Fixed minidose warfarin and aspirin alone and in combination vs adjusted-dose warfarin for stroke prevention in atrial fibrillation - Second Copenhagen Atrial Fibrillation, Aspirin, and Anticoagulation Study
Fixed minidose warfarin and aspirin alone and in combination vs adjusted-dose warfarin for stroke prevention in atrial fibrillation - Second Copenhagen Atrial Fibrillation, Aspirin, and Anticoagulation Study
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DOI：
10.1001/archinte.158.14.1513
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发表时间：
1998-07-27
影响因子：
--
通讯作者：
Boysen, G
中科院分区：
文献类型：
--
作者：
Gullov, AL;Koefoed, BG;Boysen, G
背景资料：尽管华法林钠治疗对预防心房颤动患者中风的有效性，但许多医生不愿将其开给老年患者，因为出血并发症的风险和患者的不便。华法林钠1.25 mg/d+阿司匹林300 mg/d;阿司匹林300 mg/d。并与调整剂量的华法林治疗（凝血酶原时间国际标准化比值[INR]，2.0-3.0）进行比较。卒中或全身血栓栓塞事件是主要结局事件。短暂性脑缺血发作、急性心肌梗死和死亡为次要事件。将数据作为生存数据处理，并使用考克斯比例风险模型确定风险因素。本试验计划从1993年5月1日开始，为期6年，但由于另一项研究的低强度华法林联合阿司匹林治疗无效的科学证据，我们的试验于1996年10月2日提前终止。接受小剂量华法林治疗的患者1年后的累积主要事件发生率为5.8%;华法林+阿司匹林为7.2%;阿司匹林为3.6%;调整剂量华法林为2.8%（P= 0.67）。3年后，各组之间没有差异。大出血事件是罕见的。结论：虽然差异不显着，调整剂量华法林似乎优于小剂量华法林和华法林加阿司匹林治疗1年后，上级。这些结果并不能证明调整剂量华法林（INR，2.0-3.0）用于预防房颤患者卒中的当前建议的改变是合理的。
Background: Despite the efficacy of warfarin sodium therapy for stroke prevention in atrial fibrillation, many physicians hesitate to prescribe it to elderly patients because of the risk for bleeding complications and because of inconvenience for the patients.Methods: The Second Copenhagen Atrial Fibrillation, Aspirin, and Anticoagulation Study was a randomized, controlled trial examining the following therapies: warfarin sodium, 1.25 mg/d; warfarin sodium, 1.25 mg/d, plus aspirin, 300 mg/d; and aspirin, 300 mg/d. These were compared with adjusted-dose warfarin therapy (international normalized ratio of prothrombin time [INR], 2.0-3.0). Stroke or a systemic thromboembolic event was the primary outcome event. Transient ischemic attack, acute myocardial infarction, and death were secondary events. Data were handled as survival data, and risk factors were identified using the Cox proportional hazards model. The trial was scheduled for 6 years from May 1, 1993, but due to scientific evidence of inefficiency of low-intensity warfarin plus aspirin therapy from another study, our trial was prematurely terminated on October 2, 1996.Results: We included 677 patients (median age, 74 years). The cumulative primary event rate after 1 year was 5.8% in patients receiving minidose warfarin; 7.2%, warfarin plus aspirin; 3.6%, aspirin; and 2.8%, adjusted-dose warfarin (P=.67). After 3 years, no difference among the groups was seen. Major bleeding events were rare.Conclusions: Although the difference was insignificant, adjusted-dose warfarin seemed superior to minidose warfarin and to warfarin plus aspirin after 1 year of treatment. The results do not justify a change in the current recommendation of adjusted-dose warfarin (INR, 2.0-3.0) for stroke prevention in atrial fibrillation.