在随机心力衰竭试验中,中央判定与调查人员报告的结果
Simon Wandel1, Akshay S Desai2, Chien-Wei Chen3
1Development, Novartis Pharma AG, Forum 1, Novartis Campus, CH-4056 Basel, Switzerland.
European heart journal
|November 8, 2024
概括
心血管试验中心力衰竭事件的中央判断没有显著改变治疗效果估计. 然而,即使被负面评判的心力衰竭事件仍然具有预后意义,这表明个性化试验决策.
科学领域:
- 心血管医学 心血管医学
- 临床试验方法论 临床试验方法论
- 流行病学 流行病学
背景情况:
- 心血管结果试验经常使用心力衰竭终点的集中判断.
- 中央裁决对治疗效果估计的准确性 (日志危险比率) 的影响尚不清楚.
研究的目的:
- 评估研究人员报告和中央裁决的心力衰竭和心血管死亡事件之间的一致性.
- 评估判断心力衰竭事件的预后意义.
- 为了确定治疗效果估计的相关性,基于判定与研究者报告的事件.
主要方法:
- 分析了来自七项大型心血管结局试验 (>1000名患者) 的数据,其中核心判断是心力衰竭的结果.
- 研究人员报告的与心力衰竭住院和心血管死亡的判决事件的比较.
- 评估心力衰竭事件后随后的全因死亡率.
- 从两种报告方法中对日志危险比率 (log[HR]) 的相关性分析.
主要成果:
- 判断率有所不同;心血管死亡率 (87.9%-99.2%) 比心力衰竭住院率 (61.6%-88.0%) 更高.
- 随后的全因死亡风险对于积极和消极判断的心力衰竭住院的患者来说是相似的.
- 对心血管死亡 (R2=0.80) 和复合终点 (R2=0.79) 的相关性很好,但对心力衰竭住院治疗 (R2=0.57) 的相关性较小.
结论:
- 中心裁决并没有实质性地改变整体治疗效果估计 (log[HR]) 或心血管试验的精度.
- 负面判断的心力衰竭事件保持了预后的重要性.
- 对于心力衰竭事件的中央裁决的实用性可能需要对每个试验进行个性化评估.
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