抗凝剂（氟茚二酮）与阿司匹林联合用于高危心房颤动患者。一项随机试验（氟茚二酮、心房颤动、阿司匹林与自发性造影；FFAACS）

Anticoagulant (fluindione)-aspirin combination in patients with high-risk atrial fibrillation. A randomized trial (Fluindione, Fibrillation Auriculaire, Aspirin et Contraste Spontané; FFAACS).

作者信息

Lechat P, Lardoux H, Mallet A, Sanchez P, Derumeaux G, Lecompte T, Maillard L, Mas J L, Mentre F, Pousset F, Lacomblez L, Pisica G, Solbes-Latourette S, Raynaud P, Chaumet-Riffaud P

机构信息

Pharmacology Department, Pitié-Salpêtrière Hospital, Paris, France.

出版信息

Cerebrovasc Dis. 2001;12(3):245-52. doi: 10.1159/000047711.

DOI:10.1159/000047711

PMID:11641591

Abstract

BACKGROUND

A combination of low-dose aspirin with anticoagulants may provide better protection against thromboembolic events compared to anticoagulants alone in high-risk patients with atrial fibrillation.

OBJECTIVE

Evaluation of the preventive efficacy against nonfatal thromboembolic events and vascular deaths of the combination of the oral anticoagulant fluindione and aspirin (100 mg) in patients with high-risk atrial fibrillation.

METHODS

A multicenter, placebo-controlled, double-blind, randomized trial was conducted at 49 investigating centers in France. Atrial fibrillation patients with a previous thromboembolic event or older than 65 years and with either a history of hypertension, a recent episode of heart failure or decreased left ventricular function were included in the study. Patients were treated with fluindione plus placebo (i.e. anticoagulant alone) or fluindione plus aspirin (i.e. combination therapy), with an international normalized ratio target of between 2 and 2.6. The combined primary endpoint was stroke (ischemic or hemorrhagic), myocardial infarction, systemic arterial emboli or vascular death. The secondary endpoint was the incidence of hemorrhagic complications.

RESULTS

The 157 participants (average age 74 years; 52% women; 42% with paroxysmal atrial fibrillation) were followed for an average of 0.84 years. Three nonfatal thromboembolic events were observed (1 in the anticoagulation group, 2 in the combination group) and 6 patients died (3 in the anticoagulation group, 3 in the combination group), none of them from a thromboembolic complication. However, 3 deaths were secondary to severe hemorrhagic complications (1 in the anticoagulation group, 2 in the combination group). Nonfatal hemorrhagic complications occurred more often in the combination group (n = 10, 13.1%) compared to the anticoagulation group (n = 1, 1.2%) (p = 0.003).

CONCLUSION

The combination of aspirin with anticoagulant is associated with increased bleeding in elderly atrial fibrillation patients. The effect on thromboembolism and the overall balance of benefit to risk could not be accurately assessed in this study due to the limited number of ischemic events.

摘要

背景

与单独使用抗凝剂相比，低剂量阿司匹林与抗凝剂联合使用可能为高危房颤患者提供更好的预防血栓栓塞事件的保护。

目的

评估口服抗凝剂氟茚二酮与阿司匹林（100毫克）联合使用对高危房颤患者非致命性血栓栓塞事件和血管性死亡的预防效果。

方法

在法国的49个研究中心进行了一项多中心、安慰剂对照、双盲、随机试验。有既往血栓栓塞事件或年龄超过65岁且有高血压病史、近期心力衰竭发作或左心室功能下降的房颤患者被纳入研究。患者接受氟茚二酮加安慰剂（即单独使用抗凝剂）或氟茚二酮加阿司匹林（即联合治疗），国际标准化比值目标为2至2.6。联合主要终点为中风（缺血性或出血性）、心肌梗死、全身性动脉栓塞或血管性死亡。次要终点为出血并发症的发生率。

结果

157名参与者（平均年龄74岁；52%为女性；42%为阵发性房颤）平均随访0.84年。观察到3例非致命性血栓栓塞事件（抗凝组1例，联合组2例），6例患者死亡（抗凝组3例，联合组3例），均非死于血栓栓塞并发症。然而，3例死亡继发于严重出血并发症（抗凝组1例，联合组2例）。与抗凝组（n = 1，1.2%）相比，联合组非致命性出血并发症发生率更高（n = 10，13.1%）（p = 0.003）。