2-Year Patient-Centered and Clinical Outcomes of Sirolimus- Versus Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Disease.
U, T., M, I., T, L., S, P., I, K., S, S., A, S., T, W., T, Z., & M, T. (2026). 2-Year Patient-Centered and Clinical Outcomes of Sirolimus- Versus Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Disease.. JACC. Cardiovascular interventions. https://doi.org/10.1016/j.jcin.2026.06.021
U T, M I, T L, S P, I K, S S, et al. 2-Year Patient-Centered and Clinical Outcomes of Sirolimus- Versus Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Disease.. JACC. Cardiovascular interventions. 2026; doi: 10.1016/j.jcin.2026.06.021
U T, M I, T L, et al. 2-Year Patient-Centered and Clinical Outcomes of Sirolimus- Versus Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Disease.[J]. JACC. Cardiovascular interventions. 2026. DOI: 10.1016/j.jcin.2026.06.021.
@article{u2026,
author = {Teichgräber U and Ingwersen M and Lehmann T and Platzer S and Kunstmann I and Steiner S and Schmidt A and Wittig T and Zeller T and Thieme M},
title = {2-Year Patient-Centered and Clinical Outcomes of Sirolimus- Versus Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Disease.},
journal = {JACC. Cardiovascular interventions},
year = {2026},
doi = {10.1016/j.jcin.2026.06.021},
note = {PMID: 42637297},
}
TY - JOUR AU - Teichgräber U AU - Ingwersen M AU - Lehmann T AU - Platzer S AU - Kunstmann I AU - Steiner S AU - Schmidt A AU - Wittig T AU - Zeller T AU - Thieme M TI - 2-Year Patient-Centered and Clinical Outcomes of Sirolimus- Versus Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Disease. T2 - JACC. Cardiovascular interventions PY - 2026 DO - 10.1016/j.jcin.2026.06.021 AN - PMID:42637297 ER -
BACKGROUND: Drug-coated balloons improve outcomes after femoropopliteal angioplasty, but concerns regarding the long-term safety of paclitaxel-coated devices have prompted interest in alternative antiproliferative strategies. OBJECTIVES: This study sought to evaluate the 2-year patient-centered and clinical outcomes of sirolimus-coated balloon (SCB) versus paclitaxel-coated balloon (PCB) angioplasty. METHODS: SIRONA was a prospective, multicenter, randomized, controlled, noninferiority trial comparing SCB with PCB angioplasty in patients with femoropopliteal artery disease (96.5% intermittent claudication). The present analysis reports prespecified outcomes at 2 years. Effectiveness endpoints included patient-reported outcomes (VascuQol, clinical improvement, and EQ-5D-3L), primary patency, and freedom from clinically driven target lesion revascularization. Safety endpoints included major amputation and all-cause mortality. Longer-term follow-up is ongoing to assess durability and safety up to 5 years. RESULTS: A total of 482 patients was randomized (SCB: n = 238; PCB: n = 244). Improvements in vascular quality of life were sustained through 2 years and were similar between groups (between-group difference: 0.05, 95% CI: -0.15 to 0.24; P = 0.63). Clinical improvement (≥1 Rutherford category) occurred in 88% of the SCB group and 89% of the PCB group (P = 0.89). Kaplan-Meier estimates of primary patency were 64.6% for SCB and 67.2% for PCB (log-rank P = 0.34). Freedom from clinically driven target lesion revascularization was 91.2% for SCB and 88.1% for PCB (log-rank P = 0.42). Major amputation was rare (0.4% in both groups). All-cause mortality occurred in 6.3% and 3.7%, respectively (P = 0.21), with no device- or procedure-related deaths. CONCLUSIONS: SCB angioplasty resulted in sustained patient-reported and clinical outcomes comparable to PCB angioplasty through 2 years, with similar patency, revascularization, and safety.