Document Detail


Catheter-directed thrombolysis vs. anticoagulant therapy alone in deep vein thrombosis: results of an open randomized, controlled trial reporting on short-term patency.
MedLine Citation:
PMID:  19422443     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Approximately one in four patients with acute proximal deep vein thrombosis (DVT) given anticoagulation and compression therapy develop post-thrombotic syndrome (PTS). Accelerated removal of thrombus by thrombolytic agents may increase patency and prevent PTS. OBJECTIVES: To assess short-term efficacy of additional catheter-directed thrombolysis (CDT) compared with standard treatment alone. PATIENTS AND METHODS: Open, multicenter, randomized, controlled trial. Patients (18-75 years) with iliofemoral DVT and symptoms < 21 days were randomized to receive additional CDT or standard treatment alone. After 6 months, iliofemoral patency was investigated using duplex ultrasound and air-plethysmography assessed by an investigator blinded to previous treatment. RESULTS: One hundred and three patients (64 men, mean age 52 years) were allocated additional CDT (n = 50) or standard treatment alone (n = 53). After CDT, grade III (complete) lysis was achieved in 24 and grade II (50%-90%) lysis in 20 patients. One patient suffered major bleeding and two had clinically relevant bleeding related to the CDT procedure. After 6 months, iliofemoral patency was found in 32 (64.0%) in the CDT group vs. 19 (35.8%) controls, corresponding to an absolute risk reduction (RR) of 28.2% (95% CI: 9.7%-46.7%; P = 0.004). Venous obstruction was found in 10 (20.0%) in the CDT group vs. 26 (49.1%) controls; absolute RR 29.1% (95% CI: 20.0%-38.0%; P = 0.004). Femoral venous insufficiency did not differ between the two groups. CONCLUSIONS: After 6 months, additional CDT increased iliofemoral patency from 36% to 64%. The ongoing long-term follow-up of this study will document whether patency is related to improved functional outcome.
Authors:
T Enden; N-E Kl??w; L Sandvik; C-E Slagsvold; W Ghanima; G Hafsahl; P A Holme; L O Holmen; A M Njaastad; G Sandbaek; P M Sandset;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-04-30
Journal Detail:
Title:  Journal of thrombosis and haemostasis : JTH     Volume:  7     ISSN:  1538-7836     ISO Abbreviation:  J. Thromb. Haemost.     Publication Date:  2009 Aug 
Date Detail:
Created Date:  2009-08-13     Completed Date:  2009-12-30     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101170508     Medline TA:  J Thromb Haemost     Country:  England    
Other Details:
Languages:  eng     Pagination:  1268-75     Citation Subset:  IM    
Affiliation:
Department of Hematology, Oslo University Hospital, Ullev??l, Norway. tone.enden@medisin.uio.no
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00251771
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Anticoagulants / administration & dosage*,  therapeutic use
Catheterization, Peripheral
Female
Hemorrhage / chemically induced
Humans
Male
Middle Aged
Postthrombotic Syndrome / prevention & control
Thrombolytic Therapy / methods*
Treatment Outcome
Vascular Patency / drug effects
Venous Insufficiency / drug therapy
Venous Thrombosis / complications,  drug therapy*
Young Adult
Chemical
Reg. No./Substance:
0/Anticoagulants
Comments/Corrections
Comment In:
J Thromb Haemost. 2009 Aug;7(8):1266-7   [PMID:  19453938 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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