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随机IABP-SHOCK II试验的长期6年结果

Holger Thiele1,2, Uwe Zeymer3, Nathalie Thelemann4

  • 1Heart Center Leipzig, University of Leipzig, Germany (H.T., M.A.-W., S.D.).

Circulation
|December 28, 2018
PubMed
概括

对于心脏病发作后心脏性休克患者来说,内气球逆脉冲 (IABP) 没有改善长期存活率. 死亡率仍然很高, 尽管IABP和再血管治疗.

关键词:
急性心肌梗塞血管整形术辅助设备心脏性冲击内气球反推力

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科学领域:

  • 心脏病学
  • 临床试验
  • 医疗器械

背景情况:

  • 在心脏性休克中,内气球逆脉冲 (IABP) 的作用仍在争论中,之前的试验得出了中立的结果.
  • 对IABP对急性心肌梗塞并发症的临床结果的长期影响的随机数据有限.
  • 对接受同时治疗的心脏性休克患者的一般长期结果的证据很少.

研究的目的:

  • 评估IABP对所有原因死亡的长期 (6年) 影响,这些患者患有心脏性休克并发症急性心肌梗塞.
  • 评估IABP对复发性心肌梗塞,中风,重复血管化和心脏再住院的影响.
  • 用IABP治疗的幸存者的生活质量与对照组中的患者进行比较.

主要方法:

  • 这项研究使用了多中心,随机,开放的IABP- SHOCK II试验的数据.
  • 在2009年至2012年间,有600名患有心脏性休克并发症急性心肌梗塞的患者经历了早期再血管化.
  • 随机化后长期随访的中位数为6. 2年.

主要成果:

  • 在6年随访后,IABP组 (66. 3%) 和对照组 (67. 0%) 之间没有发现任何原因死亡率的显著差异 (RR 0. 99;P=0. 98).
  • 在两组之间,复发性心肌梗塞,中风,重复血管化和心脏再住院的发生率相似 (所有P>0.05).
  • 通过EuroQol 5D和NYHA等级评估的幸存者的生活质量在IABP和对照组之间没有差异.

结论:

  • 在心脏性休克患者的6年长期随访中,心脏气球逆脉冲 (IABP) 不影响所有原因的死亡率.
  • 即使同时进行了再血管治疗,心脏性休克患者的死亡率仍然很高 (三分之二).
  • 在这种患者群体中,IABP对长期临床结果没有明显的益处.