LINC 2020: IN.PACT Global Study: 150mm Cohort

Published: 31 Jan 2020

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Prof Marianne Brodmann (Medical University of Graz, Graz, AT) discusses the IN.PACT Global Study 150mm cohort outcomes from the last 3 years.
This study examined the safety and efficacy of the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in the treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries. 
1. What was the IN.PACT global study?
2. Why was this cohort study needed and why look at the 150mm patients?
3. What were your findings?
4. What conclusions can be made from this data?
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 was the IN.PACT global study?

The IN.PACT Global Study was a real world registry with the IN.PACT Admiral balloon DCB test to gain rigorous data on a real world population cohort with peripheral arterial disease. That was the aim with global study. 

Question 2 : Why was this cohort study needed and why look at the 150mm patients?

We wanted to look at real world patients with all kind of lesions. This could be included in the global study, and there were predefined sub-cohorts, like the in-stent restenosis cohort, a CTO cohort and a long lesion cohort, and then as an add-on, there was also a 150 millimetre DCB cohort showing the safety and efficacy profile of this long impact Admiral balloon in more than 100 patients. 

Question 3 : What were your findings?

The findings were phenomenal with regard to efficacy, so high efficacy target lesion, and now I was able to present the three-year data here at LINC, and the outcome was the same as of the total IN.PACT Global Study, or comparable, with regard to patency and clinically target lesion revascularization at three years. Also, we were treating a much more complex cohort with this long balloon, and once again, if you have a very long paclitaxel coated balloon, this is a 150 millimetre, you have concerns about safety, and we didn't see that. So, no safety issues. 

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

The conclusions are that even if you use long, high-dose paclitaxel coated balloon, you have a high safety profile with regard to mortality and serious adverse events, and major adverse events, and you have a high efficacy and you do not see any procedural complications, even with a long DCB paclitaxel coated balloon. 

Question 5 : What further research is required?

Maybe we can go with this kind of long balloons to other vessel areas and see how they perform there, so this might be something which might be needed in the future.