来自CLASP IID随机试验的一年结果,用于退行性心肌反
Firas Zahr1, Robert L Smith2, Linda D Gillam3
1Oregon Health and Science University, Portland, Oregon, USA.
JACC. Cardiovascular interventions
|November 14, 2023
概括
在CLASP IID试验中发现,PASCAL系统在治疗高风险患者退行性心肌吐时,与MitraClip系统相比,不逊色. 这两种设备在一年后显示出生活质量和功能持续改善.
科学领域:
- 心血管医学 心血管医学
- 干预心脏病学 干预心脏病学
- 临床试验 临床试验
背景情况:
- CLASP IID试验是第一个随机对照试验,比较了PASCAL跨导管维修系统和MitraClip系统.
- 它的重点是患有禁止性手术风险和显著的症状性退行性部吐 (DMR) 的患者.
研究的目的:
- 报告CLASP IID试验的全部队列的初级和二级终点和一年结果.
- 与MitraClip系统相比,评估PASCAL系统的安全性和有效性.
主要方法:
- 严重DMR的阻断性风险患者被随机分为2:1接受Pascal系统或MitraClip系统.
- 一年评估包括二次有效性终点 (心肌反严重程度),临床,心声学,功能和生活质量结果.
- 评估了主要安全性 (30天复合重大不良事件) 和有效性 (6个月MR ≤2+) 终点.
主要成果:
- 三百名患者被随机分配;204人接受PASCAL,96人接受MitraClip.
- 一年后,对初级和二级有效性终点均达到了非劣势,在生存率,心力衰竭住院或主要不良事件方面没有显著差异.
- 与基线相比,这两种系统都在功能分类和生活质量方面表现出显著而持续的改善.
结论:
- CLASP IID试验满足了其主要和次要的非劣势终点.
- 帕斯卡系统在一年后显示出高生存率,显著的额头肌吐减少,以及持续的功能和生活质量益处.
- 结果支持PASCAL系统作为一种有效的治疗方法,用于患有症状的DMR的高风险患者.
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