Twelve-month safety and effectiveness of TCD-17187 drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery
Abstract
Purpose
The aim of this preapproval trial was to evaluate the 12-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/or proximal popliteal artery (PA).
Methods
This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up.
Results
Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan–Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period.
Conclusion
This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA.
CONFLICTS OF INTEREST
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article. Osamu Iida, Yoshimitsu Soga, Daizo Kawasaki, Tatsuya Nakama, Norihiko Shinozaki, Kazush Urasawa, Masato Nakamura, Hiroaki Tsujita, Kazuki Tobita, Kazunori Horie, Masahiko Fujihara, and Takao Ohki are consultants who received honoraria from TERUMO CORPORATION. Osamu Iida, Yoshimitsu Soga, Shu-Ichi Seki, Daizo Kawasaki, Hitoshi Anzai, Hitoshi Ando, Tatsuya Nakama, Norihiko Shinozaki, Amane Kozuki, Kazush Urasawa, Masato Nakamura, Hiroaki Tsujita, Kazuki Tobita, Kenji Ogata, Kazunori Horie, Naoki Hayakawa, Shinsuke Mori, Masahiko Fujihara, and Takao Ohki received honoraria from TERUMO CORPORATION. The remaining authors declare that there are no conflicts of interest.
Open Research
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.
