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

Edward Tieng Chek Choke; Eilane Yi Ling Peh; Tjun Yip Tang; Shin Chuen Cheng; Jia Sheng Tay; Darius Kang Lie Aw; Kalpana Vijaykumar

doi:10.1016/j.avsg.2023.12.096

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

Ann Vasc Surg. 2024 Apr 3:106:8-15. doi: 10.1016/j.avsg.2023.12.096. Online ahead of print.

Authors

Edward Tieng Chek Choke¹, Eilane Yi Ling Peh², Tjun Yip Tang², Shin Chuen Cheng², Jia Sheng Tay², Darius Kang Lie Aw², Kalpana Vijaykumar²

Affiliations

¹ Vascular and Endovascular Surgery Service, Department of General Surgery, Sengkang General Hospital, Singapore. Electronic address: tcchoke@hotmail.com.
² Vascular and Endovascular Surgery Service, Department of General Surgery, Sengkang General Hospital, Singapore.

PMID: 38579912
DOI: 10.1016/j.avsg.2023.12.096

Abstract

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.