Treatment of Calcified Femoro-Popliteal Lesions Using Jetstream ® Atherectomy Device and Ranger ® Drug–Coated Balloon Without Embolic Protection Device: 12-Month Results of the Ellipse Multicenter Study

Abstract

Introduction:

Endovascular treatment of complex femoro-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 (DCB) has been proposed as an alternative option. However, few reports have published midterm 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 Trans-Atlantic Inter-Society Consensus (TASC) B and C femoro-popliteal lesions using JetStream^® rotational plus aspiration atherectomy device and Ranger^® DCB (Boston Scientific, Marlborough, MA, USA).

Methods:

Between March 2020 and December 2021, consecutive patients from 8 centers, with de novo and calcified TASC B and C lesions of superficial femoral artery and/or above-knee popliteal arteries were included. Intra-stent restenosis and recent (<1 month) occlusions were excluded. All patients had disabling intermittent claudication (Rutherford class 2 and 3). Procedure was 2 steps: atherectomy using Jetstream and postdilatation using drug-coated Ranger balloon. No embolic protection device was used. Patients who had target lesion stenting were excluded.

Results:

Fifty-eight patients signed informed consent and underwent the procedure. Two patients underwent stenting of the target lesion. Two had failure to cross the lesion. Fifty-four 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. Forty-seven 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).

Conclusion:

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

Clinical Impact

The Ellipse study was a multicenter prospective observational trial on the treatment of calcified TASC B and C lesions using Jetstream atherectomy and Ranger drug-coated balloon with no embolic protection. This technique resulted in 93% technical success and no distal embolization. Twelve-month freedom from target lesion revascularization, primary and secondary patency were, respectively, 96% ± 3%, 94% ± 4%, and 98% ± 2%. Rotational atherectomy plus drug coated balloon is a safe and effective treatment of complex calcified femoro-popliteal lesions. Embolic protection might not be necessary in selected patients, when lesions at high risk of distal embolization are excluded.