[Study of combined anticoagulant (fluindione)-aspirin therapy in patients with atrial fibrillation at high risk for thromboembolic complications. A randomized trial (FFAACS)].

Abstract

BACKGROUND:

A combination of low-dose aspirin (A) and anticoagulation (AC) may provide better protection against thromboembolic events compared with AC alone in high-risk patients with atrial fibrillation (AF).

METHODS:

We performed a multicentric placebo-controlled double blind-trial to test the preventive efficacy against thromboembolic events of the addition of aspirin (A) (100 mg) or placebo (P) to anticoagulant treatment in patients with high-risk atrial fibrillation. A total of 157 patients were included, with atrial fibrillation and previous thromboembolic event or older than 65 years with either a history of hypertension, a recent episode of heart failure or a left ventricular dysfunction. All patients received fluindione (F) and P or F and A, with an INR target between 2 and 2.6. The primary endpoint was a combined endpoint of stroke (ischaemic or haemorrhagic), myocardial infarction, systemic arterial emboli or vascular death.

RESULTS:

The study had to be stopped prematurely owing to a too low recruitment rate. During follow-up (0.84 years) 3 non-fatal thromboembolic events were recorded (1P, 2A) and 6 patients died (3P, 3A), none of them from a thromboembolic complication. However, 3 deaths were secondary to severe haemorrhagic complications (1P, 2A). Non-fatal haemorrhagic complications occurred more often in group A (n = 10, 13.1 pour cent) compared with group P (n = 1, 1.2 pour cent), p = 0.003.

CONCLUSION:

The FFAACS study was not able to show any therapeutic benefit from the addition of aspirin to anticoagulant in patients with high-risk AF. Such a combination increased the incidence rate of bleeding complications, which therefore greatly reduces its potential overall benefit.

• Authors: P Lechat, H Lardoux, A Mallet, P Sanchez, G Derumeaux, T Lecompte, L Maillard, J L Mas, F Mentré, F Pousset, L Lacomblez, G Pisica, S Solbes-Latourette, P Raynaud, P Chaumet-Riffaud, Investigateurs de FFAACS
• Journal: Therapie (Therapie) 2000 Nov-Dec Vol. 55 Issue 6 Pg. 681-9 ISSN: 0040-5957 [Print] France
• Vernacular Title: Etude de l'association anticoagulant (fluindione)-aspirine, chez les patients en fibrillation auriculaire à haut risque de complications thrombo-emboliques. Une étude randomisée (FFAACS).
• PMID: 11234463 (Publication Type: Clinical Trial, Comparative Study, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticoagulants
• Phenindione
• fluindione
• Aspirin

Topics

• Aged
• Anticoagulants (therapeutic use)
• Aspirin (therapeutic use)
• Atrial Fibrillation (complications, drug therapy)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Humans
• Male
• Patient Selection
• Phenindione (analogs & derivatives, therapeutic use)
• Recurrence
• Risk Factors
• Thromboembolism (epidemiology, etiology, prevention & control)