Abstract 14548: 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
Background: 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).
Methods: 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 PCB group (PCB group, 137 patients with 142 lesions) or conventional balloon angioplasty group (BA group, 71 patients with 71 lesions). The primary endpoint was target vessel failure (TVF) at 6-month follow-up.
Results: Clinical and angiographic follow-up 6 months after intervention was performed in 207 patients (99.5%) with 208 lesions (97.7%). TVF was noted in 6.6% of PCB group and 31.0% of BA group (p<0.001). Recurrent restenosis occurred in 4.3% of PCB group and 31.9% of BA group (p<0.001). Late lumen loss was lower in PCB group than in BA group (0.11 +/- 0.33 mm vs. 0.49 +/- 0.50 mm, p<0.001). In PCB- treated lesions, recurrent restenosis occurred in 1.1% of BMS-ISR patients and in 9.1% of DES-ISR patients (p=0.04). Late lumen loss was lower in BMS-ISR patients than in DES-ISR patients (0.05 +/- 0.28 mm vs. 0.18 +/- 0.38mm, p=0.03).
Conclusions: This randomized clinical study suggested that PCB provided much better clinical and angiographic outcomes than conventional BA in patients with BMS-ISR and DES-ISR. DES-ISR was associated with poorer outcomes than BMS-ISR after treatment with PCB.
- © 2013 by American Heart Association, Inc.