Key result
Technical success following ClariVein treatment (achieved in 64.5% of 364 patients) did not yield significant differences in VCSS, AVVQ, and SF-36 scores compared to technical failure.
Why the study?
The study aimed to compare patient-reported outcomes following technical success versus technical failure after treating great saphenous vein incompetence with ClariVein.
Does technical success compared to technical failure improve patient-reported outcomes in patients treated with ClariVein for great saphenous vein incompetence?
RCT (n=364)
Double-blind
Yes
Does technical success compared to technical failure improve patient-reported outcomes in patients treated with ClariVein for great saphenous vein incompetence?
Patient-reported outcomes at 6 months do not significantly differ between those with technical success versus technical failure following ClariVein treatment for great saphenous vein incompetence.
Patient-reported outcomes improve similarly after ClariVein regardless of technical success; challenges anatomic occlusion as sole success metric and leaves open longer-term validation.
OBJECTIVE: This study aimed to compare patient-reported outcomes after technical success (TS) and technical failure (TF) in treating great saphenous vein incompetence (GSV) with ClariVein. METHODS: A subanalysis of a previous trial was conducted on symptomatic GSV incompetence patients who received ClariVein treatment with 2% or 3% polidocanol (POL) and were followed for 6 months. Blinding was implemented for observers and patients, and data from both POL groups were combined. TS was defined as at least 85% occlusion of the treated vein, while TF indicated failure to meet TS criteria. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Short-Form 36 Health Survey Questionnaire (SF-36). RESULTS: Among the 364 patients included, the TS rate was 64.5%. Comparison of VCSS, AVVQ, and SF-36 scores between TS and TF groups did not yield significant differences. CONCLUSION: This study indicates no significant variation in VCSS, AVVQ, and SF-36 scores between patients experiencing TS and TF following ClariVein treatment for GSV insufficiency.
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Alozai et al. (2023) conducted an RCT in Great saphenous vein incompetence (n=364). Technical success (TS) following ClariVein treatment vs. Technical failure (TF) was evaluated on Patient-reported outcomes (VCSS, AVVQ, and SF-36 scores). Technical success following ClariVein treatment (achieved in 64.5% of 364 patients) did not yield significant differences in VCSS, AVVQ, and SF-36 scores compared to technical failure.
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