心房颤动患者的出血风险：AMADEUS 研究。

Bleeding risk in patients with atrial fibrillation: the AMADEUS study.

机构信息

University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, England.

Department of Vascular Medicine, Academic Medical Centre, Amsterdam, The Netherlands.

出版信息

Chest. 2011 Jul;140(1):146-155. doi: 10.1378/chest.10-3270. Epub 2011 Mar 17.

DOI:10.1378/chest.10-3270

PMID:21415134

Abstract

OBJECTIVE

This study aimed to assess the impact of combination antithrombotic therapy on stroke and bleeding risk compared with anticoagulation therapy only in patients with atrial fibrillation (AF).

METHODS

Post hoc analysis of 4,576 patients with AF (mean ± SD age, 70.1 ± 9.1 years; men, 66.5%) enrolled in the Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS) trial were randomized to receive either subcutaneous idraparinux (2.5 mg weekly) (n = 2,283) or dose-adjusted vitamin K antagonists (VKAs) (international normalized ratio, 2.0-3.0) (n = 2,293). Of these patients, 848 (18.5%) received antiplatelet therapy (aspirin, clopidogrel, ticlopidine, etc) in addition to anticoagulation treatment (combination antithrombotic therapy).

RESULTS

A total of 572 (15.3% per year) clinically relevant bleeding and 103 (2.6% per year) major bleeding events occurred. Patients receiving combination antithrombotic therapy had a 2.3- to 2.5-fold increased risk of clinically relevant bleeding events and major bleeding events, respectively, compared with those receiving anticoagulation therapy only. Multivariate analyses (hazard ratio, 95% CI) revealed that the risk of clinically relevant bleeding was significantly increased by age 65 to 74 years (1.44, 1.14-1.82) and ≥ 75 years (1.59, 1.24-2.04, P = .001) and by combination antithrombotic therapy (2.47, 2.07-2.96, P < .0001). The same held true for major bleeding events, with analogous figures for age 65 to 74 years (2.26, 1.08-4.71) and ≥ 75 years (4.19, 1.98-8.87, P = .0004) and for combination antithrombotic therapy (2.23, 1.49-3.34, P < .0001). Combination antithrombotic therapy was not associated with a decrease in ischemic stroke risk compared with anticoagulation therapy only (11 [1.4% per year] vs 22 [0.7% per year]; adjusted hazard ratio, 2.01; 95% CI, 0.94-4.30; P = .07).

CONCLUSIONS

Combination antithrombotic therapy increases the risk of clinically relevant bleeding and major bleeding in patients with AF and does not appear to reduce the risk of stroke.

摘要

目的

本研究旨在评估与仅抗凝治疗相比，联合抗栓治疗对伴有心房颤动（AF）患者的卒中风险和出血风险的影响。

方法

对接受皮下依度沙班（每周 2.5 毫克）（n=2283）或调整剂量维生素 K 拮抗剂（国际标准化比值为 2.0-3.0）（n=2293）治疗的 4576 例 AF 患者（平均年龄±标准差，70.1±9.1 岁；男性，66.5%）进行事后分析。这些患者中，848 例（18.5%）除抗凝治疗（联合抗栓治疗）外还接受抗血小板治疗（阿司匹林、氯吡格雷、噻氯匹定等）。

结果

共发生 572 例（每年 15.3%）临床相关出血和 103 例（每年 2.6%）大出血事件。与仅接受抗凝治疗的患者相比，接受联合抗栓治疗的患者发生临床相关出血和大出血事件的风险分别增加 2.3-2.5 倍。多变量分析（风险比，95%CI）显示，年龄 65-74 岁（1.44，1.14-1.82）和≥75 岁（1.59，1.24-2.04，P=0.001）以及联合抗栓治疗（2.47，2.07-2.96，P<.0001）显著增加了临床相关出血的风险。大出血事件也是如此，年龄 65-74 岁（2.26，1.08-4.71）和≥75 岁（4.19，1.98-8.87，P=0.0004）以及联合抗栓治疗（2.23，1.49-3.34，P<.0001）也具有类似的数值。与仅抗凝治疗相比，联合抗栓治疗并未降低缺血性卒中风险（11 例[每年 1.4%]与 22 例[每年 0.7%]；调整后的风险比，2.01；95%CI，0.94-4.30；P=0.07）。