Cerebral microbleeds development after stroke thrombolysis: A secondary analysis of the THAWS randomized clinical trial
Cerebral microbleeds development after stroke thrombolysis: A secondary analysis of the THAWS randomized clinical trial
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DOI：
10.1177/17474930211035023
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发表时间：
2021-08-03
影响因子：
6.7
通讯作者：
Toyoda, Kazunori
中科院分区：
文献类型：
--
作者：
Miwa, Kaori;Koga, Masatoshi;Toyoda, Kazunori
背景与目的探讨急性卒中患者静脉溶栓后新发脑微出血的发生率及其对临床的影响。方法采用多中心随机对照试验，研究阿替普酶静脉溶栓治疗觉醒卒中和不明原因卒中的疗效和安全性。预先安排的T2*加权成像评估了三个时间点的脑微出血：基线、22-36小时和7-14天。结果包括出现新的脑微出血，90天时改良Rankin评分(MRS)和GT；=3，以及美国国立卫生研究院卒中评分(NIHSS)从24小时到7天的变化。结果在随机纳入的131例患者中，113例(平均年龄74.3+/-12.6岁，女性50例，静脉溶栓62例)可供分析。总体而言，46例(41%)有基线脑微出血(15例严格的脑叶微出血，14例混合性脑微出血，17例深部脑微出血)。仅静脉溶栓组(7例，11%)在中位时间28.3h内出现新的脑微出血，且在中位时间7.35d内未见增加。在调整后的模型中，脑微出血的数量(相对危险度(RR)1.3，95%可信区间(CI)：1.17~1.44)、混合分布(RR19.2，95%CI：3.94~93.7)和脑微出血负担=5(RR44.9，95%CI：5.78~349.8)与新发脑微出血有关。新的脑微出血与NIHSS评分的增加有关(p=0.023)。阿尔替普酶治疗基线=5个脑微出血的患者在顺序MRS上的结果更差(中位数[IQR]；4[3-4]比0[0-3])，而治疗组中基线=5个脑微出血患者的顺序MRS评分不同(p交互作用=0.042)。结论11%的患者在静脉溶栓后36h内出现新发脑微出血，且与脑内微出血呈混杂分布和<gt；=5有关。新的大脑微出血的发展可能会阻碍神经功能的改善。此外，脑微出血负荷可能会影响阿尔替普酶的疗效。
Background and aim We determined to investigate the incidence and clinical impact of new cerebral microbleeds after intravenous thrombolysis in patients with acute stroke. Methods The THAWS was a multicenter, randomized trial to study the efficacy and safety of intravenous thrombolysis with alteplase in patients with wake-up stroke or unknown onset stroke. Prescheduled T2*-weighted imaging assessed cerebral microbleeds at three time points: baseline, 22-36 h, and 7-14 days. Outcomes included new cerebral microbleeds development, modified Rankin Scale (mRS) >= 3 at 90 days, and change in the National Institutes of Health Stroke Scale (NIHSS) score from 24 h to 7 days. Results Of all 131 patients randomized in the THAWS trial, 113 patients (mean 74.3 +/- 12.6 years, 50 female, 62 allocated to intravenous thrombolysis) were available for analysis. Overall, 46 (41%) had baseline cerebral microbleeds (15 strictly lobar cerebral microbleeds, 14 mixed cerebral microbleeds, and 17 deep cerebral microbleeds). New cerebral microbleeds only emerged in the intravenous thrombolysis group (seven patients, 11%) within a median of 28.3 h, and did not additionally increase within a median of 7.35 days. In adjusted models, number of cerebral microbleeds (relative risk (RR) 1.30, 95% confidence interval (CI): 1.17-1.44), mixed distribution (RR 19.2, 95% CI: 3.94-93.7), and cerebral microbleeds burden >= 5 (RR 44.9, 95% CI: 5.78-349.8) were associated with new cerebral microbleeds. New cerebral microbleeds were associated with an increase in NIHSS score (p = 0.023). Treatment with alteplase in patients with baseline >= 5 cerebral microbleeds resulted in a numerical shift toward worse outcomes on ordinal mRS (median [IQR]; 4 [3-4] vs. 0 [0-3]), compared with those with = 5 cerebral microbleeds with ordinal mRS score differed according to the treatment group (p interaction = 0.042). Conclusion New cerebral microbleeds developed within 36 h in 11% of the patients after intravenous thrombolysis, and they were significantly associated with mixed-distribution and >= 5 cerebral microbleeds. New cerebral microbleeds development might impede neurological improvement. Furthermore, cerebral microbleeds burden might affect the effect of alteplase.