title: Recombinant hirudin (HBW 023) prevents troponin T release after coronary angioplasty in patients with unstable angina.
abstract: OBJECTIVE
  This study was performed to evaluate the efficacy of peri-interventional treatment with recombinant hirudin (r-hirudin [HBW 023]) compared with heparin in the prevention of troponin T release in patients with unstable angina.
  
  
  BACKGROUND
  Percutaneous transluminal coronary angioplasty in patients with unstable angina is associated with a high risk of acute thrombotic complications.
  
  
  METHODS
  Serial troponin T measurements were performed in 61 patients with unstable angina during the 48-h observation period after coronary angioplasty of the ischemia-related lesion. Patients were randomly assigned to peri-interventional intravenous treatment with either r-hirudin (dosage group I: 0.3-mg/kg body weight bolus, 0.12 mg/kg per h for 24 h; dosage group II: 0.5-mg/kg bolus, 0.24 mg/kg per h for 24 h) or heparin (150-IU/kg bolus, 20 IU/kg per h for 24 h). All patients received acetylsalicylic acid before coronary angiography. After 24 h, patients received a constant low dose infusion of either hirudin (0.04 mg/kg per h) or heparin (7 IU/kg per h) for another 24 h. The power of the study to detect a decrease in abnormal troponin T levels from 60% (heparin group) to 20% (combined r-hirudin groups) was 88%.
  
  
  RESULTS
  Serial troponin T measurements revealed two peaks within the 48 h after coronary angioplasty in the heparin but not the hirudin groups. An elevated serum troponin T concentration (> 0.2 ng/ml) within 48 h of coronary angioplasty was found in 9 (24%) of 38 patients in the hirudin groups (5 [25%] of 20 in dosage group I; 4 [22%] of 18 in dosage group II) compared with 11 (58%) of 19 in the heparin group (p = 0.01). We observed major cardiac events (death, myocardial infarction, abrupt vessel closure) in 1 (4.8%) of 21 patients in dosage group I, 1 (5.3%) of 19 in dosage group II and 3 (14.3%) of 21 in the heparin group (p = 0.33).
  
  
  CONCLUSIONS
  In this pilot trial, hirudin appears to be superior to heparin in preventing troponin T release after coronary angioplasty.
authors.affiliation: Medical Clinic II, University of Mainz, Germany.
authors.forename: H J
authors.initials: HJ
authors.lastname: Rupprecht
authors.forename: W
authors.initials: W
authors.lastname: Terres
authors.forename: C
authors.initials: C
authors.lastname: Ozbek
authors.forename: M
authors.initials: M
authors.lastname: Luz
authors.forename: A
authors.initials: A
authors.lastname: Jessel
authors.forename: G
authors.initials: G
authors.lastname: Hafner
authors.forename: J
authors.initials: J
authors.lastname: vom Dahl
authors.forename: E P
authors.initials: EP
authors.lastname: Kromer
authors.forename: W
authors.initials: W
authors.lastname: Prellwitz
authors.forename: J
authors.initials: J
authors.lastname: Meyer
mesh_terms: D000789:Angina, Unstable / Q000097:blood / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D017023:Coronary Angiography; D006493:Heparin / Q000627:therapeutic use; D024764:Hirudin Therapy; D006629:Hirudins / Q000031:analogs & derivatives*; D006801:Humans; D009206:Myocardium / Q000473:pathology; D009336:Necrosis; D010865:Pilot Projects; D011292:Premedication; D011994:Recombinant Proteins / Q000627:therapeutic use; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; D014336:Troponin / Q000097:blood*; D020107:Troponin T
chemical_list: D006629:Hirudins; D011994:Recombinant Proteins; D014336:Troponin; D020107:Troponin T; D006493:Heparin; C083544:lepirudin