Transcript Below :
Question 1 : How often do you encounter symptomatic CVS?
Well, that's the important thing, that central venous stenosis might be often, but symptomatic it is not that an common phenomenon and that's why we tend, and we are supposed to, treat only those that become symptomatic and this is a key point and that was the study about.
Question 2 : What results are you presenting at LINC?
This was an investigator-initiated European multicenter retrospective analysis evaluating the results of the use of drug-coated balloons for the treatment of symptomatic central venous stenosis in AV access. 87 patients were included in the study from 11 centres across Europe. There were two centres from Greece, 3 centres from Germany, two centres from France, two centres from Italy, one from the United Kingdom and one from Portugal. The primary outcome measure of the study was clinically assessed intervention-free period. So, we are treating a stenosis when it becomes symptomatic and the we treat it again when it becomes symptomatic again. So, for this period of time, the target lesion, primary patency there, was 62.7% at six months and very interesting finding as well was access circuit survival which was 87.7% at six months and 67.6% at two years. Patient survival was also quite high with 79.7% at two years.
Question 3 : How does treatment with DCBs compare to other treatments?
So, the goal here was to try to have a better results than PTA and we do have better results than PTA. The results are actually comparable to previous randomised control trial and the idea is that we are trying to avoid the metallic scaffold in central vein so, if you get better results with the drug-coated balloon leaving nothing behind, it will be a very good alternative and that's what we are looking for, that's the aim, that was the idea of the study.
Question 4 : What would be the desired impact of this data on clinical practice?
So, ideally performing a subgroup analysis in this study, we saw that the only significant factor that affected patency, was the size of the balloon. So, the higher the size of the balloon, the better the results. So, I would urge and encourage physicians to try to go from underestimating the lesion to proper estimating to proper size the lesion and then use a drug-coated balloon to treat the lesion.