Dual antithrombotic therapy increases severe bleeding events in patients with stroke and cardiovascular disease - A prospective, multicenter, observational study
Dual antithrombotic therapy increases severe bleeding events in patients with stroke and cardiovascular disease - A prospective, multicenter, observational study
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DOI：
10.1161/strokeaha.107.504993
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发表时间：
2008-06-01
期刊：
影响因子：
8.3
通讯作者：
Minematsu, Kazuo
中科院分区：
文献类型：
--
作者：
Toyoda, Kazunori;Yasaka, Masahiro;Minematsu, Kazuo
背景和目的——我们试图确定在日本服用口服抗血栓药物的中风和心血管疾病患者出血事件的发生率和严重程度，日本出血性中风的发生率高于西方国家。方法——进行了一项前瞻性、多中心、观察性研究； 4009 名因中风和心血管疾病而服用口服抗血栓药物的患者被纳入研究。根据抗栓治疗情况将患者分为4组：单用抗血小板药物组（47.2%）；双联抗血小板药物组（8.7%）；华法林组（32.4%）；华法林加抗血小板药物组（11.7%）。根据 MATCH 试验的定义，主要终点是危及生命或大出血。 结果 - 在 19 个月的中位随访期间，发生了 57 例危及生命的事件和 51 例大出血事件，其中包括 31 例颅内出血。主要终点事件的年发生率，单用抗血小板药物组为1.21%，双联抗血小板药物组为2.00%，华法林组为2.06%，华法林加抗血小板药物组为3.56%（P < 0.001）。调整基线特征后，在华法林中添加一种抗血小板药物会增加主要终点的风险（相对风险 = 1.76；95% CI，1.05 至 2.95），而在单一抗血小板药物治疗中添加另一种抗血小板药物会增加任何出血的次要终点，包括轻微事件（相对风险 = 1.37；95% CI，1.07 至 1.76）。尽管试验采用了不同的研究设计，但日本抗血栓治疗期间的出血事件与西方国家报道的相似。双重抗血栓治疗与出血事件风险增加独立相关。
Background and Purpose-We sought to determine the incidence and severity of bleeding events in patients with stroke and cardiovascular diseases who were taking oral antithrombotic agents in Japan, where the incidence of hemorrhagic stroke is higher than in Western countries.Methods-A prospective, multicenter, observational study was conducted; 4009 patients who were taking oral antithrombotic agents for stroke and cardiovascular diseases were enrolled. The patients were classified into 4 groups according to their antithrombotic treatment: the single antiplatelet agent group (47.2%); the dual antiplatelet agent group (8.7%); the warfarin group (32.4%); and the warfarin plus antiplatelet agent group (11.7%). The primary end point was life-threatening or major bleeding according to the MATCH trial definition.Results-During a median follow-up of 19 months, there were 57 life-threatening and 51 major bleeding events, including 31 intracranial hemorrhages. The annual incidence of the primary end point was 1.21% in the single antiplatelet agent group, 2.00% in the dual antiplatelet agent group, 2.06% in the warfarin group, and 3.56% in the warfarin plus antiplatelet agent group (P < 0.001). After adjustment for baseline characteristics, adding an antiplatelet agent to warfarin increased the risk of the primary end point (relative risk = 1.76; 95% CI, 1.05 to 2.95), and adding another antiplatelet agent to single antiplatelet agent therapy increased the secondary end point of any bleeding, including minor events (relative risk = 1.37; 95% CI, 1.07 to 1.76).Conclusions-The incidence of bleeding events during antithrombotic therapy in Japan was similar to that reported for Western countries, although the trials used different study designs. Dual antithrombotic therapy was independently related to an increased risk of bleeding events.