Transcript Below :
Question 1 : Could you summarise the updates on DCBs you presented at JIM 2020?
Yesterday, we presented the latest data on paclitaxel-coated balloons. I think the data in the coronary territory is very clear right now with very strong data towards benefit in the coronary field, especially for in-stent restenosis in the small vessels. Very intriguing new data was presented, including a couple of large meta analyses that support the use of this technology in that particular territory. The data for peripheral vascular application is a little bit more controversial because the recent controversy of interaction or relationship with all-cause mortality. But still... Physicians continue to use the technology for peripheral vascular application and new data actually suggests that when the number of patients, lost at follow-up are included, these mortality rates continues to decline. So, I really think the field continues to be strong.
Question 2 : Patients in which clinical scenarios will benefit the most from advancements in DCBs?
In-stent restenosis in the small vessels are the current indication for this particular technology. In the peripheral field right now people are more selective and they're trying to essentially look for high-risk populations, including diabetics, lung lesions, in-stent restenosis, and CTOs. So, a more selective group of population.
Question 3 : In your opinion, how should the data presented impact clinical practice?
Right now the biggest controversy is this potential toxicity issue or all-cause mortality with peripheral applications which is not really changing practise, but it's actually making physicians to be more precise in the decision-making process. So, right now for the peripheral application mainly, the data's impacting clinical practise by essentially forcing physicians to select populations that are at very high-risk for restenosis or device failure, instead of actually using the technology to every single patient.
Question 4 : Are DCBs equally efficacious as drug eluting stents?
It's difficult to say at the present time because we only have a few small randomised studies. At the present time I don't really think that there is a very clear evidence of superiority and we will see in the future which technology is going to be superior in this particular setting.
Question 5 : What questions remain unanswered that require further research?
I think just the comparative data between devices I think is something that we don't know which one is superior to which. And also the role of sirolimus-eluting balloons for this particular application. So, I think in the future we're going to start to see what happened in the coronary field which was comparative studies between devices to actually see which one is actually more superior. Also the below-the-knee application, which device or technology is better for below-the-knee application is something that at the present time we don't know yet.