The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence

Abstract

Polidocanol endovenous microfoam provided clinically meaningful benefit in treating symptoms and appearance in patients with varicose veins. Polidocanol endovenous microfoam was an effective and comprehensive minimally invasive treatment for patients with a broad spectrum of vein disease (clinical, etiology, anatomy, pathophysiology clinical class C2 to C6) and great saphenous vein diameters ranging from 3.1 to 19.4 mm. Treatment with polidocanol endovenous microfoam was associated with mild or moderate manageable side effects. VVSymQ is an important new, validated instrument for symptom assessment in patients with varicose veins.

Content Validity for the VVSymQ® Instrument: A New Patient-Reported Outcome Measure for the Assessment of Varicose Veins Symptoms

“…After psychometric validation in a quantitative study [14], the five-item VVSymQ ® instrument was implemented as part of an electronic daily diary in phase 3 clinical trials of treatment of superficial venous incompetence of the GSV system [15, 16]. …”

Consensus for Sclerotherapy

“…The most common technique for producing foam involves the use of 2 syringes and either a 3-way stopcock or a luer-to-luer connector. 29 27 The contents of the syringes are mixed back and forth approximately 10 to 15 times to produce the desired foam.…”

“…Such vessels (great and small saphenous veins) are typically treated in the United States with endovenous ablation, 49 although the 2014 availability of an FDA-approved foamed polidocanol alters the therapeutic landscape. 29 There has been a high safety profile documented with the utilization of foam in the treatment of large diameter telangiectasia, reticular veins, and truncal varicosities, with consensus on the safety of the technique. 50 Whether these neurologic events are actually related to foam microemboli remains in question.…”

Factors impacting on patient perception of procedural success and satisfaction following treatment for varicose veins

“…These factors are now recognized as important additional outcome measures in the assessment of disease. This is reflected in the increasing use of quality‐of‐life measures as primary endpoints in clinical studies.…”