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

Soga, Y ; Iida, O ; et al.

In: Cardiovascular and interventional radiology, Jg. 47 (2024-06-01), Heft 6, S. 730-740

Online academicJournal

Zugriff:

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.

Titel:	Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery.
Autor/in / Beteiligte Person:	Soga, Y ; Iida, O ; Seki, SI ; Kawasaki, D ; Anzai, H ; Ando, H ; Nakama, T ; Shinozaki, N ; Kozuki, A ; Ishihara, M ; Urasawa, K ; Toi, S ; Tsujita, H ; Tobita, K ; Ogata, K ; Horie, K ; Hayakawa, N ; Mori, S ; Fujihara, M ; Ohki, T ; Yuba, K ; Mano, T ; Ando, K ; Nakamura, M
Link:	View record at Springer (Volltext)
Zeitschrift:	Cardiovascular and interventional radiology, Jg. 47 (2024-06-01), Heft 6, S. 730-740
Veröffentlichung:	New York Ny : Springer Verlag ; <i>Original Publication</i>: [Berlin, New York] Springer International., 2024
Medientyp:	academicJournal
ISSN:	1432-086X (electronic)
DOI:	10.1007/s00270-024-03747-4
Schlagwort:	Humans Male Female Aged Prospective Studies Aged, 80 and over Treatment Outcome Japan Popliteal Artery diagnostic imaging Femoral Artery diagnostic imaging Peripheral Arterial Disease therapy Peripheral Arterial Disease diagnostic imaging Angioplasty, Balloon methods Vascular Patency Coated Materials, Biocompatible
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Corporate Authors: TCD-17187 Japan Investigators Publication Type: Journal Article; Multicenter Study Language: English [Cardiovasc Intervent Radiol] 2024 Jun; Vol. 47 (6), pp. 730-740. <i>Date of Electronic Publication: </i>2024 May 30. MeSH Terms: Popliteal Artery* / diagnostic imaging ; Femoral Artery* / diagnostic imaging ; Peripheral Arterial Disease* / therapy ; Peripheral Arterial Disease* / diagnostic imaging ; Angioplasty, Balloon* / methods ; Vascular Patency* ; Coated Materials, Biocompatible* ; Humans ; Male ; Female ; Aged ; Prospective Studies ; Aged, 80 and over ; Treatment Outcome ; Japan References: JACC Cardiovasc Interv. 2015 Jul;8(8):1105-1112. (PMID: 26117463) ; JACC Cardiovasc Interv. 2021 Nov 8;14(21):2391-2401. (PMID: 34736739) ; J Endovasc Ther. 2020 Dec;27(6):967-973. (PMID: 32813589) ; J Vasc Surg. 2019 Dec;70(6):1950-1959. (PMID: 31401115) ; J Endovasc Ther. 2018 Feb;25(1):109-117. (PMID: 29264999) ; J Endovasc Ther. 2021 Dec;28(6):927-937. (PMID: 34251279) ; J Vasc Surg. 2010 Sep;52(3):608-15. (PMID: 20573476) ; Eur Heart J. 2020 Jul 14;41(27):2541-2552. (PMID: 31989155) ; J Endovasc Ther. 2020 Oct;27(5):693-705. (PMID: 32583749) ; Circ Cardiovasc Interv. 2018 Jan;11(1):e005891. (PMID: 29326153) ; JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. (PMID: 24456716) ; Catheter Cardiovasc Interv. 2019 Mar 1;93(4):664-672. (PMID: 30747489) ; J Am Heart Assoc. 2023 Jan 3;12(1):e025677. (PMID: 36583431) ; Catheter Cardiovasc Interv. 2014 Aug 1;84(2):236-44. (PMID: 24402764) ; Vasa. 2022 Jul;51(4):247-255. (PMID: 35543439) ; Cardiovasc Intervent Radiol. 2014 Aug;37(4):898-907. (PMID: 24806955) Contributed Indexing: Investigator: Y Ikari; T Shinke; S Saito; Y Shibata; K Kishi ; Keywords: Clinically driven target lesion revascularization; Drug-coated balloon; Endovascular therapy; Peripheral artery disease; Primary patency; Superficial femoral and proximal popliteal lesions Substance Nomenclature: 0 (Coated Materials, Biocompatible) Entry Date(s): Date Created: 20240530 Date Completed: 20240610 Latest Revision: 20240613 Update Code: 20240613 PubMed Central ID: PMC11164795

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