Author + information
- Roisin Colleran1,
- Sebastian Kufner1,
- Michael Joner2,
- Janika Bohner1,
- Felix Altevogt3,
- Franz-Josef Neumann4,
- Christian Valina5,
- Mohamed Abdel-Wahab6,
- Gert Richardt6,
- Salvatore Cassese1,
- Tareq Ibrahim7,
- Heribert Schunkert2,
- Karl-Ludwig Laugwitz8,
- Adnan Kastrati2 and
- Robert Byrne1
- 1Deutsches Herzzentrum München, Technische Universität München, Munich, Germany
- 2Deutsches Herzzentrum München, Munich, Germany
- 3Deutsches Herzzentrum Muenchen, Munich, Germany
- 4Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany
- 5University Heartcenter Bad Krozingen, Bad Krozingen, Germany
- 6Heart Center, Segeberger Kliniken, Bad Segeberg, Germany
- 7Klinikum Rechts der Isar, Munich, Germany
- 8Klinikum rechts der Isar TUMk, Munich, Germany
Angioplasty with drug-coated balloons (DCB) is recommended for treatment of coronary in-stent restenosis (ISR) in European clinical practice guidelines. However there is a paucity of study data comparing different DCB devices. Our aim was to compare the performance of two widely-used paclitaxel-coated balloons (PCB) for treatment of ISR: iopromide-based Sequent Please (B. Braun, Germany) and BTHC-based Pantera Lux (Biotronik, Switzerland).
Patients treated with BTHC-PCB or iopromide-PCB for treatment of drug-eluting stent ISR in the setting of 2 consecutive trials were included. The primary angiographic endpoint was diameter stenosis (%DS) at 6-8 months. The primary clinical endpoint was a composite of death, myocardial infarction (MI) or target-lesion revascularisation (TLR) at 1 year. Multivariate analysis was used to adjust for differences in baseline characteristics between groups.
264 patients were treated with BTHC-PCB (n=127) or iopromide-PCB (n=137). Baseline characteristics were similar for both groups, although vessel size (2.89±0.49mm vs. 2.78±0.48mm, p=0.02) and %DS post-procedure (22.3±8.2% vs. 18.4±9.9%, p=0.001) were larger in the BTHC-PCB group. At 6-8 months, %DS was 40.4±21.9% vs. 37.4±21.4% in the BTHC- and iopromide-PCB groups, respectively (padjusted=0.31). At 1 year, death, MI or TLR occurred in 29 (23.2%) vs. 32 (23.4%) patients in the BTHC- and iopromide-PCB groups, respectively (padjusted=0.96).
In patients undergoing treatment of ISR, angioplasty with BTHC-PCB showed similar angiographic and clinical results at 1 year compared with iopromide-PCB.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery