Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial
Tone Enden, Ylva Haig, Nils-Einar Kløw, Carl-Erik Slagsvold, Leiv Sandvik, Waleed Ghanima, Geir Hafsahl, Pål Andre Holme, Lars Olaf Holmen, Anne Mette Njaastad, Gunnar Sandbæk, Per Morten Sandset, CaVenT Study Group, P M Sandset, N E Kløw, T Enden, Y Haig, C E Slagsvold, L Sandvik, W Ghanima, G Hafsahl, P A Holme, L O Holmen, A M Njaastad, G Sandbæk, U Abildgaard, F Brosstad, A M Njaastad, T Enden, W Aasebø, H Tran, N Schulz, D E Nilssen, W Ghanima, O Hagen, M Kalbakken, A L Schulz, T O Isaksen, P O Vandvik, O Bukten, S Donkor, G K Bekken, K M Soldal, A G Holtan, T Baisa, E Müller, E Nyquist, S Ulimoen, J Dalgaard, L Klevstul, V Steenberg, Y Benestad, J Rolke, H Risstad, H Pihlstrøm, J Asvall, S Bjørkhaug, T Holm, M Myrstad, H Lona, G Sandbæk, G Hafsahl, N E Kløw, L O Holmen, Tone Enden, Ylva Haig, Nils-Einar Kløw, Carl-Erik Slagsvold, Leiv Sandvik, Waleed Ghanima, Geir Hafsahl, Pål Andre Holme, Lars Olaf Holmen, Anne Mette Njaastad, Gunnar Sandbæk, Per Morten Sandset, CaVenT Study Group, P M Sandset, N E Kløw, T Enden, Y Haig, C E Slagsvold, L Sandvik, W Ghanima, G Hafsahl, P A Holme, L O Holmen, A M Njaastad, G Sandbæk, U Abildgaard, F Brosstad, A M Njaastad, T Enden, W Aasebø, H Tran, N Schulz, D E Nilssen, W Ghanima, O Hagen, M Kalbakken, A L Schulz, T O Isaksen, P O Vandvik, O Bukten, S Donkor, G K Bekken, K M Soldal, A G Holtan, T Baisa, E Müller, E Nyquist, S Ulimoen, J Dalgaard, L Klevstul, V Steenberg, Y Benestad, J Rolke, H Risstad, H Pihlstrøm, J Asvall, S Bjørkhaug, T Holm, M Myrstad, H Lona, G Sandbæk, G Hafsahl, N E Kløw, L O Holmen
Abstract
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 ClinicalTrials.gov, NCT00251771.
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.
Copyright © 2012 Elsevier Ltd. All rights reserved.
Source: PubMed