对稳定性心痛进行皮肤冠状动脉干预的安慰剂控制试验
Christopher A Rajkumar1, Michael J Foley1, Fiyyaz Ahmed-Jushuf1
1From Imperial College London (C.A.R., M.J.F., F.A.-J., F.A.S., S.G., R.K., R.P., G.D.C., J.P.H., D.P.F., M.J.S.-S., R.K.A.-L.), Imperial College Healthcare NHS Trust (C.A.R., M.J.F., F.A.-J., F.A.S., S.S.N., S.G., R.K., R.P., S.S., G.D.C., J.P.H., D.P.F., M.J.S.-S., R.K.A.-L.), Barking Havering and Redbridge University Hospitals NHS Trust (A.N.N., A.S.), Royal Free London NHS Foundation Trust (T. Kotecha), St. George's University Hospitals NHS Foundation Trust (R.W., J.C.S.), St. George's University of London (J.C.S.), Queen Mary University of London (D.J.C., A.S.), and Barts Health NHS Trust (A.S.), London, Essex Cardiothoracic Centre, Mid and South Essex NHS Foundation Trust, Basildon (J.R.D., R.G., G.C., J.N.D., T.R.K.), Anglia Ruskin University, Chelmsford (J.R.D., G.C., T.R.K.), University Hospitals Dorset NHS Foundation Trust, Poole (P.D.O., J.D.), Portsmouth Hospitals University NHS Trust, Portsmouth (P.H.), Worcestershire Acute Hospitals NHS Trust, Worcester (H.R., L.M.), University Hospital Southampton NHS Foundation Trust and the University of Southampton, Southampton (N.C.), Royal Berkshire NHS Foundation Trust, Reading (N.R.), Salisbury NHS Foundation Trust, Salisbury (M.S.), Cardiff and Vale University Health Board, Cardiff (T. Kinnaird), Keele University, Keele (T. Kinnaird), Buckinghamshire Healthcare NHS Trust, Amersham (R.P.), and West Hertfordshire Hospitals NHS Trust, Watford (J.S.) - all in the United Kingdom.
皮肤冠状动脉干预 (PCI) 与安慰剂相比,在患有稳定性 angina 的患者中,显著降低了 angina 症状得分. 这表明PCI可以改善心痛缓解的健康状况,当抗心痛药物最小时.
科学领域:
- 心脏病学 心脏病学
- 干预心脏病学 干预心脏病学
- 临床试验 临床试验
背景情况:
- 稳定性胸痛通常通过皮肤冠状动脉干预 (PCI) 进行治疗.
- 在不服用抗血管性药物的患者中,PCI与安慰剂的疗效尚未得到充分证实.
- 对缺血的客观证据对于评估治疗有效性至关重要.
研究的目的:
- 为了确定皮肤穿冠状动脉干预 (PCI) 与安慰剂程序相比,是否能提供优越的胸痛症状缓解.
- 评估PCI对患有稳定性胸痛和最低限度抗胸痛药物治疗的患者健康状况的影响.
- 在严格控制的,双盲的,随机的环境中评估PCI的有效性.
主要方法:
- 一个双盲,随机,安慰剂对照试验,涉及301名患有稳定性胸痛的患者.
- 在随机化之前,患者接受了为期2周的抗血管药物症状评估.
- 参与者被分为1:1进行PCI或安慰剂程序,随访时间为12周.
主要成果:
- 在12周 (P<0.001) 中,PCI组 (2.9) 与安慰剂组 (5.6) 相比,心肌痛症状平均得分显著较低.
- 缺血的客观证据通过分量流量储备和即时无波比测量得到证实.
- 包括急性冠状动脉综合征在内的不良事件在PCI和安慰剂组之间是可比的.
结论:
- 穿皮冠状动脉干预 (PCI) 在患有稳定的心痛和最小的药物治疗的患者中,与安慰剂相比,导致心痛症状得分较低.
- PCI显示,与心痛相关的健康状况显著改善.
- 这些发现支持PCI用于缓解特定患有稳定性胸痛和客观性缺血的患者的症状.
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