Document Detail


A comparison of two intensities of warfarin for the prevention of recurrent thrombosis in patients with the antiphospholipid antibody syndrome.
MedLine Citation:
PMID:  13679527     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Many patients with the antiphospholipid antibody syndrome and recurrent thrombosis receive doses of warfarin adjusted to achieve an international normalized ratio (INR) of more than 3.0. However, there are no prospective data to support this approach to thromboprophylaxis. METHODS: We performed a randomized, double-blind trial in which patients with antiphospholipid antibodies and previous thrombosis were assigned to receive enough warfarin to achieve an INR of 2.0 to 3.0 (moderate intensity) or 3.1 to 4.0 (high intensity). Our objective was to show that high-intensity warfarin was more effective in preventing thrombosis than moderate-intensity warfarin. RESULTS: A total of 114 patients were enrolled in the study and followed for a mean of 2.7 years. Recurrent thrombosis occurred in 6 of 56 patients (10.7 percent) assigned to receive high-intensity warfarin and in 2 of 58 patients (3.4 percent) assigned to receive moderate-intensity warfarin (hazard ratio for the high-intensity group, 3.1; 95 percent confidence interval, 0.6 to 15.0). Major bleeding occurred in three patients assigned to receive high-intensity warfarin and four patients assigned to receive moderate-intensity warfarin (hazard ratio, 1.0; 95 percent confidence interval, 0.2 to 4.8). CONCLUSIONS: High-intensity warfarin was not superior to moderate-intensity warfarin for thromboprophylaxis in patients with antiphospholipid antibodies and previous thrombosis. The low rate of recurrent thrombosis among patients in whom the target INR was 2.0 to 3.0 suggests that moderate-intensity warfarin is appropriate for patients with the antiphospholipid antibody syndrome.
Authors:
Mark A Crowther; Jeff S Ginsberg; Jim Julian; Judah Denburg; Jack Hirsh; James Douketis; Carl Laskin; Paul Fortin; David Anderson; Clive Kearon; Ann Clarke; William Geerts; Melissa Forgie; David Green; Lorrie Costantini; Wendy Yacura; Sarah Wilson; Michael Gent; Michael J Kovacs
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  349     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2003 Sep 
Date Detail:
Created Date:  2003-09-18     Completed Date:  2003-09-24     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1133-8     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2003 Massachusetts Medical Society
Affiliation:
Department of Medicine, McMaster University, Hamilton, Ont, Canada. crowthrm@mcmaster.ca
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Antibodies, Antiphospholipid / blood
Anticoagulants / administration & dosage*,  adverse effects
Antiphospholipid Syndrome / blood,  complications,  drug therapy*
Double-Blind Method
Female
Follow-Up Studies
Hemorrhage / chemically induced
Humans
International Normalized Ratio
Male
Middle Aged
Myocardial Infarction / prevention & control
Pulmonary Embolism / prevention & control
Recurrence / prevention & control
Stroke
Venous Thrombosis / prevention & control*
Warfarin / administration & dosage*,  adverse effects
Chemical
Reg. No./Substance:
0/Antibodies, Antiphospholipid; 0/Anticoagulants; 81-81-2/Warfarin
Comments/Corrections
Comment In:
N Engl J Med. 2003 Dec 25;349(26):2568-70; author reply 2568-70   [PMID:  14699650 ]
N Engl J Med. 2003 Dec 25;349(26):2568-70; author reply 2568-70   [PMID:  14695423 ]
N Engl J Med. 2003 Sep 18;349(12):1177-9   [PMID:  13679533 ]
Rev Cardiovasc Med. 2004 Spring;5(2):135-8   [PMID:  15184845 ]
ACP J Club. 2004 Mar-Apr;140(2):38   [PMID:  15122858 ]
N Engl J Med. 2003 Dec 25;349(26):2568-70; author reply 2568-70   [PMID:  14699652 ]
N Engl J Med. 2003 Dec 25;349(26):2568-70; author reply 2568-70   [PMID:  14699651 ]
Curr Rheumatol Rep. 2007 Jun;9(3):187   [PMID:  17531168 ]
Erratum In:
N Engl J Med. 2003 Dec 25;349(26):2577
N Engl J Med. 2004 Jul 8;351(2):200

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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