title: Routine upfront abciximab versus standard periprocedural therapy in patients undergoing primary percutaneous coronary intervention for cardiogenic shock: The PRAGUE-7 Study. An open randomized multicentre study.
abstract: BACKGROUND
  The outcome of acute myocardial infarction (AMI) complicated with cardiogenic shock is poor. The aim of this study was to analyse, whether upfront abciximab administration could improve the outcomes of cardiogenic shock.
  
  
  METHODS
  This multicentre open trial randomized 80 patients with AMI complicated by cardiogenic shock expected to undergo primary PCI into group A (routine upfront-pre-procedural-abciximab bolus followed by 12-h abciximab infusion) and group B (standard therapy). The study primary objective was 30-day combined outcome (death/reinfarction/stroke/new severe renal failure).
  
  
  RESULTS
  PCI was technically successful in 90% (A) versus 87.5% (B) patients. Abciximab was used in 100% (A) versus 35% (B). The primary endpoint occurred in 17 group A patients (42.5%) and 11 group B patients (27.5%, P = 0.24). Ejection fraction among survivors after 30 days was 44 ± 11% (A) versus 41 ± 12% (B, P = 0.205). Major bleeding occurred in 17.5% (A) versus 7.5% (B, P = 0.310). No differences (A versus B) were found in TIMI-flow and MBG after PCI.
  
  
  CONCLUSIONS
  This study did not show any benefit from routine pre-procedural abciximab when compared with a selective abciximab use during the intervention in patients with cardiogenic shock undergoing primary PCI. However, small sample size of the trial preclude any definitive conclusion, a larger prospective, randomized, multicentered trial is needed.
authors.affiliation: Cardiocenter, 3rd Faculty of Medicine, Charles University, University Hospital Vinohrady, Prague, Czech Republic. tousek@email.cz
authors.forename: Petr
authors.initials: P
authors.lastname: Tousek
authors.forename: Richard
authors.initials: R
authors.lastname: Rokyta
authors.forename: Jitka
authors.initials: J
authors.lastname: Tesarova
authors.forename: Radek
authors.initials: R
authors.lastname: Pudil
authors.forename: Jan
authors.initials: J
authors.lastname: Belohlavek
authors.forename: Josef
authors.initials: J
authors.lastname: Stasek
authors.forename: Filip
authors.initials: F
authors.lastname: Rohac
authors.forename: Petr
authors.initials: P
authors.lastname: Widimsky
mesh_terms: D000077284:Abciximab; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D018153:Czech Republic; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011446:Prospective Studies; D012770:Shock, Cardiogenic / Q000150:complications / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D013318:Stroke Volume; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D000077284:Abciximab