title: Facilitated PCI in patients with ST-elevation myocardial infarction.
abstract: BACKGROUND
  We hypothesized that percutaneous coronary intervention (PCI) preceded by early treatment with abciximab plus half-dose reteplase (combination-facilitated PCI) or with abciximab alone (abciximab-facilitated PCI) would improve outcomes in patients with acute ST-segment elevation myocardial infarction, as compared with abciximab administered immediately before the procedure (primary PCI).
  
  
  METHODS
  In this international, double-blind, placebo-controlled study, we randomly assigned patients with ST-segment elevation myocardial infarction who presented 6 hours or less after the onset of symptoms to receive combination-facilitated PCI, abciximab-facilitated PCI, or primary PCI. All patients received unfractionated heparin or enoxaparin before PCI and a 12-hour infusion of abciximab after PCI. The primary end point was the composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomization, cardiogenic shock, and congestive heart failure during the first 90 days after randomization.
  
  
  RESULTS
  A total of 2452 patients were randomly assigned to a treatment group. Significantly more patients had early ST-segment resolution with combination-facilitated PCI (43.9%) than with abciximab-facilitated PCI (33.1%) or primary PCI (31.0%; P=0.01 and P=0.003, respectively). The primary end point occurred in 9.8%, 10.5%, and 10.7% of the patients in the combination-facilitated PCI group, abciximab-facilitated PCI group, and primary-PCI group, respectively (P=0.55); 90-day mortality rates were 5.2%, 5.5%, and 4.5%, respectively (P=0.49).
  
  
  CONCLUSIONS
  Neither facilitation of PCI with reteplase plus abciximab nor facilitation with abciximab alone significantly improved the clinical outcomes, as compared with abciximab given at the time of PCI, in patients with ST-segment elevation myocardial infarction. (ClinicalTrials.gov number, NCT00046228 [ClinicalTrials.gov].)
authors.affiliation: Department of Cardiovascular Medicine, the Cleveland Clinic, F25, 9500 Euclid Ave., Cleveland, OH 44195, USA. elliss@ccf.org
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Ellis
authors.forename: Michal
authors.initials: M
authors.lastname: Tendera
authors.forename: Mark A
authors.initials: MA
authors.lastname: de Belder
authors.forename: Ad J
authors.initials: AJ
authors.lastname: van Boven
authors.forename: Petr
authors.initials: P
authors.lastname: Widimsky
authors.forename: Luc
authors.initials: L
authors.lastname: Janssens
authors.forename: H R
authors.initials: HR
authors.lastname: Andersen
authors.forename: Amadeo
authors.initials: A
authors.lastname: Betriu
authors.forename: Stefano
authors.initials: S
authors.lastname: Savonitto
authors.forename: Jerzy
authors.initials: J
authors.lastname: Adamus
authors.forename: Jan Z
authors.initials: JZ
authors.lastname: Peruga
authors.forename: Maciej
authors.initials: M
authors.lastname: Kosmider
authors.forename: Olivier
authors.initials: O
authors.lastname: Katz
authors.forename: Thomas
authors.initials: T
authors.lastname: Neunteufl
authors.forename: Julia
authors.initials: J
authors.lastname: Jorgova
authors.forename: Maria
authors.initials: M
authors.lastname: Dorobantu
authors.forename: Liliana
authors.initials: L
authors.lastname: Grinfeld
authors.forename: Paul
authors.initials: P
authors.lastname: Armstrong
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Brodie
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.forename: Gilles
authors.initials: G
authors.lastname: Montalescot
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Mark B
authors.initials: MB
authors.lastname: Effron
authors.forename: Elliot S
authors.initials: ES
authors.lastname: Barnathan
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
mesh_terms: D000077284:Abciximab; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D002544:Cerebral Infarction / Q000139:chemically induced; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D009203:Myocardial Infarction / Q000145:classification / Q000150:complications / Q000401:mortality / Q000628:therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D011994:Recombinant Proteins; C087896:reteplase; D010959:Tissue Plasminogen Activator; D000077284:Abciximab