RECOMBINANT HIRUDIN (HBW-023) PREVENTS TROPONIN-T RELEASE AFTER CORONARY ANGIOPLASTY IN PATIENTS WITH UNSTABLE ANGINA

Objectives. This study was performed to evaluate the efficacy of peri- interventional treatment with recombinant hirudin (r-hirudin [HEW 023] ) compared with heparin in the prevention of troponin T release in pat ients with unstable angina. Background. Percutaneous transluminal coro nary angioplasty in patients with unstable angina is associated with a high risk of acute thrombotic complications. Methods. Serial troponin T measurements mere performed in 61 patients with unstable angina dur ing the 48-h observation period after coronary angioplasty of the isch emia-related lesion. Patients were randomly assigned to peri-intervent ional 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 bolu s, 20 IU/kg per h for 24 h). All patients received acetylsalicylic aci d before coronary angiography. After 24 h, patients received a constan t 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 dec rease in abnormal troponin T levels from 60% (heparin group) to 20% (c ombined r-hirudin groups),vas 88%. Results. Serial troponin T measurem ents revealed two peaks within the 48 h after coronary angioplasty in the heparin but not the hirudin groups. An elevated serum troponin T c oncentration (>0.2 ng/ml) within 48 h of coronary angioplasty was foun d in 9 (24%) of 38 patients in the hirudin groups (5 [25%] of 20 in do sage group I; 4 [22%] of 18 in dosage group II) compared,vith 11 (58%) of 19 in the heparin group (p = 0.01). We observed major cardiac even ts (death, myocardial infarction, abrupt vessel closure) in 1 (4.8%) o f 21 patients in dosage group I, 1 (5.3%) of 19 in dosage group IT 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 angio plasty. (J Am Coll Cardiol 199 5;26:1637-42)