Transcript Below :
Question 1 : Why are Sirolimus DCBs needed as a technology?
Well Sirolimus is a new drug, is a new concept like a presentation I had today on DCB. Paclitaxel has been tested and used in the last 12 years. Now we need a new drug, which is Sirolimus or any other Limus drugs related to this class of drugs. The need for it, is that paclitaxel, not all DCBs eluting this drug are affective on the long term, we've seen some bad signals in the periphery with some older generation paclitaxel devices. Sirolimus has a wider therapeutic range if compared to paclitaxel, and what is difficult with this drug is that you have to deliver it with an excipient that will help you to maintain the drug in the vessel wall for at least one month.
Question 2 : How does the Sirolimus coating work?
It works just like any other drug with a balloon. The difference is related to the pharmacodynamic properties of the drug, 'cause you deliver it and then you have to use an excipient and nanotechnology like for the Concept Medical one, in order to maintain it there. How does it work? It is an anti-restenotic drug, and differently from paclitaxel, it is also an anti-inflammatory drug.
Question 3 : What data supports there use in comparison to other DCBs?
Today there are not any direct comparison between sirolimus and paclitaxel. We only have one small study in the ISR setting with one device. We will have some data probably during EuroPCR, we will present the Sir-Pac study, which is the first large scale, 1,000 patient comparison between sirolimus and paclitaxel. So, now we only have indirect comparison between these two drugs.
Question 4 : When are you using DCBs in your practice?
We use it in around 40% of our PCIs. They are the first choice in the small vessel disease, PCI for example, vessel which are up to trio, long lesions and we use it a lot also in complex settings, for example, very long lesions when we want to avoid paving with stents of the entire coronary artery. So, we may decide to put a stent in the proximal part of the lesion and then a drug-coated ballon in the distal part, this is our preferred strategy.
Question 5 : What further research is required to validate sirolimus DCBs as the coating of choice?
Well, now we need randomised clinical trials of comparison with DES and also with the best-in-class PCB, which means paclitaxel-coated balloons. We don't have this data yet, we are going to start with a couple of studies on it with a Concept Medical MagicTouch device, but we need this data because we have just seen in single-arm registries or in large registries with clinical endpoints how they are working, but we need a comparison to the best-in-class devices that we have.