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

• Published in: Catheterization and cardiovascular interventions 2022-11, Vol.100 (6), p.1100-1109
• Main Authors: Iida, Osamu, Soga, Yoshimitsu, Seki, Shu‐Ichi, Kawasaki, Daizo, Anzai, Hitoshi, Ando, Hiroshi, Nakama, Tatsuya, Shinozaki, Norihiko, Kozuki, Amane, Ishihara, Masaharu, Urasawa, Kazushi, Toi, Satoru, Tsujita, Hiroaki, Tobita, Kazuki, Ogata, Kenji, Horie, Kazunori, Hayakawa, Naoki, Mori, Shinsuke, Fujihara, Masahiko, Ohki, Takao, Yuba, Kenichiro, Mano, Toshiaki, Nakamura, Masato
• Format: Article
• Language: English
• Subjects: Amputation; Arteriosclerosis; Atherosclerosis; Balloon treatment; Calcification; clinically driven target lesion revascularization; Diabetes mellitus; drug‐coated balloon; endovascular therapy; Femoral artery; Femur; Lesions; Patients; peripheral artery disease; primary patency; Restenosis; Safety; superficial femoral and proximal popliteal lesions; Thrombosis; Vascular diseases
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.30408

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.