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EUROPEAN PHASE III RANDOMISED CONTROLLED TRIAL COMPARING VARISOLVE WITH SURGERY OR SCLEROTHERAPY
The trial was an open-label, multi-centre, randomised, prospective study comparing Varisolve to surgery and sclerotherapy in the management of patients with moderate to severe varicose veins. The results of the trial showed that Varisolve met the study objective in that overall it was shown to be non-inferior to alternative treatments, with 83.4% efficacy for Varisolve and 88.1% efficacy for alternative treatments at three months, and 78.9% efficacy for Varisolve and 80.4% efficacy for alternatives at 12 months. "These full data from the one-year follow-up of the European Phase III trial confirm that Varisolve is an effective and well tolerated treatment for varicose veins, with significant advantages for patients over alternative treatments," commented Louise Makin, BTG's CEO. "We continue to believe Varisolve has significant commercial potential, and are continuing its US development with the phase II safety study." In the trial, patients were treated in two randomised cohorts, Varisolve vs surgery (178 Varisolve patients) and Varisolve vs sclerotherapy (259 Varisolve patients) to receive either the Varisolve procedure or the alternative treatment in a ratio of 2:1 in favour of the Varisolve technique. Efficacy and safety were assessed by duplex scanning on days 7 and 28, and at months 3 and 12. The primary endpoint was the response to treatment at month 3, defined as the occlusion of incompetent trunk vein(s) and the elimination of reflux in the treated vein(s). To be a responder, both occlusion (or for surgery the absence) of the treated vein and elimination of junctional reflux were required. Secondary endpoints included: severity of post-procedure pain, time taken to return to normal activities, number of treatment sessions required and month 12 response rate. Analysing the cohorts separately at month 3, the response rates were 68.2% for Varisolve and 87.2% for surgery in the Varisolve vs surgery cohort, and 93.8% for Varisolve and 88.8% for sclerotherapy in the Varisolve vs sclerotherapy cohort. At month 12, the superiority of surgery over Varisolve was maintained in the Varisolve vs surgery cohort (86.2% versus 63.1%), while Varisolve was superior to sclerotherapy in the Varisolve vs sclerotherapy cohort (89.6% versus 76%). The authors of the paper conclude that the reduced efficacy of Varisolve when delivered by vascular surgeons resulted in part from the lack of experience of this group in using sclerotherapy for large veins. In terms of the secondary endpoints, surgery was associated with more pain than Varisolve (day 6: surgery median score 9, Varisolve median score 2 on the visual analogue scale). The median time to resume normal activities was 2 days following treatment with Varisolve compared with 13 days following surgical treatment in the Varisolve vs surgery cohort. No difference was observed in the time to resume normal activities between the patients treated with Varisolve or sclerotherapy in the Varisolve vs sclerotherapy cohort. More patients completed treatment in a single session in the Varisolve group than in the sclerotherapy group (92.2% versus 74.4%). The most common adverse events relating to Varisolve use were mild contusion, skin discolouration and limb pain. There were six reports of neurological symptoms occurring within 24 h of treatment, which were short-lived and resulted in no clinical findings during follow-up examinations. Deep vein thromboses occurred in 11 patients treated with the Varisolve procedure, prompting technique changes and following which no further DVTs have been found in 150 patients treated subsequently in this and other studies. The authors conclude that Varisolve is capable of sclerosing major incompetent trunk veins and tributaries, usually in a single outpatient session. It is effective in over 80% of cases and is well tolerated, which support the Varisolve technique as an appropriate future treatment for patients with varicose veins and trunk vein incompetence.
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