TY - JOUR
T1 - Quality of Life after Stenting for Iliofemoral Venous Obstruction
T2 - A Randomised Controlled Trial with One Year Follow Up
AU - Shekarchian, Soroosh
AU - Van Laanen, Jorinde
AU - Barbati, Mohammad Esmaeil
AU - Vleugels, Marie-José
AU - Nelemans, Patty
AU - Razavi, Mahmood K
AU - Mees, Barend
AU - Jacobs, Michael J
AU - Jalaie, Houman
PY - 2023/11
Y1 - 2023/11
N2 - OBJECTIVE: Deep venous obstruction (DVO) has a great burden on the healthcare system and patients' quality of life (QoL). Case series show stenting is safe and effective; however, most studies lack control groups and QoL changes have not been compared with conventional treatment. The aim was to assess the difference in QoL changes from baseline to 12 months between stent and conventionally treated patients with DVO. METHODS: Subjects > 18 years old with DVO due to post-thrombotic (PTS) or non-thrombotic iliac vein lesions (NIVLs) in a tertiary hospital were prospectively randomised to best medical therapy (BMT) or stent placement with BMT in a ratio 2:1, stratified for PTS or NIVL. The primary outcome was the between group difference in VEINES-QoL scores change from baseline to 12 months after treatment. Secondary outcomes included the difference in scores change for EuroQoL 5-Dimension 5-Level (EQ-5D-5L), Pain Disability Index (PDI), Venous Clinical Severity Score (VCSS), and the Villalta score. STUDY REGISTRATION NUMBER: NCT03026049. RESULTS: After three years, the inclusion rate dropped to almost zero, therefore the study had to be stopped. Sixty-three patients were randomised to either the stent (n = 42) or control group (n = 21). Overall, 50 patients had available data for primary outcome analysis. The adjusted mean difference between 12 month scores for VEINES-QoL and VEINES-Sym was 8.07 (95% CI 3.04 - 13.09) and 5.99 (95% CI 0.75 - 11.24) (p = .026), respectively, in favour of the stent group. The differences were significant, but a predefined meaningful 14 point improvement in QoL was not reached. The mean difference between 12 month scores for VCSS was -2.93 (95% CI -5.71 - 0.16, p = .040), -11.83 (95% CI -20.81 - 2.86, p = .011) for PDI, 0.015 (95% CI -0.12 - 0.15, p = .82) for the EQ-5D index, and -2.99 (95% CI -7.28 - 1.30, p = .17) for the Villalta score. CONCLUSION: Symptomatic patients with DVO who received dedicated venous stents had significantly higher VEINES-QoL/Sym scores at 12 months compared with the control group, but the between group difference was lower than the pre-specified clinically relevant QoL difference of at least 14 points.
AB - OBJECTIVE: Deep venous obstruction (DVO) has a great burden on the healthcare system and patients' quality of life (QoL). Case series show stenting is safe and effective; however, most studies lack control groups and QoL changes have not been compared with conventional treatment. The aim was to assess the difference in QoL changes from baseline to 12 months between stent and conventionally treated patients with DVO. METHODS: Subjects > 18 years old with DVO due to post-thrombotic (PTS) or non-thrombotic iliac vein lesions (NIVLs) in a tertiary hospital were prospectively randomised to best medical therapy (BMT) or stent placement with BMT in a ratio 2:1, stratified for PTS or NIVL. The primary outcome was the between group difference in VEINES-QoL scores change from baseline to 12 months after treatment. Secondary outcomes included the difference in scores change for EuroQoL 5-Dimension 5-Level (EQ-5D-5L), Pain Disability Index (PDI), Venous Clinical Severity Score (VCSS), and the Villalta score. STUDY REGISTRATION NUMBER: NCT03026049. RESULTS: After three years, the inclusion rate dropped to almost zero, therefore the study had to be stopped. Sixty-three patients were randomised to either the stent (n = 42) or control group (n = 21). Overall, 50 patients had available data for primary outcome analysis. The adjusted mean difference between 12 month scores for VEINES-QoL and VEINES-Sym was 8.07 (95% CI 3.04 - 13.09) and 5.99 (95% CI 0.75 - 11.24) (p = .026), respectively, in favour of the stent group. The differences were significant, but a predefined meaningful 14 point improvement in QoL was not reached. The mean difference between 12 month scores for VCSS was -2.93 (95% CI -5.71 - 0.16, p = .040), -11.83 (95% CI -20.81 - 2.86, p = .011) for PDI, 0.015 (95% CI -0.12 - 0.15, p = .82) for the EQ-5D index, and -2.99 (95% CI -7.28 - 1.30, p = .17) for the Villalta score. CONCLUSION: Symptomatic patients with DVO who received dedicated venous stents had significantly higher VEINES-QoL/Sym scores at 12 months compared with the control group, but the between group difference was lower than the pre-specified clinically relevant QoL difference of at least 14 points.
KW - May–Thurner syndrome
KW - Post-thrombotic syndrome
KW - Quality of life
KW - Stent
KW - Venous thromboembolism
U2 - 10.1016/j.ejvs.2023.07.044
DO - 10.1016/j.ejvs.2023.07.044
M3 - Article
SN - 1078-5884
VL - 66
SP - 678
EP - 685
JO - European Journal of Vascular and Endovascular Surgery
JF - European Journal of Vascular and Endovascular Surgery
IS - 5
ER -