Cor Vasa 2021, 63(4):442-447 | DOI: 10.33678/cor.2021.013

In-stent restenosis treatment with seal-wing paclitaxel-eluting balloon catheters

Leoš Pleva^{a, b}, Pavel Kukla^a, Jana Zapletalová^c, Ota Hlinomaz^{d, e}

^a Department of Cardiovascular Diseases, Clinic of Internal Medicine and Cardiology, University Hospital Ostrava, Ostrava

^b Medical Faculty, University of Ostrava, Ostrava

^c Department of Medical Biophysics, Palacky University, Olomouc

^d Department of Cardioangiology, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno

^e International Clinical Research Center, St. Anne's University Hospital, Brno

Objectives: We aimed to compare the long-term clinical outcomes of seal-wing and iopromide-coated paclitaxel eluting balloon catheters (PEB) in the treatment of bare-metal stent restenosis (BMS-ISR).

Methods: A 3-year clinical follow-up of 132 patients with BMS-ISR was performed, of whom 64 were treated with seal-wing PEB; the control group consisted of 68 patients from iopromide-coated PEB branch of the previous TIS study. The primary endpoint was the occurrence of major adverse cardiac events (MACE; cardiovascular [CV] death, myocardial infarction [MI], or target vessel revascularization [TVR]).

Results: Compared to iopromide-coated PEB, the incidence of 3-year MACE was significantly higher (40.6% vs. 19.1%; p = 0.008) in the seal-wing PEB group; a similar difference was achieved when comparing the need for TVR (26.9% vs. 8.8%; p = 0.011). The event-free survival in the iopromide-coated PEB group was significantly longer (p = 0.021). There were no differences in cardiovascular mortality (4.7% vs. 5.9%; p = 1.000), occurrence of MI (6.3% vs. 4.4%; p = 0.712), definite ST (0% vs. 2.9%; p = 0.497) or repeated MACE (4.7% vs. 1.5%; p = 0.354) between the two groups.

Conclusion: Compared to iopromide-coated PEB, the use of seal-wing PEB in the treatment of BMS-ISR is associated with a significantly higher 3-year incidence of MACE and TVR (ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825).

Keywords: In-stent restenosis, Paclitaxel-eluting balloon, Seal-wing PEB

Received: December 21, 2020; Revised: December 21, 2020; Accepted: January 15, 2021; Published: August 25, 2021  Show citation