在穿皮冠状动脉干预 (RIVER- PCI) 后不完全复血管化的患者中:多中心,随机,双盲,安慰剂对照试验
Giora Weisz1, Philippe Généreux2, Andres Iñiguez3
1Shaare Zedek Medical Center, Jerusalem, Israel; New York Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA; Cardiovascular Research Foundation, New York, NY, USA.
通过皮肤进行冠状动脉干预后不完全恢复血管的患者的治疗结果没有改善. 这种抗缺血药物并没有降低因缺血导致的复合血管化或住院率.
科学领域:
- 心脏病学
- 药理学
- 临床试验
背景情况:
- 穿皮冠状动脉干预 (PCI) 后的不完全重血管化与较高的死亡率和不良心血管事件有关.
- 确定有效的治疗方法以改善这些高风险患者的预后至关重要.
研究的目的:
- 评估Ranolazine作为PCI后不完全复血管化的患者的辅助抗缺血疗法的疗效.
- 评估罗纳对缺血导致的复血管和住院率的影响.
主要方法:
- 一项多中心,随机,双盲,安慰剂对照试验,涉及2651名患有慢性心痛和不完全血管化的患者.
- 根据糖尿病和急性冠状动脉综合征史分层,患者每天两次服用口服罗纳1000毫克或安慰剂.
- 主要终点:第一次因缺血症引起的血管回收或因缺血症引起的住院时间.
主要成果:
- 罗纳和安慰剂组之间的综合初级终点没有显著差异 (HR 0. 95, p=0. 48).
- 缺血导致的复血管和住院的发病率在不同组之间没有显著差异.
- 在 ranolazine 组中,由于不良事件而停止药物治疗的比率更高 (14% vs 11%).
结论:
- 在PCI后不完全恢复血管的患者中,兰洛没有显著降低因缺血导致的复合复血管化或住院的比率.
- 需要进一步研究以确定有效的治疗方法来改善这种高风险患者群体的预后.
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