Welcome to NGC. Skip directly to: Search Box, Navigation, Content.


Brief Summary

GUIDELINE TITLE

Guidelines on oral anticoagulation (warfarin): third edition - 2005 update.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

** 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.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Recommendation grades (A-C) and levels of evidence (Ia-IV) are defined at the end of the "Major Recommendations" field.

Indications for Anticoagulation

Table: Indications for Oral Anticoagulation, Target International Normalised Ratio (INR) and Grade of Recommendations

Indication Target INR Grade of Recommendation
Pulmonary embolus 2.5 A
Proximal deep vein thrombosis 2.5 A
Calf vein thrombus 2.5 A
Recurrence of venous thromboembolism when no longer on warfarin therapy 2.5 A
Recurrence of venous thromboembolism whilst on warfarin therapy 3.5 C
Symptomatic inherited thrombophilia 2.5 A
Antiphospholipid syndrome 2.5 A
Non-rheumatic atrial fibrillation 2.5 A
Atrial fibrillation due to rheumatic heart disease, congenital heart disease and thyrotoxicosis 2.5 C
Cardioversion 2.5 or 3.0 (see original guideline document text) B
Mural thrombus 2.5 B
Cardiomyopathy 2.5 C
Mechanical prosthetic heart valve – aortic 3.0 or 2.5 (see Table II, below) B
Mechanical prosthetic heart valve – mitral 3.5 or 3.0 (see Table II, below) B
Bioprosthetic valve 2.5 if anticoagulated (see original 1998 guideline*)  
Ischaemic stroke without atrial fibrillation Not indicated C
Retinal vessel occlusion Not indicated C
Peripheral arterial thrombosis Not indicated A
Arterial grafts 2.5 if anticoagulated (see original guideline document text)  
Coronary artery thrombosis 2.5 if anticoagulated (see original guideline document text)  
Coronary artery graft Not indicated A
Coronary angioplasty and stents Not indicated A

*British Committee for Standards in Haematology (BCSH) 1998. Guidelines on oral anticoagulation: third edition. British Journal of Haematology, 101; 374-87.

Venous Thromboembolism (VTE)

A target INR of 2.5 is recommended for long-term oral anticoagulant (vitamin K antagonist [VKA]) therapy for secondary prevention of VTE (grade A, level 1b).

Duration of Anticoagulation

Anticoagulation for 1 month is inadequate treatment after an episode of VTE (grade A, level 1b). At least 6 weeks anticoagulation is recommended after calf vein thrombosis (grade A, level 1b) and at least 3 months after proximal deep venous thrombosis (DVT) or pulmonary embolism (PE) (grade A, level 1b). For patients with temporary risk factors and a low risk of recurrence, 3 months of treatment may be sufficient. For patients with idiopathic VTE or permanent risk factors, at least 6 months anticoagulation is recommended.

Antiphospholipid Syndrome

A target INR of 2.5 is recommended for patients with DVT or PE associated with antiphospholipid syndrome (grade A, level Ib).

Intravenous Drug Users

Treatment with low molecular weight heparin (LMWH) is an alternative to oral anticoagulation in patients with VTE secondary to intravenous drug use (grade C, level IV).

Cardioversion

A target INR of 2.5 is recommended for 3 weeks before and 4 weeks after cardioversion (grade B, level III). To minimise cardioversion cancellations due to low INRs on the day of the procedure a higher target INR, e.g. 3.0, can be used prior to the procedure.

Heart Valve Prostheses

For patients in whom valve type and location are known specific target INRs are recommended (see Table II below). Otherwise a target INR of 3.0 is recommended for valves in the aortic position and 3.5 in the mitral position.

Table II. Recommendations for Valve-Location-Specific Target INRs

Valve Type Position Target INR
Bileaflet Aortic 2.5
Tilting disk Aortic 3.0
Bileaflet Mitral 3.0
Tilting disk Mitral 3.0
Caged ball or caged disk Aortic or mitral 3.5

Peripheral Arterial Thrombosis and Grafts

Antiplatelet drugs remain first line intervention for secondary antithrombotic prophylaxis. If long-term anticoagulation is given to patients at high risk of femoral vein graft failure a target INR of 2.5 is recommended (grade B, level IIb).

Coronary Artery Thrombosis

If oral anticoagulant therapy is prescribed a target INR of 2.5 is recommended (grade A, level I).

Paroxysmal Nocturnal Haemoglobinuria (PNH)

Long-term anticoagulation with a target INR of 2.5 is recommended for patients with large PNH clones (PNH granulocytes >50%) and a platelet count greater than 100 × 109 per liter (grade B, level III). Anticoagulation can also be considered for patients with smaller clones and platelet counts less than 100 × 109 per liter dependent on additional risk factors for thrombosis and bleeding (grade C, level IV).

Cancer

Warfarin is generally inferior to therapeutic LMWH for treatment of VTE in patients with cancer (grade A, level Ib).

Commencement and Discontinuation of Anticoagulation

Induction Regimens for Patients Requiring Heparin

For outpatients who do not require rapid anticoagulation a slow-loading regimen is safe and achieves therapeutic anticoagulation in the majority of patients within 3–4 weeks (grade B, level IIb). This appears to avoid over-anticoagulation and bleeding associated with rapid loading.

For patients requiring rapid initiation of oral anticoagulation regimens that start with 5 milligram (mg) doses or a single 10 mg dose followed by 5 mg doses may be preferable to regimens that start with repeated 10 mg doses in certain patient groups, e.g., the elderly (>60 years of age), those with liver disease or cardiac failure and those at high risk of bleeding (grade B, level IIb).

Discontinuation of Anticoagulation

Oral anticoagulant therapy can be discontinued abruptly when the duration of therapy is completed (grade B, level IIb).

Managing Anticoagulation in the Perioperative Period

Previous recommendations remain unchanged. Unless there is a very high risk of thromboembolism anticoagulation should be temporarily discontinued in preparation for surgery. Anticoagulation does not need to be stopped for dental extraction for patients in therapeutic range, i.e., INR <3.0.

Managing Bleeding and Excessive Anticoagulation

Reversal of anticoagulation in patients with major bleeding requires administration of a factor concentrate in preference to fresh frozen plasma, when this is available (grade B, level III), and administration of intravenous rather than oral vitamin K (grade B, level IIa).

Near-Patient Testing (NPT) and Patient Self-Management (PSM)

For either NPT or PSM programmes:

  • Patients should conduct NPT, with or without PSM, within a managed programme.
  • The same standards of total quality management as practiced in hospital-based clinics should be adhered to.
  • Patients should be assessed for capability: only patients considered competent to follow total quality management procedures should complete training and undertake NPT, with or without PSM, as appropriate.
  • NPT and PSM programmes should be reviewed and audited at regular intervals for both technical (INR measurement) and clinical utility. Controls assurance procedures should include regular review of proportion of INRs in range and the incidence of over-anticoagulation, bleeding and thrombotic adverse events.

Definitions:

Classification of Evidence Levels

Ia Evidence obtained from meta-analysis of randomised controlled trials.

Ib Evidence obtained from at least one randomised controlled trial.

IIa Evidence obtained from at least one well-designed controlled study without randomisation.

IIb Evidence obtained from at least one other type of well-designed quasi-experimental study (a situation in which implementation of an intervention is without the control of the investigators, but an opportunity exists to evaluate its effect).*

III Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case studies.

IV Evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities.

*Refers to a situation in which implementation of an intervention is out with the control of the investigators, but an opportunity exists to evaluate its effect.

Classification of Grades of Recommendations

Grade A - Requires at least one randomised controlled trial as part of a body of literature of overall good quality and consistency addressing specific recommendation. (Evidence levels Ia, Ib).

Grade B - Requires the availability of well conducted clinical studies but no randomised clinical trials on the topic of recommendation. (Evidence levels IIa, IIb, III).

Grade C - Requires evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities. Indicates an absence of directly applicable clinical studies of good quality. (Evidence level IV).

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

2006 Feb

GUIDELINE DEVELOPER(S)

British Committee for Standards in Haematology - Professional Association

SOURCE(S) OF FUNDING

British Committee for Standards in Haematology

GUIDELINE COMMITTEE

Not stated

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Authors: T. P. Baglin, Addenbrooke's NHS Trust, Cambridge; D. M. Keeling, Oxford Haemophilia Centre and Thrombosis Unit, Churchill Hospital, Oxford; H. G. Watson, Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

None of the authors declared a conflict of interest.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available from the British Committee for Standards in Haematology Web site.

Print copies: Available from the British Committee for Standards in Haematology; Email: bcsh@b-s-h.org.uk.

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI Institute on May 22, 2008.

COPYRIGHT STATEMENT

DISCLAIMER

NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .

NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
DHHS Logo