Dr Michael Lichtenberg (Vascular Centre Clinic Arnsberg, Arnsberg, DE) discusses the latest findings from the Prestige Pilot study.

 

Prestige Pilot investigates if a lesion preparation strategy with Phoenix® atherectomy before DCB (drug coated balloon) usage in patients with PAD (peripheral artery disease) Rutherford Stage 4-5 and mild/moderate/severe calcium can improve outcomes including patency and limb salvage and evaluate safety and performance of the combination therapy.

 

Questions

1. What clinical scenarios in infrapopliteal disease would you recommend using atherectomy + DCB?

2. Can you describe the study design and inclusion criteria for this study?

3. What is the data that you are presenting at LINC 2020?

4. What conclusions can be made as a result of the data from this study?

5. What further research is required?

 

Filmed on location at the Leipzig Interventional Course 2020. 

 

Interviewer: David Ramsey

Videographer: Natascha Wienand

 

Transcript Below :

Question 1 : What clinical scenarios in infrapopliteal disease would you recommend using atherectomy + DCB?

So below the knee we are facing a lot of challenges. Patients with critical limb ischemia were showing up have a lot of calcification within the vessels. So we definitely need to discuss how to treat calcified long lesions and definitely achieve a good lumen gain. Lumen gain is important for clinical improvement and therefore atherectomy is a very good option. And we analysed a combination therapy of IVUS plus atherectomy and then followed by drug-coated balloon for these particular patients with BTK disease in critical limb ischemia. 

Question 2 : Can you describe the study design and inclusion criteria for this study?

So the study design is a prospective multicenter single arm study including 75 patients. Only including patients with Rutherford four and five situations. So we want to see the worst of the worst patients. Inclusion criteria are definitely solid BTK problems so that we can learn how this combination therapy IVUS guided atherectomy plus DCB works in these patients. 

Question 3 : What is the data that you are presenting at LINC 2020?

We had the first glimpse at our data analysing 35 patients and we showed the technical success of the combination therapy using atherectomy IVUS guided plus DCB. So what we found out, as this study was co-lab adjudicated, that angiography didn't show us the real lumen diameter. So the reference vessel diameter was significantly different on IVUS to angio. And having said that we decided in all the cases then on IVUS the size of the balloon, the DCB balloon. And we hopefully then want to see that the lumen gain and respective the clinical outcome in these patients based on this IVUS guided balloon diameter decision then helps to improve the clinical outcome in these patients. 

Question 4 : What conclusions can be made as a result of the data from this study?

So far with this very interim data I can say IVUS guidance is helpful. Because it gives you much more information than angio. It gives you more information about the lesion. It gives you more about information about dissection post angioplasty. It gives you more information if persistent restenotic problems are still there and need to be treated. This is a pilot study. So the next step would be after that study definitely to do a randomised trial, IVUS guided therapy versus angio guided therapy. 

Question 5 : What further research is required?

So this can clearly then work out in endpoints, clinical outcome endpoints, if IVUS is a real definitely helpful tool to treat your outpatients.