WARFARIN IN THE PREVENTION OF STROKE ASSOCIATED WITH NONRHEUMATIC ATRIAL-FIBRILLATION
WARFARIN IN THE PREVENTION OF STROKE ASSOCIATED WITH NONRHEUMATIC ATRIAL-FIBRILLATION
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DOI：
10.1056/nejm199211123272002
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发表时间：
1992-11-12
影响因子：
158.5
通讯作者：
DEYKIN, D
中科院分区：
文献类型：
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作者：
EZEKOWITZ, MD;BRIDGERS, SL;DEYKIN, D
背景。非风湿性房颤在老年人中很常见，并与卒中风险增加有关。我们研究了华法林抗凝是否会降低这种风险。我们进行了一项随机、双盲、安慰剂对照研究，以评估571名慢性非风湿性心房颤动男性患者使用华法林低强度抗凝（凝血酶原时间比，1.2至1.5）；525名患者以前没有发生过脑梗死，而46名患者以前发生过脑梗死。主要终点为脑梗死；次要终点为脑出血和死亡。在没有中风史的患者中，在平均随访1.7年（每年4.3%）的265名安慰剂组患者中有19名发生脑梗死，在平均随访1.8年（每年0.9%）的260名华法林组患者中有4名发生脑梗死。华法林治疗的风险降低率为0.79（95%可信区间，0.52 - 0.90;P = 0.001）。在228名70岁以上的患者中，安慰剂组的年事件发生率为4.8%，华法林组为0.9%（风险降低，0.79;P = 0.02）。华法林组唯一的脑出血发生在一名73岁的患者身上。其他主要出血，都是胃肠道出血，发生在10例患者中：安慰剂组4例，发生率为每年0.9%，华法林组6例，发生率为每年1.3%。有37例死亡之前没有脑终点——安慰剂组22例，华法林组15例（风险降低，0.31;P = 0.19）。脑梗死在有脑梗死史的患者中（安慰剂组为9.3% /年，华法林组为6.1% /年）比无脑梗死史的患者更常见。华法林低强度抗凝可预防非风湿性心房颤动患者的脑梗死，而不会产生大出血的额外风险。这种益处延伸到70岁以上的患者。
Background. Nonrheumatic atrial fibrillation is common among the elderly and is associated with an increased risk of stroke. We investigated whether anticoagulation with warfarin would reduce this risk.Methods. We conducted a randomized, double-blind, placebo-controlled study to evaluate low-intensity anticoagulation with warfarin (prothrombin-time ratio, 1.2 to 1.5) in 571 men with chronic nonrheumatic atrial fibrillation; 525 patients had not previously had a cerebral infarction, whereas 46 patients had previously had such an event. The primary end point was cerebral infarction; secondary end points were cerebral hemorrhage and death.Results. Among the patients with no history of stroke, cerebral infarction occurred in 19 of the 265 patients in the placebo group during an average follow-up of 1.7 years (4.3 percent per year) and in 4 of the 260 patients in the warfarin group during an average follow-up of 1.8 years (0.9 percent per year). The reduction in risk with warfarin therapy was 0.79 (95 percent confidence interval, 0.52 to 0.90; P = 0.001). The annual event rate among the 228 patients over 70 years of age was 4.8 percent in the placebo group and 0.9 percent in the warfarin group (risk reduction, 0.79; P = 0.02). The only cerebral hemorrhage occurred in a 73-year-old patient in the warfarin group. Other major hemorrhages, all gastrointestinal, occurred in 10 patients: 4 in the placebo group, for a rate of 0.9 percent per year, and 6 in the warfarin group, for a rate of 1.3 percent per year. There were 37 deaths that were not preceded by a cerebral end point - 22 in the placebo group and 15 in the warfarin group (risk reduction, 0.31; P = 0.19). Cerebral infarction was more common among patients with a history of cerebral infarction (9.3 percent per year in the placebo group and 6.1 percent per year in the warfarin group) than among those without such a history.Conclusions. Low-intensity anticoagulation with warfarin prevented cerebral infarction in patients with nonrheumatic atrial fibrillation without producing an excess risk of major hemorrhage. This benefit extended to patients over 70 years of age.