This is the current release of the guideline.

This guideline updates a previous version: Salem DN, Daudelin HD, Levine HJ, Pauker SG, Eckman MH, Riff J. Antithrombotic therapy in valvular heart disease. Chest 2001 Jan;119(1 Suppl):207S-219S.

Stein PD, Alpert JS, Bussey HI, Dalen JE, Turpie AG. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest 2001 Jan;119(1 Suppl):220S-227S.

The rating scheme is defined at the end of the "Major Recommendations" field.

Rheumatic Mitral Valve Disease

Rheumatic Mitral Valve Disease with Atrial Fibrillation (AF) or a History of Systemic Embolism

For patients with rheumatic mitral valve disease and AF, or a history of previous systemic embolism:

1. The guideline developers recommend long-term oral anticoagulant (OAC) therapy (target international normalized ratio [INR], 2.5; range, 2.0 to 3.0) (Grade 1C+).

For patients with rheumatic mitral valve disease and AF, or a history of previous systemic embolism:

2. The guideline developers suggest clinicians not use concomitant therapy with OAC and antiplatelet agent (APA) (Grade 2C).

   Underlying values and preferences: This recommendation places a relatively high value on avoiding the additional bleeding risk associated with concomitant OAC and antiplatelet therapy.

For patients with rheumatic mitral valve disease with AF or a history of systemic embolism who suffer systemic embolism while receiving OACs at a therapeutic INR:

3. The guideline developers recommend adding aspirin, 75 to 100 mg/d (Grade 1C). For those patients unable to take aspirin, the guideline developers recommend adding dipyridamole, 400 mg/d, or clopidogrel (Grade 1C).

Patients with Mitral Valve Disease in Sinus Rhythm

1. In patients with rheumatic mitral valve disease and normal sinus rhythm with a left atrial diameter >5.5 cm, the guideline developers suggest long-term vitamin K antagonist therapy (target INR, 2.5; range, 2.0 to 3.0) [Grade 2C].

   Underlying values and preferences: This recommendation places a relatively high value on avoiding systemic embolism and its consequences and a relatively low value on avoiding the bleeding risk and inconvenience associated with OAC therapy.

2. In patients with rheumatic mitral valve disease and normal sinus rhythm with a left atrial diameter <5.5 cm, the guideline developers suggest clinicians not use antithrombotic therapy (Grade 2C).

Patients Undergoing Mitral Valvuloplasty

1. For patients undergoing mitral valvuloplasty, the guideline developers suggest anticoagulation with vitamin K antagonists with a target INR of 2.5 (range, 2.0 to 3.0) for 3 weeks prior to the procedure and for 4 weeks after the procedure (Grade 2C).

Mitral Valve Prolapse (MVP)

1. In people with MVP who have not experienced systemic embolism, unexplained transient ischemic attacks (TIAs), or AF, the guideline developers recommend against any antithrombotic therapy (Grade 1C).
2. In patients with MVP who have documented but unexplained TIAs, the guideline developers recommend long-term aspirin therapy, 50 to 162 mg/d (Grade 1A).
3. In patients with MVP who have documented systemic embolism or recurrent TIAs despite aspirin therapy, the guideline developers suggest long-term vitamin K antagonist therapy (target INR, 2.5; range, 2.0 to 3.0) [Grade 2C].

Mitral Annular Calcification (MAC)

1. In patients with MAC complicated by systemic embolism, not documented to be calcific embolism, the guideline developers suggest treatment with long-term OAC therapy (target INR, 2.5; INR range, 2.0 to 3.0) [Grade 2C].

Aortic Valve and Aortic Arch Disorders

1. In patients with aortic valve disease, the guideline developers suggest that clinicians not use long-term vitamin K antagonist therapy unless they have another indication for anticoagulation (Grade 2C).
2. The guideline developers suggest OAC therapy in patients with mobile aortic atheromas and aortic plaques >4 mm as measured by transesophageal echocardiography (TEE) [Grade 2C].

Prosthetic Heart Valves - Mechanical Prosthetic Heart Valves

1. For all patients with mechanical prosthetic heart valves, the guideline developers recommend vitamin K antagonists (Grade 1C+). The guideline developers suggest administration of unfractionated heparin or low molecular weight heparin (LMWH) until the INR is stable and at a therapeutic level for 2 consecutive days (Grade 2C).
2. For patients with a St. Jude Medical bileaflet valve in the aortic position, the guideline developers recommend a target INR of 2.5 (range 2.0 to 3.0) [Grade 1A].
3. For patients with tilting disk valves and bileaflet mechanical valves in the mitral position, the guideline developers recommend a target INR of 3.0 (range 2.5 to 3.5) [Grade 1C+].
4. For patients with CarboMedics bileaflet valve or Medtronic Hall tilting disk mechanical valves in the aortic position, normal left atrium size, and sinus rhythm, the guideline developers recommend a target INR of 2.5 (range 2.0 to 3.0) [Grade 1C+].
5. In patients who have mechanical valves and additional risk factors such as AF, myocardial infarction, left atrial enlargement, endocardial damage, and low ejection fraction, the guideline developers recommend a target INR of 3.0 (range 2.5 to 3.5), combined with low doses of aspirin, 75 to 100 mg/d (Grade 1C+).
6. For patients with caged ball or caged disk valves, the guideline developers suggest a target INR of 3.0 (range, 2.5 to 3.5) in combination with aspirin, 75 to 100 mg/d (Grade 2A).
7. For patients with mechanical prosthetic heart valves who suffer systemic embolism despite a therapeutic INR, the guideline developers recommend aspirin, 75 to 100 mg/d, in addition to vitamin K antagonists, and maintenance of the INR at a target of 3.0 (range 2.5 to 3.5) [Grade 1C+].
8. In patients with prosthetic heart valves in whom vitamin K antagonist must be discontinued, the guideline developers recommend LMWH (Grade 1C) or aspirin 80 to 100 mg/day (Grade 1C).

Prosthetic Heart Valves - Bioprosthetic Valves

First 3 Months after Valve Insertion

1. For patients with bioprosthetic valves in the mitral position, the guideline developers recommend vitamin K antagonists with a target INR of 2.5 (range 2.0 to 3.0) for the first 3 months after valve insertion (Grade 1C+).
2. For patients with bioprosthetic valves in the aortic position, the guideline developers suggest vitamin K antagonists with a target INR of 2.5 (range 2.0 to 3.0) for the first 3 months after valve insertion (Grade 2C) or aspirin 80 to 100 mg/day (Grade 1C).
3. In patients who have undergone valve replacement, the guideline developers suggest heparin (low molecular weight or unfractionated) until the INR is stable at therapeutic levels for 2 consecutive days (Grade 2C).
4. For patients with bioprosthetic valves who have a history of systemic embolism, the guideline developers recommend vitamin K antagonists for 3 to 12 months (Grade 1C).
5. In patients with bioprosthetic valves who have evidence of a left atrial thrombus at surgery, the guideline developers recommend vitamin K antagonists with a dose sufficient to prolong the INR to a target of 2.5 (range 2.0 to 3.0) (Grade 1C).

   Values and preferences: This recommendation places a relatively high value on preventing thromboembolic events and a relatively lower value on bleeding complications.

Long-Term Treatment

1. In patients with bioprosthetic valves who have AF, the guideline developers recommend long-term treatment with vitamin K antagonists with a target INR of 2.5 (range 2.0 to 3.0) [Grade 1C+].
2. For patients with bioprosthetic valves who are in sinus rhythm and do not have AF, the guideline developers recommend long-term therapy with aspirin, 75 to 100 mg/d (Grade 1C+).

Infective Endocarditis and Nonbacterial Thrombotic Endocarditis (NBTE)

1. In patients with a mechanical prosthetic valve and endocarditis who have no contraindications, the guideline developers suggest continuation of long-term vitamin K antagonists (Grade 2C).
2. For patients with NBTE and systemic or pulmonary emboli, the guideline developers recommend treatment with full-dose unfractionated intravenous or subcutaneous heparin (Grade 1C).
3. For patients with disseminated cancer or debilitating disease with aseptic vegetations, the guideline developers suggest administration of full-dose unfractionated heparin (Grade 2C).

Definitions

*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.

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Not applicable: The guideline was not adapted from another source.

2001 Jan (revised 2004 Sep)

American College of Chest Physicians - Medical Specialty Society

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.

American College of Chest Physicians Consensus Panel on Antithrombotic and Thrombolytic Therapy

Primary Authors: Deeb N. Salem, MD, FCCP (Chair); Paul D. Stein, MD, FCCP; Amin Al-Ahmad, MD; Henry I. Bussey, Pharm D, FCCP; Dieter Horstkotte, MD; Nancy Miller, RN; Stephen G. Pauker, 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

Dr. Salem has received an honorarium for speaking for Sanofi-Synthelabo-Organon.

Dr. Stein received honoraria for speaking at educational events from Aventis Pharma and Dupont Pharma. He was a consultant for Shiley several years ago.

Dr. Al-Ahmad has nothing to declare.

Dr. Bussey has received research funding from Aventis, Organon-Sanofi-Synthelabo, AstraZeneca, Bristol-Myers Squibb, Bertek Pharmaceuticals, and Novartis and has participated on advisory boards and/or research steering committees for Aventis, Organon-Sanofi-Synthelabo, and AstraZeneca. He also has received speaking honoraria from and/or served as a consultant for Aventis, AstraZeneca, Bristol-Myers Squibb, and Organon-Sanofi-Synthelabo.

Dr. Stephen Pauker has received research funding from Schering-Plough, but none related to antithrombotic therapy. Dr. Pauker is a member of the Board of Regents of the American College of Physicians.

This is the current release of the guideline.

This guideline updates a previous version: Salem DN, Daudelin HD, Levine HJ, Pauker SG, Eckman MH, Riff J. Antithrombotic therapy in valvular heart disease. Chest 2001 Jan;119(1 Suppl):207S-219S.

Stein PD, Alpert JS, Bussey HI, Dalen JE, Turpie AG. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest 2001 Jan;119(1 Suppl):220S-227S.

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 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 is based on the original guideline, which is subject to the guideline developer's copyright restrictions.