Initial clinical results of tenecteplase (TNK) in catheter-directed thrombolytic therapy.
OBJECTIVE
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.
Razavi
Mahmood K
MK
Division of Interventional Radiology, Stanford University Hospital, CA 94305, USA. mrazavi@stanford.edu
Wong
Humberto
H
Kee
Stephen T
ST
Sze
Daniel Y
DY
Semba
Charles P
CP
Dake
Michael D
MD
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001157:Arterial Occlusive Diseases / Q000188:drug therapy*; D002406:Catheterization, Peripheral / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000188:drug therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D000077785:Tenecteplase; D015912:Thrombolytic Therapy / Q000009:adverse effects*; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000188:drug therapy*
D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase