SELUTION Sirolimus-coated balloons safe and effective treatment for femoropopliteal disease in symptomatic patients, unravels research

FP lesions, which affect the femoral and popliteal arteries, are a significant concern in vascular disease management. Traditional treatments like angioplasty have variable success rates, and innovative approaches are needed to improve patient outcomes. The SELUTION SLR SCB uses proprietary microreservoir technology combining sirolimus and biodegradable polymer, potentially offering better results for FP disease treatment.

The objective of the SELUTION SFA JAPAN study was to evaluate the safety and efficacy of the SELUTION SLR SCB in treating mild-to-moderate FP disease in a Japanese population. This multicenter, prospective, single-arm study enrolled 134 patients with FP disease. An imaging core laboratory and clinical events committee independently adjudicated the trial. The primary endpoint was 12-month primary patency, defined as a peak systolic velocity ratio of ≥2.5 by duplex ultrasound, compared against a prespecified performance goal of 60% based on established angioplasty data.

• The mean age of participants was 73.8 ± 6.9 years, and 60.3% had diabetes mellitus.

• The mean lesion length was 127.4 ± 59.7 mm; 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery.

• The 12-month primary patency rate was 87.9%.

• Freedom from Clinically Driven Target Lesion Revascularization (CD-TLR): The rate was 97.0% per Kaplan-Meier estimate.

• The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none related to the device or procedure.

• Ankle-Brachial Index (ABI): ABI improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days post-procedure, sustaining at 0.94 ± 0.13 through 12 months.

The SELUTION SFA JAPAN trial's findings are significant, indicating that the novel SELUTION SCB is both safe and effective for treating FP disease in symptomatic patients. The high primary patency rate of 87.9% and the low major adverse event rate of 6.7% underscore the potential of SCB as a superior treatment option. The substantial improvement in ABI further supports the effectiveness of this approach.

The SELUTION SFA JAPAN trial demonstrated that the SELUTION SLR SCB is a safe and effective treatment for FP disease in symptomatic patients. These results suggest that SCBs could be a valuable addition to the arsenal of treatments for vascular disease, offering hope for improved patient outcomes.

Reference:

Iida, O., Soga, Y., Saito, S., Mano, T., Hayakawa, N., Ichihashi, S., Kawasaki, D., Suzuki, K., Yamaoka, T., Fujihara, M., Nakama, T., Nakamura, M., Horie, K., Shah, T., Lansky, A., & Kozuki, A. (2024). A novel sirolimus-coated balloon for the treatment of femoropopliteal lesions. JACC. Cardiovascular Interventions. https://doi.org/10.1016/j.jcin.2024.03.029