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血栓切除术使用pRESET与Solitaire支架取回器作为一线大血管阻塞中风治疗:一项随机临床试验
Raul G Nogueira1, Donald Lobsien2, Joachim Klisch2
1Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center, UPMC Stroke Institute, Pittsburgh, Pennsylvania.
JAMA neurology
|January 2, 2024
概括
在治疗大血管阻塞 (LVO) 卒中方面,pRESET支架检索器表现出与Solitaire支架检索器相比的非劣势. 这一发现表明pRESET是中风血栓切除术的安全有效替代品.
科学领域:
- 神经学 神经学
- 干预心脏病学 干预心脏病学
- 医疗器械 医疗器械
背景情况:
- 大血管封闭 (LVO) 病例需要及时干预.
- 支架取回器对于LVO中风的机械血栓切除术至关重要.
- 关于不同支架检索器技术的比较数据有限.
研究的目的:
- 为了比较pRESET支架检索器与Solitaire支架检索器在LVO中风血栓切除术中的有效性和安全性.
- 在90天后实现功能独立方面,与Solitaire相比,确定pRESET的非劣势性.
主要方法:
- 一个多中心的,前性的,随机的,受控的,适应性的,非劣等性试验.
- 340名LVO中风患者被随机分组1:1接受血栓切除术,使用pRESET或Solitaire支架检索器.
- 主要结果是90天的功能独立率,pRESET的非劣势率为-12.5%.
主要成果:
- 在pRESET组中,54.9%的患者和在Solitaire组中57.5%的患者获得了90天的功能独立 (绝对差异:-2.57%;95%CI:-11.42至6.28).
- 普雷塞特猎犬达到非劣势差额,表现出与Solitaire猎犬相似的功能结果.
- 两种设备之间的二次临床和血管学结果,以及安全概况 (症状性内出血,死亡率) 是相似的.
结论:
- 使用pRESET支架检索器进行的血栓切除术在LVO中风患者中与Solitaire支架检索器相比并非劣.
- 在LVO中风患者恢复血液流动和减少残疾时,pRESET猎犬是一种安全有效的选择.
- 这项研究提供了有价值的比较数据,支持pRESET在临床实践中的使用.
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