TY - JOUR
T1 - Comparative efficacy of two paclitaxel-coated balloons with different excipient coatings in patients with coronary in-stent restenosis
T2 - 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
AU - Intracoronary Stenting and Angiographic Results: Optimizing treatment of Drug Eluting Stent In-Stent Restenosis 3 and 4 (ISAR-DESIRE 3 and ISAR-DESIRE 4) investigators
AU - Colleran, Roisin
AU - Joner, Michael
AU - Kufner, Sebastian
AU - Altevogt, Felix
AU - Neumann, Franz Josef
AU - Abdel-Wahab, Mohamed
AU - Bohner, Janika
AU - Valina, Christian
AU - Richardt, Gert
AU - Zrenner, Bernhard
AU - Cassese, Salvatore
AU - Ibrahim, Tareq
AU - Laugwitz, Karl Ludwig
AU - Schunkert, Heribert
AU - Kastrati, Adnan
AU - Byrne, Robert A.
N1 - Publisher Copyright:
© 2017 Elsevier Ireland Ltd
PY - 2018/2/1
Y1 - 2018/2/1
N2 - 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 6–8 month angiographic surveillance. The secondary endpoint of interest was the composite of death, myocardial infarction (MI) or target-lesion revascularisation (TLR) at 1 year. 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 6–8 month 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, Padjusted = 0.32). At 1 year, 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 1 year compared with iopromide-PCB.
AB - 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 6–8 month angiographic surveillance. The secondary endpoint of interest was the composite of death, myocardial infarction (MI) or target-lesion revascularisation (TLR) at 1 year. 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 6–8 month 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, Padjusted = 0.32). At 1 year, 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 1 year compared with iopromide-PCB.
KW - Angiographic follow-up
KW - Drug-coated balloon
KW - In-stent restenosis
KW - Paclitaxel-coated balloon
UR - http://www.scopus.com/inward/record.url?scp=85035340355&partnerID=8YFLogxK
U2 - 10.1016/j.ijcard.2017.11.076
DO - 10.1016/j.ijcard.2017.11.076
M3 - Article
C2 - 29203209
AN - SCOPUS:85035340355
SN - 0167-5273
VL - 252
SP - 57
EP - 62
JO - International Journal of Cardiology
JF - International Journal of Cardiology
ER -