Tenecteplase in acute lower-leg ischemia: efficacy, dose, and adverse events.
OBJECTIVE
To prospectively evaluate tenecteplase (TNK) for thrombolysis in acute lower-limb ischemia.


METHODS
Forty-three consecutive limbs in 37 patients (15 male, 22 female) were treated for acute lower-limb ischemia. Group 1 included 22 limbs treated with TNK infusion of 0.25 mg/h and group 2 included 21 limbs treated with TNK at 0.125 mg/h. Technical success was defined by 95% clearing of thrombus, and clinical success was defined by Society of Interventional Radiology category for acute ischemia of +1. Complications were ranked by severity and relation to TNK administration. Logistic regression, Student t test, and analysis of variance were performed.


RESULTS
TNK infusions averaged 24 hours in duration (SD, 13 h), with means of 20 hours in group 1 and 27 hours in group 2 (P = .071). Technical success was achieved in 84% of limbs (36 of 43): 82% in group 1 (18 of 22) and 86% in group 2 (18 of 21; P = .827). The SIR ischemia category improved (ie, +1) in 86% of limbs (37 of 43), stayed the same (ie, category 0) in 12% of limbs (five of 43), and worsened (ie, -1) in 2% of limbs (one of 43). TNK-related complications were seen in 12% of limbs (n = 5) and were correlated with percentage decrease in fibrinogen level, initial TNK bolus, and abciximab administration (P = .001, P < .001, and P = .036, respectively). Initial TNK boluses of 1.5 mg or less were associated with fewer complications than boluses of 3-5 mg (P = .045). The percentage decrease in fibrinogen level in group 1 was 23% (SD, 29%), compared with 7% in group 2 (SD, 20%; P = .045). There was a 7% incidence of major bleeding complications (n = 3) and no intracranial hemorrhages.


CONCLUSIONS
Treatment of acute lower-limb ischemia with TNK infusion at 0.25 mg/h and 0.125 mg/h is associated with similar success and complication rates. TNK-related complications correlated with initial TNK bolus, abciximab treatment, and percent decrease in fibrinogen level. The initial TNK bolus dose should be limited to 1.5 mg.
Hull
Jeffrey Eaton
JE
Vascular Center, Chippenham & Johnston-Willis Medical Center, Richmond, Virginia 23225, USA. jeffrey.hull@hcahealthcare.com
Hull
Mary Kathryn
MK
Urso
James A
JA
Park
H Andy
HA
D000077284:Abciximab; D000704:Analysis of Variance; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D000925:Anticoagulants / Q000008:administration & dosage; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006493:Heparin / Q000008:administration & dosage; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage; D007262:Infusions, Intravenous; D007511:Ischemia / Q000188:drug therapy*; D007866:Leg / Q000098:blood supply*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D000077785:Tenecteplase; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D006493:Heparin; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase; D000077284:Abciximab