Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Jan;39(1):47-56.
doi: 10.1007/s12928-023-00953-8. Epub 2023 Aug 29.

One-year safety and effectiveness of the Agent paclitaxel-coated balloon for the treatment of small vessel disease and in-stent restenosis

Masato Nakamura  1 , Tsuyoshi Isawa  2 , Shigeru Nakamura  3 , Kenji Ando  4 , Atsuo Namiki  5 , Yoshisato Shibata  6 , Toshiro Shinke  7 , Yoshiaki Ito  8 , Kenshi Fujii  9 , Junya Shite  10 , Ken Kozuma  11 , Shigeru Saito  12 , Junichi Yamaguchi  13 , Seiji Yamazaki  14 , Paul Underwood  15 , Dominic J Allocco  15
Affiliations
Randomized Controlled Trial

One-year safety and effectiveness of the Agent paclitaxel-coated balloon for the treatment of small vessel disease and in-stent restenosis

Masato Nakamura et al. Cardiovasc Interv Ther. 2024 Jan.

Abstract

The Agent device consists of a semi-compliant balloon catheter, which is coated with a therapeutic low-dose formulation of paclitaxel (2 µg/mm2) blended with an inactive excipient acetyl-tri-n-butyl citrate (ATBC). AGENT Japan SV is a randomized controlled study that enrolled 150 patients from 14 Japanese sites treated with Agent or SeQuent Please paclitaxel-coated balloon. This study also includes a single-arm substudy evaluating the safety and effectiveness of Agent in patients with in-stent restenosis (ISR). Patients with a single de novo native lesion (lesion length ≤ 28 mm and reference diameter ≥ 2.00 to < 3.00 mm) were randomized 2:1 to receive either Agent (n = 101) or SeQuent Please (n = 49). The ISR substudy enrolled 30 patients with lesion length ≤ 28 mm and reference diameter ≥ 2.00 to ≤ 4.00 mm. In the SV RCT, target lesion failure (TLF) at 1 year occurred in four patients treated with Agent (4.0%) versus one patient with SeQuent Please (2.0%; P = 1.00). None of the patients in either treatment arm died. There were no significant differences in the rates of myocardial infarction, target lesion revascularization and target lesion thrombosis through 1 year. In the ISR substudy, the 1-year rates of TLF and target lesion thrombosis were 6.7% and 0.0%, respectively. These data support the safety and effectiveness of the Agent paclitaxel-coated balloon in patients with small vessels and ISR.

Keywords: Drug-coated balloon; In-stent restenosis; Small vessel disease.

PubMed Disclaimer

Conflict of interest statement

The AGENT Japan trial was sponsored and funded by BSC Japan K.K. Dr. Ando received honoraria from Terumo, Japan Lifeline, Bristol Myers Squibb, Japan Medtronic, Abbott Medical Japan and Biotronik Japan. Dr. Shite received honoraria from Abbott, Terumo and Nipro. Dr. Ken Kozuma received the honoraria and research and scholarship grants from BSC Japan K.K. Dr. Yamaguchi received honoraria from Abbott and endowments from Abbott, BSC Japan K.K, Medtronic and Terumo. Drs. Underwood and Allocco are full-time employees and shareholders in BSC. Drs. M Nakamura, Isawa, S Nakamura, Namiki, Shibata, Shinke, Ito, Fujii, Saito and Yamazaki have no conflicts of interest to disclose.

Figures

Fig. 1
Fig. 1
AGENT Japan enrollment and follow-up. F/U follow-up; ISR in-stent restenosis, RCT randomized control trial, SV small vessel
Fig. 2
Fig. 2
Target lesion failure (TLF) through 1 year of follow-up. Time-to-event curves for AGENT Japan A SV RCT and B ISR substudy. ISR in-stent restenosis, SV small vessel. P value from log-rank test for the SV RCT
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Tian J, da Tang Y, Qiao S, et al. Two-year follow-up of a randomized multicenter study comparing a drug-coated balloon with a drug-eluting stent in native small coronary vessels: the RESTORE Small Vessel Disease China trial. Catheter Cardiovasc Interv. 2020;95(Suppl 1):587–597. doi: 10.1002/ccd.28705. - DOI - PubMed
    1. Jeger RV, Farah A, Ohlow MA, et al. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018;392(10150):849–856. doi: 10.1016/S0140-6736(18)31719-7. - DOI - PubMed
    1. Kleber FX, Mathey DG, Rittger H, Scheller B, German Drug-eluting Balloon Consensus Group How to use the drug-eluting balloon: recommendations by the German consensus group. EuroIntervention. 2011;7(Suppl K):K125–K128. doi: 10.4244/EIJV7SKA21. - DOI - PubMed
    1. Her A-Y, Shin E-S, Bang LH, et al. Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2021;28(1):136–149. doi: 10.5603/CJ.a2019.0093. - DOI - PMC - PubMed
    1. Jeger RV, Eccleshall S, Wan Ahmad WA, et al. Drug-coated balloons for coronary artery disease: third report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020;13(12):1391–1402. doi: 10.1016/j.jcin.2020.02.043. - DOI - PubMed

Publication types