1. Axial Ablation versus Terminal Interruption of the Reflux Source (AAVTIRS): A Randomised Controlled Trial.
- Author
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Cr K, D W, M T, T A, W T, and Sr W
- Subjects
- Aged, Female, Humans, Male, Middle Aged, Ablation Techniques adverse effects, Endovascular Procedures adverse effects, Quality of Life, Sclerosing Solutions administration & dosage, Sclerosing Solutions adverse effects, Time Factors, Treatment Outcome, Venous Insufficiency therapy, Venous Insufficiency surgery, Venous Insufficiency physiopathology, Venous Insufficiency diagnostic imaging, Sclerotherapy adverse effects, Varicose Ulcer therapy, Varicose Ulcer surgery, Varicose Ulcer physiopathology, Wound Healing
- Abstract
Introduction: Treatment of reflux has been shown to improve time to healing of Venous Leg Ulcers (VLU). Terminal Interruption of the Reflux Source (TIRS) treats reflux within the plexus of veins around an active VLU using foam sclerotherapy. The efficacy of TIRS in managing VLU has never been tested., Methods: We performed a pragmatic, single centre, assessor-blinded, randomised controlled trial comparing endovenous ablation of the axial superficial veins (Axial Ablation-AA) vs TIRS. Patients of any age with VLU of any duration were eligible., Results: 98 Participants were randomised to AA or TIRS. 39/55, 70.9% (95%CI; 57.1-82.37) healed their VLU in the AA group, while 29/39, 74.36% (95%CI; 57.87-86.96) healed their VLU in the TIRS group, P = 0.45.4 were lost to follow-up. Median time to ulcer healing was 84 days (95%CI; 74.67-93.33) in the axial ablation group and 84 days (95%CI; 73.02-94.98) in the TIRS group. Hazard Ratio for ulcer healing with AA vs TIRS was 0.96 (95%CI 0.59-1.56). There were no significant quality of life differences., Conclusion: The AAVTIRS trial did not show that axial ablation was superior to TIRS in the primary outcome of number of VLU healed in 6 months, or time to VLU healing. This trial is not powered to show non-inferiority. TIRS is a viable option for treatment of VLU. Further investigation is necessary before it can be recommended as an alternative to axial ablation.Trial registered at clinicaltrials.gov NCT04484168., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
- Published
- 2024
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