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See also:
All atrial fibrillation clinical trials
All clinical trials of antithrombotics
All clinical trials of warfarin low dose + aspirin
|
|
Treatments
Studied treatment |
warfarin low dose (1.25 mg/d) + aspirin 75 mg/d
|
Control treatment |
no treatment
|
Concomittant treatment |
All patients were given sotalol to reach homogeneity for heart rate modulation. The dosage was openly adjusted during a 2 week run-in-period to obtain a heart rate at rest between 60 and 100 bpm and with a QTc of <0.52 s after heart rate modulation.
Patients were told not to take aspirin or other antiplatelet drug. |
Patients
Patients |
Low-medium risk patients with non valvular atrial fibrillation. |
Inclusion criteria |
Eligible patients were all men and women aged
60 years or older with electrocardiographic documentation
of persistent or permanent AF in the
preceding 4 weeks.
|
Exclusion criteria |
Prosthetic heart valves, significant valvular diseases, previous stroke or TIA,
and other requirements for or contraindications to
aspirin or warfarin therapy,severe heart failure (NYHA III/IV), bradycardia
of <60 beats min)1 (bpm), severe hypertension
[systolic blood pressure (SBP) > 190 mmHg and/or
diastolic blood pressure (DBP) >110 mmHg],S-potassium (<3.6 mmol L)1 and >5.2 mmol L)1),
chronic obstructive lung disease, primary liver disorder, known bleeding disorder, thyreotoxicosis
and impaired renal function (S-creatinine
>200 lmol L)1), patients with ischaemic heart
disease receiving aspirin. |
Baseline characteristics |
age(mean) |
72.5 |
male(%) |
62.5 |
weight(mean) |
79 |
systolic blood pressure(mean) |
145.5 |
diastolic blood pressure(mean) |
85 |
|
Method and design
Randomized effectives |
334 / 334 (studied vs. control) |
Design |
Parallel groups |
Blinding |
Open |
Follow-up duration |
33 months |
Premature discontinuation |
Premature discontinuation for insufficient enrollement |
Lost to follow-up |
1.4% |
Number of centre |
62 |
Geographic area |
Sweden |
Primary endpoint |
stroke |
Withdrawals (T1/T0) |
24.3 / 24.3 |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
systemic thrombo-embolic complication
5 / 334
5 / 334
classic
1,00 [0,29;3,42]
myocardial infarction (fatal and non fatal)
14 / 334
18 / 334
0,78 [0,39;1,54]
All cause death
31 / 334
36 / 334
0,86 [0,55;1,36]
Bleeding
19 / 334
4 / 334
classic
4,75 [1,63;13,81]
Haemmorhagic stroke
2 / 334
2 / 334
classic
1,00 [0,14;7,06]
Fatal stroke
7 / 334
4 / 334
classic
1,75 [0,52;5,92]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
systemic thrombo-embolic complication
|
5 / 334 (1,5%) |
5 / 334 (1,5%) |
1,00 |
[0,29;3,42] |
|
|
myocardial infarction (fatal and non fatal)
|
14 / 334 (4,2%) |
18 / 334 (5,4%) |
0,78 |
[0,39;1,54] |
|
|
All cause death
|
31 / 334 (9,3%) |
36 / 334 (10,8%) |
0,86 |
[0,55;1,36] |
|
|
Bleeding
|
19 / 334 (5,7%) |
4 / 334 (1,2%) |
4,75 |
[1,63;13,81] |
|
|
Haemmorhagic stroke
|
2 / 334 (0,6%) |
2 / 334 (0,6%) |
1,00 |
[0,14;7,06] |
|
|
Fatal stroke
|
7 / 334 (2,1%) |
4 / 334 (1,2%) |
1,75 |
[0,52;5,92] |
|
|
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
0:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction (for a follow-up of 33 months)
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
systemic thrombo-embolic complication |
1,50% |
1,50% |
0,00%
|
myocardial infarction (fatal and non fatal) |
4,19% |
5,39% |
-1,20%
|
All cause death |
9,28% |
10,78% |
-1,50%
|
Bleeding |
5,69% |
1,20% |
4,5%
|
Haemmorhagic stroke |
5,99‰ |
5,99‰ |
0,00%
|
Fatal stroke |
2,10% |
1,20% |
0,90%
|
Meta-analysis of all similar trials:
antithrombotics in atrial fibrillation for primary prevention of thromboembolic events
Reference(s)
TrialResults-center ID |
TRC2650
|
Trials register # |
NA
|
-
Edvardsson N, Juul-Moller S, Omblus R, Pehrsson K.
Effects of low-dose warfarin and aspirin versus no treatment on stroke in a medium-risk patient population with atrial fibrillation..
J Intern Med 2003 Jul;254:95-101
Pubmed
|
Hubmed
| Fulltext
-
Edvardsson N, Juul-Moller S, Omblus R, Pehrsson K.
Effects of low-dose warfarin and aspirin versus no treatment on stroke in a medium-risk patient population with atrial fibrillation..
J Intern Med 2003 Jul;254:95-101
Pubmed
|
Hubmed
| Fulltext
|