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Brief Summary

GUIDELINE TITLE

Antithrombotic therapy during percutaneous coronary intervention: 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: Popma JJ, Ohman EM, Weitz J, Lincoff AM, Harrington RA, Berger P. Antithrombotic therapy in patients undergoing percutaneous coronary intervention. Chest 2001 Jan;119(1 Suppl):321S-336S.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s)/intervention(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.
  • June 8, 2007, Troponin-I Immunoassay: Class I Recall of all lots of the Architect Stat Troponin-I Immunoassay. The assay may report falsely elevated or falsely decreased results at and near a low level, which may impact patient treatment.

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 Undergoing Percutaneous Coronary Intervention (PCI): Oral Antiplatelet Therapy

Aspirin

  1. For patients undergoing PCI, the guideline developers recommend pretreatment with aspirin, 75 to 325 mg (Grade 1A).
  2. For long-term treatment after PCI, the guideline developers recommend aspirin, 75 to 162 mg/day (Grade 1A).
  3. For long-term treatment after PCI in patients who receive antithrombotic agents such as clopidogrel or warfarin, the guideline developers recommend lower-dose aspirin, 75 to 100 mg/day (Grade 1C+).

Thienopyridine Derivatives

Ticlopidine versus Clopidogrel after Stent Placement

  1. For patients who underwent stent placement, the guideline developers recommend the combination of aspirin and a thienopyridine derivative (ticlopidine or clopidogrel) over systemic anticoagulation therapy (Grade 1A).
  2. The guideline developers recommend clopidogrel over ticlopidine (Grade 1A).

Pretreatment with Thienopyridines prior to PCI

  1. The guideline developers recommend a loading dose of 300 mg of clopidogrel at least 6 hours prior to planned PCI (Grade 1B). If clopidogrel is started <6 hours prior to PCI, the guideline developers suggest a 600-mg loading dose of clopidogrel (Grade 2C).
  2. If ticlopidine is administered, the guideline developers recommend a loading dose of 500 mg at least 6 hours before planned PCI (Grade 2C).

Aspirin Intolerant Patients

  1. For PCI patients who cannot tolerate aspirin, the guideline developers recommend that the loading dose of clopidogrel (300 mg) or ticlopidine (500 mg) be administered at least 24 hours prior to the planned PCI (Grade 2C).

Duration of Thienopyridine Therapy after Stent Placement

  1. After PCI, the guideline developers recommend, in addition to aspirin, clopidogrel (75 mg/day) for at least 9 to 12 months (Grade 1A).
  2. If ticlopidine is used in place of clopidogrel after PCI, the guideline developers recommend ticlopidine for 2 weeks after placement of a bare metal stent in addition to aspirin (Grade 1B).
  3. In patients with low atherosclerotic risk, such as those with isolated coronary lesions, the guideline developers recommend clopidogrel for at least 2 weeks after placement of a bare metal stent (Grade 1A), for 2 to 3 months after placement of a sirolimus-eluting stent (Grade 1C+), and 6 months after placement of a paclitaxel-eluting stent (Grade 1C).

Other Oral Antiplatelet Agents

  1. For patients after stent placement, the guideline developers suggest ticlopidine (Grade 1B) or clopidogrel (Grade 1C) over cilostazol.
  2. In aspirin-intolerant patients undergoing PCI, the guideline developers suggest clinicians not use dipyridamole as an alternative to a thienopyridine derivative (Grade 2C).

Patients Undergoing PCI: Glycoprotein (GP) IIb-IIIa Inhibitors

  1. For all patients undergoing PCI, particularly those undergoing primary PCI, or those with refractory unstable angina (UA) or other high-risk features, the guideline developers recommend use of a GP IIb-IIIa antagonist (abciximab or eptifibatide) (Grade 1A).
  2. In patients undergoing PCI for ST-segment elevation myocardial infarction (STEMI), the guideline developers recommend abciximab over eptifibatide (Grade 1B).

    Remark: Whenever possible, abciximab should be started prior to balloon inflation.

  3. The guideline developers recommend administration of abciximab as a 0.25 mg/kg bolus followed by a 12-hour infusion at a rate of 10 micrograms/min (Grade 1A) and eptifibatide as a double bolus (each 180 micrograms/kg administered 10 min apart), followed by an 18-hour infusion of 2.0 micrograms/kg/min (Grade 1A).
  4. In patients undergoing PCI, the guideline developers recommend against the use of tirofiban as an alternative to abciximab (Grade 1A).
  5. For patients with non-ST-segment elevation myocardial infarction (NSTEMI)/UA who are designated as moderate-to-high risk based on thrombolysis in myocardial infarction (TIMI) score, the guideline developers recommend that upstream use of GP IIb-IIIa antagonist (either eptifibatide or tirofiban) be started as soon as possible prior to PCI (Grade 1A).
  6. In NSTEMI/UA patients who receive upstream treatment with tirofiban, the guideline developers recommend that PCI be deferred for at least 4 hours after initiating the tirofiban infusion (Grade 2C).
  7. With planned PCI in NSTEMI/UA patients with an elevated troponin level, the guideline developers recommend that abciximab be started within 24 hours prior to the intervention (Grade 1A).

    Underlying values and preferences: These recommendations for the use of GP IIb-IIIa inhibitors place a relatively high value on preventing cardiovascular events and a relatively low value on cost and bleeding complications.

Patients Undergoing PCI: Unfractionated Heparin (UFH)

  1. In patients receiving a GP IIb-IIIa inhibitor, the guideline developers recommend a heparin bolus of 50 to 70 IU/kg to achieve a target activated clotting time (ACT) >200 seconds (Grade 1C).
  2. In patients not receiving a GP IIb-IIIa inhibitor, the guideline developers recommend that heparin be administered in doses sufficient to produce an ACT of 250 to 350 seconds (Grade 1C+). The guideline developers suggest a weight-adjusted heparin bolus of 60 to 100 IU/kg (Grade 2C).
  3. In patients after uncomplicated PCI, the guideline developers recommend against routine postprocedural infusion of heparin (Grade 1A).

Patients Undergoing PCI: Low Molecular Weight Heparin (LMWH)

  1. In patients who have received LMWH prior to PCI, the guideline developers recommend that administration of additional anticoagulant therapy is dependent on the timing of the last dose of LMWH (Grade 1C). If the last dose of enoxaparin was administered <8 hours prior to PCI, the guideline developers suggest no additional anticoagulant therapy (Grade 2C). If the last dose of enoxaparin was administered between 8 hours and 12 hours before PCI, the guideline developers suggest a 0.3 mg/kg bolus of intravenous (IV) enoxaparin at the time of PCI (Grade 2C). If the last enoxaparin dose was administered >12 hours before PCI, the guideline developers suggest conventional anticoagulation therapy during PCI (Grade 2C).

Patients Undergoing PCI: Direct Thrombin Inhibitors

  1. For patients undergoing PCI who are not treated with a GP IIb-IIIa antagonist, the guideline developers recommend bivalirudin (0.75 mg/kg bolus followed by an infusion of 1.75 mg/kg/hour for the duration of PCI) over heparin during PCI (Grade 1A).
  2. In PCI patients who are at low risk for complications, the guideline developers recommend bivalirudin as an alternative to heparin as an adjunct to GP IIb-IIIa antagonists (Grade 1B).
  3. In PCI patients who are at high risk for bleeding, the guideline developers recommend bivalirudin over heparin as an adjunct to GP IIb-IIIa antagonists (Grade 1B).

Patients Undergoing PCI: Vitamin K Antagonists

  1. In patients who undergo PCI with no other indication for systemic anticoagulation therapy, the guideline developers recommend against routine use of warfarin (or other vitamin K antagonists) after PCI (Grade 1A).

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

GUIDELINE DEVELOPER COMMENT

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: Jeffrey J. Popma, MD; Peter Berger, MD; E. Magnus Ohman, MD, FCCP; Robert A. Harrington, MD; Cindy Grines, MD; Jeffrey I. Weitz, 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. Popma has received research grant support from Cordis Corporation, Boston Scientific, Medtronic, Guidant, Abbott Vascular, Radiant Medical, Biocompatibles within the Angiographic Core Laboratory and has participated as a speaker over the past 3 years at events sponsored directly or indirectly by Schering-Plough, Millenium, Aventis, Medicines Company, Bristol-Myers Squibb, Eli Lilly, Merck, and Sanofi.

Dr. Berger has received a small amount of research support from Bristol-Myer Squibb/Sanofi and Cordis/Johnson & Johnson. He formerly served on a scientific advisory board for Bristol-Myer Squibb/Sanofi. He currently serves on a scientific advisory board for Cordis/Johnson & Johnson and Genentech. He has spoken at scientific symposia supported by Merck, Aventis, Bristol-Myer Squibb/Sanofi and the Medicines Co.

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

Dr. 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. Weitz has received research funding from AstraZeneca and The Medicines Company and has received honoraria for his participation on advisory boards and/or as a speaker at educational events from AstraZeneca, Aventis, and Daiichi.

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Popma JJ, Ohman EM, Weitz J, Lincoff AM, Harrington RA, Berger P. Antithrombotic therapy in patients undergoing percutaneous coronary intervention. Chest 2001 Jan;119(1 Suppl):321S-336S.

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 31, 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 July 12, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Troponin-1 Immunoassay. This summary was updated by ECRI Institute on March 14, 2008 following the updated FDA advisory on heparin sodium injection.

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