CANADIAN ATRIAL-FIBRILLATION ANTICOAGULATION (CAFA) STUDY
CANADIAN ATRIAL-FIBRILLATION ANTICOAGULATION (CAFA) STUDY
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DOI：
10.1016/0735-1097(91)90585-w
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发表时间：
1991-08-01
影响因子：
24
通讯作者：
JOYNER, C
中科院分区：
文献类型：
--
作者：
CONNOLLY, SJ;LAUPACIS, A;JOYNER, C
加拿大的房颤抗凝研究是一项随机、双盲、安慰剂对照试验，旨在评估华法林降低全身血栓栓塞症及其固有的出血风险的潜力。由于另外两项类似设计和目的的“积极”研究的发表，这项研究在630名患者的计划招募完成之前就提前停止了。187名患者随机服用华法林，191名患者服用安慰剂。在接受华法林治疗的患者和接受安慰剂治疗的患者中，26%的患者发生了永久停止研究药物的情况。国际标准化比率的目标范围为2~3。接受华法林治疗的患者，43.7%的研究天数国际标准化比率在目标范围内，16.6%的研究天数大于目标范围，39.6%的研究天数低于目标范围。在接受华法林治疗的患者中，致命或大出血的年发生率为2.5%，在接受安慰剂治疗的患者中，年发生率为0.5%。接受华法林治疗的患者中有16%出现轻微出血，接受安慰剂治疗的患者中有9%发生轻微出血。主要结果事件组为非腔隙性卒中、非中枢神经系统栓塞和致命性或颅内出血。如果事件发生在研究药物永久停止后28天内，则将其包括在初步疗效分析中。接受华法林治疗的患者和接受安慰剂治疗的患者的主要结果事件组的年发生率分别为3.5%和5.2%，相对风险降低37%(95%可信区间，-63.5%，75.5%，p=0.17)。抗凝治疗对房颤益处的估计与先前报道的估计一致，并支持在非风湿性瓣膜性房颤患者中使用华法林预防系统性血栓栓塞症。
The Canadian Atrial Fibrillation Anticoagulation Study was a randomized double-blind placebo-controlled trial to assess the potential of warfarin to reduce systemic thromboembolism and its inherent risk of hemorrhage. As a result of the publication of two other "positive" studies of similar design and objective, this study was stopped early before completion of its planned recruitment of 630 patients. There were 187 patients randomized to warfarin and 191 to placebo. Permanent discontinuation of study medication occurred in 26% of warfarin-treated and 23% of placebo-treated patients. The target range of the international normalized ratio was 2 to 3. For the warfarin-treated patients, the international normalized ratio was in the target range 43.7% of the study days, above it 16.6% of the study days and below it 39.6% of the study days. Fatal or major bleeding occurred at annual rates of 2.5% in warfarin-treated and 0.5% in placebo-treated patients. Minor bleeding occurred in 16% of patients receiving warfarin and 9% receiving placebo. The primary outcome event cluster was nonlacunar stroke, noncentral nervous systemic embolism and fatal or intracranial hemorrhage. Events were included in the primary analysis of efficacy if they occurred within 28 days of permanent discontinuation of the study medication. The annual rates of the primary outcome event cluster were 3.5% in warfarin-treated and 5.2% in placebo-treated patients, with a relative risk reduction of 37% (95% confidence limits, -63.5%, 75.5%, p = 0.17). This estimate of benefit of anticoagulant therapy in atrial fibrillation is consistent with the estimates from previous reports and supports the use of warfarin in patients with nonrheumatic valvular atrial fibrillation for the prevention of systemic thromboembolism.