Comparison of Sirolimus- vs Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Artery Disease: The SIRONA Randomized Noninferiority Trial.

BACKGROUND

Paclitaxel-coated balloon (PCB) angioplasty is effective for femoropopliteal interventions. However, the increased mortality risk associated with PCB has not yet been cleared, and alternative antiproliferative drugs may offer additional advantages.

OBJECTIVES

The authors aimed to investigate whether sirolimus-coated balloon (SCB) angioplasty achieves noninferior primary vessel patency and clinical efficacy and safety compared with PCB angioplasty.

METHODS

SIRONA is a multicenter randomized, controlled, noninferiority trial comparing SCB with PCB angioplasty in patients with symptomatic femoropopliteal artery disease. The study was conducted at 25 centers in Germany and Austria. Patients aged 18 years or older with a single target lesion were randomized 1:1 using permuted blocks, stratified by center. Participants and outcome assessors were masked to allocation. Primary endpoints were primary patency and the composite clinical endpoint of freedom from clinically driven target vessel revascularization, major target limb amputation, and device- or procedure-related death at 12 months based on available case intention-to-treat analysis. Prespecified noninferiority margins were 10%. Long-term follow-up is ongoing.

RESULTS

Between April 21, 2021, and September 23, 2022, 482 patients were assigned to SCB (n = 238) or PCB (n = 244) groups. The mean age was 68.0 ± 8.9 years; 311 participants (64.5%) were male; and 464 participants (96.3%) presented with intermittent claudication. Mean lesion length was 8.4 ± 6.1 cm and 160 lesions (33.2%) were chronic total occlusions. Primary patency was achieved in 150 of 203 participants (73.9%) with SCBs and in 149 of 199 participants (74.9%) with PCBs (risk difference: -1.0%; 95% CI: -9.6% to 7.6%; Pnoninferiority = 0.019). However, sensitivity analyses revealed that noninferiority was achieved but statistically not robust. The primary clinical endpoint was achieved in 199 of 220 participants (90.5%) with SCBs and in 202 of 218 participants (92.7%) with PCBs (risk difference: -2.2% (95% CI: -7.7% to 3.2%.); Pnoninferiority = 0.003). These results were confirmed by sensitivity analyses.

CONCLUSIONS

Among patients with femoropopliteal artery disease, SCBs demonstrated noninferior clinical important outcomes and comparable improvement in vascular quality of life compared with PCBs. Although the noninferiority of primary patency was not statistically robust, this suggests that SCBs may be a valuable alternative to PCBs. (Sirolimus- vs Paclitaxel-Drug Coated Balloons in Patients With Peripheral Artery Disease [SIRONA]; NCT04475783]; Head-to-Head Comparison of Sirolimus vs Paclitaxel Drug-Eluting Balloon Angioplasty in the Femoropopliteal Artery [SIRONA]; DRKS00022452).