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

Objectives: We aimed to compare the long-term clinical outcomes of seal-wing and iopromide-coated pacli-taxel 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; cardio-vascular [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 signifi-cantly 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 as-sociated with a significantly higher 3-year incidence of MACE and TVR