Ulf Teichgräber, Maja Ingwersen, Thomas Lehmann, Stephanie Platzer, Ina Kunstmann, Sabine Steiner, Andrej Schmidt, Tim Wittig, Thomas Zeller, Marcus Thieme, Hans Krankenberg, Martin Werner, Marianne Brodmann, Nasser Malyar, Stefan Müller-Hülsbeck, Luca de Paoli, Oliver Schlager, Martin Austermann, Gunnar Tepe, Christian Erbel, Wulf Ito, Rainer Waßmer, Lars Maiwald, René Aschenbach, Christian Wissgott, Martin Andrassy, Florian Wolf, Ulrich Beschorner, Maciej Pech, Konstantinos Katsanos, Dierk Scheinert, SIRONA Trial Investigators
SCB angioplasty resulted in sustained patient-reported and clinical outcomes comparable to PCB angioplasty through 2 years, with similar patency, revascularization, and safety.
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.