Dr Sabine Steiner (Medical University of Vienna, Vienna, AT) discusses the 1-year results of the full cohort from the COMPARE-RCT of low dose vs high dose Paclitaxel coated balloons.

Questions:
Can you define the difference between low and high dosing is in this study? 
What was the design of the study and which patients were eligible? 
What are the main outcomes presented at LINC 2020? 
How should these findings be interpreted? 
What future research is required for this class of DCB? 

Filmed on location at the Leipzig Interventional Course 2020. 

Interviewer: Ashlynne Merrifield
Videographer: Natascha Wienand

Transcript Below : 

Question 1 : Can you define the difference between low and high dosing is in this study? 

Well in the compare trial, we actually study it's the Ranger DCP and the IN.PACT DCP. And they do have profound differences with respect to their coating technologies. So one important difference was the particular dosage. In the Range, for the Ranger DCP, it's 2 micrograms per square millimetre, and for the IN.PACT DCP, it's 3.5 micrograms per square millimetre. Importantly they also do have differences with respect to the carrier that was used. 

Question 2 : What was the design of the study and which patients were eligible? 

I think it's a typical femoropopliteal disease, steady populations, so we included patients with symptomatic femoropopliteal disease, presenting in Rutherford category two to four. So we did not include Critical Limb Ischemia with respect to tissue loss. The design of this study is an investigator-initiated, randomised control trial with a non-inferiority design. 

Question 3 : What are the main outcomes presented at LINC 2020? 

So today we presented the primary endpoints with respect to safety and efficacy. For the efficacy outcome, we looked at primary patency through 12 months. And actually we had a really excellent primary patency rate for both devices over 80% and the non-inferiority endpoint both met for efficacy. Safety was freedom from major adverse events at 12 months and also here the primary non-inferiority endpoint was met. 

Question 4 : How should these findings be interpreted?

Well, this is actually the first head-to-head comparison of two drug-coated balloons in the field. So far, we only could rely on metre analysis making indirect comparisons between the devices. And interestingly enough, they actually suggested a better efficacy of a higher drug dose. Though I think it's really important that this is a head-to-head comparison showing comparable effectiveness and safety of two drug-coated balloons. 

Question 5 : What future research is required for this class of DCB?

Well, of course we are all aware of the mortality signal and I am not going to tackle this one. I think what we need for devices in general is really head-to-head comparisons so to go for comparative effectiveness. And of course, to follow up our patients for a longer time periods. So, also in the compare trial, we are actually performing a 5-year followup for safety events.