title: Safety of concomitant therapy with eptifibatide and enoxaparin in patients undergoing percutaneous coronary intervention: results of the Coronary Revascularization Using Integrilin and Single bolus Enoxaparin Study.
abstract: OBJECTIVE
  This study was designed to assess whether use of enoxaparin during percutaneous coronary intervention (PCI) increased bleeding compared with unfractionated heparin, in addition to background therapy with eptifibatide.
  
  
  BACKGROUND
  Data supporting the benefits of enoxaparin and the glycoprotein IIb/IIIa inhibitor eptifibatide evolved in parallel. Information on combining these two classes of medications is limited.
  
  
  METHODS
  A total of 261 patients undergoing elective or urgent PCI were randomized to either eptifibatide plus enoxaparin or eptifibatide plus unfractionated heparin.
  
  
  RESULTS
  The primary end point of the study, the bleeding index (change in hemoglobin corrected for blood transfusions), was 0.8 in the patients randomized to enoxaparin and 1.1 in patients randomized to unfractionated heparin (p = 0.15). The rate of vascular access site complications was 9.3% in the enoxaparin arm versus 9.8% in the unfractionated heparin arm (p = NS). The rate of bleeding complications was not significantly different between the two arms of the study, including in those patients who received vascular closure devices. The rate of angiographic complications was 6.3% in the enoxaparin group and 6.2% in the unfractionated heparin group (p = NS). Similarly, there were no significant differences in the composite of death, myocardial infarction, or urgent target vessel revascularization at 48 h or 30 days.
  
  
  CONCLUSIONS
  Compared with unfractionated heparin plus eptifibatide, the combination of enoxaparin plus eptifibatide is not associated with an excess of bleeding or vascular complications, including in those receiving closure devices. Despite no monitoring of anticoagulation activity with enoxaparin, there was no apparent increase in angiographic or clinical complications.
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. bhattd@ccf.org
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.forename: Benjamin I
authors.initials: BI
authors.lastname: Lee
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Casterella
authors.forename: Mark
authors.initials: M
authors.lastname: Pulsipher
authors.forename: Matthew
authors.initials: M
authors.lastname: Rogers
authors.forename: Marc
authors.initials: M
authors.lastname: Cohen
authors.forename: Victor E
authors.initials: VE
authors.lastname: Corrigan
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Ryan
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Breall
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Eaton
authors.forename: Mitchel A
authors.initials: MA
authors.lastname: Sklar
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
mesh_terms: D000328:Adult; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D017023:Coronary Angiography / Q000009:adverse effects; D004359:Drug Therapy, Combination; D017984:Enoxaparin / Q000009:adverse effects / Q000627:therapeutic use*; D000077542:Eptifibatide; D004864:Equipment and Supplies / Q000009:adverse effects; D005260:Female; D006470:Hemorrhage / Q000453:epidemiology / Q000209:etiology; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D015607:Stents; D013536:Suture Techniques / Q000009:adverse effects; D016896:Treatment Outcome; D014652:Vascular Diseases / Q000453:epidemiology / Q000209:etiology
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D010455:Peptides; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D006493:Heparin; D000077542:Eptifibatide