Duke University, Durham, North Carolina 27710, USA.
JACC Cardiovasc Imaging. 2010 Jan;3(1):52-60. doi: 10.1016/j.jcmg.2009.09.014. Epub 2010 Jan 12.
The purpose of the study was to understand determinants of infarct size in a primary percutaneous intervention (PCI) population treated with pexelizumab compared with placebo.
In the multicenter APEX-AMI (Pexelizumab in Conjunction With Angioplasty in Acute Myocardial Infarction) trial, pexelizumab did not reduce 90-day mortality. Cardiac magnetic resonance (CMR) with delayed enhancement was used in a substudy evaluating infarct size and left ventricular ejection fraction (LVEF).
Consecutive patients undergoing primary PCI for first myocardial infarction (MI) as part of the APEX-AMI trial were enrolled in this substudy at 5 centers. The CMR was completed on days 3 to 5 (n=99) and day 90 (n=83) following PCI. Central core lab-masked analyses for quantified LVEF, volumes, and infarct size by planimetry were performed.
Patients were 60+/-12 years of age, male (n=83 [84%]), had similar time from symptom onset to presentation (median 2.6 h vs. 2.5 h; p=1.0), and similar baseline ST-segment deviation (13.5 mm vs. 14 mm; p=0.59) in both groups. Pexelizumab-treated patients had smaller infarct size (day 3 LV 10.5% vs. 16.2%, p=0.022; day 90 LV 5.9% vs. 12.4%, p=0.015) and higher LVEF (day 3 50.3% vs. 46.2%, p=0.073; day 90 53.9% vs. 49.3%, p=0.036) compared with placebo-treated patients. The median peak creatine kinase in the pexelizumab group was also significantly less than placebo (922 mg/dl vs. 1,973 mg/dl; p=0.03). Notably, the pexelizumab group had lower Thrombolysis In Myocardial Infarction (TIMI) flow grade pre-PCI (46.9% vs. 75.0%; p=0.018), a difference not seen in the overall APEX-AMI study. A multivariate model including baseline features and pexelizumab treatment found anterior MI location and pre-PCI TIMI flow to be significant independent predictors infarct size (p=0.001), whereas pexelizumab was not (p=0.29). No death, heart failure, or shock was noted in either substudy group at 90 days.
In a CMR substudy of pexelizumab in MI, baseline TIMI flow grade and anterior location were the only predictors of infarct size, with a reduction of pre-PCI TIMI flow grade 0 by 28%, leading to a 35% reduction in infarct size. (The APEX-AMI Trial; NCT00091637).
本研究旨在了解与安慰剂相比，接受培昔单抗治疗的经皮冠状动脉介入治疗（PCI）患者的梗死面积的决定因素。
在多中心 APEX-AMI（培昔单抗联合急性心肌梗死血管成形术）试验中，培昔单抗并未降低 90 天死亡率。心脏磁共振（CMR）延迟增强用于评估梗死面积和左心室射血分数（LVEF）的子研究。
本子研究纳入了作为 APEX-AMI 试验一部分接受首次心肌梗死（MI）的患者，在 5 个中心进行了这项子研究。在 PCI 后第 3 至 5 天（n=99）和第 90 天（n=83）完成 CMR。进行了中心核心实验室盲法分析，用于量化 LVEF、容积和梗死面积的平面测量。
患者年龄为 60+/-12 岁，男性（n=83 [84%]），从症状发作到就诊的时间相似（中位数 2.6 h 与 2.5 h；p=1.0），两组的基线 ST 段偏移也相似（13.5 mm 与 14 mm；p=0.59）。与安慰剂组相比，培昔单抗治疗组的梗死面积较小（第 3 天 LV 为 10.5% 与 16.2%，p=0.022；第 90 天 LV 为 5.9% 与 12.4%，p=0.015），LVEF 更高（第 3 天 50.3% 与 46.2%，p=0.073；第 90 天 53.9% 与 49.3%，p=0.036）。培昔单抗组的肌酸激酶峰值中位数也明显低于安慰剂组（922 mg/dl 与 1,973 mg/dl；p=0.03）。值得注意的是，培昔单抗组的 PCI 前 TIMI 血流分级较低（46.9% 与 75.0%；p=0.018），而这在整体 APEX-AMI 研究中并未出现。包括基线特征和培昔单抗治疗的多变量模型发现，前壁 MI 部位和 PCI 前 TIMI 血流是梗死面积的独立显著预测因素（p=0.001），而培昔单抗不是（p=0.29）。在 90 天时，两个亚组均未发生死亡、心力衰竭或休克。
在培昔单抗治疗 MI 的 CMR 子研究中，基线 TIMI 血流分级和前壁部位是梗死面积的唯一预测因素，PCI 前 TIMI 血流分级降低 28%，导致梗死面积减少 35%。（APEX-AMI 试验；NCT00091637）。
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