Aortic & peripheral vascular disease
A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions: The SELUTION SFA Japan Trial
Authors' conclusion
The SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.
Study context
- Population
- Japanese patients with mild-to-moderate femoropopliteal disease127 (94.8%) with 12-month data
- Participants
- 134 patients
- Exposure
- SELUTION SLR sirolimus-coated balloons (SCB) vs prespecified performance goal of 60%
- SELUTION SLR SCBn = 134
- Outcome
- Primary patency (peak systolic velocity ratio ≥2.5 by duplex ultrasound) vs performance goal of 60%
- Follow-up
- 12 months
Methodological detailsmulticentre, independent imaging core laboratory and clinical events committee adjudication
- Multicentre
- Independent imaging core laboratory and clinical events committee adjudication
Main finding
As reported in the abstract
12-month primary patency (PSVR ≥2.5 by duplex ultrasound)
12-month primary patency rate
87.9%
Observational data: associations, not effects.
Further findings
Freedom from clinically driven target lesion revascularization (CD-TLR) · 12 months
- Freedom from CD-TLR (Kaplan-Meier estimate)
- 97.0%
Ankle-brachial index
- Baseline (mean ± SD)
- 0.73 ± 0.16
- 30 days postprocedure (mean ± SD)
- 0.96 ± 0.14
- 12 months (mean ± SD)
- 0.94 ± 0.13
- Improved significantly from baseline, sustained through 12 months
Safety
- Major adverse event rate
- 6.7%
- CD-TLRs
- 4
- Deaths (none related to device or procedure)
- 5
Original publication
A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions: The SELUTION SFA Japan Trial. JACC Cardiovasc Interv. Published 5 June 2024. doi:10.
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