Effects of low-dose warfarin and aspirin versus no treatment on stroke in a medium-risk patient population with atrial fibrillation.
(2003) In Journal of Internal Medicine 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)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/115703
- author
- Edvardsson, N ; Juul-Möller, Steen LU ; Omblus, R and Pehrsson, K
- organization
- publishing date
- 2003
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Journal of Internal Medicine
- volume
- 254
- issue
- 1
- pages
- 95 - 101
- publisher
- Wiley-Blackwell
- external identifiers
-
- pmid:12823646
- wos:000183583600010
- scopus:0038686385
- ISSN
- 1365-2796
- DOI
- 10.1046/j.1365-2796.2003.01159.x
- language
- English
- LU publication?
- yes
- additional info
- The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Emergency medicine/Medicine/Surgery (013240200)
- id
- 434a3837-2d0a-4bf1-8aa0-095ef1659e5e (old id 115703)
- date added to LUP
- 2016-04-01 16:16:38
- date last changed
- 2022-01-28 18:34:00
@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 (<=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}},
series = {{Journal of Internal Medicine}},
title = {{Effects of low-dose warfarin and aspirin versus no treatment on stroke in a medium-risk patient population with atrial fibrillation.}},
url = {{https://lup.lub.lu.se/search/files/4623502/623807.pdf}},
doi = {{10.1046/j.1365-2796.2003.01159.x}},
volume = {{254}},
year = {{2003}},
}