JAMA:甲泼尼龙辅助血管内血栓切除术治疗大血管闭塞性卒中:MARVEL随机临床试验

24天前 来源:JAMA

本文由小咖机器人翻译整理

期刊来源:JAMA

原文链接:https://doi.org/10.1001/jama.2024.0626

摘要内容如下:

重要性

目前尚不清楚静脉甲基强的松龙能否改善因大血管闭塞(LVO)导致的急性缺血性卒中患者接受血管内血栓切除术的预后。

目的

评价静脉注射小剂量甲基强的松龙辅助血管内血栓切除术治疗继发于LVO的急性缺血性卒中的疗效和不良反应。

设计、设置和参与者

这项由研究者发起的、随机、双盲、安慰剂对照试验在中国82家医院进行,纳入了1680名卒中患者,这些患者在最后已知良好的时间内出现近端颅内LVO。招募于2022年2月9日至2023年6月30日进行,最后一次随访于2023年9月30日进行。

干预措施

符合条件的患者被随机分配接受静脉注射甲基强的松龙(n=839)(2 mg/kg/d)或安慰剂(n=841),为期3天,辅助血管内血栓切除术。

主要成果和措施

主要疗效转归是90天时的残疾程度,通过改良Rankin量表评分的总体分布来衡量(范围为0[无症状]至6[死亡])。主要安全性转归包括90天时的死亡率和48小时内症状性颅内出血的发生率。

结果

在1680名随机分组的患者中(中位年龄69岁;727名女性[43.3%]),1673名(99.6%)完成了试验。甲基强的松龙组的90天改良Rankin量表评分中位数为3(IQR,1-5),安慰剂组为3(IQR,1-6)(较低残疾水平的校正总体比值比为1.10[95%CI,0.96-1.25];P=.17)。甲基强的松龙的死亡率较低(23.2%比28.5%;校正风险比,0.84[95%CI,0.71-0.98];P=.03)和较低的症状性颅内出血发生率(8.6%比11.7%;校正风险比,0.74[95%CI,0.55-0.99];P=.04)与安慰剂相比。

结论和相关性

在因LVO而接受血管内血栓切除术的急性缺血性卒中患者中,在血管内血栓切除术的基础上加用甲基强的松龙并不能显著改善总体残疾程度。

试用注册

CHICTR.org.CN标识符:CHICTR2100051729。

英文原文如下:

Abstracts

Importance  It is uncertain whether intravenous methylprednisolone improves outcomes for patients with acute ischemic stroke due to large-vessel occlusion (LVO) undergoing endovascular thrombectomy.

Objective  To assess the efficacy and adverse events of adjunctive intravenous low-dose methylprednisolone to endovascular thrombectomy for acute ischemic stroke secondary to LVO.

Design, Setting, and Participants  This investigator-initiated, randomized, double-blind, placebo-controlled trial was implemented at 82 hospitals in China, enrolling 1680 patients with stroke and proximal intracranial LVO presenting within 24 hours of time last known to be well. Recruitment took place between February 9, 2022, and June 30, 2023, with a final follow-up on September 30, 2023.

Interventions  Eligible patients were randomly assigned to intravenous methylprednisolone (n = 839) at 2 mg/kg/d or placebo (n = 841) for 3 days adjunctive to endovascular thrombectomy.

Main Outcomes and Measures  The primary efficacy outcome was disability level at 90 days as measured by the overall distribution of the modified Rankin Scale scores (range, 0 [no symptoms] to 6 [death]). The primary safety outcomes included mortality at 90 days and the incidence of symptomatic intracranial hemorrhage within 48 hours.

Results  Among 1680 patients randomized (median age, 69 years; 727 female [43.3%]), 1673 (99.6%) completed the trial. The median 90-day modified Rankin Scale score was 3 (IQR, 1-5) in the methylprednisolone group vs 3 (IQR, 1-6) in the placebo group (adjusted generalized odds ratio for a lower level of disability, 1.10 [95% CI, 0.96-1.25]; P = .17). In the methylprednisolone group, there was a lower mortality rate (23.2% vs 28.5%; adjusted risk ratio, 0.84 [95% CI, 0.71-0.98]; P = .03) and a lower rate of symptomatic intracranial hemorrhage (8.6% vs 11.7%; adjusted risk ratio, 0.74 [95% CI, 0.55-0.99]; P = .04) compared with placebo.

Conclusions and Relevance  Among patients with acute ischemic stroke due to LVO undergoing endovascular thrombectomy, adjunctive methylprednisolone added to endovascular thrombectomy did not significantly improve the degree of overall disability.

Trial Registration  ChiCTR.org.cn Identifier: ChiCTR2100051729.

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