MagicTouch sirolimus-coated balloons are non-inferior for both safety and efficacy endpoints compared to paclitaxel-coated balloons, reports new SIRONA trial data in patients with femoropopliteal artery disease. Head-to-head data from the SIRONA study were presented by Ulf Teichgräber, MD, from the University Hospital Jena, Germany, and Friedrich-Schiller-University Jena, Germany, at the Transcatheter Cardiovascular Technologies (TCT) 2024 meeting in Washington, DC, on Tuesday. Speaking in a late-breaking trial session at TCT, Teichgräber noted that while sirolimus drug-coated balloons (DCB) have demonstrated promise as an alternative drug eluting device to existing paclitaxel coated balloon platforms for the treatment of peripheral arterial disease (PAD), whether sirolimus DCBs have advantages over paclitaxel DCB in a direct comparison of peripheral arterial disease patients remains unknown. “This head-to-head comparison of sirolimus-coated balloons with paclitaxel-coated balloons during angioplasty of the femoropopliteal artery shows comparable results between the two study groups,” said Teichgräber, in an accompanying press release. “Understanding the safety and efficacy of these two types of balloons, especially compared to one another, can help provide the best patient care possible.” The study was funded by Concept Medical Inc, manufacturers of the MagicTouch sirolimus-coated balloon Study details The SIRONA study is a prospective, randomized controlled, multi-center, non-inferiority trial comparing sirolimus- with paclitaxel- coated balloon angioplasty in the femoropopliteal artery. The trial enrolled a total of 482 participants with Rutherford category 2 to 4 femoropopliteal artery disease at 25 clinical sites in Germany and Austria. Patients were randomized 1:1 to receive angioplasty with either a sirolimus-coated balloon (n=241) or a paclitaxel-coated balloon (n=241). Teichgräber noted that the primary efficacy endpoint was primary patency, defined as peak systolic velocity ratio (PSVR) of less than 2.4 and no target lesion revascularisation (TLR) at 12 months, while the primary safety endpoint was a composite of clinically driven target vessel revascularization (TVR) major target limb amputation, and device- or procedure-related death. The rate of the primary efficacy endpoint of primary patency at 12 months was 73.8% in the sirolimus DCB group compared with 75.0% in the paclitaxel DCB group, with a rate difference of -1.2% (-9.7% to 7.4%, p=0.022, non-inferiority), said Dr. Teichgräber in the press release. The rate of the composite primary safety outcome at 12 months of clinically driven target vessel revascularization (cdTVR), major amputation, or death was 9.4% in the sirolimus DCB versus 7.3% in the paclitaxel DCB, with a between-group difference of 2.1% (95% confidence interval [CI]: -3.2% to 7.5%, p=0.003, non-inferiority), he added. Furthermore, functional outcomes were similar between the two groups, said Teichgräber, noting that change from baseline was 2.0 for the sirolimus DCB group and 2.2 for the paclitaxel DCB (95% CI: 0.1 (-0.1 to 0.4), p = 0.19), while clinical improvement of at least one grade in the Rutherford category was achieved in 88.9% of patients in the sirolimus DCB and 88.7% of patients in the paclitaxel DCB (p = 0.19). Image Caption: Ulf Teichgräber, MD, speaks during a news conference Tuesday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC. Image Credit: Bailey G. Salimes/CRTonline.org