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ISET 24: TOBA II BTK: Sub-Analysis Shows Tack Repair Performs Well in Complex Lesions

Published: 02 Feb 2024

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ISET 24 - Dr Marianne Brodmann (Medical University of Graz, AT) joins us to discuss the findings of a sub-analysis of the TOBA II BTK Study (NCT02942966), which aimed to analyse the safety and effectiveness of Tack repair in complex lesions.

After treatment for artery dissections, patients were included in the TOBA II BTK trial. 233 patients were enrolled in the trial, where 169 had complex lesions, including 111 CTOs, 57 with a lesion length greater or equal to 115mm and 86 with moderate to severe calcification. Results from the sub-analysis were comparable to those from the whole cohort. This data reinforces the notion that Tack repair works, even in patients with more complex lesions, whether they are chronic total occlusions (CTOs), long, or calcified.

Questions:

  1. What are the current treatment options for patients with peripheral arterial disease, and what are the unmet needs?
  2. What was the study design and patient population for this sub-analysis?
  3. What were the key findings from the sub-analysis revealed at ISET 24?
  4. What further study is still required?

Recorded remotely from Graz, 2024.

Editor: Jordan Rance
Video Specialist: Dan Brent

Transcript

"I'm Marianne Brodmann from the medical university in Graz, Austria and I'm the head of the division of angiology.

Current Treatment Options for Patients with Peripheral Artery Disease and Unmet Needs

The current treatment options for patients with PAD with regard to the endovascular approach is for sure an adequate vessel preparation, very often still done with POBA or specialty balloons, atherectomies, especially in Europe, also getting a little bit it more into the field and then the final treatment is drug-eluting balloon or drug-eluting stents.

And the unmet needs are, even if we use stents and I think this is very, very important to know, even if you use stents, we have then at the end of the day, at a certain point some kind of in-stent restenosis issues and that is really causing us problems. And therefore the unmet need is what kind of mechanical treatment, if we have dissections, if we have long lesions with acute recall, we should apply, and I think this is for sure a very unmet need in the endovascular space in PAD, not to know what kind of mechanical solution we should apply to our patients.

Study Design and Patient Population

But TOBA II BTK was that we included patients with dissections only. So after treatment of the patients and if they had dissections then they were included in the TOBA II BTK study, because this tool, the tack system, is a dissection sealing system. So therefore only dissected arteries were included into the study.

And with regard to the sub-analysis, we have data so far for the whole cohort and I think it's very important to know if these tiny metal implants are also able to solve the issues with regard to this section in complex patient cohorts like long lesions, calcified lesions, CTOs. So this was the reasons for the sub-analysis.

Key Findings

The key findings are that tack is also useful and helping solving dissections in complex lesions and is working there as well as in the whole cohort. So not only in simple short lesions, but also in complex lesions, what we are seeing more and more in daily practice.

Further Study

What further studies required with regard to the tack system, maybe to have a randomised controlled study of just using DCB compared to DCB plus tack and see if the outcome is better with tack system. So this could be an idea, in my opinion.”

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