Document Detail


Low-dose aspirin for preventing recurrent venous thromboembolism.
MedLine Citation:
PMID:  23121403     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Patients who have had a first episode of unprovoked venous thromboembolism have a high risk of recurrence after anticoagulants are discontinued. Aspirin may be effective in preventing a recurrence of venous thromboembolism.
METHODS: We randomly assigned 822 patients who had completed initial anticoagulant therapy after a first episode of unprovoked venous thromboembolism to receive aspirin, at a dose of 100 mg daily, or placebo for up to 4 years. The primary outcome was a recurrence of venous thromboembolism.
RESULTS: During a median follow-up period of 37.2 months, venous thromboembolism recurred in 73 of 411 patients assigned to placebo and in 57 of 411 assigned to aspirin (a rate of 6.5% per year vs. 4.8% per year; hazard ratio with aspirin, 0.74; 95% confidence interval [CI], 0.52 to 1.05; P=0.09). Aspirin reduced the rate of the two prespecified secondary composite outcomes: the rate of venous thromboembolism, myocardial infarction, stroke, or cardiovascular death was reduced by 34% (a rate of 8.0% per year with placebo vs. 5.2% per year with aspirin; hazard ratio with aspirin, 0.66; 95% CI, 0.48 to 0.92; P=0.01), and the rate of venous thromboembolism, myocardial infarction, stroke, major bleeding, or death from any cause was reduced by 33% (hazard ratio, 0.67; 95% CI, 0.49 to 0.91; P=0.01). There was no significant between-group difference in the rates of major or clinically relevant nonmajor bleeding episodes (rate of 0.6% per year with placebo vs. 1.1% per year with aspirin, P=0.22) or serious adverse events.
CONCLUSIONS: In this study, aspirin, as compared with placebo, did not significantly reduce the rate of recurrence of venous thromboembolism but resulted in a significant reduction in the rate of major vascular events, with improved net clinical benefit. These results substantiate earlier evidence of a therapeutic benefit of aspirin when it is given to patients after initial anticoagulant therapy for a first episode of unprovoked venous thromboembolism. (Funded by National Health and Medical Research Council [Australia] and others; Australian New Zealand Clinical Trials Registry number, ACTRN12605000004662.).
Authors:
Timothy A Brighton; John W Eikelboom; Kristy Mann; Rebecca Mister; Alexander Gallus; Paul Ockelford; Harry Gibbs; Wendy Hague; Denis Xavier; Rafael Diaz; Adrienne Kirby; John Simes;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-11-04
Journal Detail:
Title:  The New England journal of medicine     Volume:  367     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-22     Completed Date:  2012-12-05     Revised Date:  2013-06-27    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1979-87     Citation Subset:  AIM; IM    
Affiliation:
Department of Haematology, South Eastern Area Laboratory Services (SEALS), Prince of Wales Hospital, Sydney, Australia. aspire@ctc.usyd.edu.au
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MeSH Terms
Descriptor/Qualifier:
Aspirin / administration & dosage*,  adverse effects,  therapeutic use
Double-Blind Method
Female
Follow-Up Studies
Hemorrhage / chemically induced,  epidemiology
Humans
Incidence
Male
Middle Aged
Platelet Aggregation Inhibitors / administration & dosage*,  adverse effects,  therapeutic use
Recurrence / prevention & control
Risk
Venous Thromboembolism / epidemiology,  prevention & control*
Chemical
Reg. No./Substance:
0/Platelet Aggregation Inhibitors; 50-78-2/Aspirin
Investigator
Investigator/Affiliation:
T Brighton / ; J Eikelboom / ; W Hague / ; A Kirby / ; R Mister / ; J Simes / ; A Gallus / ; P Ockelford / ; R Baker / ; H Gibbs / ; P Coughlin / ; D Xavier / ; R Diaz / ; G Agnelli / ; H Gibbs / ; T Karplus / ; J Fletcher / ; A van Rij / ; Anthony Rogers / ; C Hayward / ; Graham Young / ; P Crispin / ; J Slade / ; C Ward / ; N Tadayon / ; J Koutts / ; L Fisher / ; T Brighton / ; K McCardie / ; A Bianchi / ; J Trinh / ; J Joseph / ; P Plenge / ; B Chong / ; S Davidson / ; J Waites / ; P Cahill / ; C Tiley / ; M Lacey / ; D Jackson / ; J Boys / ; M Seldon / ; M Gambrill / ; H Nandurkar / ; H Worland / ; H Salem / ; C Gollogly / ; P Campbell / ; I Marshall / ; K Hamilton / ; C Goss / ; H Salem / ; L Poulton / ; M Jackson / ; T de Man / ; E Gan / ; A Cummins / ; M Leyden / ; C Sturtz / ; P Kubler / ; X Sansome / ; A McCann / ; C Downey / ; P Carroll / ; M Duroux / ; S Hamwood / ; G Styles / ; N Buckmaster / ; T Schmidt / ; D Colquhoun / ; A Jardim / ; A Gallus / ; J Osmond / ; W Jeffries / ; B Trezona / ; S McRae / ; D King / ; R Baker / ; K Courtley / ; R Kimber / ; L Oliver / ; A MacDonald / ; J Shepherd / ; P Ockelford / ; M Hulton / ; G Royle / ; L Haycock / ; D Simpson / ; K Yap / ; B Baker / ; H McQuilkin / ; J Carter / ; J Body / ; L Lai Heng / ; M Tan / ; J Chin Tay / ; J Zou / ; H Kumar Pandharpurkar / ; Remya G / ; E Stephen / ; A Benjamin / ; S C Desai / ; R Singh / ; K R Suresh / ; Girija K R / ; S Natarajan / ; D Goel / ; R Gupta / ; B S Mishra / ; G Sidhu / ; R Singh Sidhu / ; R Parakh / ; R Sharma / ; S Joshi / ; M Mahajan / ; T Grover / ; K Sharma / ; P Patel / ; A Kothurkar / ; P Ranade / ; J L Fedele / ; A C Cristófaro / ; E Gelersztein / ; M Gelersztein / ; A S Sánchez / ; L C Bowen / ; R O García Durán / ; F Cámpora / ; H Héctor Ferro / ; M V Casais / ; R Mister / ; A Kirby / ; K Mann / ; C Van Holst Pellekaan / ; S Chinchen / ; A Lucas / ; W Hague / ; J Simes / ; D Xavier / ; P Pais / ; A Sigamani / ; N Mathur / ; Anupama M / ; Deepthi K B / ; R Diaz / ; C Chacon / ; R Rucci /
Comments/Corrections
Comment In:
Dtsch Med Wochenschr. 2013 Feb;138(6):244   [PMID:  23479792 ]
Rev Clin Esp. 2013 May;213(4):212
Nat Rev Cardiol. 2013 Jan;10(1):4   [PMID:  23165071 ]
N Engl J Med. 2012 Nov 22;367(21):2039-41   [PMID:  23121404 ]
Ann Intern Med. 2013 Mar 19;158(6):JC2   [PMID:  23552619 ]
N Engl J Med. 2013 Feb 21;368(8):772-3   [PMID:  23425174 ]
N Engl J Med. 2013 Feb 21;368(8):772   [PMID:  23425173 ]
N Engl J Med. 2013 Feb 21;368(8):773   [PMID:  23425172 ]

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


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