title: Tenecteplase in acute lower-leg ischemia: efficacy, dose, and adverse events.
abstract: 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.
authors.affiliation: Vascular Center, Chippenham & Johnston-Willis Medical Center, Richmond, Virginia 23225, USA. jeffrey.hull@hcahealthcare.com
authors.forename: Jeffrey Eaton
authors.initials: JE
authors.lastname: Hull
authors.forename: Mary Kathryn
authors.initials: MK
authors.lastname: Hull
authors.forename: James A
authors.initials: JA
authors.lastname: Urso
authors.forename: H Andy
authors.initials: HA
authors.lastname: Park
mesh_terms: 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
chemical_list: D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D006493:Heparin; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase; D000077284:Abciximab