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In Silico Clinical Trials for Cardiovascular Disease
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心肌再血管化试验
Marc Ruel1, Volkmar Falk2, Michael E Farkouh3
1University of Ottawa Heart Institute, University of Ottawa, Canada (M.R., D.G.).
Circulation
|December 20, 2018
概括
最近对皮肤冠状动脉干预 (PCI) 和冠状动脉旁路移植 (CABG) 进行比较的试验可能会夸大PCI的益处. 对于未来的研究,建议仔细解释证据并改进试验设计.
科学领域:
- 心血管医学
- 干预心脏病学
- 心脏外科
背景情况:
- 穿皮冠状动脉干预 (PCI) 和冠状动脉旁路移植 (CABG) 是治疗左主冠状动脉疾病和多血管冠状动脉疾病的主要重血管化策略.
- 最近的试验将PCI与CABG的疗效和安全性进行了比较,结果复杂且有时存在争议.
研究的目的:
- 批判性地审查最近的心肌再血管化试验的证据,比较PCI和CABG.
- 分析可能影响结果解释的试验设计,患者选择和终点选择的潜在偏差.
- 为谨慎解释当前证据和设计未来临床试验提供建议.
主要方法:
- 对主要随机对照试验的已公布数据进行系统审查和批判性评估.
- 试验方法的分析,包括患者的纳入/排除标准和结果定义.
- 综合证据以评估PCI和CABG在特定患者小组中的比较有效性.
主要成果:
- 在某些患者群体 (例如非糖尿病患者,低解剖复杂度患者) 中,PCI的非劣质性可能受到试验设计的影响.
- 患者选择有利于PCI和终点优化可能导致PCI优于CABG的结果.
- 有证据表明,CABG在特定复杂患者群体中仍然可以提供优异的长期结果.
结论:
- 需要谨慎地解释目前比较PCI和CABG的证据.
- 未来的试验应优先考虑强大的设计,公正的患者选择和适当的终点,以准确地反映比较有效性.
- 在试验设计和进行方面开展合作对于提高心血管干预方面的知识至关重要.
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