Key result
Additional catheter-directed thrombolysis did not improve quality of life compared with standard treatment alone in patients with proximal DVT (EQ-5D mean difference 0.04; 95% CI -0.10 to 0.17).
Why the study?
Does additional catheter-directed thrombolysis improve long-term quality of life compared with standard treatment alone in patients with proximal deep vein thrombosis?
RCT (n=209)
Open-label
randomised
Yes
Does additional catheter-directed thrombolysis improve long-term quality of life compared with standard treatment alone in patients with proximal deep vein thrombosis?
Mean Difference: 0.04 (95% CI -0.1–0.17)
p-value: p=>0.37
Additional catheter-directed thrombolysis did not significantly improve long-term quality of life compared to standard anticoagulation and compression therapy in patients with proximal deep vein thrombosis, although the development of post-thrombotic syndrome was strongly associated with poorer quality of life.
Does not support adding catheter-directed thrombolysis to improve quality of life in proximal DVT; confirms neutral primary endpoint in this RCT.
OBJECTIVES: To investigate whether additional catheter-directed thrombolysis (CDT) improves long-term quality of life (QOL) compared with standard treatment with anticoagulation and compression stockings alone in patients with proximal deep vein thrombosis (DVT). DESIGN: Open-label randomised controlled trial. SETTING: 19 Hospitals in the Norwegian southeastern health region. PARTICIPANTS: Patients (18-75 years) with a high proximal DVT, symptoms <21 days and no increased risk of bleeding were eligible. 189 of 209 recruited patients completed 24 months of follow-up. INTERVENTIONS: Participants were randomised to additional CDT with alteplase for 1-4 days or to standard treatment only with 6 months of anticoagulation and 24 months of compression stockings. PRIMARY AND SECONDARY OUTCOME MEASURES: Planned secondary outcome measures included QOL as assessed with the generic instrument EQ-5D and the disease-specific instrument VEINES-QOL/Sym. Primary outcome measure was post-thrombotic syndrome (PTS) after 24 months. RESULTS: After 24 months there were no differences in QOL between the additional CDT and standard treatment arms; mean difference for the EQ-5D index was 0.04 (95% CI -0.10 to 0.17), for the VEINES-QOL score 0.2 (95% CI -2.8 to 3.0) and for the VEINES-Sym score 0.5 (95% CI -2.4 to 3.4; p values>0.37). Independent of treatment arms, patients with PTS had poorer outcomes than patient without PTS; mean difference for EQ-5D was 0.09 (95% CI 0.03 to 0.15), for VEINES-QOL score 8.6 (95% CI 5.9 to 11.2) and for VEINES-Sym score 9.8 (95% CI 7.3 to 12.3; p values<0.001). CONCLUSIONS: QOL did not differ between patients treated with additional CDT compared with standard treatment alone. Patients who developed PTS reported poorer QOL and more symptoms than patients without PTS. QOL should be included as an outcome measure in clinical studies on patients at risk of PTS. TRIAL REGISTRATION: NCT00251771.
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Enden et al. (2013) conducted an RCT in proximal deep vein thrombosis (DVT) (n=209). catheter-directed thrombolysis (CDT) with alteplase vs. standard treatment only with 6 months of anticoagulation and 24 months of compression stockings was evaluated on QOL as assessed with the generic instrument EQ-5D (MD 0.04, 95% CI -0.10 to 0.17, p=>0.37). Additional catheter-directed thrombolysis did not improve quality of life compared with standard treatment alone in patients with proximal DVT (EQ-5D mean difference 0.04; 95% CI -0.10 to 0.17).
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