Efficacy of a seal-wing paclitaxel-eluting balloon catheters in the treatment of bare metal stent restenosis

Leos Pleva, Pavel Kukla, Jana Zapletalova, Ota Hlinomaz, Leos Pleva, Pavel Kukla, Jana Zapletalova, Ota Hlinomaz

Abstract

Background: Our study aimed to compare the efficacy of seal-wing paclitaxel-eluting balloon catheters (PEB) with iopromide-coated PEB and everolimus-eluting stents (EES) for treating bare metal stent restenosis (BMS-ISR).

Methods: We enrolled 64 patients with 69 BMS-ISR. The control group comprised patients from the iopromide-PEB and EES arms of a previous TIS study. The primary end-point was 12-month in-segment late lumen loss (LLL). Secondary end-points included incidence of binary in-stent restenosis and 12-month major adverse cardiac events (MACE).

Results: Compared to iopromide-coated PEB, seal-wing PEB was associated with significantly higher 12-month LLL (0.30 vs. 0.02 mm; p < 0.0001), repeated binary restenosis (28.12% vs. 8.7%; p = 0.012), 12-month MACE (26.98% vs. 10.29%; p = 0.003), and target vessel revascularization (TVR; 20.63% vs. 7.35%; p = 0.009). Compared to EES, no significant differences were found in the 12-month LLL (0.30 vs. 0.19 mm; p = 1.000), repeated binary restenosis (28.12% vs. 19.12%; p = 0.666), 12-month MACE (26.98% vs. 19.12%; p = 0.102) or TVR (20.63% vs. 16.18%; p = 0.360).

Conclusion: BMS-ISR treatment using seal-wing PEB led to significantly higher 12-month LLL, repeated binary restenosis, MACE, and TVR compared to iopromide-coated PEB. However, no significant differences were found in comparison with EES.

Trial registration: ClinicalTrials.gov; NCT01735825.

Keywords: Drug-eluting stent; In-stent restenosis; Paclitaxel-elution balloon.

Conflict of interest statement

Ethics approval and consent to participate

Written informed consent was obtained from each patient before enrollment in the study. The study protocol complied with the Declaration of Helsinki and was approved by the Ethics Committee of University Hospital Ostrava, Czech Republic. The study was registered at ClinicalTrials.gov (NCT01735825).

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT study flow diagram
Fig. 2
Fig. 2
Event-free survival

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