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加拿大房颤抗凝(CAFA)研究

Canadian Atrial Fibrillation Anticoagulation (CAFA) Study.

作者信息

Connolly S J, Laupacis A, Gent M, Roberts R S, Cairns J A, Joyner C

机构信息

Hamilton General Hospital, Ontario, Canada.

出版信息

J Am Coll Cardiol. 1991 Aug;18(2):349-55. doi: 10.1016/0735-1097(91)90585-w.

Abstract

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).(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

加拿大房颤抗凝治疗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及其固有出血风险的潜力。由于另外两项设计和目标相似的“阳性”研究的发表,该研究在计划招募的630名患者完成招募之前提前终止。187名患者被随机分配接受华法林治疗,191名接受安慰剂治疗。接受华法林治疗的患者中有26%、接受安慰剂治疗的患者中有23%永久停用研究药物。国际标准化比值的目标范围是2至3。对于接受华法林治疗的患者,国际标准化比值在目标范围内的时间占研究天数的43.7%,高于目标范围的时间占16.6%,低于目标范围的时间占39.6%。接受华法林治疗的患者致命或大出血的年发生率为2.5%,接受安慰剂治疗的患者为0.5%。接受华法林治疗的患者中有16%发生轻微出血,接受安慰剂治疗的患者中有9%发生轻微出血。主要结局事件组包括非腔隙性卒中、非中枢神经系统栓塞以及致命性或颅内出血。如果事件发生在研究药物永久停用后28天内,则纳入疗效的主要分析。接受华法林治疗的患者主要结局事件组的年发生率为3.5%,接受安慰剂治疗的患者为5.2%,相对风险降低37%(95%置信区间,-63.5%,75.5%,p = 0.17)。(摘要截断于250字)

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