1. Comparative efficacy of two paclitaxel-coated balloons with different excipient coatings in patients with coronary in-stent restenosis: A pooled analysis of the Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 3 and 4 (ISAR-DESIRE 3 and ISAR-DESIRE 4) trials.
- Author
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Colleran R, Joner M, Kufner S, Altevogt F, Neumann FJ, Abdel-Wahab M, Bohner J, Valina C, Richardt G, Zrenner B, Cassese S, Ibrahim T, Laugwitz KL, Schunkert H, Kastrati A, and Byrne RA
- Subjects
- Aged, Angioplasty, Balloon, Coronary standards, Coated Materials, Biocompatible standards, Coronary Angiography standards, Drug-Eluting Stents standards, Female, Follow-Up Studies, Humans, Middle Aged, Prosthesis Design standards, Treatment Outcome, Angioplasty, Balloon, Coronary methods, Coated Materials, Biocompatible administration & dosage, Coronary Angiography methods, Coronary Restenosis diagnostic imaging, Coronary Restenosis therapy, Drug-Eluting Stents adverse effects
- Abstract
Background: Angioplasty with paclitaxel-coated balloons (PCB) is recommended for treatment of patients with coronary in-stent restenosis (ISR) according to European clinical practice guidelines. Most clinical trials have investigated iopromide-based PCB and there is a paucity of data comparing efficacy against butyryl-tri-hexyl citrate (BTHC)-based PCB. Our aim was to compare the performance of two widely-used PCB in the treatment of coronary ISR., Methods: We analysed patients treated with BTHC- or iopromide-PCB for treatment of drug-eluting stent ISR in the setting of 2 consecutive trials with identical inclusion and exclusion criteria. The primary endpoint was diameter stenosis at 6-8month angiographic surveillance. The secondary endpoint of interest was the composite of death, myocardial infarction (MI) or target-lesion revascularisation (TLR) at 1year. Multivariate analysis was performed to adjust for differences in baseline characteristics between groups., Results: In total, 264 patients were treated with BTHC-PCB (n=127) or iopromide-PCB (n=137). Baseline patient characteristics were similar for both groups. Post-procedure stenosis was slightly larger with BTHC-PCB (22.3 [SD 8.2]% vs. 18.4 [SD 9.9]%, P=0.001). At 6-8month angiography, diameter stenosis was 40.4 [SD 21.9]% vs. 37.4 [SD 21.4]% in the BTHC-PCB and iopromide-PCB groups, respectively (P=0.16, P
adjusted =0.32). At 1year, death, MI or TLR occurred in 29 (23.2%) vs. 32 (23.4%) patients in the BTHC-PCB and iopromide-PCB groups, respectively (HR 1.03 [95% CI 0.62-1.70], P=0.91, Padjusted =0.96)., Conclusions: In patients undergoing intervention for ISR, angioplasty with BTHC-PCB showed similar angiographic and clinical results at 1year compared with iopromide-PCB., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)- Published
- 2018
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