Stanford Center for Clinical Research (SCCR), Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Quantitative Sciences Unit, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Int J Cardiol. 2018 Nov 1;270:96-101. doi: 10.1016/j.ijcard.2018.06.034. Epub 2018 Jun 8.
Controversies exist over the appropriate definition for peri-procedural myocardial infarction (PPMI) and its association with mortality. This study aims to evaluate one-year survival following percutaneous coronary intervention (PCI) and the association of different definitions of PPMI with survival among patients with stable angina (SA) or acute coronary syndrome (ACS) in the contemporary era.
We used data from the CHAMPION PLATFORM and CHAMPION PCI trials of patients undergoing PCI and conducted univariable and multivariable Cox proportional hazard regression models to evaluate mortality risk during the first year after PCI. A blinded events committee adjudicated suspected PPMI defined by biomarker elevations ≥3× the upper limit of normal (ULN) or new Q-waves. We further analyzed PPMI by the magnitude of CK-MB elevation ([a] 3 to <5× ULN, [b] 5 to <10× ULN, [c] ≥10× ULN) or by the 2 universal definition of myocardial infarction (UDMI) excluding patients with evidence of myocardial infarction (MI) prior to PCI.
Of 13,968 patients, 11% initially presented with SA, and 89% with ACS. One-year mortality was 3.4% (SA: 1.5%; ACS: 3.6%). PPMI occurred in 6.3% of the patients (3 to <5× ULN: 2.5%; 5 to <10× ULN: 2.1%; ≥10× ULN: 1.6%; UDMI: 2.7%). After multivariable adjustment, a significantly higher risk of one-year mortality was observed for patients with PPMI compared with patients without PPMI (HR 2.35 [1.74-3.18], p < 0.001; 3 to <5× ULN: 1.55 [0.92-2.62], p = 0.10; 5 to <10× ULN: 1.22 [0.67-2.20], p = 0.52; ≥10× ULN: 4.78 [3.06-7.47], p < 0.001; UDMI: 2.19 [1.29-3.73], p = 0.004).
PPMI occurred in 6.3% of the patients and was associated with increased risk of death within one year. Survival was not significantly impacted by PPMI if defined by periprocedural CK-MB elevations <10× ULN alone and without additional evaluation of symptoms or evidence of ischemia. These findings highlight the importance of PPMI for long-term outcome in the contemporary era and of its definition in the planning and interpretation of clinical trials.
关于围手术期心肌梗死(PPMI)的适当定义及其与死亡率的关系存在争议。本研究旨在评估经皮冠状动脉介入治疗(PCI)后 1 年的生存率,并评估稳定型心绞痛(SA)或急性冠状动脉综合征(ACS)患者中不同 PPMI 定义与生存率的关系。
我们使用了来自 CHAMPION PLATFORM 和 CHAMPION PCI 试验中接受 PCI 治疗的患者的数据,并进行了单变量和多变量 Cox 比例风险回归模型分析,以评估 PCI 后第一年的死亡率风险。一个盲法事件委员会裁定了由生物标志物升高≥3×正常值上限(ULN)或新 Q 波定义的可疑 PPMI。我们进一步通过 CK-MB 升高幅度([a] 3 至 <5×ULN、[b] 5 至 <10×ULN、[c] ≥10×ULN)或排除 PCI 前有心肌梗死(MI)证据的患者的 2 个通用心肌梗死定义(UDMI)来分析 PPMI。
在 13968 名患者中,11%最初表现为 SA,89%表现为 ACS。1 年死亡率为 3.4%(SA:1.5%;ACS:3.6%)。6.3%的患者发生 PPMI(3 至 <5×ULN:2.5%;5 至 <10×ULN:2.1%;≥10×ULN:1.6%;UDMI:2.7%)。多变量调整后,与无 PPMI 的患者相比,有 PPMI 的患者 1 年死亡率的风险显著更高(HR 2.35 [1.74-3.18],p<0.001;3 至 <5×ULN:1.55 [0.92-2.62],p=0.10;5 至 <10×ULN:1.22 [0.67-2.20],p=0.52;≥10×ULN:4.78 [3.06-7.47],p<0.001;UDMI:2.19 [1.29-3.73],p=0.004)。
6.3%的患者发生了 PPMI,与 1 年内死亡风险增加相关。如果仅根据围手术期 CK-MB 升高<10×ULN 且不进一步评估症状或缺血证据来定义 PPMI,则 PPMI 与生存率之间没有显著相关性。这些发现突出了 PPMI 在当代对长期结局的重要性及其在临床试验的规划和解释中的定义。