Roisin Colleran1, Michael Joner2, Sebastian Kufner1, Felix Altevogt1, Franz-Josef Neumann3, Mohamed Abdel-Wahab4, Janika Bohner1, Christian Valina3, Gert Richardt4, Bernhard Zrenner5, Salvatore Cassese1, Tareq Ibrahim6, Karl-Ludwig Laugwitz7, Heribert Schunkert2, Adnan Kastrati2, Robert A Byrne8. 1. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. 2. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Munich Heart Alliance, Munich, Germany. 3. Division of Cardiology and Angiology II, Heart Center University of Freiburg, Bad Krozingen, Germany. 4. Herzzentrum der Segeberger Kliniken Gruppe, Bad Segeberg, Germany. 5. Krankenhaus Landshut-Achdorf, Medizinische Klinik I, Landshut, Germany. 6. I. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany. 7. I. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Munich Heart Alliance, Munich, Germany. 8. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Munich Heart Alliance, Munich, Germany. Electronic address: byrne@dhm.mhn.de.
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 withBTHC-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, Padjusted=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.
RCT Entities:
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, Padjusted=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.