Post Hoc Analysis of SIRONA Randomized Trial Compares Sirolimus and Paclitaxel DCBs

November 5, 2024—A post hoc analysis of the SIRONA trial investigated how sirolimus-coated balloon angioplasty compares to various paclitaxel drug-coated balloon (DCB) types.

Ulf Teichgräber, MD, presented the findings from the analysis in the third late-breaking clinical trials session at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

According to the VIVA24 press release, the multicenter, randomized SIRONA trial provided a head-to-head comparison of sirolimus and paclitaxel DCB angioplasty for femoropopliteal lesions. However, the efficacy of paclitaxel DCB types varies considerably between vendors. Therefore, the purpose of this post hoc analysis was to determine whether the effectiveness of a sirolimus DCB (MagicTouch, Concept Medical) (n = 241) was dependent on the type of paclitaxel DCB used as a control.

As summarized in the VIVA24 press release, the study enrolled 482 participants with Rutherford category 2 to 4 femoropopliteal artery disease. The mean lesion length was 84 ± 61 mm; 34% of lesions were totally occluded and 28% were severely calcified. The main subcontrol groups considered were Luminor 35 (iVascular) (n = 84), Lutonix (BD Interventional) (n = 46), Ranger (Boston Scientific Corporation) (n = 36), and In.Pact Admiral (Medtronic) (n = 36).

The primary efficacy endpoint was noninferiority in 12-month primary patency of sirolimus versus paclitaxel DCB and was met: 73.8% versus 75% (rate difference of -1.2%; 95% CI, -9.97% to 7.4%; P = .022). The odds ratio for binary restenosis did not differ significantly between study groups, regardless of the type of paclitaxel DCB used.

There was no significant difference in 12-month freedom from clinically driven target lesion revascularization between sirolimus and paclitaxel DCB, regardless of the paclitaxel DCB used. The primary composite safety noninferiority endpoint for the sirolimus DCB was met.

Given that sirolimus has a wider therapeutic window than paclitaxel, it may serve as a welcome alternative for femoropopliteal DCB angioplasty, the study concluded in the VIVA24 press release.