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

Michael Vasquez, Antonios P Gasparis, Varithena® 017 Investigator Group, Michael Vasquez, Antonios P Gasparis, Varithena® 017 Investigator Group

Abstract

Objectives * Varithena 017 Investigator Group: Michael Vasquez, MD, Venous Institute of Buffalo, Amherst, NY; Antonios Gasparis, MD, Stony Brook University Medical Center, Stony Brook, NY; Kathleen Gibson, MD, Lake Washington Vascular, Bellevue, WA; James Theodore King, MD, Vein Clinics of America, Oakbrook Terrace, IL; Nick Morrison, MD, Morrison Vein Institute, Scottsdale, AZ; Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC; Eulogio J. Sanchez, MD, Batey Cardiovascular Center, Bradenton, FL. Varithena® is a trademark of Provensis Ltd, a BTG International group company. To determine the efficacy and safety of polidocanol endovenous microfoam (PEM 0.5%, 1.0%) and placebo each administered with endovenous thermal ablation. Methods A multicenter, randomized, placebo-controlled, blinded study was conducted in patients with great saphenous vein incompetence and symptomatic and visible superficial venous disease. Co-primary endpoints were physician-assessed and patient-assessed appearance change from Baseline to Week 8. Results A total of 117 patients received treatment (38 placebo, 39 PEM 0.5%, 40 PEM 1%). Physician-rated vein appearance at Week 8 was significantly better with PEM ( p = 0.001 vs. placebo); patient-assessed appearance trended similarly. Polidocanol endovenous microfoam provided improvements in clinically meaningful change in patient-assessed and physician-assessed appearance ( p < 0.05), need for additional treatment ( p < 0.05), saphenofemoral junction reflux elimination, symptoms, and QOL. In PEM recipients, the most frequent adverse event was superficial thrombophlebitis (35.4%) Conclusions Endovenous thermal ablation + PEM significantly improved physician-assessed appearance at Week 8, increased the proportion of patients with a clinically meaningful change in appearance, and reduced need for additional treatment. www.clinicaltrials.gov (NCT01197833).

Keywords: Varicose veins; polidocanol; polidocanol injectable microfoam; saphenous vein; self-report.

Figures

Figure 1.
Figure 1.
Patient disposition. All patients who received treatment had endovenous thermal ablation therapy immediately prior to treatment with polidocanol endovenous microfoam (PEM) ablation or placebo.
Figure 2.
Figure 2.
Photographs of a study patient who received ETA and PEM 1%. The patient was a 36-year-old white female with BMI 30.1 kg/m2.
Figure 3.
Figure 3.
Percentage of patients with clinically meaningful change in appearance as assessed by clinicians (IPR-V3 score) and patients (PA-V3 score) after treatment with endovenous thermal ablation and either placebo or PEM (pooled 0.5% and 1.0%).
Figure 4.
Figure 4.
(a) Percentage of patients who did not require additional treatment between Week 8 and Month 6 and (b) Percentage of patients for whom endovenous thermal ablation (ETA) eliminated saphenofemoral junction reflux (SFJ).

References

    1. Maurins U, Hoffmann BH, Lösch C, et al. Distribution and prevalence of reflux in the superficial and deep venous system in the general population – results from the Bonn Vein Study, Germany. J Vasc Surg 2008; 48: 680–687.
    1. Langer RD, Ho E, Denenberg JO, et al. Relationships between symptoms and venous disease: the San Diego population study. Arch Intern Med 2005; 165: 1420–1424.
    1. Beebe-Dimmer JL, Pfeifer JR, Engle JS, et al. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol 2005; 15: 175–184.
    1. García-Gimeno M, Rodríguez-Camarero S, Tagarro-Villalba S, et al. Duplex mapping of 2036 primary varicose veins. J Vasc Surg 2009; 49: 681–689.
    1. Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011; 53(5 suppl): 2S–48S.
    1. King T, Coulomb G, Goldman A, et al. Experience with concomitant ultrasound-guided foam sclerotherapy and endovenous laser treatment in chronic venous disorder and its influence on health related quality of life: interim analysis of more than 1000 consecutive procedures. Int Angiol 2009; 28: 289–297.
    1. Soffer AD. Combination of endovenous thermal ablation and ultrasound guided foam sclerotherapy. Presentation at: New Cardiovascular Horizons (NCVH) Vein Forum, New Orleans, LA, 27-29 May 2015, (accessed 24 August 2015).
    1. Pavlović MD, Schuller-Petrović S, Pichot O, et al. Guidelines of the First International Consensus Conference on Endovenous Thermal Ablation for Varicose Vein Disease-ETAV Consensus Meeting 2012. Phlebology 2015; 30: 257–273.
    1. Guex JJ, Allaert FA, Gillet JL, et al. Immediate and midterm complications of sclerotherapy: report of a prospective multicenter registry of 12,173 sclerotherapy sessions. Dermatol Surg 2005; 31: 123–128.
    1. Bush RG, Derrick M, Manjoney D. Major neurological events following foam sclerotherapy. Phlebology 2008; 23: 189–192.
    1. Forlee MV, Grouden M, Moore DJ, et al. Stroke after varicose vein foam injection sclerotherapy. J Vasc Surg 2006; 43: 162–164.
    1. Hill DA. Neurological and chest symptoms following sclerotherapy: a single centre experience. Phlebology 2014; 29: 619–627.
    1. Parsi K. Paradoxical embolism, stroke and sclerotherapy. Phlebology 2012; 27: 147–167.
    1. Asbjornsen CB, Rogers CD, Russell BL. Middle cerebral air embolism after foam sclerotherapy. Phlebology 2012; 27: 430–433.
    1. Leslie-Mazwi TM, Avery LL, Sims JR. Intra-arterial air thrombogenesis after cerebral air embolism complicating lower extremity sclerotherapy. Neurocrit Care 2009; 11: 97–100.
    1. Todd KL, 3rd, Wright DI. 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: 608–618.
    1. Orfe E, Evans E, King T, et al. Validation of new patient/clinician reported outcomes tool: capturing the visual impact of varicose veins. Poster presented at: Drug Information Association 48th annual meeting, Philadelphia, PA, 24–28 June 2012.
    1. US Food and Drug Administration. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. (December 2009, accessed 21 August 2015).
    1. Farrar JT, Young JP, Jr, LaMoreaux L, et al. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001; 94: 149–158.
    1. Vasquez MA, Wang J, Mahathanaruk M, et al. The utility of the Venous Clinical Severity Score in 682 limbs treated by radiofrequency saphenous vein ablation. J Vasc Surg 2007; 45: 1008–1014.
    1. Vasquez MA, Rabe E, McLafferty RB, et al. Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg 2010; 52: 1387–1396.
    1. Lamping DL, Schroter S, Kurz X, et al. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. J Vasc Surg 2003; 37: 410–419.
    1. Hirsh J, Guyatt G, Albers GW, et al. American College of Chest Physician. Antithrombotic and thrombolytic therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133(6 Suppl): 110S–112S.
    1. Lautz TB, Abbas F, Walsh SJ, et al. Isolated gastrocnemius and soleal vein thrombosis: should these patients receive therapeutic anticoagulation? Ann Surg 2010; 251: 735–742.
    1. Macdonald PS, Kahn SR, Miller N, et al. Short-term natural history of isolated gastrocnemius and soleal vein thrombosis. J Vasc Surg 2003; 37: 523–527.
    1. Van den Bos R, Arends L, Kockaert M, et al. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg 2009; 49: 230–239.
    1. Theivacumar NS, Darwood RJ, Dellegrammaticas D, et al. The clinical significance of below-knee great saphenous vein reflux following endovenous laser ablation of above-knee great saphenous vein. Phlebology 2009; 24: 17–20.

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