A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of varithena® (Polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence

Phlebology

Volumn 32, Issue 3, 2017, Pages 185-193

  Gibson, Kathleen ^a,c   Kabnick, Lowell ^b   Morrison, Nick ^d   Munavalli, Gilly ^e   Regan, John D ^f  

^a Lake Washington Vascular   (United States)

^b NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

^c Lake Washington Vascular Surgeons   (United States)

^d Morrison Vein Institute   (United States)

^e Medical Center Boulevard ^*  (United States)

^f WAKE FOREST SCHOOL OF MEDICINE   (United States)

Author keywords

Great saphenous vein incompetence; Patient reported outcomes; Patientreported outcome measures; Polidocanol; Polidocanol injectable foam; Saphenofemoral incompetence; Saphenous vein; Self report; Varicose veins

Indexed keywords

PLACEBO; POLIDOCANOL; MACROGOL DERIVATIVE; SCLEROSING AGENT;

ADULT; ARTHRALGIA; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; CONTUSION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; FEMALE; FEMORAL VEIN; HEADACHE; HEMATOMA; HUMAN; INGUINAL PAIN; LIMB DISEASE; LIMB PAIN; MALE; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; MYALGIA; PAIN; PARESTHESIA; PERIPHERAL EDEMA; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SAPHENOUS VEIN; SINGLE BLIND PROCEDURE; SKIN IRRITATION; SWELLING; THORAX PAIN; VARICOSIS; VEIN EMBOLISM; VEIN INSUFFICIENCY; AGED; CLINICAL TRIAL; MIDDLE AGED; PATHOPHYSIOLOGY; VARICOSE VEINS; VENOUS INSUFFICIENCY;

ADULT; AGED; FEMALE; FEMORAL VEIN; HUMANS; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; SAPHENOUS VEIN; SCLEROSING SOLUTIONS; VARICOSE VEINS; VENOUS INSUFFICIENCY;

EID: 85018284642     PISSN: 02683555     EISSN: 14333031     Source Type: Journal    
DOI: 10.1177/0268355516635386     Document Type: Article

References (37)

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.
2. 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.
3. Beebe-Dimmer JL, Pfeifer JR, Engle JS, et al. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol 2005; 15: 175–184.
4. Paty J. VVSymQ™ and patient profiles: interpreting a new patient-reported outcome (PRO) instrument for great saphenous vein incompetence (GSVI). J Vasc Interv Radiol 2014; 25: S101. Abstract no. 216.
5. Paty J, Turner-Bowker DM, Elash CA, et al. The VVSymQ® instrument: use of a new patient-reported outcome measure for assessment of varicose vein symptoms. Phlebology 2016; 31: 481–488.
6. Paty J. VVSymQ® score and patient profiles: interpreting a new patient-reported outcome (PRO) instrument for great saphenous vein incompetence (GSVI). In: Annual Meeting of the Society for Interventional Radiology, 22–27 March 2014, San Diego, California.
7. 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: 2S–48S.
8. Cabrera J, Cabrera J Jr and García-Olmedo MA. Treatment of varicose long saphenous veins with sclerosant in microfoam form: long-term outcomes. Phlebology 2000; 15: 19–23.
9. Cabrera J, Cabrera J Jr and García-Olmedo MA. Sclerosants in microfoam. A new approach in angiology. Int Angiol 2001; 20: 322–329.
10. Frullini A. New technique in producing sclerosing foam in a disposable syringe. Dermatol Surg 2000; 26: 705–706.
11. Cavezzi A, Frullini A, Ricci S, et al. Treatment of varicose veins by foam sclerotherapy: two clinical series. Phlebology 2002; 17: 13–18.
12. Tessari L. Nouvelle technique d’obtention de al scleramousse. Phlebologie 2000; 53: 129.
13. Carugo D, Ankrett DN, Zhao X, et al. Benefits of polidocanol endovenous microfoam (Varithena®) compared with physician-compounded foams. Phlebology 2016; 31: 283–295.
14. Hill DA. Air embolism following sclerotherapy. Poster presented at: 27th Annual Meeting, American Venous Forum; February 25–27, 2015; Palm Springs, CA.
15. Asbjornsen CB, Rogers CD and Russell BL. Middle cerebral air embolism after foam sclerotherapy. Phlebology 2012; 27: 430–433.
16. Bush RG, Derrick M and Manjoney D. Major neurological events following foam sclerotherapy. Phlebology 2008; 23: 189–192.
17. Leslie-Mazwi TM, Avery LL and Sims JR. Intra-arterial air thrombogenesis after cerebral air embolism complicating lower extremity sclerotherapy. Neurocrit Care 2009; 11: 97–100.
18. DeLaney MC, Bowe CT and Higgins GL III. Acute stroke from air embolism after leg sclerotherapy. Western J Emerg Med 2010; 11: 397.
19. Frullini A, Barsotti MC, Santoni T, et al. Significant endothelin release in patients treated with foam sclerotherapy. Dermatol Surg 2012; 38: 741–747.
20. Ferrara F and Ferrara G. The chemical mediators of some sclerotherapy complications (Les méídiateurs chimiques dans certaines complications de la scléírothéírapie). Phléíbologie 2012; 65: 27–31.
21. Wright D, Gobin JP, Bradbury AW, et al. Varisolve® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial. Phlebology 2006; 21: 180–190.
22. Regan JD, Gibson KD, Rush JE, et al. Clinical significance of cerebrovascular gas emboli during polidocanol endovenous ultra-low nitrogen microfoam ablation and correlation with magnetic resonance imaging in patients with right-to-left shunt. J Vasc Surg 2011; 53: 131–137.
23. Todd KL 3rd and 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.
24. 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.
25. Launois R, Reboul-Marty J and Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res 1996; 5: 539–554.
26. CIVIQ Users’ Guide. Scoring and missing data, http://www.civiq-20.com/scoring-missing-data/ (2015, accessed 5 August 2015).
27. Wright D, Paty J, Turner-Bowker DM, et al. Psychometric evaluation of a new Patient-Reported Outcome (PRO) symptom diary for varicose veins: VVSymQ® instrument. Patient (in press 2016).
28. 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.
29. 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.
30. King JT, O’Byrne M, Vasquez M, et al. Treatment of truncal incompetence and varicose veins with a single administration of a new polidocanol endovenous microfoam preparation improves symptoms and appearance. Eur J Vasc Endovasc Surg 2015; 50: 784–793.
31. Jones RT and Kabnick LS. Perioperative duplex ultrasound following endothermal ablation of the saphenous vein: is it worthless? J Invasive Cardiol 2014; 26: 548–550.
32. 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.
33. 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.
34. Kearon C, Kahn SR, Agnelli G, et al. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition) Chest. 2008; 133: 454–545.
35. Pearson’s correlation, http://www.statstutor.ac.uk/ resources/uploaded/pearsons.pdf (accessed 19 August 2015).
36. Forlee MV, Grouden M, Moore DJ, et al. Stroke after varicose vein foam injection sclerotherapy. J Vasc Surg 2006; 43: 162–164.
37. Morrison N, Neuhardt D, Rogers C, et al. Incidence of side effects using carbon dioxide–oxygen foam for chemical ablation of superficial veins of the lower extremity. Eur J Vasc Endovasc Surg 2010; 40: 407–413.