Feiz Farnia, Sedghi Reyhane, Salehi Alireza, Hatam Nahid, Bahmei Jamshid, Borhani-Haghighi Afshin
Clinical Neurology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; These authors contributed equally to this work.
Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
J Vasc Interv Neurol. 2016 Jun;9(1):35-41.
Anticoagulation with adjusted dose warfarin is a well-accepted treatment for the prevention of recurrent stroke in patients with atrial fibrillation. Meanwhile, using bridging therapy with heparin or heparinoids before warfarin for initiation of anticoagulation is a matter of debate. We compared safety, efficacy, and tolerability of low-molecular-weight heparin (LMWH) and unfractionated heparin (UFH) as a bridging method in patients with recent ischemic stroke due to atrial fibrillation.
This study was a randomized single-blind controlled trial in patients with acute ischemic stroke due to atrial fibrillation who were eligible for receiving warfarin and were randomly treated with 60 milligrams (mg) of LMWH (enoxaparin) subcutaneously every 12 h, or 1000 units/h of continuous intravenous heparin. The primary efficacy endpoints were recurrence of new ischemic stroke, myocardial infarction and/or death. The primary safety endpoint was central nervous system and/or systemic bleeding.
Seventy-four subjects were recruited. Baseline demographic and clinical characteristics of two groups were matched. Composite endpoint outcome of new ischemic stroke, myocardial infarction, and/or death in follow-up period was seen in 10 subjects (27.03%) in UFH group and in four subjects (10.81%) in LMWH group (p value: 0.136). All hemorrhages and symptomatic central nervous system (CNS) hemorrhages in follow-up period were in 7 (18.9%) and 4 (10.8%) patients in UFH group, in 5 (13.5%), and 3 (8.1%) patients in LMWH group (p values: 0.754 and 0.751), respectively. Drop out and major adverse-effects such as heparin-induced thrombocytopenia and drug hypersensitivity were not seen in any patient.
Enoxaparin can be a safe and efficient alternative for UFH as bridging therapy.
调整剂量华法林抗凝是预防心房颤动患者复发性卒中的一种广泛接受的治疗方法。同时,在华法林抗凝起始前使用肝素或类肝素进行桥接治疗存在争议。我们比较了低分子量肝素(LMWH)和普通肝素(UFH)作为桥接方法在近期因心房颤动导致缺血性卒中患者中的安全性、有效性和耐受性。
本研究是一项随机单盲对照试验,纳入因心房颤动导致急性缺血性卒中且符合接受华法林治疗条件的患者,随机给予每12小时皮下注射60毫克(mg)LMWH(依诺肝素),或持续静脉输注肝素1000单位/小时。主要疗效终点为新发缺血性卒中、心肌梗死和/或死亡的复发。主要安全终点为中枢神经系统和/或全身出血。
共招募74名受试者。两组的基线人口统计学和临床特征相匹配。UFH组10名受试者(27.03%)和LMWH组4名受试者(10.81%)在随访期出现新发缺血性卒中、心肌梗死和/或死亡的复合终点结局(p值:0.136)。随访期内所有出血和有症状的中枢神经系统(CNS)出血在UFH组分别为7例(18.9%)和4例(10.8%)患者,在LMWH组分别为5例(13.5%)和3例(8.1%)患者(p值分别为0.754和0.751)。所有患者均未出现脱落及肝素诱导的血小板减少症和药物过敏等主要不良反应。
依诺肝素作为桥接治疗可作为UFH的一种安全有效的替代方案。