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A Novel Sirolimus-Coated Balloon for Treatment of PAD
Quick Takes
- A novel sirolimus-coated balloon was tested in patients with femoropopliteal PAD.
- Use of this novel balloon was associated with a high level of efficacy, with 12-month patency in 87.9% of patients and improved ABI.
- The rate of major adverse events was low (6.7%), driven by five deaths unrelated to device or procedure.
Study Questions:
What is the safety and efficacy of the SELUTION SLR sirolimus-coated balloon (SCB) when used to treat mild and moderate femoropopliteal lesions in a Japanese population?
Methods:
The authors conducted a multicenter, prospective, single-arm study (SELUTION SFA JAPAN), which enrolled 134 patients with femoropopliteal peripheral artery disease (PAD). Independent adjudication was performed by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as a peak systolic velocity ratio ≥2.5 by duplex ultrasound or target lesion revascularization for ≥50% restenosis with worsening symptoms. All patients were treated with aspirin and a P2Y12 inhibitor started pre-intervention and continued for ≥1-month post-intervention.
Results:
Between July 2020 and September 2021, 134 patients enrolled in the study (mean age 73.8 ± 6.9 years, 81.3% male). Mean baseline ankle-brachial index (ABI) was 0.73 ± 0.16 and 60.2% had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusion, and 47.8% involved the popliteal artery. Follow-up at 12 months was completed for 94.8% of patients with a patency rate of 87.9%, and freedom from clinically driven target lesion revascularization was 97.0% by Kaplan-Meier estimate. The rate of major adverse events was 6.7%, driven by four target lesion revascularizations and five deaths, none of which were related to device or procedure. Mean ABI improved from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days and was sustained through 12 months (0.94 ± 0.13).
Conclusions:
The authors conclude that the novel SELUTION SCB is a safe and effective treatment option for femoropopliteal disease in symptomatic patients.
Perspective:
Paclitaxel-coated balloons have become standard of care for patients with femoropopliteal disease due to their high level of patency and low target lesion revascularization needs compared to noncoated balloon angioplasty. Sirolimus is a promising alternative to paclitaxel that may have a larger safety and therapeutic margin along with anti-inflammatory properties. This single-arm study of a novel SCB for femoropopliteal PAD demonstrated a high efficacy and reassuring safety profile for the use of this novel drug-coated balloon. Future studies will need to be conducted in a more diverse population before this novel balloon is ready for clinical use broadly.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Interventions and Vascular Medicine
Keywords: Peripheral Arterial Disease, Angioplasty, Balloon
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