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.
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References
- 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.
- 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.
- Beebe-Dimmer JL, Pfeifer JR, Engle JS, et al. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol 2005; 15: 175–184.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- Bush RG, Derrick M, Manjoney D. Major neurological events following foam sclerotherapy. Phlebology 2008; 23: 189–192.
- Forlee MV, Grouden M, Moore DJ, et al. Stroke after varicose vein foam injection sclerotherapy. J Vasc Surg 2006; 43: 162–164.
- Hill DA. Neurological and chest symptoms following sclerotherapy: a single centre experience. Phlebology 2014; 29: 619–627.
- Parsi K. Paradoxical embolism, stroke and sclerotherapy. Phlebology 2012; 27: 147–167.
- Asbjornsen CB, Rogers CD, Russell BL. Middle cerebral air embolism after foam sclerotherapy. Phlebology 2012; 27: 430–433.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Source: PubMed