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Brief Summary

GUIDELINE TITLE

Thrombolysis and adjunctive therapy in acute myocardial infarction: 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: Ohman EM, Harrington RA, Cannon CP, Agnelli G, Cairns JA, Kennedy JW. Intravenous thrombolysis in acute myocardial infarction. Chest 2001 Jan;119(1 Suppl):253S-277S.

** 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.

Patients with Acute Myocardial Infarction (MI): Thrombolysis

Thrombolysis with Streptokinase, Tissue Plasminogen Activator (tPA), Anistreplase, Reteplase and Tenecteplase

  1. For patients with ischemic symptoms characteristic of acute MI of <12 hours in duration, and ST-segment elevation or left bundle-branch block (of unknown duration) on electrocardiography (ECG), the guideline developers recommend administration of any approved fibrinolytic agent (Grade 1A).
  2. The guideline developers recommend the use of streptokinase, anistreplase, alteplase, reteplase, or tenecteplase (all Grade 1A).
  3. For patients with symptom duration <6 hours, the guideline developers recommend the administration of alteplase or tenecteplase over streptokinase (Grade 1A).
  4. For patients with known allergy or sensitivity to streptokinase, the guideline developers recommend alteplase, reteplase, or tenecteplase (Grade 1A).
  5. For patients with recurrent acute MI, the guideline developers suggest clinicians do not use repeat administration of streptokinase (Grade 2C).
  6. For patients with ischemic symptoms characteristic of acute MI of <12 hours in duration and 12-lead ECG findings consistent with a true posterior MI, the guideline developers suggest fibrinolytic therapy (Grade 2C).
  7. For high-risk patients with ongoing symptoms characteristic of acute MI or hemodynamic compromise and duration of 12 to 24 hours who have ST elevation or left bundle-branch block, the guideline developers suggest administration of intravenous (IV) fibrinolytic therapy (Grade 2B).
  8. In health-care settings where prehospital administration of fibrinolytic therapy is feasible and primary angioplasty is not available, the guideline developers recommend prehospital administration of fibrinolytic therapy only (Grade 1A).
  9. For patients with acute MI who are candidates for fibrinolytic therapy, the guideline developers recommend administration within 30 minutes of arrival to the hospital or first contact with the health-care system (Grade 1A).
  10. In patients with any history of intracranial hemorrhage (ICH), closed head trauma, or ischemic stroke within past 3 months, the guideline developers recommend against administration of fibrinolytic therapy (Grade 1C+).

Adjunctive Treatment with Antithrombotic Agents in Patients Receiving Fibrinolysis for Acute MI

Adjunctive Treatment with Aspirin

  1. For patients with acute ST-elevation MI, whether or not they receive fibrinolytic therapy, the guideline developers recommend aspirin, 160 to 325 mg orally (po), at initial evaluation by health-care personnel followed by indefinite therapy, 75 to 162 mg/day po (both Grade IA).

    Note: Please refer to the National Guideline Clearinghouse (NGC) summary of the American College of Chest Physicians (ACCP) guideline Antithrombotic Therapy for Coronary Artery Disease for more information on this topic.

Adjunctive Treatment with Clopidogrel

  1. In patients who are allergic to aspirin, the guideline developers suggest administration of clopidogrel with a loading dose of 300 mg and a maintenance dose of 75 mg/day as an alternative therapy to aspirin (Grade 2C).

Adjunctive Treatment with Unfractionated Heparin (UFH)

  1. For patients receiving streptokinase, the guideline developers suggest administration of either IV UFH, 5,000-U bolus, followed by 1,000-U/hour for patients >80 kg, 800 U/hour for <80 kg with a target activated partial thromboplastin time (aPTT) of 50 to 75 seconds (Grade 2C), or subcutaneous (SC) UFH, 12,500 U every 12 hours for 48 hours (Grade 2A).
  2. For all patients at high risk of systemic or venous thromboembolism (anterior MI, pump failure, previous embolus, atrial fibrillation, or left ventricular thrombus), the guideline developers recommend administration of IV UFH while receiving streptokinase (Grade 1C+).
  3. For patients receiving alteplase, tenecteplase, or reteplase for fibrinolysis in acute MI, the guideline developers recommend administration of weight-adjusted heparin (60 U/kg bolus for a maximum of 4,000 U) followed by 12 U/kg/hour (1,000 U/hour maximum) adjusted to maintain an aPTT 50 to 75 seconds for 48 hours (Grade 1C).

Adjunctive Treatment with Low-Molecular-Weight Heparin (LMWH)

  1. For patients aged <75 years with preserved renal function (creatinine <2.5 mg/dL in male and <2.0 mg/dL in female patients), the guideline developers suggest use of enoxaparin (30-mg bolus IV followed by 1 mg/kg SC every 12 hours) with tenecteplase up to 7 days (Grade 2B).

Adjunctive Therapy with Glycoprotein (GP) IIb/IIIa Receptor Blockers

  1. The guideline developers recommend against the combination of standard-dose abciximab and half-dose reteplase or half-dose tenecteplase with low-dose IV UFH over standard-dose reteplase or tenecteplase (Grade 1B).
  2. The guideline developers suggest clinicians not use the combination of streptokinase and any GP IIb/IIIa inhibitor (Grade 2B).

Adjunctive Therapy with Direct Thrombin Inhibitors

  1. For patients with acute ST-elevation MI treated with streptokinase, the guideline developers suggest clinicians do not use bivalirudin routinely (Groups 2A).
  2. For patients with known or suspected heparin-induced thrombocytopenia (HIT) who are receiving fibrinolytic therapy, the guideline developers recommend administration of hirudin with tPA (Grade 1A) and recommend bivalirudin with streptokinase (Grade 2A).

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: Venu Menon, MD; Robert A. Harrington, MD; Judith S. Hochman, MD; Christopher P. Cannon, MD; Shaun D. Goodman, MD; Robert G. Wilcox, MD; Holger J. Schünemann, MD, PhD, FCCP; E. Magnus Ohman, MD, FCCP

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. Menon has received honoraria from Roche Inc.

Dr. Cannon, through the Department of Medicine of Brigham and Women’s Hospital, currently receives research grant support from Bristol-Myers Squibb, Merck, and Sanofi-Synthelabo. He is a consultant to Asahi Chemical Company, Bayer, Pfizer Limited, Vertex, Medicines Company, Ortho-Clinical Diagnostics, AstraZeneca, GlaxoSmithKline. Dr. Cannon is on the speaker bureau of Aventis, Bristol-Myers Squibb, Centocor, Eli Lilly, Genentech, Merck, Millennium, Sanofi-Synthelabo. He has received honoraria for preparation of educational materials from Best Med, Discovery East, Excerpta Medica, Medical Decision Point, and NCME.

Dr. Robert Harrington has received research grants through the Duke Clinical Research Institute from Aventis, AstraZeneca, Millennium, Schering, Merck, Lilly, Centocor, Roche, The Medicines Company, BMS, Sanofi, Glaxo, Daiichi.

Dr. Goodman has received research funding and has received honoraria for his participation on advisory boards and/or as a speaker at educational events from AstraZeneca, Aventis Pharma, Bayer, Biovail, Boehringer Ingelheim, BrystolMyers Squibb, CanAm, Centocor, Daiichi, Eli Lilly, Fournier Pharma, Hoffman-La Roche, Key Schering/Schering Plough, Millenium, Merck, Novartis, Sanofi Synthelabo, Servier, and Solvay.

Dr. Wilcox has received research funding from AstraZeneca, Aventis and Bristol-Myers Squibb.

Dr. Ohman has received research grants from the following organizations: BMS, Sanofi, Millennium, Schering-Plough, Aventis, and Berlex.

Dr. Schünemann has received research funding from AstraZeneca, Boehringer Ingelheim, Pfizer, and Amgen Inc. He has received honoraria and consultant fees from AstraZeneca, Boehringer Ingelheim, and Amgen that were deposited into research accounts at the University of Buffalo and McMaster University.

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Ohman EM, Harrington RA, Cannon CP, Agnelli G, Cairns JA, Kennedy JW. Intravenous thrombolysis in acute myocardial infarction. Chest 2001 Jan;119(1 Suppl):253S-277S.

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 October 17, 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.

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