Dr. Vasquez's 2017 publication

Multicenter, randomized evaluation of thermal ablation with and without Varithena

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Objective

To determine the efficacy and safety of Varithena (PEM) when administered in combination with ETA.

  • Co-primary endpoints were change in appearance assessed by both physicians and patients from Baseline to Week 8
  • Secondary endpoint of symptom improvement using VEINES-QOL/Sym and VCSS

Patients

(n= 117; multicenter, randomized, placebo-controlled, blinded)

  • Symptomatic patients with C2–C5 chronic venous insufficiency
  • Patients had to be candidates for ETA (endovenous thermal ablation) of the proximal incompetent GSV (great saphenous vein) who also required treatment for visible varicosities
  • PA-V3 of moderately noticeable or worse and IPR-V3 of moderate or worse  

Methods

  • Study drug could be used above and below the knee for visible varicosities and incompetent areas of the GSV system or tortuous areas of the saphenous trunk not treated with ETA
  • Patients were randomized prior to ETA on a 1:1:1 basis receive ETA and either PEM 0.5% or 1.0% or placebo
  • Unblinded ETA was immediately followed by treatment with either double-blind PEM (patients and care providers) or single-blind placebo (patients) up to 15 mL

Assessment

  • An IPR Panel independently scored standardized photographs (Baseline, Week 8, Month 6) for varicose veins appearance using the IPR-V3 instrument
  • Patients assessed the live appearance of their veins, without comparison to baseline using the PA-V3 instrument
  • Patient Global Impression of Change in Appearance (PGIC-Appearance) and Clinician Global Impression of Change in Appearance (CGIC-Appearance) rated the change as Much worse (-3 points) to Much better/Much Improved (+3 points)

 

Key results

  • A significantly higher percentage of patients achieved clinically meaningful change with (pooled) PEM than with placebo for both IPR-V3 (Week 8: 84% vs. 58%, p=0.004) and PA-V3 (Week 8: 72% vs. 55%,  p=0.06)
  • Change scores for VCSS and m-VEINES-QOL at Week 8 were slightly better for PEM recipients than for placebo recipients, though not statistically significant
  • Mean PEM volume administered during the initial procedure was 11.5 mL for PEM 0.5% and 12.3 mL for PEM 1.0%
  • Fewer patients required retreatment if they were treated with ETA + PEM
  • ETA alone eliminated reflux through the SFJ in 78.9% of patients vs 87.3% with ETA + PEM patients
  • Minor adverse events included asymptomatic DVT in two PEM patients — both in the 0.5%, three occurrences of isolated gastrocnemius vein thrombosis and superficial thrombophlebitis in 28 patients — 13 with 0.5% PEM and 15 with 1.0% PEM

 

Change in IPR-V3 score

Chart summarizing findings and results from the IPRV3 study on Varithena efficacy..

References

Vasquez, Michael. “A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities.” Phlebology.2017 May;32(4):272-281. doi: 10.1177/0268355516637300. The author is a consultant for Boston Scientific.