Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Issue 2 (February 2016)

• Record Type: Journal Article
• Authors: Haig, Ylva; Enden, Tone; Grøtta, Ole; Kløw, Nils-Einar; Slagsvold, Carl-Erik; Ghanima, Waleed; Sandvik, Leiv; Hafsahl, Geir; Holme, Pål Andre; Holmen, Lars Olaf; Njaaastad, Anne Mette; Sandbæk, Gunnar; Sandset, Per Morten
• Is Part Of: Lancet. Volume 3:Issue 2(2016)
• Page Start: e64
• Page End: e71
• Publication Date: 2016-02
• Subjects: Hematology -- Periodicals; Blood -- Diseases -- Periodicals; 616.15005
• DOI: 10.1016/S2352-3026(15)00248-3
• Languages: English
• ISSNs: 2352-3026

Abstract

Summary: Background: Post-thrombotic syndrome is a common complication after acute proximal deep vein thrombosis (DVT) and is associated with reduced quality of life and a substantial cost burden. In the 2-year results of the CaVenT study, additional catheter-directed thrombolysis reduced the risk of post-thrombotic syndrome by 14% compared with conventional therapy, but did not affect quality of life. In this study we report results at the 5-year follow-up, aiming to assess whether findings for post-thrombotic syndrome and quality of life have persisted. Methods: Between Jan 3, 2006, and Dec 22, 2009, we recruited patients aged 18–75 years with a first-time high proximal leg DVT from 20 hospitals in the Norwegian southeastern health region. With sealed envelopes, participants were randomly assigned (1:1) to standard treatment with compression stockings and anticoagulants (control group) or to standard treatment plus catheter-directed thrombolysis with alteplase within 21 days from symptom onset. Pre-specified outcomes in this analysis were post-thrombotic syndrome at 5 years as assessed with the Villalta score and scores for quality of life at 5 years with EQ-5D and the disease-specific VEINES-QOL/Sym. Analyses were by intention to treat. The trial is registered withClinicalTrials.gov, numberNCT00251771 . Findings: At 5 year follow-up (last date Oct 14, 2014), data were available for 176 patients (84% of the 209 patients originally randomised)—87 originally assigned to catheter-directed thrombolysis and 89 originally assigned to the control group. 37 patients (43%; 95% CI 33–53) allocated to catheter-directed thrombolysis developed post-thrombotic syndrome, compared with 63 (71%; 95% CI 61–79) allocated to the control group (p<0·0001), corresponding to an absolute risk reduction of 28% (95% CI 14–42) and a number needed to treat of 4 (95% CI 2–7). Four (5%) patients assigned to catheter-directed thrombolysis and one (1%) to standard treatment had severe post-thrombotic syndrome (Villalta score ≥15 or presence of an ulcer). Quality-of-life scores with either assessment scale did not differ between the treatment groups. Interpretation: Additional catheter-directed thrombolysis resulted in a persistent and increased clinical benefit during follow-up for up to 5 years, supporting the use of additional catheter-directed thrombolysis in patients with extensive proximal DVT. However, allocation to this therapy did not lead to better quality of life. The optimal endovascular thrombolytic approach needs further investigation. Funding: Southeastern Norway Regional Health Authority, the Research Council of Norway, University of Oslo, Oslo University Hospital.