Safety of Dabigatran in Acute Ischemic Stroke Patients with Microbleeds: Post Hoc Analysis of DATAS-II Randomized Trial.

IF 2.2 4区医学 Q2 CLINICAL NEUROLOGY Canadian Journal of Neurological Sciences Pub Date : 2025-01-30 DOI:10.1017/cjn.2024.371

Pargol Balali, Ken Butcher, Kelvin K H Ng, Raed A Joundi, Scott E Kasner, Aristeidis H Katsanos, Mukul Sharma, Ashkan Shoamanesh

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Abstract

Background: Cerebral microbleeds are associated with an increased risk of hemorrhagic transformation (HT) following acute ischemic stroke. We investigated whether the effect of dabigatran (vs. aspirin) in patients with acute minor non-cardioembolic ischemic stroke/transient ischemic attack (TIA) is modified by baseline microbleeds on MRI.

Methods: The Dabigatran Treatment of Acute Stroke II trial randomized 305 patients with acute minor non-cardioembolic ischemic stroke/TIA to dabigatran (150/110 mg twice daily) or aspirin (81 mg daily) for 30 days. Microbleeds were centrally adjudicated in patients with an interpretable blood-sensitive sequence on baseline MRI. In this post hoc analysis, we used multivariable regression models to determine the association between microbleeds and any incident HT on day-30 MRI and excellent functional outcome (modified Rankin scale = 0-1) at 90 days.

Results: A total of 251 (82.3%) participants (mean age = 66 ± 13 years, 36% women, median [IQR] onset-to-randomization time = 40[27-55] hours; median [IQR] NIHSS = 1 [0-2]) were included, of whom 82 (33%) had microbleeds. On day-30 MRI, 6% (n = 14) developed HT, and 80% (n = 191) achieved 90-day mRS of 0-1. We found no association between microbleed presence and HT (adjusted OR = 0.84; 95%CI:0.21-3.25) or excellent functional outcome (adjusted RR = 1.09; 95%CI:0.94-1.26). The rate of HT in patients with microbleeds was 3% with dabigatran and 4% with aspirin (OR = 0.85; 95%CI:0.11-6.75). Excellent functional outcome occurred in 74% and 84% of dabigatran and aspirin-treated patients, respectively (RR = 0.88; 95%CI:0.69-1.12). The presence, severity or location of microbleeds did not modify the effect of dabigatran on these outcomes (p-interaction > 0.05).

Conclusions: Early dabigatran treatment appears safe in patients with acute minor non-cardioembolic ischemic stroke/TIA and hemorrhage-prone cerebral small vessel disease marked by microbleeds on MRI.

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达比加群在急性缺血性卒中微出血患者中的安全性：事后分析的数据- ii随机试验。

背景：脑微出血与急性缺血性卒中后出血转化（HT）的风险增加有关。我们研究了达比加群（与阿司匹林相比）对急性轻度非心脏栓塞性缺血性卒中/短暂性脑缺血发作（TIA）患者的影响是否可以通过MRI上的基线微出血来改变。方法：达比加群治疗急性卒中II试验将305例急性轻度非心栓塞性缺血性卒中/TIA患者随机分为达比加群（150/110 mg，每日2次）或阿司匹林（81 mg，每日2次），疗程30天。在基线MRI上具有可解释的血敏感序列的患者中集中判定微出血。在这项事后分析中，我们使用多变量回归模型来确定微出血与第30天MRI上任何事件HT和90天良好功能预后（修正Rankin量表= 0-1）之间的关系。结果：共有251名（82.3%）参与者(平均年龄= 66±13岁，36%为女性，中位[IQR]发病至随机化时间= 40[27-55]小时；中位数[IQR] NIHSS = 1[0-2])，其中82例（33%）有微出血。在第30天的MRI中，6% （n = 14）出现HT， 80% （n = 191）的90天mRS为0-1。我们发现微出血的存在与HT没有关联(校正OR = 0.84；95%CI:0.21-3.25)或良好的功能结局(调整后RR = 1.09；95%置信区间:0.94—-1.26)。微出血患者HT发生率达比加群为3%，阿司匹林为4% (OR = 0.85；95%置信区间:0.11—-6.75)。达比加群和阿斯匹林治疗的患者中，分别有74%和84%的患者出现了良好的功能结局(RR = 0.88；95%置信区间:0.69—-1.12)。微出血的存在、严重程度或位置并没有改变达比加群对这些结果的影响（p-相互作用0.05）。结论：早期达比加群治疗急性轻度非心源性缺血性卒中/TIA和MRI上以微出血为标志的易出血性脑血管疾病患者是安全的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Canadian Journal of Neurological Sciences 医学-临床神经学

CiteScore

4.30

自引率

3.30%

发文量

330

审稿时长

4-8 weeks

期刊介绍： Canadian Neurological Sciences Federation The Canadian Journal of Neurological Sciences is the official publication of the four member societies of the Canadian Neurological Sciences Federation -- Canadian Neurological Society (CNS), Canadian Association of Child Neurology (CACN), Canadian Neurosurgical Society (CNSS), Canadian Society of Clinical Neurophysiologists (CSCN). The Journal is a widely circulated internationally recognized medical journal that publishes peer-reviewed articles. The Journal is published in January, March, May, July, September, and November in an online only format. The first Canadian Journal of Neurological Sciences (the Journal) was published in 1974 in Winnipeg. In 1981, the Journal became the official publication of the member societies of the CNSF.