Efficacy of seal-wing paclitaxel-eluting balloon catheters in the treatment of drug-eluting stent restenosis

Aim: Our study aimed to compare the efficacy of seal-wing paclitaxel-eluting balloon catheters (PEB) for treating drug elutingstent restenosis (DES-ISR).Methods: We enrolled 17 patients with 19 DES-ISR lesions. The control group comprised of 64 patients with bare-metal stentrestenosis (BMS-ISR) from the seal-wing PEB arm of a previous TIS study. The primary end-point was 12-month in-segment latelumen loss (LLL). Secondary end-points included incidence of binary in-stent restenosis, 12-month major adverse cardiac events(MACE) and target vessel revascularisation (TVR).Results: Compared to BMS-ISR, seal-wing PEB used for DES-ISR treatment was associated with a significantly higher LLL (1.12 ±0.83 mm vs. 0.47 ± 0.57 mm; p = 0.008), percent diameter stenosis (% DS; 62.6 ± 29.2 % vs. 42.4 ± 27.9 %; p = 0.020) and incidenceof repeated binary restenosis (64.3 % vs. 28.1 %; p = 0.014). Differences at the 12-month clinical follow-up (MACE and TVR) did notreach statistical significance (50 % vs. 30 %; p = 0.077 and 43.7 % vs. 20.6 %; p = 0.103, respectively).Conclusion: Treatment of DES-ISR using seal-wing PEB was associated with significantly worse 12-month angiographic outcomes.Differences at the 12-month clinical follow-up (MACE and TVR) did not reach statistical significance. (ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825.)