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Axial ablation versus terminal interruption of the reflux source (AAVTIRS): a randomised controlled trial
C R Keohane1,2, D Westby3,4, M Twyford5,4
1University Hospital Galway, Galway, Ireland. columkeohane@rcsi.ie.
Trials
|June 10, 2022
Summary
Terminal ablation of the reflux source (TIRS) offers a less invasive approach for superficial venous reflux treatment. This study compares TIRS to axial ablation (AA) for healing venous ulcers, aiming to improve patient outcomes and reduce recurrence.
Area of Science:
- Vascular Surgery
- Dermatology
- Wound Healing
Background:
- Superficial venous reflux significantly impacts venous ulcer healing and recurrence rates.
- Terminal Ablation of the Reflux Source (TIRS) using sclerosant foam is a patient-preferred alternative to traditional endovenous ablation or surgery.
- Axial Ablation (AA) is a standard treatment for superficial venous reflux.
Purpose of the Study:
- To compare the efficacy of TIRS versus AA in healing venous ulcers within six months.
- To evaluate the proportion of ulcers healed in patients undergoing either AA or TIRS.
Main Methods:
- An assessor-blinded randomized controlled trial (AAVTIRS) was conducted.
- Patients were recruited from dedicated ulcer and vascular surgical clinics.
- Ulcer healing proportion at six months post-treatment was the primary endpoint.
Main Results:
- The study aims to determine if TIRS is superior, non-inferior, or inferior to AA in venous ulcer healing.
- Results will inform clinical practice regarding the optimal ablation strategy for venous ulcers.
Conclusions:
- This trial is the first powered randomized study to evaluate TIRS in venous ulcer management.
- Findings will guide treatment decisions, potentially favoring less invasive TIRS if proven effective.
- Results could impact healthcare economics by promoting less invasive, potentially more cost-effective treatments.
