Dr Kenneth Ouriel (Syntactx, New York, NY, US) discusses the in depth independent safety analysis conducted by Syntactx (CRO) of the Lutonix® SFA drug coated balloon. 

 

Questions:

1. What were the main safety outcomes of the Lutonix® DCB?

2. Why was this study initiated and independent analysis required? 

3. What methods were used to conduct this safety analysis?

4. How should this data be used to ensure patient safety? 

5. What conclusion can be made from this data and what questions require further research?

 

Filmed on location at the Leipzig Interventional Course 2020. 

Interviewer: Ashlynne Merrifield

Videographer: Natascha Wienand

 

Transcript Below :

Question 1 : What were the main safety outcomes of the Lutonix® DCB?

[Ouriel ] The main outcome we looked at was death and the cause of death. It was adjudicated by an independent panel of key opinion leaders that included this time for the first time an oncologist who might be able to assess whether or not the death was related to Paclitaxel or not. 

Question 2 : Why was this study initiated and independent analysis required?

[Ouriel] The study was initiated after the meta analysis of Katsanos back in December of 2019, and the first time that these deaths were looked at they were adjudicated but no one had ever assumed that Paclitaxel might be related to death, and so almost by design they were said not to be related to Paclitaxel. Well, in the end that was correct, but it took another look at everything to make sure that deaths related to Paclitaxel weren't missed. 

Question 3 : What methods were used to conduct this safety analysis?

[Ouriel] So we looked at every death. We got source documents. We wrote narratives And then we used an electronic system to adjudicate these, determining for instance whether the death was related to Paclitaxel, whether it was related to the procedure, whether it was related to a device. And, as well, we looked at adverse events, serious adverse events, to see if maybe those might be related to Paclitaxel. 

Question 4 : How should this data be used to ensure patient safety?

[Ouriel] Well of course we were all worried that there might be some causative factor. There's an association maybe between patients that had drug coated balloons and mortality, but was it causation? And after this analysis we were all very sure that it was association but not causation. 

Question 5 : What conclusion can be made from this data and what questions require further research?

[Ouriel] Well I think the conclusion is that the drug coated balloons are safe. We knew they were effective. No one's ever questioned that. But we didn't know they were safe. Now we can say they're safe. What's going to be our plans going forward, well, we never figured out really why there is an association. It probably is related to trial design and we need to figure that out because there are going to be new trials for different things and we don't want to have the same flawed design. We think it's related to follow-up. And if we make sure that we have 100% or close to 100% follow-up on every patient, then I think we can avoid the problems we saw here with trial design.