Document Detail

Effects of low-dose warfarin and aspirin versus no treatment on stroke in a medium-risk patient population with atrial fibrillation.
MedLine Citation:
PMID:  12823646     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: To assess the optimal stroke prevention treatment for patients with atrial fibrillation (AF) and a low-medium risk (< or =4%) of stroke. DESIGN: A total of 668 patients with persistent or permanent AF, without an indication for full dose and with adequate rate control on sotalol, were randomized to warfarin 1.25 mg + aspirin 75 mg daily (W/A, 334 patients) or no anticoagulation (C, 334 patients). The mean follow-up period was 33 months. The protocol intended to verify a 37% relative risk reduction provided a 4% stroke incidence in the C group. RESULTS: The stroke incidence was less in the W/A group, although the reduction was not statistically significant (W/A 9.6% versus C 12.3%). Four haemorrhagic strokes were identified, two in each group. Secondary end-points were transient ischaemic attacks (TIA) (W/A 3.3% versus C 4.5%), all cause mortality (W/A 9.3% versus C 10.8%), cardiovascular morbidity (W/A 17.7% versus C 22.2%) and the combination of stroke + TIA (W/A 11.7% versus C 16.5%). Bleedings were documented in 19 versus four patients (W/A 5.7% versus C 1.2%) (P = 0.003), although none fatal. Sinus rhythm (SR) was recorded occasionally in 68 patients (W/A 9.6% versus C 10.8%). The stroke incidence tended to be higher in those with SR than without, 16.2% versus 10.4%. CONCLUSIONS: Our results were inconclusive, but consistent with a small beneficial effect of W/A for reduction of stroke and major vascular events in AF patients at moderate risk. The low-dose regiment produced, however, a significantly increased risk of bleedings. Documented SR occasionally recorded may represent a subpopulation that warrants full dose warfarin.
N Edvardsson; S Juul-Möller; R Omblus; K Pehrsson
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of internal medicine     Volume:  254     ISSN:  0954-6820     ISO Abbreviation:  J. Intern. Med.     Publication Date:  2003 Jul 
Date Detail:
Created Date:  2003-06-25     Completed Date:  2003-08-11     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8904841     Medline TA:  J Intern Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  95-101     Citation Subset:  IM    
Division of Cardiology, Sahlgrenska University Hospital, Stockholm, Sweden.
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MeSH Terms
Aged, 80 and over
Anticoagulants / administration & dosage*
Aspirin / administration & dosage*,  adverse effects
Atrial Fibrillation / complications*,  mortality
Double-Blind Method
Hemorrhage / chemically induced
Middle Aged
Platelet Aggregation Inhibitors / administration & dosage*,  adverse effects
Stroke / mortality,  prevention & control*
Warfarin / administration & dosage*,  adverse effects
Withholding Treatment
Reg. No./Substance:
0/Anticoagulants; 0/Platelet Aggregation Inhibitors; 50-78-2/Aspirin; 81-81-2/Warfarin

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

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