title: Mortality at 1 year with combination platelet glycoprotein IIb/IIIa inhibition and reduced-dose fibrinolytic therapy vs conventional fibrinolytic therapy for acute myocardial infarction: GUSTO V randomized trial.
abstract: BACKGROUND
  Among patients with acute myocardial infarction, combination reperfusion therapy with a platelet glycoprotein IIb/IIIa receptor inhibitor (abciximab) and a half dose of a plasminogen activator (reteplase) did not significantly reduce mortality at 30 days compared with a full dose of reteplase. Rates of nonfatal ischemic complications were significantly diminished.
  
  
  OBJECTIVE
  To determine if the beneficial effects of abciximab and reteplase (combination therapy) on early nonfatal complications would translate into a reduction in the risk of death by 1 year.
  
  
  METHODS
  One-year follow-up of a randomized controlled trial (Global Use of Strategies To Open Coronary Arteries [GUSTO] V). Of 16 588 patients who had been treated in 820 community and referral hospitals in 20 countries between July 1999 and February 2001, mortality data were available for 16 453 (99.2%).
  
  
  METHODS
  Patients were randomly assigned to receive (intravenously) a standard dose of reteplase (two 10-U boluses, 30 minutes apart) or the combination of a standard dose of abciximab (0.25 mg/kg bolus, 0.125 microg/kg per minute infusion [maximum 10 micro g/min for 12 hours]) and a half dose of reteplase (two 5-U boluses, 30 minutes apart).
  
  
  METHODS
  One-year all-cause mortality rates.
  
  
  RESULTS
  All-cause mortality at 1 year occurred in 692 (8.38%) of 8260 patients in the reteplase group and 698 (8.38%) of the 8328 patients in the combination therapy group (hazard ratio [HR], 1.00; 95% confidence interval [CI], 0.90-1.11; P>.99). Reinfarction within the first 7 days occurred in 3.5% of patients in the reteplase group and 2.3% of patients in the combination therapy group, and was significantly associated with 1-year mortality (22.6% in patients with reinfarction vs 8.0% in patients without reinfarction; HR, 3.08; 95% CI, 2.53-3.75; P<.001). However, treatment assignment did not significantly influence time of mortality regardless of reinfarction status.
  
  
  CONCLUSIONS
  Combination therapy (abciximab and reteplase) did not reduce mortality over 1 year compared with fibrinolytic therapy with reteplase alone.
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195, USA. lincofa@ccf.org
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: Frans
authors.initials: F
authors.lastname: Van de Werf
authors.forename: James T
authors.initials: JT
authors.lastname: Willerson
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: Paul W
authors.initials: PW
authors.lastname: Armstrong
authors.forename: Victor
authors.initials: V
authors.lastname: Guetta
authors.forename: W Brian
authors.initials: WB
authors.lastname: Gibler
authors.forename: Judith S
authors.initials: JS
authors.lastname: Hochman
authors.forename: Christoph
authors.initials: C
authors.lastname: Bode
authors.forename: Alec
authors.initials: A
authors.lastname: Vahanian
authors.forename: P Gabriel
authors.initials: PG
authors.lastname: Steg
authors.forename: Diego
authors.initials: D
authors.lastname: Ardissino
authors.forename: Stefano
authors.initials: S
authors.lastname: Savonitto
authors.forename: Frits
authors.initials: F
authors.lastname: Bar
authors.forename: Zygmunt
authors.initials: Z
authors.lastname: Sadowski
authors.forename: Amadeo
authors.initials: A
authors.lastname: Betriu
authors.forename: Joan E
authors.initials: JE
authors.lastname: Booth
authors.forename: Kathy
authors.initials: K
authors.lastname: Wolski
authors.forename: Michael
authors.initials: M
authors.lastname: Waller
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
mesh_terms: D000077284:Abciximab; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use*; D016019:Survival Analysis; D015912:Thrombolytic Therapy; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000911:Antibodies, Monoclonal; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; C087896:reteplase; D010959:Tissue Plasminogen Activator; D000077284:Abciximab