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Brief Summary

GUIDELINE TITLE

Antithrombotic therapy for non-ST-segment elevation acute coronary syndromes. 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 updates a previous version: Harrington RA, Becker RC, Ezekowitz M, Meade TW, O'Connor CM, Vorchheimer DA, Guyatt GH. Antithrombotic therapy for coronary artery disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004 Sep;126(3 Suppl):513S-48S.

** 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.

Recommendations for Antiplatelet Therapies

  1. For all patients presenting with non-ST-segment elevation acute coronary syndromes (NSTE ACS) without a clear allergy to aspirin, the guideline developers recommend immediate aspirin (162 to 325 mg orally [po]) and then daily oral aspirin (75 to 100 mg) (Grade 1A).
  2. For all NSTE ACS patients with an aspirin allergy, the guideline developers recommend immediate treatment with clopidogrel, 300 mg po bolus, followed by 75 mg/d indefinitely (Grade 1A).
  3. For NSTE ACS patients who are at moderate or greater risk (e.g., ongoing chest pain, hemodynamic instability, positive troponin, or dynamic ECG changes) for an ischemic event and who will undergo an early invasive management strategy (i.e., diagnostic catheterization followed by anatomy-driven revascularization):
    1. The guideline developers recommend "upstream" treatment either with clopidogrel (300 mg po bolus, followed by 75 mg/d) or a small-molecule intravenous (IV) glycoprotein (GP) IIb/IIIa inhibitor (eptifibatide or tirofiban) (Grade 1A).
    2. The guideline developers suggest upstream use of both clopidogrel and a small-molecule IV GP IIb/IIIa inhibitor (Grade 2A). Scrupulous attention to weight- and renal-based dosing algorithms must be part of eptifibatide or tirofiban administration.
    3. For patients presenting with NSTE ACS, the guideline developers  recommend against abciximab as initial treatment except when coronary anatomy is known and percutaneous coronary intervention (PCI) is planned within 24 hours (Grade 1A).
  4. For NSTE ACS patients who are at moderate or greater risk for an ischemic event and for whom an early conservative or a delayed invasive strategy of management is to be used:
    1. The guideline developers recommend upstream treatment with clopidogrel (300 mg oral bolus, followed by 75 mg/d) (Grade 1A).
    2. The guideline developers suggest upstream use of both clopidogrel and a small-molecule IV GP IIb/IIIa inhibitor (Grade 2B).
  5. For NSTE ACS patients who undergo PCI, the guideline developers recommend treatment with both clopidogrel and an IV GP IIb/IIIa inhibitor (Grade 1A)
    1. The guideline developers recommend a loading dose of 600 mg of clopidogrel given at least 2 hours prior to planned PCI followed by 75 mg/d (Grade 1B).
    2. If ticlopidine is given, the guideline developers suggest that a loading dose of 500 mg be given at least 6 hours before planned PCI (Grade 2C).
    3. For PCI patients who cannot tolerate aspirin, the guideline developers suggest that the loading dose of clopidogrel (600 mg) or ticlopidine (500 mg) be given at least 24 hours prior to planned PCI (Grade 2C).
    4. The guideline developers recommend use of a GP IIb/IIIa antagonist (abciximab or eptifibatide) (Grade 1A) for all NSTE ACS patients with at least moderate risk features undergoing PCI in whom a GP IIb/IIIa inhibitor has not been started "upstream." 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, given 10 minutes apart) followed by an 18-hour infusion of 2.0 micrograms/kg/min (Grade 1A). Appropriate dose reduction of eptifibatide must be based on renal function.
    5. In patients undergoing PCI in whom a GP IIb/IIIa inhibitor has not been started upstream, the guideline developers recommend against the use of tirofiban as an alternative to abciximab (Grade 1B).
  6. For NSTE ACS patients who have received clopidogrel and are scheduled for coronary bypass surgery, the guideline developers suggest discontinuing clopidogrel for at least 5 days prior to the scheduled surgery (Grade 2A).

Anticoagulant Therapies

  1. For all patients presenting with NSTE ACS, the guideline developers recommend anticoagulation with unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) or bivalirudin or fondaparinux over no anticoagulation (Grade 1A).
    1. The guideline developers recommend weight-based dosing of UFH and maintenance of the activated partial thromboplastin time (APTT) between 50 and 70 seconds (Grade 1B).
    2. The guideline developers recommend against routine monitoring of the anticoagulant effect of LMWH (Grade 1C). Careful attention is needed to appropriately adjust LMWH dose in patients with renal insufficiency.
  2. For NSTE ACS patients who will undergo an early invasive strategy of management (i.e., diagnostic catheterization followed by anatomy-driven revascularization)
    1. The guideline developers recommend UFH (with a GP IIb/IIIa inhibitor) over either LMWH or fondaparinux (Grade 1B).
    2. The guideline developers suggest bivalirudin over UFH in combination with a thienopyridine as an initial antithrombotic strategy in patients with moderate-to-high risk features presenting with a NSTE ACS and scheduled for very early coronary angiography (< 6 hours) (Grade 2B).
  3. For NSTE ACS patients in whom an early conservative or a delayed invasive strategy of management is to be used:
    1. The guideline developers recommend fondaparinux over enoxaparin (Grade 1A). For patients treated with upstream fondaparinux and undergoing PCI, the guideline developers recommend that additional IV boluses of UFH be given at the time of the procedure (for example, 50 to 60 U/kg) as well as additional IV doses of fondaparinux (2.5 mg if also receiving a GP IIb/IIIa inhibitor and 5 mg if not) (Grade 1B). Additionally, PCI operators should regularly flush the catheters with UFH during the procedure as well.
    2. The guideline developers recommend LMWH over UFH (Grade 1B). The guideline developers recommend continuing LMWH during PCI treatment of patients with NSTE ACS when LMWH has been started as the upstream anticoagulant (Grade 1B). If the last dose of enoxaparin was given <8 hours prior to PCI, the guideline developers recommend no additional anticoagulant therapy (Grade 1B). If the last dose of enoxaparin was given 8 to 12 hours before PCI, the guideline developers recommend a 0.3 mg/kg bolus of IV enoxaparin at the time of PCI (Grade 1B).
  4. In low-to-moderate risk patients with NSTE ACS undergoing PCI, the guideline developers recommend either bivalirudin with provisional ("bail-out") GP IIb/IIIa inhibitors or UFH plus a GP IIb/IIIa inhibitor over alternative antithrombotic regimens (Grade 1B).

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: Robert A. Harrington, MD, FCCP; Richard C. Becker, MD, FCCP; Christopher P. Cannon, MD; David Gutterman, MD, FCCP; A. Michael Lincoff, MD; Jeffrey J. Popma, MD; Gabriel Steg, MD, FCCP; Gordon H. Guyatt, MD, FCCP; and Shaun G. Goodman, 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. Harrington discloses that he holds a fiduciary position as Director of the Duke Clinical Research Institute (DCRI). Either he or the DCRI have received grant monies from the following: Abbott Laboratories; Abbott Vascular Business; Acorn Cardiovascular; Actelion, Ltd; Acusphere, Inc; Adolor Corporation; Advanced Cardiovascular Systems, Inc; Air Products; PLC; Ajinomoto; Alexion, Inc; Allergan, Inc; Alsius Corporation; Amgen, Inc; Amylin Pharmaceuticals; Anadys; Angel Medical Systems, Inc; AnGes MG Inc; Angiometrx, Inc; ArgiNox Pharmaceuticals; Ark Therapeutics; Astellas Pharma US; Astra Hassle; AstraZeneca; Atritech; Aventis; BARRX Medical, Inc; Baxter; Bayer AG; Bayer Corporation US; Berlex, Inc; Bioheart; Biolex Therapeutics; Biosense Webster, Inc; Biosite, Inc (also Biosite Diagnostics); Biosysnexus; Boehringer Ingelheim; Boston MedTech Advisors; Bristol Scientific Corporation; Bristol-Myers Squibb; CanAm Bioresearch; Cardio Thoracic Systems; CardioDynamics International; CardioKinetix; CardioOptics; Celgene Corporation; Celsion Corporation; Centocor; Cerexa, Inc; Chase Medical; Chugai Pharmaceutical; Cierra Inc; Coley Pharmaceutical Group; Conor Medsystems; Corautus Genetics; Cordis; Critical Therapeutics; Cubist Pharmaceuticals; CV Therapeutics; Cytokinetics; Daiichi Sankyo; deCode Genetics; Dyax; Echosens, Inc; Eclipse Surgical Technologies; Edwards Lifesciences; Eli Lilly & Company; EnteroMedics; Enzon Pharmaceutical; EOS Electro Optical Systems; EPI-Q, Inc; ev3, Inc; Evalve, Inc; Flow Cardia Inc; Fox Hollow Pharmaceuticals; Fujisawa; Genentech; General Electric Company; General Electric Healthcare; General Electric Medical Systems; Genzyme Corporation; Getz Bros & Co, Inc; GlaxoSmithKline; Globelmmune; Gloucester Pharmaceuticals; Guidant Pharmaceuticals; Heartscape Technologies; Hoffmann- LaRoche; Human Genome Sciences, Inc; ICAGEN; iCo Therapeutics; IDB Medical; Idenix Pharmaceutical; Indigo Pharmaceutical; INFORMD, Inc; InfraReDx; Inhibitex; Innocoll Pharmaceuticals; Inspire Pharmaceuticals; Intarcia Therapeutics; Integrated Therapeutics Group; Inverness Medical Innovations; Ischemix, Inc; Johnson & Johnson; Jomed, Inc; KAI Pharmaceuticals; Kerberos Proximal Solutions, Inc; Kinetic Concepts, Inc; King Pharmaceuticals; Kuhera Chemical Co; Lilly; Lumen Biomedical, Inc; Medical Educations Solutions Group; Medicure International; MiniMed; Medi-Flex, Inc; MedImmune; Medtronic AVE; Medtronic Diabetes; Medtronic, Inc; Medtronic Vascular; Merck Group; Microphage, Inc; Millennium Pharmaceutical; Mosby; Mycosol, Inc; NABI Biopharma; Neuron Pharmaceuticals; NicOx; NitroMed; NovaCardia Inc; Novartis AG Group; Novartis Pharmaceuticals; OLG Research; Ortho Biotech; OSI Eyetech; Osiris Therapeutics; Otsuka Pharmaceutical; Pathway Medical Technologies; PDL bio Pharma; PDxRx, Inc; Peregrine Pharmaceuticals; Pfizer; Pharmacyclics; Pharmanetics; Pharmassest; Pharsight, Inc; Portola Pharmaceutical; Proctor & Gamble; Radiant; Reata Pharmaceuticals; Recom Managed Systems, Inc; Regado Biosciences; Reliant Pharmaceuticals; Roche Diagnostic Corp; Salix Pharmaceuticals; Sanofi Pasteur, Inc (formerly Aventis-Pasteur); Sanofi-Aventis; Sanofi- Synthelabo; Schering-Plough Corporation; SciClone Pharmaceuticals; Scios; Seredigm; Sicel Technologies; Siemens; Skyline Ventures; Social Scientific Solutions; Spectranetics; Summit; Suneis; TAP Pharmaceutical Products; Tengion; Terumo Corporation; The Medicines Company; Theravance; TherOx, Inc; Thoratec Corporation; Titan Pharmaceuticals; United Therapeutics; Uptake Medical Corporation; Valleylab; Valeant Pharmaceuticals International; Valentis, Inc; Vascular Solutions, Inc; Velocimen, Inc; Veridex; Vertex Pharmaceuticals; VIASYS Healthcare; Vicuron Pharmaceuticals (formerly Versicor); ViroChem Pharma, Inc; Watson Pharmaceuticals; WebMD; Wyeth; Xsira Pharmaceuticals (formerly Norak Biosciences); and/or XTL Biopharma.

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

Dr. Cannon discloses that he has received grant monies from Accumetrics, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Sanofi-Aventis, and Schering Plough.

Dr. Lincoff discloses that he has received grant monies from The Medicines Company, Sanofi, Lilly, Pfizer, Schering, and AstraZeneca. He is also on advisory committees for Sanofi, The Medicines Company, and Pfizer.

Dr. Steg discloses that he has received grant monies from Sanofi-Aventis, and consultant fees from Sanofi-Aventis, Astra- Zeneca, BMS, Boehringer Ingelheim, Takeda, Amgen, Thermedicine, MSD, GSK, and Servier. He has served on the speakers bureau at Sanofi-Aventis, AstraZeneca, BMS, Boehringer Ingelheim, Takeda, Amgen, Thermedicine, MSD, GlaxoSmithKline, and Servier.

Dr. Popma discloses that he has received monies from Cordis, Boston Scientific, Medtronic, and Abbott. He is involved with the speakers bureaus of Pfizer, BMS, Lilly, and Sanofi, and has served on advisory committees of Medtronix, BSC, Abbott, and Cordis.

Dr. Goodman discloses that he has received grant monies from Biovail, Bristol-Myers Squibb, GlaxoSmithKline, Hoffman- La Roche, Lilly, Merck, Sanofi-Aventis, Schering, and The Medicines Company. He has also received consultant fees from Bristol-Myers Squibb, GlaxoSmithKline, Hoffman-La Roche, Lilly, Sanofi-Aventis, and The Medicines Company.

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

Dr. Gutterman discloses that he has received grant monies from the Veterans Administration and the National Institutes of Health. He is also a shareholder of Johnson & Johnson and has a relative who is a vice president at Glaxo-Wellcome.

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 updates a previous version: Harrington RA, Becker RC, Ezekowitz M, Meade TW, O'Connor CM, Vorchheimer DA, Guyatt GH. Antithrombotic therapy for coronary artery disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004 Sep;126(3 Suppl):513S-48S.

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 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 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 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 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 December 8, 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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