SAFT(warfarin low dose + aspirin vs no treatment) Trial

SAFT(warfarin low dose + aspirin vs no treatment) study, 2003	TRC2650
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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

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

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
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	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction (for a follow-up of 33 months)
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
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