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Hellemons BS, Langenberg M, Lodder J, et al. Primary prevention of arterial thromboembolism in non-rheumatic atrial fibrillation in primary care: randomised controlled trial comparing two intensities of coumarin with aspirin

Department of General Practice, University of Maastricht, 6200 MD Maastricht, Netherlands.
BMJ Clinical Research (Impact Factor: 14.09). 11/1999; 319(7215):958-64. DOI: 10.1136/bmj.319.7215.958
Source: PubMed

ABSTRACT To investigate the effectiveness of aspirin and coumarin in preventing thromboembolism in patients with non-rheumatic atrial fibrillation in general practice.
Randomised controlled trial.
729 patients aged >/=60 years with atrial fibrillation, recruited in general practice, who had no established indication for coumarin. Mean age was 75 years and mean follow up 2. 7 years.
Primary care in the Netherlands.
Patients eligible for standard intensity coumarin (international normalised ratio 2.5-3.5) were randomly assigned to standard anticoagulation, very low intensity coumarin (international normalised ratio 1.1-1.6), or aspirin (150 mg/day) (stratum 1). Patients ineligible for standard anticoagulation were randomly assigned to low anticoagulation or aspirin (stratum 2).
Stroke, systemic embolism, major haemorrhage, and vascular death.
108 primary events occurred (annual event rate 5.5%), including 13 major haemorrhages (0.7% a year). The hazard ratio was 0.91 (0.61 to 1.36) for low anticoagulation versus aspirin and 0.78 (0.34 to 1.81) for standard anticoagulation versus aspirin. Non-vascular death was less common in the low anticoagulation group than in the aspirin group (0.41, 0.20 to 0.82). There was no significant difference between the treatment groups in bleeding incidence. High systolic and low diastolic blood pressure and age were independent prognostic factors.
In a general practice population (without established indications for coumarin) neither low nor standard intensity anticoagulation is better than aspirin in preventing primary outcome events. Aspirin may therefore be the first choice in patients with atrial fibrillation in general practice.

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    • "1.1 years 72 INR 2.0 to 3.0 FLD warfarin plus aspirin (325 mg) Target INR 1.2 to 1.5 with initial dose of FLD warfarin AFASAK-II 1998 [46] 2.2 years 73 INR 2.0 to 3.0 Aspirin (300 mg), FLD warfarin, FLD warfarin plus aspirin (300 mg) Mean INR with FLD Warf 1.14 and 1.12 with FLD warfarin plus Aspirin MWNAF 1998 [47] 2.5 years 64 INR 2.0 to 3.0 FLD warfarin (1.25 mg) — PATAF 1999 [48] (EAC group only) 2.7 years 75 INR 2.5 to 3.5 Aspirin (150 mg), FLD warfarin Only patients eligible for anticoagulation; target INR 1.1 to 1.6 with initial dose of FLD warfarin Evans et al. 2001 [49] 2 years 78 INR 2.0 to 3.0 Aspirin (75—300 mg) Not a randomised trial SPORTIF-III 2003 [17] 1.5 years 70 INR 2.0 to 3.0 Ximelagatran (72 mg) — SPORTIF-V 2004 [18] 1.7 years 72 INR 2.0 to 3.0 Ximelagatran (72 mg) — "
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    ABSTRACT: To compare the effectiveness of aspirin, warfarin, and ximelagatran as thromboprophylaxis in patients with non-valvular atrial fibrillation (NVAF). Systematic review of randomised controlled trials in patients with NVAF treated with adjusted-dose warfarin and aspirin, fixed low-dose (FLD) warfarin, ximelagatran or placebo. Outcome measures studied were ischaemic stroke, systemic embolism, mortality and haemorrhage. Meta-analysis was performed using a fixed effects model. We identified 13 trials (n=14,423 participants) of sufficient quality to be included in the analysis. Adjusted-dose warfarin significantly reduced the risk of ischaemic stroke or systemic embolism compared with aspirin (relative risk [RR] 0.59; 95% confidence interval [CI]: 0.40 to 0.86), FLD warfarin (RR 0.36; 95% CI: 0.23 to 0.58), or placebo (RR 0.33; 95% CI: 0.24 to 0.45). However, aspirin and placebo had a lower risk of major bleeding compared to warfarin (RR 0.58; 95% CI: 0.35 to 0.97 and RR 0.45; 95% CI: 0.25 to 0.82, respectively). The oral direct thrombin inhibitor, ximelagatran was as effective as adjusted-dose warfarin in the prevention of ischaemic strokes or systemic emboli (RR 1.04; 95% CI: 0.77 to 1.40) with less risk of major bleeding (RR 0.74; 95% CI: 0.56 to 0.96). Adjusted-dose warfarin significantly reduced mortality compared to placebo (RR 0.69; 95% CI: 0.53 to 0.89), but not for any of the other comparisons (aspirin: RR 0.87; 95% CI: 0.67 to 1.13; FLD warfarin: RR 1.11; 95% CI: 0.81 to 1.52; ximelagatran: RR 1.04; 95% CI: 0.86 to 1.26). We have extended previous analyses, making this the largest systematic review and meta-analysis of thromboprophylaxis trial data in AF--and have included recent trials with the new oral direct thrombin inhibitor, ximelagatran. This systematic review confirms the superiority of anticoagulation therapy over aspirin as thromboprophylaxis in patients with NVAF. The new oral direct thrombin inhibitor, ximelagatran, appears as effective as adjusted-dose warfarin for the prevention of thromboembolic events in NVAF, with a lower risk of bleeding.
    Thrombosis Research 02/2006; 118(3):321-33. DOI:10.1016/j.thromres.2005.08.007 · 2.43 Impact Factor
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    • "Studiu % din timp % din timp % din timp corect dozat supradozat subdozat Holm 1999 [10] 63 8 29 Beyth 1997 <ref type="bibr" target="#b10" coords="1;63.44;153.553;298.77810999999997;240.13136"><ref type="bibr" target="#b10" coords="1;63.44;153.553;298.77810999999997;240.13136">[11]</ref></ref> 33 16 51 Sawicki 1999 <ref type="bibr" target="#b11" coords="1;63.44;153.553;298.77810999999997;240.13136">[12]</ref> 34 16 50 Palaretti 1996 <ref type="bibr" target="#b8" coords="1;63.44;153.553;298.77810999999997;240.13136"><ref type="bibr" target="#b8" coords="1;63.44;153.553;298.77810999999997;240.13136">[9]</ref></ref> 68 6 26 Cannegeister 1995 <ref type="bibr" target="#b7" coords="1;63.44;153.553;298.77810999999997;240.13136"><ref type="bibr" target="#b7" coords="1;63.44;153.553;298.77810999999997;240.13136">[8]</ref></ref> 61 8 31 Hellemons 1999 <ref type="bibr" target="#b12" coords="1;63.44;153.553;298.77810999999997;240.13136">[13]</ref> 48 24 28 AFASAK 1989 [14] 73 1 26 BAATAF 1990 [15] "
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