Author + information
- Received February 3, 1995
- Revision received June 1, 1995
- Accepted July 13, 1995
- Published online December 1, 1995.
- Hans-Jürgen Rupprecht, MDa,*,
- Wolfram Terres, MD*,
- C.E.M. Özbek, MD†,
- Matthias Luz, MD‡,
- Andreas Jessel, MD‡,
- Gerd Hafner, MDa,
- Jürgen Vom Dahl, MD§,
- Eckhard P. Kromer, MD||,
- Winfried Prellwitz, MDa and
- Jürgen Meyer, MDa
- ↵*Address for correspondence: Dr. Hans-Jürgen Rupprecht, II. Medizinische Klinik, Johannes Gutenberg-Universität, Langenbeckstrasse 1, D-55131 Mainz, Germany.
Objectives. 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.
This study was supported by Behringwerke AG, Marburg, Germany.
- Received February 3, 1995.
- Revision received June 1, 1995.
- Accepted July 13, 1995.
- American College of Cardiology