Initial clinical results of tenecteplase (TNK) in catheter-directed thrombolytic therapy.

PURPOSE: To investigate the safety and immediate efficacy of 2 different doses of tenecteplase (TNK) in peripheral catheter-directed thrombolytic therapy of arterial occlusions and deep vein thrombosis (DVT).

METHODS: Over a 20-month period, 63 nonconsecutive patients underwent catheter-directed thrombolytic therapy with either 0.25 mg/h or 0.50 mg/h of TNK in a nonrandomized, open-label study. Of these, 55 patients (60 limbs) were treated for DVT (36 limbs in 16 men and 15 women; mean age 41 years, range 21-73) or peripheral arterial occlusions (24 limbs in 16 men and 8 women; mean age 63 years, range 32-91). The primary endpoints were major bleeding complications and angiographic reduction in clot burden.

RESULTS: The mean duration of infusion was 18 +/- 4 hours in patients with arterial occlusions and 30 +/- 13 in those with DVT. Twenty-one (87.5%) patients with occlusive disease had marked or complete lysis of clot. Thirty (83.3%) limbs with DVT had either marked or complete resolution of thrombus. There were 4 (7.3%) episodes of minor bleeding with 1 (1.8%) major hemorrhagic event. Fibrinogen levels dropped by an average of 23%.

CONCLUSIONS: Preliminary evidence suggests that TNK doses of 0.25 mg/h to 0.50 mg/h appear to be safe and effective. The potential benefits of TNK therapy warrant further investigation.