Atsushi Funatsu1,2, Shigeru Nakamura3, Naoto Inoue4, Shinsuke Nanto5, Masato Nakamura6, Masashi Iwabuchi7, Kenji Ando7, Ryuta Asano8, Seiji Habara9, Shigeru Saito10, Ken Kozuma11, Kazuaki Mitsudo9. 1. Kyoto Katsura Hospital, Kyoto, Japan. kcvc.funatsu@katsura.com. 2. , 17 Yamada hirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan. kcvc.funatsu@katsura.com. 3. Kyoto Katsura Hospital, Kyoto, Japan. 4. Sendai Kousei Hospital, Sendai, Japan. 5. Osaka University Graduate school of Medicine, Osaka, Japan. 6. Toho University Ohashi Medical Center, Tokyo, Japan. 7. Kokura Memorial Hospital, Kitakyushu, Japan. 8. Sakakibara Heart institute, Tokyo, Japan. 9. Kurashiki Central Hospital, Kurashiki, Japan. 10. Shonan Kamakura General Hospital, Kamakura, Japan. 11. Teikyo University Hospital, Tokyo, Japan.
Abstract
AIM: We investigated the efficacy and safety of using paclitaxel-coated balloon (PCB) to treat small vessel disease. METHODS AND RESULTS: In this multicenter, prospective, randomized controlled trial, one-hundred and thirty-five patients with native coronary lesions in small vessels were randomized into a PCB group and plain balloon angioplasty (POBA) group at a ratio of 2:1. There were no differences in target vessel failure (TVF) that was defined as cardiac death or target vessel-related myocardial infarction or target lesion revascularization (TLR), between the two groups (3.4 vs. 10.3%; P = 0.20), and TLR was slightly lower in the PCB group (2.3%) than that in the POBA group (10.3%) during 24 weeks follow-up. The late lumen loss (LLL) was significantly lower in the PCB group (0.01 ± 0.31 vs. 0.32 ± 0.34 mm; P < 0.01) and late lumen enlargement (LLE) was more frequently observed in the PCB group (48 vs. 15%; P < 0.01) by angiographic follow-up after 24 weeks. There were no cases of death, myocardial infarction, thrombosis and reocclusion in either group. CONCLUSIONS: This study was not able to demonstrate superiority of PCB compared with POBA.
RCT Entities:
AIM: We investigated the efficacy and safety of using paclitaxel-coated balloon (PCB) to treat small vessel disease. METHODS AND RESULTS: In this multicenter, prospective, randomized controlled trial, one-hundred and thirty-five patients with native coronary lesions in small vessels were randomized into a PCB group and plain balloon angioplasty (POBA) group at a ratio of 2:1. There were no differences in target vessel failure (TVF) that was defined as cardiac death or target vessel-related myocardial infarction or target lesion revascularization (TLR), between the two groups (3.4 vs. 10.3%; P = 0.20), and TLR was slightly lower in the PCB group (2.3%) than that in the POBA group (10.3%) during 24 weeks follow-up. The late lumen loss (LLL) was significantly lower in the PCB group (0.01 ± 0.31 vs. 0.32 ± 0.34 mm; P < 0.01) and late lumen enlargement (LLE) was more frequently observed in the PCB group (48 vs. 15%; P < 0.01) by angiographic follow-up after 24 weeks. There were no cases of death, myocardial infarction, thrombosis and reocclusion in either group. CONCLUSIONS: This study was not able to demonstrate superiority of PCB compared with POBA.
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