Implications of different criteria for percutaneous coronary intervention-related myocardial infarction on study results of three large phase III clinical trials: The CHAMPION experience
Implications of different criteria for percutaneous coronary intervention-related myocardial infarction on study results of three large phase III clinical trials: The CHAMPION experience
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DOI：
10.1177/2048872616661692
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发表时间：
2018-03-01
影响因子：
4.1
通讯作者：
Mahaffey, Kenneth W.
中科院分区：
文献类型：
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作者：
Leonardi, Sergio;Lopes, Renato D.;Mahaffey, Kenneth W.
目的：本研究的目的是测试坎格雷洛与标准治疗之间是否存在差异，以实现血小板抑制的最佳管理。（CHAMPION）PCI/PLATFORM和PHOENIX试验部分是由于经皮冠状动脉介入治疗（PCI）相关心肌梗死（MI）的不同定义。方法和结果：在急性冠状动脉综合征（ACS）患者中，CHAMPION PCI和PLATFORM中MI的定义相同，不需要评估基线心脏生物标志物状态，而在PHOENIX中，特定MI标准与不同的患者表现相关。PCI、PLATFORM和PHOENIX对稳定型心绞痛患者使用相同的MI标准。Logistic回归评估了坎格雷洛对PCI/PLATFORM联合人群和PHOENIX中MI（PCI相关和非PCI相关）的影响。评价了坎格雷洛在PCI/PLATFORM和PHOENIX中对稳定型心绞痛患者和ACS患者（伴或不伴ST段抬高）的作用的一致性。总体而言，PCI/PLATFORM和PHOENIX中48小时PCI相关MI的发生率分别为6.3%和4.0%。在ACS患者中，PCI/PLATFORM和PHOENIX的MI发生率分别为6.4%和1.7%，稳定型心绞痛患者分别为6.3%和5.6%。PCI/PLATFORM（比值比（OR）1.03，95%置信区间（CI）0.90-1.17）和PHOENIX（OR 0.80，95% CI 0.66-0.98）之间，坎格雷洛对PCI相关MI的影响不同，p（INT）=0.04。这种差异在ACS患者中最为明显（p（INT）= 0.06），而在稳定型心绞痛患者中效果一致（p（INT）=0.81）。结果是相似的，当所有的MI进行了analysed.Conclusions：PCI相关MI的定义有重要意义的事件发生率，治疗效果和研究结果。这说明了在ACS患者的临床试验中严格评估PCI相关MI的重要性。
Aims: The purpose of this study was to test whether different results between Cangrelor versus standard therapy to acHieve optimal Management of Platelet InhibitiON (CHAMPION) PCI/PLATFORM and PHOENIX trials are due in part to different definitions of percutaneous coronary intervention (PCI)-related myocardial infarction (MI).Methods and results: In patients with acute coronary syndrome (ACS), the definition of MI was identical in CHAMPION PCI and PLATFORM and did not require an assessment of baseline cardiac biomarker status, while in PHOENIX specific MI criteria were associated with different patient presentations. The same MI criteria were used in PCI, PLATFORM, and PHOENIX for patients with stable angina. Logistic regression assessed the effect of cangrelor on MI (PCI- and non-PCI related) in the combined PCI/PLATFORM population and in PHOENIX. Consistency of cangrelor's effect in PCI/PLATFORM and in PHOENIX in patients with stable angina and in those with an ACS (with or without ST elevation) was evaluated. Overall, the incidence of PCI-related MI at 48 h was 6.3% in PCI/PLATFORM and 4.0% in PHOENIX. In patients with ACS, MI incidence was 6.4% in PCI/PLATFORM and 1.7% in PHOENIX, and 6.3% and 5.6%, respectively in stable angina patients. Cangrelor's effect on PCI-related MI differed between PCI/PLATFORM (odds ratio (OR) 1.03, 95% confidence interval (CI) 0.90-1.17) and PHOENIX (OR 0.80, 95% CI 0.66-0.98) with p(INT)=0.04. This difference was mostly evident in patients with ACS (p(INT)= 0.06) while the effect was consistent in patients with stable angina (p(INT)=0.81). Results were similar when all MIs were analyzed.Conclusions: The definition of PCI-related MI has important implications for event rates, treatment effect, and study results. This illustrates the importance of a rigorous assessment of PCI-related MI in clinical trials of patients with an ACS.