RECOMBINANT TISSUE-PLASMINOGEN ACTIVATOR FOR THE TREATMENT OF LOWER-EXTREMITY PERIPHERAL VASCULAR OCCLUSIVE DISEASE

PURPOSE: Regional thrombolysis in the recanalization of peripheral vas cular occlusive disease is an increasingly accepted therapeutic modali ty, Efficacy and complication rate are major issues in thrombolytic th erapy, This prospective study was undertaken to determine if locally d elivered recombinant tissue plasminogen activator (r-TPA) is safe and effective in clot lysis at non-weight-adjusted doses, PATIENTS AND MET HODS: Twenty patients (undergoing 21 infusions) from two centers under went fibrinolytic therapy with use of r-TPA, at a dose rate of 2 mg/h. The mean duration of arterial occlusion was 27.2 days (range, 1-117 d ays), Concomitant intravenous heparin anticoagulation was administered to all patients, A coaxial infusion delivery system was employed. Hem atologic parameters and angiographic follow-up were evaluated at 4-hou r intervals during thrombolytic infusion, The chosen maximum r-TPA dos e of 40 mg could be extended at investigator discretion, RESULTS: Comp lete clot lysis was achieved in 18 of 21 (85.7%) infusions at a mean t otal dose of 38.9 mg (range, 8-84 mg), The mean infusion duration was 19.7 hours. In 16 of 19 (84.2%) infusions, in which the nadir fibrinog en level was recorded, it remained greater than 65% of baseline, Three of 21 (14.3%) infusions resulted in three major bleeding complication s, one of which resulted in death, CONCLUSION: In this two-center tria l, catheter-directed r-TPA infusion at 2 mg/h is effective for clot ly sis, When combined with concomitant heparin administration, this treat ment may result in an unacceptably high frequency of bleeding complica tions.