Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery

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2024年5月30日

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Yoshimitsu Soga,
Osamu Iida,
Shu-Ichi Seki,
Daizo Kawasaki,
Hitoshi Anzai,
Hiroshi Ando,
Tatsuya Nakama,
Norihiko Shinozaki,
Amane Kozuki,
Masaharu Ishihara,
Kazushi Urasawa,
Satoru Toi,
Hiroaki Tsujita,
Kazuki Tobita,
Kenji Ogata,
Kazunori Horie,
Naoki Hayakawa,
Shinsuke Mori,
Masahiko Fujihara,
Takao Ohki,
Kenichiro Yuba,
Toshiaki Mano,
Kenji Ando,
Masato Nakamura,
Yuji Ikari,
Toshiro Shinke,
Shigeru Saito,
Yoshisato Shibata,
Koichi Kishi

摘要

Purpose

In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients.

Methods

This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate.

Results

Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD.

Conclusion

This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months.

Level of Evidence

Level 3, Cohort study.

Clinical Trial Registration: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.