FFAACS

Fluindione, Fibrillation Auriculaire, Aspirine et Contraste Spontané (2001)

Condition

Prevention of thromboembolic events in high-risk patients with AF

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Objective

To assess whether a combination of the anticoagulant fluindione and low-dose ASA provides better protection against thromboembolic events compared to fluindione alone

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Trial design

Randomized, double-blind, placebo-controlled phase III trial
Active treatment: fluindione standard dose (target INR 2.0–2.6) plus ASA 100 mg once daily (ASA group) (n=76)
Control treatment: fluindione standard dose (target INR 2.0–2.6) plus placebo (n=81)

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Endpoints

Primary endpoint: composite of stroke (ischemic or hemorrhagic), myocardial infarction, systemic arterial emboli, or vascular death
Secondary endpoint: hemorrhagic complications

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Trial participants

157 patients (mean age 74 years) with non-valvular AF and a previous thromboembolic event, or aged >65 years with hypertension, a recent episode of heart failure, or left ventricular dysfunction

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Results

Primary outcome: For the primary endpoint no statistical difference was seen between the groups (incidence 2.9% vs. 7.9% per 100 patient-years). Non-fatal thromboembolic events occurred in 2 patients receiving fluindione plus ASA and in 1 patient receiving fluindione plus placebo. 6 patients in each group died, none of them from a thromboembolic complication
Safety outcome: Death from severe bleeding complications occurred in
2 patients treated with fluindione plus ASA and in 1 patient receiving fluindione plus placebo. Non-fatal hemorrhagic complications were significantly more frequent in patients with fluindione plus ASA (n=10; 13.1%) than in patients with fluindione plus placebo (n=1; 1.2%)
The trial was prematurely stopped because the slower than expected inclusion rate would have necessitated a longer trial duration incompatible with the financial resources allocated to the study

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Summary

Efficacy: The incidence of primary endpoint events was not statistical different between the groups. The effect on thromboembolism could not be accurately assessed in this study due to the limited number of ischemic events
Safety: Hemorrhagic complications were significantly more frequent in the fluindione plus ASA group. So far the combination of fluindione plus ASA cannot be recommended in high-risk patients with AF

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Reference

Lechat P, Lardoux H, Mallet A, Sanchez P, Derumeaux G, Lecompte T, Maillard L, Mas JL, Mentre F, Pousset F, Lacomblez L, Pisica G, Solbes-Latourette S, Raynaud P, Chaumet-Riffaud P. Anticoagulant (fluindione)-aspirin combination in patients with high-risk atrial fibrillation. A randomized trial (Fluindione, Fibrillation Auriculaire, Aspirin et Contraste Spontane; FFAACS). Cerebrovasc Dis 2001;12:245-252

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Corresponding author

Philippe Lechat, Pharmacology Department, AP-HP, Pitié-Salpêtrière Hospital 47, Boulevard de l’Hôpital, F-75013 Paris (France), e-mail: phillipe.lechat@psl.ap-hop-paris.fr

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