Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial

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• 作者：Tone Enden ; MD^a ; ^b ; Ylva Haig ; MD^b ; ^f ; Prof Nils-Einar Klø ; w ; MD^b ; ^f ; Carl-Erik Slagsvold ; MD^c ; Prof Leiv Sandvik ; PhD^d ; ^f ; Waleed Ghanima ; MD^g ; Geir Hafsahl ; MD^b ; På ; l Andre Holme ; MD^a ; Lars Olaf Holmen ; MD^h ; Anne Mette Njaastad ; MD^e ; Gunnar Sandbæ ; k ; MD^b ; ^f ; Prof Per Morten Sandset ; MD^a ; ^f ; ^{p.m.sandset@medisin.uio.no} ; on behalf of the CaVenT Study Group
• 刊名：The Lancet
• 出版年：2012
• 出版时间：7-13 January 2012
• 年：2012
• 卷：379
• 期：9810
• 页码：31-38
• 全文大小：148 K

文摘

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Summary

Background

Conventional anticoagulant treatment for acute deep vein thrombosis (DVT) effectively prevents thrombus extension and recurrence, but does not dissolve the clot, and many patients develop post-thrombotic syndrome (PTS). We aimed to examine whether additional treatment with catheter-directed thrombolysis (CDT) using alteplase reduced development of PTS.

Methods

Participants in this open-label, randomised controlled trial were recruited from 20 hospitals in the Norwegian southeastern health region. Patients aged 18-75 years with a first-time iliofemoral DVT were included within 21 days from symptom onset. Patients were randomly assigned (1:1) by picking lowest number of sealed envelopes to conventional treatment alone or additional CDT. Randomisation was stratified for involvement of the pelvic veins with blocks of six. We assessed two co-primary outcomes: frequency of PTS as assessed by Villalta score at 24 months, and iliofemoral patency after 6 months. Analyses were by intention to treat. This trial is registered at , .

Findings

209 patients were randomly assigned to treatment groups (108 control, 101 CDT). At completion of 24 months' follow-up, data for clinical status were available for 189 patients (90 % ; 99 control, 90 CDT). At 24 months, 37 (41¡¤1 % , 95 % CI 31¡¤5-51¡¤4) patients allocated additional CDT presented with PTS compared with 55 (55¡¤6 % , 95 % CI 45¡¤7-65¡¤0) in the control group (p=0¡¤047). The difference in PTS corresponds to an absolute risk reduction of 14¡¤4 % (95 % CI 0¡¤2-27¡¤9), and the number needed to treat was 7 (95 % CI 4-502). Iliofemoral patency after 6 months was reported in 58 patients (65¡¤9 % , 95 % CI 55¡¤5-75¡¤0) on CDT versus 45 (47¡¤4 % , 37¡¤6-57¡¤3) on control (p=0¡¤012). 20 bleeding complications related to CDT included three major and five clinically relevant bleeds.

Interpretation

Additional CDT should be considered in patients with a high proximal DVT and low risk of bleeding.

Funding

South-Eastern Norway Regional Health Authority; Research Council of Norway; University of Oslo; Oslo University Hospital.