Document Detail

Primary prevention of arterial thromboembolism in non-rheumatic atrial fibrillation in primary care: randomised controlled trial comparing two intensities of coumarin with aspirin.
MedLine Citation:
PMID:  10514159     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To investigate the effectiveness of aspirin and coumarin in preventing thromboembolism in patients with non-rheumatic atrial fibrillation in general practice.
DESIGN: Randomised controlled trial.
PARTICIPANTS: 729 patients aged >/=60 years with atrial fibrillation, recruited in general practice, who had no established indication for coumarin. Mean age was 75 years and mean follow up 2. 7 years.
SETTING: Primary care in the Netherlands.
INTERVENTIONS: Patients eligible for standard intensity coumarin (international normalised ratio 2.5-3.5) were randomly assigned to standard anticoagulation, very low intensity coumarin (international normalised ratio 1.1-1.6), or aspirin (150 mg/day) (stratum 1). Patients ineligible for standard anticoagulation were randomly assigned to low anticoagulation or aspirin (stratum 2).
MAIN OUTCOME MEASURES: Stroke, systemic embolism, major haemorrhage, and vascular death.
RESULTS: 108 primary events occurred (annual event rate 5.5%), including 13 major haemorrhages (0.7% a year). The hazard ratio was 0.91 (0.61 to 1.36) for low anticoagulation versus aspirin and 0.78 (0.34 to 1.81) for standard anticoagulation versus aspirin. Non-vascular death was less common in the low anticoagulation group than in the aspirin group (0.41, 0.20 to 0.82). There was no significant difference between the treatment groups in bleeding incidence. High systolic and low diastolic blood pressure and age were independent prognostic factors.
CONCLUSION: In a general practice population (without established indications for coumarin) neither low nor standard intensity anticoagulation is better than aspirin in preventing primary outcome events. Aspirin may therefore be the first choice in patients with atrial fibrillation in general practice.
B S Hellemons; M Langenberg; J Lodder; F Vermeer; H J Schouten; T Lemmens; J W van Ree; J A Knottnerus
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  BMJ (Clinical research ed.)     Volume:  319     ISSN:  0959-8138     ISO Abbreviation:  BMJ     Publication Date:  1999 Oct 
Date Detail:
Created Date:  1999-11-19     Completed Date:  1999-11-19     Revised Date:  2013-04-17    
Medline Journal Info:
Nlm Unique ID:  8900488     Medline TA:  BMJ     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  958-64     Citation Subset:  AIM; IM    
Department of General Practice, University of Maastricht, 6200 MD Maastricht, Netherlands. Bep.Hellemons@HAG.Unimaas.NL
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MeSH Terms
Anticoagulants / administration & dosage*,  adverse effects
Aspirin / administration & dosage*,  adverse effects
Atrial Fibrillation / prevention & control*
Coumarins / administration & dosage*,  adverse effects
Follow-Up Studies
Middle Aged
Platelet Aggregation Inhibitors / administration & dosage*,  adverse effects
Proportional Hazards Models
Survival Analysis
Thromboembolism / prevention & control*
Treatment Outcome
Reg. No./Substance:
0/Anticoagulants; 0/Coumarins; 0/Platelet Aggregation Inhibitors; 50-78-2/Aspirin; A4VZ22K1WT/coumarin
Comment In:
BMJ. 2000 Apr 8;320(7240):1009   [PMID:  10809556 ]
BMJ. 2000 Apr 8;320(7240):1009   [PMID:  10809555 ]
BMJ. 2000 Apr 8;320(7240):1008-9; author reply 1010-1   [PMID:  10753166 ]
BMJ. 2000 Apr 8;320(7240):1009-10   [PMID:  10809557 ]
BMJ. 2000 Apr 8;320(7240):1010   [PMID:  10809559 ]
BMJ. 2000 Apr 8;320(7240):1010   [PMID:  10809558 ]
BMJ. 2000 Aug 12;321(7258):449   [PMID:  10991594 ]

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