CC BY 4.0 · The Arab Journal of Interventional Radiology 2024; 08(02): 070-077
DOI: 10.1055/s-0044-1782664
Original Article

Combined Treatment of Native Femoropopliteal Occlusions in Chronic Limb-Threatening Ischemia Using Atherectomy Debulking and a New Sirolimus Drug-Coated Balloon (SELUTION SLR)

Joseph Sumner
1   GKT School of Medical Education, King's College London, London, United Kingdom
,
Sajal Patel
2   Department of Interventional Radiology, Guy's and St. Thomas' Hospitals NHS Foundation Trust, London, United Kingdom
,
Iakovos Theodoulou
2   Department of Interventional Radiology, Guy's and St. Thomas' Hospitals NHS Foundation Trust, London, United Kingdom
3   Department of Radiology, Barts Health NHS Trust, London, United Kingdom
,
2   Department of Interventional Radiology, Guy's and St. Thomas' Hospitals NHS Foundation Trust, London, United Kingdom
,
Panos Gkoutzios
2   Department of Interventional Radiology, Guy's and St. Thomas' Hospitals NHS Foundation Trust, London, United Kingdom
,
Irfan Ahmed
2   Department of Interventional Radiology, Guy's and St. Thomas' Hospitals NHS Foundation Trust, London, United Kingdom
,
Athanasios Saratzis
4   National Institute for Health and Care Research Leicester Biomedical Research Centre, University of Leicester, Leicester, United Kingdom
,
Athanasios Diamantopoulos
2   Department of Interventional Radiology, Guy's and St. Thomas' Hospitals NHS Foundation Trust, London, United Kingdom
5   School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom
› Author Affiliations

Abstract

Objective The aim of this study was to report the primary outcomes of a pilot study investigating the safety and efficacy of sirolimus drug-coated balloons (SELUTION) for endovascular postatherectomy treatment of native occluded femoropopliteal lesions in patients with chronic limb-threatening ischemia (CLTI).

Materials and Methods This study analyzes a cohort of CLTI patients with femoropopliteal artery occlusions treated with combined rotational atherectomy and postatherectomy angioplasty using the SELUTION device. The primary outcome measures were amputation-free survival (AFS) defined as time to major limb (above ankle) amputation of the index leg or death from any cause. Secondary outcome measures included technical success, overall survival, major amputation of the index leg, major adverse limb event (MALE) defined as major amputation or any further major revascularization intervention of the treated segment during the follow-up period and primary patency at 12 months.

Results Between April 2021 and January 2022, nine patients (mean age: 64.0 ± 8.4, 66.7% male) with femoropopliteal occlusive lesions (mean lesion length: 141.1mm, range: 40–400) were treated with the above-combined approach. Technical success was 100%. At 12 months, the AFS was 88.9%, with one death and zero major amputations (88.9% survival and 100% limb salvage, respectively); only two patients (22.2%) suffered a MALE; primary patency was 75%. No adverse events related to the sirolimus drug-coated balloon nor to the atherectomy device were observed.

Conclusion Combining sirolimus drug-coated balloon and atherectomy for treatment of femoropopliteal occlusions in CLTI patients is a safe and effective approach achieving satisfactory patency and adverse event rates.



Publication History

Article published online:
19 April 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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