IFT09 - Treatment of complex femoro-popliteal lesions using Jetstream atherectomy device and Ranger drug coated balloon without embolic protection: 12-month results of the ELLIPSE multicenter study.

Objectives: Endovascular treatment of complex femora-popliteal lesions using plain angioplasty balloon and bare stents carries a high incidence of in-stent restenosis. Debulking using atherectomy device followed by angioplasty with drug coated balloon has been proposed as an alternative option. However, few reports have published mid-term outcomes, and were focused on large inclusion criteria.
The aim of this multicenter study was to report 12-month freedom from target lesion revascularization (TLR) following treatment of TASC C femoro-popliteal lesions using JetStream rotational plus aspiration atherectomy device and Ranger drug coated balloon (Boston Scientific, Marlborough, MA).

Methods: Between March 2020 and December 2021, consecutive patients from 8 centers, with de novo calcified TASC B and C lesions of superficial femoral and/or above-knee popliteal arteries were included. Intra-stent restenosis and recent (less than one month) occlusions were excluded. All patients had disabling intermittent claudication (Rutherford class 2 and 3).
Procedure was two steps: atherectomy using Jetstream and post-dilatation using drug coated Ranger balloon. No embolic protection device was used. Patients who had target lesion stenting were excluded.

Results: 58 patients signed informed consent and underwent the procedure. Two patients underwent stenting of the target lesion. Two had failure to cross the lesion. 54 patients had the full procedure (technical success 93% (54/58)). Postoperative course was uneventful in all patients and no embolic event was observed. During follow-up, 2 patients died and 5 were lost to follow-up. 47 patients had complete 12 months clinical and duplex follow-up.
Two patients had target lesion restenosis respectively at 3 and 9 months, which were treated by balloon angioplasty. Kaplan-Meier 12-month freedom from TLR was 96% +- 3% (95% confidence interval 0.9-1).

Conclusions: Treatment of complex femoro-popliteal lesions using rotational atherectomy and drug coated balloon without embolic protection was safe and effective, with high technical success rate, no postoperative embolic events and satisfactory 12-month freedom from TLR.