Okay, well, we'll move over the next session and, I'd like to introduce ...gibson ...the podium to speak about endovenous adhesive vs radiofrequency patients...three years which is a long term results of a veclose study of ...thank you so, I'm going to present today for the first-time in europe the thirty six ...results from the veclose trial these were first presented a few days ago in miami. And, these are my disclosures.
Sorry. So, the veclose trial was a randomized controlled trial comparing the venaseal... akerley closure system to radiofrequency ablation for treatment of incompetent great And, this was a us multi-center trial that was randomized and the primary end point was to show noninferiority
at three months in terms of anatomical closure rates comparing venaseal ...radiofrequency search hundred-forty to patients enrolled and the follow-up visits shown here twenty those patients were role in patients to familiarize the sites with the new technique and two hundred-twenty to ...randomized so our primary end point was complete closure of the target vein at three months and complete closure was defined as a vein showing no
discrete areas of patency that were exceeding five centimeters either by flow or by compression secondary end points included pain during the procedure and bruising at day three. Additional assessments included venous clinical severity scores and quality of life measures using the aberdeen varicose vein questionnaire and...generic ...five de we also compared adverse events are related to the
target means and looking at adverse very rate of disease-specific invents these were the participating centers in the united states. And, again, our study ...so two hundred forty two patients were treated to hundred-twenty to were randomized ...and eight in the venaseal group and a...and fourteen in the radiofrequency group there were pre-operative evaluations baseline assessments and follow-up as shown.
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, 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.
Disclaimer: Content and materials on Medlantis are provided for educational purposes only, and are intended for use by medical professionals, not to be used self-diagnosis or self-treatment. It is not intended as, nor should it be, a substitute for independent professional medical care. Medical practitioners must make their own independent assessment before suggesting a diagnosis or recommending or instituting a course of treatment. The content and materials on Medlantis should not in any way be seen as a replacement for consultation with colleagues or other sources, or as a substitute for conventional training and study.