华法林治疗且 INR 低于治疗范围的急性缺血性脑卒中患者行静脉溶栓治疗的安全性。
Safety of Intravenous Thrombolysis for Acute Ischemic Stroke in Patients Taking Warfarin with Subtherapeutic INR.
机构信息
Division of Endovascular Neurosurgery, Department of Neurological Surgery, Keck School of Medicine, University of Southern California (USC), 1200 North State St., Suite 3300, Los Angeles, CA 90033, United States.
Department of Neurology, Emory University, Atlanta, GA, United States.
出版信息
J Stroke Cerebrovasc Dis. 2021 May;30(5):105678. doi: 10.1016/j.jstrokecerebrovasdis.2021.105678. Epub 2021 Feb 26.
INTRODUCTION
Current guidelines allow the administration of intravenous recombinant tissue plasminogen activator (IV r-tPA) to warfarin-treated patients with acute ischemic stroke (AIS) who have an international normalized ratio (INR) of ≤1.7. However, concerns remain about the safety of using IV r-tPA in this situation due to a conceivable risk of symptomatic intracranial hemorrhage (sICH), lack of dedicated randomized controlled trials and the conflicts in the available data. We aimed to determine the risk of sICH in warfarin-treated patients with subtherapeutic INR who received IV r-tPA for AIS in our large volume comprehensive center.
METHODS
Patients who had received IV r-tPA for AIS in a 9.6-year period were retrospectively investigated (n = 834). Patients taking warfarin prior to presentation were identified (n = 55). One patient was excluded due to elevated INR beyond the acceptable range for IV r-tPA treatment. Because of the significant difference in the sample size (54 vs 779), warfarin group was matched with 54 non-warfarin patients adjusted for independent risk factors for sICH (age, admission NIHSS, history of diabetes). Good outcome was defined as mRS of 0-2 on discharge and sICH was defined as an ICH causing increase in NIHSS ≥4 or death. Warfarin-treated group was further dichotomized based on INR (1-1.3 vs 1.3-1.7) and safety and outcome measures were compared between resultant groups.
RESULTS
No significant difference was found between warfarin-treated and the non-warfarin groups in terms of chance of good outcome on discharge (27.8% in warfarin group vs 26.4% in non-warfarin group; p-value >0.05), or the rate of occurrence of sICH (3.7% in warfarin group vs 11.1% in non-warfarin group; p-value >0.05). Furthermore, rate of sICH (5.1% in patients with INR <1.3 versus 0.0% in patients with INR 1.3-1.7; p-value >0.05) or chance of good outcome on discharge (28.2% of patients with INR <1.3 versus 26.7% in patients with INR 1.3-1.7; p-value >0.05) were not found to be different after the warfarin-treated group was dichotomized.
CONCLUSION
Administration of IV r-tPA for AIS in warfarin-treated patients with subtherapeutic INR <1.7 does not increase the risk of sICH.
介绍
目前的指南允许在国际标准化比值（INR）≤1.7 的情况下，对接受华法林治疗的急性缺血性卒中（AIS）患者使用静脉内重组组织型纤溶酶原激活剂（IV r-tPA）。然而，由于可能存在症状性颅内出血（sICH）的风险、缺乏专门的随机对照试验以及现有数据存在冲突，人们仍然对在这种情况下使用 IV r-tPA 的安全性存在担忧。我们旨在确定在我们大容量综合中心中， INR 低于治疗范围的接受华法林治疗的 AIS 患者接受 IV r-tPA 治疗的 sICH 风险。
方法
回顾性调查了 9.6 年内接受 IV r-tPA 治疗的 AIS 患者（n=834）。确定了在出现症状前服用华法林的患者（n=55）。由于 INR 超出 IV r-tPA 治疗的可接受范围，1 名患者被排除在外。由于样本量（54 与 779）存在显著差异，因此根据 sICH 的独立危险因素（年龄、入院 NIHSS、糖尿病史），对 54 名非华法林患者进行了匹配。出院时 mRS 为 0-2 定义为良好结局，ICH 定义为 NIHSS 增加≥4 或死亡的 ICH。根据 INR（1-1.3 与 1.3-1.7）进一步将华法林治疗组分为两组，并比较两组之间的安全性和结局指标。
结果
华法林治疗组和非华法林组在出院时良好结局的可能性（华法林组 27.8%，非华法林组 26.4%；p 值>0.05）或 sICH 发生率（华法林组 3.7%，非华法林组 11.1%；p 值>0.05）方面无显著差异。此外，INR<1.3 的患者的 sICH 发生率（5.1%与 INR 1.3-1.7 的患者的 0.0%；p 值>0.05）或出院时良好结局的可能性（INR<1.3 的患者为 28.2%，INR 1.3-1.7 的患者为 26.7%；p 值>0.05）在华法林治疗组分为两组后并未发现不同。
结论
在 INR<1.7 的接受华法林治疗的 INR 低于治疗范围的 AIS 患者中使用 IV r-tPA 不会增加 sICH 的风险。
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