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Pexelizumab and Infarct Size in Patients With Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

A Delayed Enhancement Cardiac Magnetic Resonance Substudy From the APEX-AMI Trial

Manesh R. Patel, MD^_*,_*, Stephen G. Worthley, MD, PhD, Amanda Stebbins, MS^_*, Thorsten Dill, MD, Frank E. Rademakers, MD, PhD, Uma S. Velleti, MD^¶, Gregory W. Barsness, MD^¶, Frans Van de Werf, MD, PhD, Christian W. Hamm, MD, Paul W. Armstrong, MD^||, Christopher B. Granger, MD^_*, Raymond J. Kim, MD^_*

^_* Duke University, Durham, North Carolina
University of Adelaide, Adelaide, Australia
Kerckhoff-Klinik, Bad Nauheim, Germany
University of Leuven, Leuven, Belgium
^¶ Mayo Clinic, Rochester, Minnesota
^|| University of Alberta, Edmonton, Alberta, Canada

^_* Reprint requests and correspondence: Dr. Manesh R. Patel, Box 3850 Medical Center, Duke University, Durham, North Carolina 27710 (Email: manesh.patel{at}duke.edu).

Objectives: 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.

Background: 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).

Methods: 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.

Results: 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.

Conclusions: 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)

Key Words: cardiac magnetic resonance imaging • pexelizumab • infarct size • APEX-AMI trial

Abbreviations and Acronyms   CK = creatine kinase   CMR = cardiac magnetic resonance   DE = delayed enhancement   ECG = electrocardiogram   LVEF = left ventricular ejection fraction   MO = microvascular obstruction   PCI = percutaneous coronary intervention   STEMI = ST-segment elevation myocardial infarction   TIMI = Thrombolysis In Myocardial Infarction

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