Journal Article

A multicenter randomized comparison of paclitaxel-coated balloon catheter with conventional balloon angioplasty in patients with bare-metal stent restenosis and drug-eluting stent restenosis

Nanto, Shinsuke, Inoue, Naoto, Shiode, Nobuo, Kotani, Jun-ichi, Nakamura, Shigeru, Ikari, Yuji, Asano, Ryuta, Saito, Shigeru, Kozuma, Ken, Hosokawa, Joji, Iwabuchi, Masashi, Kimura, Takeshi, Nakamura, Masato, Habara, Seiji, Hayashi, Yasuhiko, Mitsudo, Kazuaki

2013

Overview

The aim of this study was to investigate the efficacy and safety of paclitaxel-coated balloon (PCB) for the treatment of the bare-metal stent restenosis (BMS-ISR) and drug-eluting stent restenosis (DES-ISR). This study was a prospective, multicenter, randomized (2:1) trial conducted in 208 patients with 213 in-stent restenosis lesions (BMS-ISR: 123 lesions, DES-ISR: 90 lesions) at 13 centers in Japan. Patients were randomly assigned to a PCB group (137 patients with 142 lesions) or a conventional balloon angioplasty (BA) group (71 patients with 71 lesions). The primary end point was target vessel failure at 6-month follow-up. Clinical and angiographic follow-up 6 months after intervention was performed in 207 patients (99.5%) with 208 lesions (97.7%). Target vessel failure was noted in 6.6% of the PCB group and 31.0% of the BA group (P < .001). Recurrent restenosis occurred in 4.3% of the PCB group and 31.9% of the BA group (P < .001). Late lumen loss was lower in the PCB group than in the BA group (0.11 ± 0.33 mm vs 0.49 ± 0.50 mm, P < .001). In PCB-treated lesions, recurrent restenosis occurred in 1.1% of patients with BMS-ISR and in 9.1% of patients with DES-ISR (P = .04). Late lumen loss was lower in patients with BMS-ISR than in patients with DES-ISR (0.05 ± 0.28 mm vs 0.18 ± 0.38 mm, P = .03). This randomized clinical study suggested that PCB provided much better clinical and angiographic outcomes than did conventional BA in patients with BMS-ISR and DES-ISR. Drug-eluting stent restenosis was associated with poorer outcomes compared with BMS-ISR after treatment with PCB.

• Publisher: Mosby, Inc,Elsevier Limited
• Subject: Aged / Aged, 80 and over / Angioplasty / Angioplasty, Balloon, Coronary - adverse effects / Angioplasty, Balloon, Coronary - methods / Cardiovascular / Coronary Angiography / Coronary Restenosis - etiology / Coronary Restenosis - therapy / Drug-Eluting Stents - adverse effects / Female / Follow-Up Studies / Graft Occlusion, Vascular - etiology / Graft Occlusion, Vascular - therapy / Heart attacks / Humans / Ischemia / Japan / Laboratories / Male / Medical imaging / Metals / Middle Aged / Paclitaxel - therapeutic use / Prospective Studies / Stents / Stents - adverse effects / Success / Thrombosis / Treatment Outcome