers bureau for Boehringer Ingelheim, and advisory committees for Astra, Aventis, Boehringer Ingelheim, NMT Medical, Bristol-Myers Squibb, and Sanofi.

Dr. Dalen reveals no real or potential conflicts of interest or commitment.

Dr. Fang reveals no real or potential conflicts of interest or commitment.

Dr. Go reveals no real or potential conflicts of interest or commitment.

Dr. Halperin discloses that he has received consulting fees from Astellas Pharma, Bayer AG Healthcare, Boehringer Ingelheim, Daiichi Sankyo Pharma, GlaxoSmithKline, Johnson & Johnson, and Sanofi-Aventis.

Dr. Manning reveals no real or potential conflicts of interest or commitment.

Professor Lip discloses that he has received grant monies from the British Heart Foundation, Sanofi, and AstraZeneca. He is also on the speaker bureaus for AstraZeneca and Bayer, and has served on an advisory committee for AstraZeneca, Daiichi Sankyo, Bayer, and Astellas.

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 is updates a previous version: Singer DE, Albers GW, Dalen JE, Go AS, Halperin JL, Manning WJ. Antithrombotic therapy in atrial fibrillation: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004 Sep;126(3 Suppl):429S-56S.

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

The following are available:

Executive Summary:

  • Antithrombotic and thrombolytic therapy executive summary. Chest 2008 Jun; 133:71S-109S.

Background Articles:

  • Antithrombotic and thrombolytic therapy. Chest 2008 Jun; 133:110S-112S.
  • Methodology for antithrombotic and thrombolytic therapy guideline development. Chest 2008 Jun; 133:113S-122S.
  • Grades of recommendation for antithrombotic agents. Chest 2008 Jun; 133:123S-131S.
  • Strategies for incorporating resource allocation and economic considerations. Chest 2008 Jun; 133:132S-140S.

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.

PATIENT RESOURCES

None available

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. This NGC summary was updated by ECRI Institute on November 26, 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.

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