基于风险的初始测试策略与疑似冠状动脉疾病的稳定症状患者的常规测试的比较:精确的随机临床试验
Pamela S Douglas1, Michael G Nanna2, Michelle D Kelsey1
1Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
JAMA cardiology
|August 23, 2023
概括
使用冠状动脉计算机断层扫描血管造影 (cCTA) 和风险评分的新策略改善了稳定胸痛患者的临床效率. 这种方法在不影响安全的情况下减少了不必要的导管,这需要进一步的研究.
科学领域:
- 心脏病学 心脏病学
- 诊断成像 诊断成像 诊断成像
- 临床试验 临床试验
背景情况:
- 目前的指导方针建议初始冠状动脉计算机断层扫描血管造影 (cCTA) 稳定胸痛,但存在关于过度测试和不必要的导管治疗的担忧.
- 修改后的cCTA策略旨在提高临床效率,与通常的测试 (UT) 相比.
研究的目的:
- 评估一个精度策略 (PS) 结合风险分层和cCTA与选择性CT衍生分流储备 (FFR-CT) 与常规测试 (UT) 对稳定的胸痛.
- 评估这种修改后的cCTA策略对临床效率和患者安全的影响.
主要方法:
- 一项实用随机临床试验涉及2103名患者,在65个北美和欧洲地区患有稳定的胸痛.
- 患者被随机分配到精度策略 (PS) 或通常测试 (UT) 中.
- 在PS组使用了PROMISE最小风险得分来对低风险患者进行延期测试,而其他患者则接受了cCTA和选择性的FFR-CT.UT涉及现场选择的压力测试或导管.
主要成果:
- 主要终点 (临床效率和安全性复合) 发生在PS组的4.2%与UT组的11.3% (HR,0.35) 中.
- 在PS组中,临床效率明显更高,在没有阻塞性冠状动脉疾病的情况下,导管率明显较低 (2.6%与10.2%相比).
- 死亡或心肌梗塞 (MI) 的综合安全终点在各组之间是相似的,尽管PS组的非致命MI率较高 (1.2%vs0.5%).
结论:
- 使用定量风险分层的初步诊断方法,对风险最小的患者推迟测试,以及对其他患者选择性FFR-CT的cCTA显著提高了稳定的胸痛患者的临床效率.
- 虽然该策略显示出更高的临床效率,但需要进一步的随机试验来证实这些发现,特别是关于安全结果.
- 一年后,在PS组中观察到增加了降脂和抗血小板药物的使用.
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