So, baseline characteristics were similar between the two groups of note the gs ...on average was a fairly small around six and dc assess and quality of life scores between the two groups were equivalent. So, the amount of sano akerley delivered on average to ...gs v was about one-point-two cc's. One thing that we noted...although there were numeric differences there were no statistical
differences in pain between the two procedures however this was on a scale of zero to ten and even in the radiofrequency group with tumescence these pain skills in both groups of patients were fairly low and my opinion is the reason for that is that when you ask patients to participate in a randomised trial in which they can I have no sedation and they volunteer to have their treatment pick for them you don't pick patients with low pain tolerance so that's why I think are pain scores in both groups.
in terms of n said and narcotic use there was no difference between the two groups in the first twenty four hours only one patient required narcotics and that was in the one of the radiofrequency patients. We did find that there was significantly less bruising in the venaseal group compared to the radiofrequency group at day three. The primary end point three months was equivalent between the two groups complete occlusion was ninety nine percent in the venaseal group and...five-point-four percent and
...and this data's been previously presented. This is the new data so, at thirty six months the closure rate for venaseal is ninety-four point ninety four ninety four point four percent and rsa group ninety ...percent and this is statistically significant highly statistically significant for noninferiority of venaseal at three years.
So, patients don't come to us complaining of reflux of saying that's why they're there nor do they come back and say they're happy because they're veins closed they care about venous clinical severity what the severity their symptoms and their quality of life so I think these next slides are really important so we see that in both groups out to three years improvements in vc ss score are maintained and...between each other. And, we see this also with the aberdeen varicose vein questionnaire that
they are the same between the two groups and still sustained at three years. then finally the eq five d again no difference between the two groups at three years. Adverse events between...two years in three years are shown here...were ...adverse events both of them in the venaseal group one patient had a late onset of phlebitis in her distal gs v just above the and, the second patient heady scar that the
investigator thought was more prominent than it should be at the access site there were no reports of deep vein thrombosis in this cohort no allergic revenge of events and no in an anticipated adverse events so the largest number of adverse events occurred in the first thirty days and were mild and self-limited.
So, in summary for through at three years veclose trial showed that venaseal has a non-inferior closure rate compared to radiofrequency of ninety four
point four percent we had statistically significant improvements in baseline from dc...aberdeen varicose vein questionnaire...five de at three years these improvement seem to be maintained with no difference between the two patient groups there are no reported dts or allergic reactions or other serious adverse events through thirty six months early events were mild and self-limiting and we had few delayed events so in
summary the veclose randomized clinical trial shows that there is the venaseal safe and reliable as a nonthermal nontumescent treatment option out to thirty six. Nothing.
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