TCT 24: SIRONA: Sirolimus- vs. Paclitaxel-Coated Balloon Angioplasty in the Femoropopliteal Artery
TCT Conference 2024 - Safety and efficacy outcomes show that percutaneous transluminal angioplasty (PTA) with the sirolimus drug coated balloon (DCB) in patients with femoropopliteal artery disease was noninferior to PTA with the paclitaxel DCB.
Prof Ulf Teichgräber joins us onsite at TCT Conference to discuss the findings from the SIRONA 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.
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