title: Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis.
abstract: BACKGROUND
  For patients with acute iliofemoral deep vein thrombosis, it remains unclear whether the addition of intravascular high-frequency, low-power ultrasound energy facilitates the resolution of thrombosis during catheter-directed thrombolysis.
  
  
  RESULTS
  In a controlled clinical trial, 48 patients (mean age 50 ± 21 years, 52% women) with acute iliofemoral deep vein thrombosis were randomized to receive ultrasound-assisted catheter-directed thrombolysis (N = 24) or conventional catheter-directed thrombolysis (N = 24). Thrombolysis regimen (20 mg r-tPA over 15 hours) was identical in all patients. The primary efficacy end point was the percentage of thrombus load reduction from baseline to 15 hours according to the length-adjusted thrombus score, obtained from standardized venograms and evaluated by a core laboratory blinded to group assignment. The percentage of thrombus load reduction was 55% ± 27% in the ultrasound-assisted catheter-directed thrombolysis group and 54% ± 27% in the conventional catheter-directed thrombolysis group (P = 0.91). Adjunctive angioplasty and stenting was performed in 19 (80%) patients and in 20 (83%) patients, respectively (P > 0.99). Treatment-related complications occurred in 3 (12%) and 2 (8%) patients, respectively (P > 0.99). At 3-month follow-up, primary venous patency was 100% in the ultrasound-assisted catheter-directed thrombolysis group and 96% in the conventional catheter-directed thrombolysis group (P = 0.33), and there was no difference in the severity of the post-thrombotic syndrome (mean Villalta score: 3.0 ± 3.9 [range 0-15] versus 1.9 ± 1.9 [range 0-7]; P=0.21), respectively.
  
  
  CONCLUSIONS
  In this randomized controlled clinical trial of patients with acute iliofemoral deep vein thrombosis treated with a fixed-dose catheter thrombolysis regimen, the addition of intravascular ultrasound did not facilitate thrombus resolution.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT01482273.
authors.affiliation: From the Division of Angiology, Department of Medicine, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (R.P.E., A.A.); Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland (R.P.E., T.W., D.-D.D., I.B., N.K.); and Institute of Pharmacology, University of Bern, Switzerland (D.S.).
authors.forename: Rolf P
authors.initials: RP
authors.lastname: Engelberger
authors.affiliation: From the Division of Angiology, Department of Medicine, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (R.P.E., A.A.); Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland (R.P.E., T.W., D.-D.D., I.B., N.K.); and Institute of Pharmacology, University of Bern, Switzerland (D.S.).
authors.forename: David
authors.initials: D
authors.lastname: Spirk
authors.affiliation: From the Division of Angiology, Department of Medicine, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (R.P.E., A.A.); Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland (R.P.E., T.W., D.-D.D., I.B., N.K.); and Institute of Pharmacology, University of Bern, Switzerland (D.S.).
authors.forename: Torsten
authors.initials: T
authors.lastname: Willenberg
authors.affiliation: From the Division of Angiology, Department of Medicine, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (R.P.E., A.A.); Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland (R.P.E., T.W., D.-D.D., I.B., N.K.); and Institute of Pharmacology, University of Bern, Switzerland (D.S.).
authors.forename: Adriano
authors.initials: A
authors.lastname: Alatri
authors.affiliation: From the Division of Angiology, Department of Medicine, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (R.P.E., A.A.); Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland (R.P.E., T.W., D.-D.D., I.B., N.K.); and Institute of Pharmacology, University of Bern, Switzerland (D.S.).
authors.forename: Dai-Do
authors.initials: DD
authors.lastname: Do
authors.affiliation: From the Division of Angiology, Department of Medicine, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (R.P.E., A.A.); Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland (R.P.E., T.W., D.-D.D., I.B., N.K.); and Institute of Pharmacology, University of Bern, Switzerland (D.S.).
authors.forename: Iris
authors.initials: I
authors.lastname: Baumgartner
authors.affiliation: From the Division of Angiology, Department of Medicine, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland (R.P.E., A.A.); Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland (R.P.E., T.W., D.-D.D., I.B., N.K.); and Institute of Pharmacology, University of Bern, Switzerland (D.S.). nils.kucher@insel.ch.
authors.forename: Nils
authors.initials: N
authors.lastname: Kucher
mesh_terms: D000328:Adult; D000368:Aged; D017115:Catheter Ablation; D003131:Combined Modality Therapy; D005260:Female; D005268:Femoral Vein / Q000000981:diagnostic imaging* / Q000473:pathology; D005500:Follow-Up Studies; D006801:Humans; D007084:Iliac Vein / Q000000981:diagnostic imaging* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015912:Thrombolytic Therapy; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D020246:Venous Thrombosis / Q000628:therapy*
keywords: catheter; stent; thrombolysis; thrombosis; vein