The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation.
The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation.
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DOI：
10.1056/nejm199011293232201
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发表时间：
1990-11
期刊：
影响因子：
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通讯作者：
D. Singer;R. Hughes;D. Gress;Mary A. Sheehan;L. Oertel;S. W. Maraventano;D. Blewett;B. Rosner;J. Kistler
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文献类型：
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作者：
D. Singer;R. Hughes;D. Gress;Mary A. Sheehan;L. Oertel;S. W. Maraventano;D. Blewett;B. Rosner;J. Kistler
背景：非风湿性心房颤动增加了中风的风险，可能是由于心房血栓栓塞。长期华法林治疗预防卒中的疗效和风险尚不确定。方法：我们对非风湿性房颤患者进行了一项长期、低剂量华法林治疗（目标凝血酶原时间比为1.2 - 1.5）的非盲、随机、对照试验。对照组不给予华法林，但可选择服用阿司匹林。结果：共有420例患者进入试验（华法林组212例，对照组208例），平均随访2.2年。华法林组的凝血酶原时间在83%的时间内处于目标范围内。只有10%的患者被分配接受华法林永久停药。华法林组有2例卒中（发病率，每年0.41%），而对照组有13例卒中（发病率，每年2.98%），卒中风险降低86%（华法林：对照组发病率比= 0.14; 95%置信区间，0.04 - 0.49; P = 0.0022）。共有37人死亡。华法林组的死亡率明显低于对照组：每年2.25%，对照组为5.97%，发生率为0.38（95%置信区间为0.17 ~ 0.82; P = 0.005）。每组各有1例致死性出血。两组中导致住院或输血的出血事件频率基本相同。华法林组的轻微出血发生率高于对照组（38 vs. 21例患者）。结论：长期低剂量华法林治疗对预防非风湿性房颤患者卒中非常有效，并且在仔细监测下相当安全。
BACKGROUND Nonrheumatic atrial fibrillation increases the risk of stroke, presumably from atrial thromboemboli. There is uncertainty about the efficacy and risks of long-term warfarin therapy to prevent stroke. METHODS We conducted an unblinded, randomized, controlled trial of long-term, low-dose warfarin therapy (target prothrombin-time ratio, 1.2 to 1.5) in patients with nonrheumatic atrial fibrillation. The control group was not given warfarin but could choose to take aspirin. RESULTS A total of 420 patients entered the trial (212 in the warfarin group and 208 in the control group) and were followed for an average of 2.2 years. Prothrombin times in the warfarin group were in the target range 83 percent of the time. Only 10 percent of the patients assigned to receive warfarin discontinued the drug permanently. There were 2 strokes in the warfarin group (incidence, 0.41 percent per year) as compared with 13 strokes in the control group (incidence, 2.98 percent per year), for a reduction of 86 percent in the risk of stroke (warfarin:control incidence ratio = 0.14; 95 percent confidence interval, 0.04 to 0.49; P = 0.0022). There were 37 deaths altogether. The death rate was markedly lower in the warfarin group than in the control group: 2.25 percent as compared with 5.97 percent per year, for an incidence ratio of 0.38 (95 percent confidence interval, 0.17 to 0.82; P = 0.005). There was one fatal hemorrhage in each group. The frequency of bleeding events that led to hospitalization or transfusion was essentially the same in both groups. The warfarin group had a higher rate of minor hemorrhage than the control group (38 vs. 21 patients). CONCLUSIONS Long-term low-dose warfarin therapy is highly effective in preventing stroke in patients with non-rheumatic atrial fibrillation, and can be quite safe with careful monitoring.