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Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial.

Publication ,  Journal Article
APEX AMI Investigators, ; Armstrong, PW; Granger, CB; Adams, PX; Hamm, C; Holmes, D; O'Neill, WW; Todaro, TG; Vahanian, A; Van de Werf, F
Published in: JAMA
January 3, 2007

CONTEXT: Reperfusion with percutaneous transluminal coronary intervention (PCI) is effective at improving outcomes in patients with acute ST-elevation myocardial infarction (STEMI). However, in patients without prompt reestablishment of brisk coronary flow and tissue perfusion, mortality remains high, providing an opportunity for novel treatments, including anti-inflammatory agents. OBJECTIVE: To evaluate the effectiveness of pexelizumab, a humanized monoclonal antibody that binds the C5 component of complement, as an adjunct to PCI in improving 30-day mortality from STEMI. DESIGN, SETTING, AND PATIENTS: This trial was a prospective, multicenter, double-blind, placebo-controlled, phase 3 study of the intravenous administration of pexelizumab in conjunction with primary PCI in STEMI with prespecified high-risk electrocardiographic findings. The trial was intended to enroll 8500 patients, but in conjunction with the US Food and Drug Administration enrollment was modified to 5745 patients presenting from 296 hospitals in 17 countries from July 13, 2004, to May 11, 2006. INTERVENTIONS: Two thousand eight hundred eighty-five patients were randomly assigned to receive placebo and 2860 to receive pexelizumab given as a 2-mg/kg intravenous bolus prior to PCI followed by 0.05-mg/kg per hour infusion over the subsequent 24 hours. Patients were randomized within 6 hours of symptom onset. MAIN OUTCOME MEASURES: The primary end point was all-cause mortality through day 30. Secondary end points were death through day 90 and the composite of death, cardiogenic shock, or congestive heart failure through days 30 and 90. RESULTS: No difference in mortality through day 30 was observed between the pexelizumab and placebo treatment groups, with 116 patients (4.06%) and 113 patients (3.92%) who died in the respective groups (hazard ratio [HR], 1.04; 95% confidence interval [CI], 0.80-1.35; log-rank P = .78). The composite end points of death, shock, or heart failure were also similar with 257 patients (8.99%) receiving pexelizumab and 265 patients (9.19%) receiving placebo at 30 days (HR, 0.98; 95% CI, 0.83-1.16; P = .81) and 293 patients (10.24%) receiving pexelizumab and 293 patients (10.16%) receiving placebo at 90 days (HR, 1.01; 95% CI, 0.86-1.19; P = .91). CONCLUSION: In this large clinical trial of patients treated with primary PCI for STEMI, mortality was low and unaffected by administration of pexelizumab. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00091637.

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Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

January 3, 2007

Volume

297

Issue

1

Start / End Page

43 / 51

Location

United States

Related Subject Headings

  • Survival Analysis
  • Single-Chain Antibodies
  • Shock, Cardiogenic
  • Prospective Studies
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Infusions, Intravenous
  • Humans
  • Heart Failure
 

Citation

APA
Chicago
ICMJE
MLA
NLM
APEX AMI Investigators, ., Armstrong, P. W., Granger, C. B., Adams, P. X., Hamm, C., Holmes, D., … Van de Werf, F. (2007). Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA, 297(1), 43–51. https://doi.org/10.1001/jama.297.1.43
APEX AMI Investigators, Frans, Paul W. Armstrong, Christopher B. Granger, Peter X. Adams, Christian Hamm, David Holmes, William W. O’Neill, Thomas G. Todaro, Alec Vahanian, and Frans Van de Werf. “Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial.JAMA 297, no. 1 (January 3, 2007): 43–51. https://doi.org/10.1001/jama.297.1.43.
APEX AMI Investigators, Armstrong PW, Granger CB, Adams PX, Hamm C, Holmes D, et al. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA. 2007 Jan 3;297(1):43–51.
APEX AMI Investigators, Frans, et al. “Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial.JAMA, vol. 297, no. 1, Jan. 2007, pp. 43–51. Pubmed, doi:10.1001/jama.297.1.43.
APEX AMI Investigators, Armstrong PW, Granger CB, Adams PX, Hamm C, Holmes D, O’Neill WW, Todaro TG, Vahanian A, Van de Werf F. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA. 2007 Jan 3;297(1):43–51.
Journal cover image

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

January 3, 2007

Volume

297

Issue

1

Start / End Page

43 / 51

Location

United States

Related Subject Headings

  • Survival Analysis
  • Single-Chain Antibodies
  • Shock, Cardiogenic
  • Prospective Studies
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Infusions, Intravenous
  • Humans
  • Heart Failure