TCT Conference 2024 - Safety and efficacy outcomes of the trial shows that percutaneous transluminal angioplasty (PTA) with the sirolimus drug coated balloon (DCB) in patients with femoropopliteal artery disease was/was not noninferior to PTA with the paclitaxel DCB.

Prof Ulf Teichgräber joins us onsite at TCT Conference to discuss the findings from the sirolimus- vs. paclitaxel-coated balloon angioplasty trial (NCT04475783).

Prof Teichgräber discusses an interventional, multi-center, 1:1 randomized non-inferiority trial investigating the use of the sirolimus DCB (MagicTouch) for PTA in patients with femoropopliteal artery disease. 478 patients were enrolled in the trial and were followed-up one year after study procedure and through 12 months post-procedure. The primary outcome measures were patency rates defined as absence of clinically driven target lesion revascularization and composite of freedom from device and procedure-related death.

Findings showed that the head-to-head comparison of sirolimus drug-coated balloons with paclitaxel drug-coated balloons showed comparable results between study groups, with the primary patency of sirolimus DCB noninferor to the paclitaxel DCBs. There was no significant difference between groups in freedom from cdTLR. 

Interview Questions:
1. What is the reasoning behind the trial?
2. What was the study design and patient population?
3. What were the key findings?
4. What are your take-home messages?
5. What further research is needed, and what are the next steps?

Recorded at TCT Conference in Washington, 2024.

Editors: Yazmin Sadik, Jordan Rance
Videographers: David Ben-Harosh, Oliver Miles

Support: This is an independent interview produced by Radcliffe Vascular.