title: Comparison of drug-eluting and bare-metal stents for primary percutaneous coronary intervention with or without abciximab in ST-segment elevation myocardial infarction: DEBATER: the Eindhoven reperfusion study.
abstract: OBJECTIVE
  The goal of this study was to demonstrate superiority of sirolimus-eluting stents (SES) over bare-metal stents (BMS) and of abciximab over no abciximab in primary percutaneous coronary intervention (PCI).
  
  
  BACKGROUND
  Drug-eluting stents (DES) are increasingly used in primary PCI, but the recommendations for use in primary PCI are based on a few randomized controlled trials with selected patients. The usefulness of abciximab in primary PCI is not established.
  
  
  METHODS
  Nine hundred seven patients referred to the Catharina Hospital were randomized to SES or BMS, and to abciximab or no abciximab in a prospective, randomized, open 2 × 2 factorial trial with blinded evaluation. Primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of death, myocardial infarction (MI), stroke, repeat revascularization, and bleeding at 1 year (stent arm) and the composite of death, target vessel MI, target vessel revascularization (TVR), and bleeding at 30 days (abciximab arm).
  
  
  RESULTS
  At 1 year, the rate of MACCE was lower in the SES arm (16.5% vs. 25.8%, p = 0.001), mainly driven by less repeat revascularization (9.8% vs. 16.8%; p = 0.003) and without influencing the cumulative incidence of death and MI (5.2% vs. 5.8%; p = 0.68). At 30 days, the rate of the composite of death, target vessel MI, TVR, and bleeding was lower in the abciximab arm (8.2% vs. 12.4%, p = 0.04), mainly driven by less TVR due to less stent thrombosis (1.2% vs.7.4%, p < 0.001). However, bleeding complications occurred more frequently in the abciximab group (5.7% vs. 2.8%, p = 0.03).
  
  
  CONCLUSIONS
  Primary PCI with SES reduces adverse events at 1 year, mainly by reduction of repeat revascularization, whereas abciximab reduces early stent thrombosis, at the expense of more bleeding complications. (Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction [DEBATER]; NCT00986050).
authors.affiliation: Department of Cardiology, Catharina Hospital Eindhoven, Eindhoven, the Netherlands.
authors.forename: Inge
authors.initials: I
authors.lastname: Wijnbergen
authors.forename: Harold
authors.initials: H
authors.lastname: Helmes
authors.forename: Jan
authors.initials: J
authors.lastname: Tijssen
authors.forename: Guus
authors.initials: G
authors.lastname: Brueren
authors.forename: Kathinka
authors.initials: K
authors.lastname: Peels
authors.forename: Jan Melle
authors.initials: JM
authors.lastname: van Dantzig
authors.forename: Marcel
authors.initials: M
authors.lastname: Van' t Veer
authors.forename: Jacques J
authors.initials: JJ
authors.lastname: Koolen
authors.forename: Nico H J
authors.initials: NH
authors.lastname: Pijls
authors.forename: Rolf
authors.initials: R
authors.lastname: Michels
mesh_terms: D000077284:Abciximab; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D016009:Chi-Square Distribution; D054855:Drug-Eluting Stents; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D009426:Netherlands; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D002317:Cardiovascular Agents; D007140:Immunoglobulin Fab Fragments; D008670:Metals; D010975:Platelet Aggregation Inhibitors; D020123:Sirolimus; D000077284:Abciximab