通过皮肤进行冠状动脉干预治疗稳定性心痛 (ORBITA):双盲随机对照试验
Rasha Al-Lamee1, David Thompson1, Hakim-Moulay Dehbi2
1Imperial College London, London, UK; Imperial College Healthcare NHS Trust, London, UK.
Lancet (London, England)
|November 7, 2017
概括
穿皮冠状动脉干预 (PCI) 与安慰剂相比,在稳定的心脏病患者中没有显著改善运动时间. 这一盲目的试验表明PCI
科学领域:
- 心脏病学
- 干预心脏病学
- 临床试验
背景情况:
- 皮肤冠状动脉干预 (PCI) 常用于缓解稳定性心痛的症状.
- 然而,从盲目的安慰剂对照试验中缺乏强有力的证据证明其在缓解心痛方面的有效性.
研究的目的:
- 评估PCI与安慰剂疗法在患有稳定性心痛和严重冠状动脉狭窄症的患者中的疗效.
- 在盲目的随机环境中评估PCI对运动能力和症状缓解的影响.
主要方法:
- 这项ORBITA试验是一项盲目的多中心随机对照试验.
- 患有严重单血管狭窄症的患者接受了优化药物治疗,然后随机分配到PCI或安慰剂程序.
- 主要终点是通过心肺运动测试评估的运动时间增加的差异.
主要成果:
- 在PCI组和安慰剂组之间没有观察到运动时间增加的显著差异 (16. 6秒,95% CI- 8. 9至42. 0, p=0. 200).
- 这项研究招募了200名患者,其中105人被随机分为PCI和95人接受安慰剂治疗.
- 没有死亡;严重的不良事件在不同组之间是可比的,而安慰剂组的一些并发症需要PCI.
结论:
- 与安慰剂相比,在经过药物治疗的心脏病和严重冠状动脉狭窄症患者中,PCI 在运动时间方面没有显著的额外益处.
- 这项研究强调了安慰剂对照试验在评估侵袭性心脏手术的有效性方面的重要性.
- 这些发现表明,PCI在该群体中的症状益处可能主要归因于程序效应,而不是直接的损伤再血管化.
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