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Effects of low-dose warfarin and aspirin versus no treatment on stroke in a medium-risk patient population with atrial fibrillation.

Edvardsson, N; Juul-Möller, Steen LU ; Omblus, R and Pehrsson, K (2003) In Journal of Internal Medicine1989-01-01+01:00 254(1). p.95-101
Abstract
Objectives. To assess the optimal stroke prevention treatment for patients with atrial fibrillation (AF) and a low-medium risk (<=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... (More)
Objectives. To assess the optimal stroke prevention treatment for patients with atrial fibrillation (AF) and a low-medium risk (<=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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Journal of Internal Medicine1989-01-01+01:00
volume
254
issue
1
pages
95 - 101
publisher
Wiley-Blackwell Publishing Ltd
external identifiers
  • pmid:12823646
  • wos:000183583600010
  • scopus:0038686385
ISSN
1365-2796
DOI
language
English
LU publication?
yes
id
434a3837-2d0a-4bf1-8aa0-095ef1659e5e (old id 115703)
date added to LUP
2007-07-18 09:39:11
date last changed
2018-05-29 11:16:58
@article{434a3837-2d0a-4bf1-8aa0-095ef1659e5e,
  abstract     = {Objectives. To assess the optimal stroke prevention treatment for patients with atrial fibrillation (AF) and a low-medium risk (&lt;=4%) of stroke.<br/><br>
<br/><br>
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.<br/><br>
<br/><br>
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%.<br/><br>
<br/><br>
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.},
  author       = {Edvardsson, N and Juul-Möller, Steen and Omblus, R and Pehrsson, K},
  issn         = {1365-2796},
  language     = {eng},
  number       = {1},
  pages        = {95--101},
  publisher    = {Wiley-Blackwell Publishing Ltd},
  series       = {Journal of Internal Medicine1989-01-01+01:00},
  title        = {Effects of low-dose warfarin and aspirin versus no treatment on stroke in a medium-risk patient population with atrial fibrillation.},
  url          = {http://dx.doi.org/},
  volume       = {254},
  year         = {2003},
}