Published in:
01-10-2017 | Original Paper
A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients with small vessel disease
Authors:
Atsushi Funatsu, Shigeru Nakamura, Naoto Inoue, Shinsuke Nanto, Masato Nakamura, Masashi Iwabuchi, Kenji Ando, Ryuta Asano, Seiji Habara, Shigeru Saito, Ken kozuma, Kazuaki Mitsudo
Published in:
Clinical Research in Cardiology
|
Issue 10/2017
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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.