Drug-Coated Balloon for the Treatment of Small Vessel Coronary Artery Disease ― A Randomized Non-Inferiority Trial ―
Masato Nakamura, Tsuyoshi Isawa, Shigeru Nakamura, Kenji Andò, Atsuo Namiki, Yoshisato Shibata, Toshiro Shinke, Yoshiaki Ito, Kenshi Fujii, Junya Shite, Ken Kozuma, Shigeru Saito, Junichi Yamaguchi, Seiji Yamazaki, Paul Underwood, Dominic J. Allocco
Abstract
BACKGROUND: Drug-coated balloons (DCB) have shown promising results for the treatment of in-stent restenosis (ISR) and small vessel disease (SVD). However, data comparing the treatment efficacy of different DCBs are limited. METHODS AND RESULTS: =0.0012). There were no deaths or thrombosis, and angiographic and quality-of-life outcomes were comparable between groups. The AGENT Japan ISR substudy (n=30) primary endpoint was met because the one-sided 97.5% UCB for 6-month TLF (3.3%) was significantly less than the study success criterion of 15.1% (97.5% UCB=9.8%; P<0.0001). CONCLUSIONS: Data from this study demonstrate good clinical outcomes with the Agent DCB when used to treat patients with SVD or ISR.