Efficacy

Proven efficacy: Varithena® improves symptoms, appearance, and underlying GSV system incompetence1,2

DATA ONCE AGAIN DEMONSTRATES THE EFFICACY AND DURABILITY OF VARITHENA® TREATMENT >

Study designs: VANISH-1 and VANISH-2

Randomized, blinded, parallel-group, multicenter Phase 3 studies for Varithena®

SYMPTOMS RESULTS | APPEARANCE RESULTS | PHYSIOLOGICAL RESPONSE


Inclusion criteria

  • Saphenofemoral junction (SFJ) incompetence as evidenced by reflux of the great saphenous vein (GSV) or other major accessory vein
  • Symptomatic
  • Visible varicosities
  • CEAP clinical class 2-6
  • Age 18-75
No exclusions based on vein diameter, vein anatomy, or previous treatment


Treatment

  • VANISH-1: Single treatment session
  • VANISH-2: Optional second blinded treatment 1 week after the first
  • Maximum volume of microfoam per treatment session: 15 mL
  • Post-procedure compression therapy for 14 days


Baseline Characteristics


*VVSymQ® instrument: Patient-reported outcomes tool for varicose vein symptoms
†IPR-V3: Independent photography review of visible varicose veins (physician assessment)


Study Populations

efficacy-study-pop-chart.jpg
*Varithena® 0.125% was used as a control for the duplex response analysis to blind the clinician assessing response


Endpoints

efficacy-study-endpoints-chart.jpg


Varithena® improves symptoms2

Improvement in symptoms as measured by change in VVSymQ® Score
from baseline to Week 81,8

Symptoms.jpg
A reduction in VVSymQ® Score indicates an improvement in symptoms.
VVSymQ® instrument: Patient-reported outcomes tool for varicose vein symptoms


Varithena® improves varicose vein appearance1,2

Improvement in appearance as measured by change in IPR-V3 rating*
from baseline to Week 8

Symptoms-B.jpg
A reduction in IPR-V3 rating indicates an improvement in appearance.
*IPR-V3: Independent photography review of visible varicose veins (physician assessment); physicians rated appearance of patients’ visible varicosities on a 5-point scale



before-after-improvement-(1).jpg



Varithena® addresses underlying venous incompetence1,2


Physiological response to treatment as measured by duplex ultrasound at Week 8

Duplex response = Elimination of SFJ reflux and/or complete occlusion of all incompetent trunk veins

Symptoms-C-(2).jpg
*Varithena® 0.125% was used as a control for the duplex response analysis to blind the clinician assessing response
 

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INDICATIONS

Varithena®  (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena®  improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

IMPORTANT SAFETY INFORMATION

The use of Varithena®  is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease.

Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.

Varithena®  can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis.

Physicians administering Varithena®  must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena® .

See Full Prescribing Information for Varithena®.

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References

1. Varithena® (polidocanol injectable foam) [prescribing information]. London, England; Provensis Ltd, a BTG International group company; 2014.
2. Data on file. Provensis Ltd, a BTG International group company; 2013.
3. Eckmann DM. Polidocanol for endovenous microfoam sclerosant therapy. Expert Opin Investig Drugs. 2009;18(12):1919-1927. 
4. O'Leary DP, Chester JF, Jones SM. Management of varicose veins according to reason for presentation. Ann R Coll Surg Engl. 1996;78(3 (Pt 1)):214-216.
5. Darvall KA, Bate GR, Sam RC, Adam DJ, Silverman SH, Bradbury AW. Patients' expectations before and satisfaction after ultrasound guided foam sclerotherapy for varicose veins. Eur J Vasc Endovasc Surg. 2009;38(5):642-647.
6. Palfreyman SJ, Drewery-Carter K, Rigby K, Michaels JA, Tod AM. Varicose veins: a qualitative study to explore expectations and reasons for seeking treatment. J Clin Nurs. 2004;13(3):332-340.
7. Tessari L, Cavezzi A, Fruilini A. Preliminary experience with new sclerosing foam in the treatment of varicose veins. Dermatol Surg. 2001;27(1):58-60.
8. Todd KL III, Wright DI, and the VANISH-2 Investigator Group. 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. Phlebology. 2014;29(9):608-618. doi:10.1177/0268355513497709.
9. Mason H, Baker R, Donaldson C. Understanding public preferences for prioritizing health care interventions in England: does the type of health gain matter? J Health Serv Res Policy. 2011;16(2):81-89.
10. Lindsey B, Campbell WB. Rationing of treatment for varicose veins and use of new treatment methods: a survey of practice in the United Kingdom. Eur J Vasc Endovasc. 2006;32(4):472.
11. Santangelo, K. Treating C6 Venous Disease Requires Tandem Effort. Endovascular Today. 2017; 16: 78-80. EVToday.com. BTG International, Jan. 2017. Web. 26 Jan. 2017.
12. Margolis et al. J Am Acad Dermatology. 2002;46(3):381-386
13. Rice 2014, Olin 1999, Ma 2014 and The SAGE Group
14. Franks, Peter J., et al. "Management of Patients with Venous Leg  Ulcers." Journal of Wound Care 25.6 (2016):n.pag
15. Deak T. Retrograde administration of ultrasound-guided endovenous microfoam chemical ablation for the treatment of superficial venous insufficiency. J Vasc Surg. 2018 July; 6(4):477-484
In a single center retrospective review of 250 patients with C2-C6 CVI, complete elimination of venous valvular reflux, vein closure, and symptom improvement was documented in 94.4% of patients. Two patients experienced asymptomatic DVTs, one experienced a common femoral vein thrombus extension, and four experienced superficial venous thrombi, accompanied by minor discomfort. This information supplements the data from the VANISH-1 and VANISH-2 trials, where the more stringent criteria of “duplex response” (elimination of reflux through the SFJ and/or complete occlusion of all incompetent GSV and major accessory veins at baseline) was evaluated. In VANISH-1 and VANISH-2, patients in the Varithena 1.0% group reported an 80.4% and 86.2% response to treatment respectively.

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