MagicTouch PTA Sirolimus-Coated Balloon for Femoropopliteal and Below-the-Knee Disease: 3-Year Outcomes of the XTOSI Trial.

Autor:	Choke ETC; Vascular and Endovascular Surgery Service, Department of General Surgery, Sengkang General Hospital, Singapore. Electronic address: tcchoke@hotmail.com., Peh EYL; Vascular and Endovascular Surgery Service, Department of General Surgery, Sengkang General Hospital, Singapore., Tang TY; Vascular and Endovascular Surgery Service, Department of General Surgery, Sengkang General Hospital, Singapore., Cheng SC; Vascular and Endovascular Surgery Service, Department of General Surgery, Sengkang General Hospital, Singapore., Tay JS; Vascular and Endovascular Surgery Service, Department of General Surgery, Sengkang General Hospital, Singapore., Aw DKL; Vascular and Endovascular Surgery Service, Department of General Surgery, Sengkang General Hospital, Singapore., Vijaykumar K; Vascular and Endovascular Surgery Service, Department of General Surgery, Sengkang General Hospital, Singapore.
Jazyk:	angličtina
Zdroj:	Annals of vascular surgery [Ann Vasc Surg] 2024 Sep; Vol. 106, pp. 8-15. Date of Electronic Publication: 2024 Apr 03.
DOI:	10.1016/j.avsg.2023.12.096
Abstrakt:	Background: Sirolimus-coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). There are currently no long-term clinical data for this novel treatment for PAD. We present the 3-year results of the first-in-human study of MagicTouch PTA SCB for treatment of PAD for both femoropopliteal and below-the-knee arteries. Methods: The XTOSI pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAD. Assessments through 3 years included freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, amputation-free survival (AFS), overall survival, and ulcer-free status. Results: At 3 years, the overall freedom from CD-TLR was 84.4%, freedom from major amputation was 86.1%, AFS was 63.3%, overall survival was 63.3%, and ulcer-free status in remaining survivors with intact limbs was 100%. For femoropopliteal lesions, at 3 years, the freedom from CD-TLR was 92.9%, freedom from major amputation was 93.3%, AFS was 70%, and overall survival was 70%. For below-the-knee lesions, at 3 years, the freedom from CD-TLR was 77.8%, freedom from major amputation was 81.0%, AFS was 58.6%, and overall survival was 58.6%. Conclusions: SCB in the XTOSI pilot study showed promising clinical results sustained to 3 years, and no long-term safety concerns were raised. Randomized trials are currently ongoing to investigate the safety and efficacy of SCB for treatment of PAD. (Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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