LINC 2020: Stellarex® in the Real-World

Published: 05 Feb 2020

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Dr Konstantinos Stavroulakis (St. Franziskus Hospital GmbH, Münster, DE) discusses the Stellarex® drug-coated angioplasty balloon device for below-the-knee (BTK) and the latest data from its real-world application study, SAVER.
1. Please tell us about the Stellarex® device and the study for the BTK cohort?
2. What was the design of the study? How many patients were enrolled and what were the endpoints?
3. What did the results show? 
4. Were there any safety issues?
5. What conclusions can be made from this data?
Filmed on location at the Leipzig Interventional Course 2020. 
Interviewer: Ashlynne Merrifield
Videographer: Natascha Wienand

Transcript Below :

Question 1 : Please tell us about the Stellarex® device and the study for the BTK cohort?

So the Stellarex is a drug-coated balloon aimed to deliver low-dose Paclitaxel, just two micrograms, and has hybrid Paclitaxel coating, with the same time has the effect that you can deliver the drug on the vessel wall to achieve an effectiveness and on the same time, you don't have a problem with the distal embolization. Up to now, it was evaluated in a number of clinical studies, pivotal trials, and so on. 

Question 2 : What was the design of the study? How many patients were enrolled and what were the endpoints?

Now we evaluate the data of the SAVER registry which evaluated enrolled patients with a fem-pop disease below the knee both closed accounts and Cl TI patients from R alpha plus 2 to R alpha plus 6 the SAVER in stream it evaluated as I said the Stellarex performance both include the constancy LTI patients aim of the registry is to recruit more than 2,000 patients up to now there are thousand seven hundred enrolled in the BTK cohort after now have 97 patients and we have the first interim analysis of the first patients with six months follow up in the clothed accounts of course the endpoint would be to evaluate the efficacy of the balloon in 12 months and the BTK in six months aiming to evaluate the rates of clinical driven TL are also we have an analysis of safety and points concerning mortality and amputation rates and so on like in every CLTI and cloud can study. 

Question 3 : What did the results show?

A very important finding in this in the shaver industry is that at least almost 65% of the patient had at least one very severe factor affecting in general population the performance and vascular therapy meaning CTO's long lesions there were diabetics or severely calcification one of the main findings for the cohort above-the-knee disease is that have a very good results both in challenging lesions and in the overall cohort secondly we have great results in Severely calcified lesions with no difference between a non-severely calcified and severely calcified lesions and especially for the BTK lesions who have very promising CTLR rate of less than 6% in six months. 

Question 4 : Were there any safety issues?

Well when you evaluate the BTK study most of times you are we are concerned about the problem of distal embolization local complication amputation rates we didn't have any issues of course there the first interim analysis would have to evaluate the overall BTK cohort when the follow-up will be completed after now we didn't have any unexpected complications and the mortality issue wasn't a problem at least in the BTK cohort. 

Question 4 : What conclusions can be made from this data?

I think that most of the physicians are reluctant to use an antinustorotic therapy before below-the-knee disease now we know that some studies failed last years because of inappropriate vessel preparation insufficient sizing and so on I think that Stellarex it's a safe device or at least the data that we now have show us it's a safe device to use and because of the combined coating with practicex we don't have big issues with distal embolization actually we didn't find any distal embolization in the BTK cohort in this in our analysis until now I think that the development of new vessel prep modalities for the BTK lesions in combination with the Stellarex balloon might help us to really treat this challenging cohort of patients with very good results and save limbs and accordingly lives