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

Abstract

Aim: Our study aimed to compare the efficacy of seal-wing paclitaxel-eluting balloon catheters (PEB) for treating drug eluting stent restenosis (DES-ISR). Methods: We enrolled 17 patients with 19 DES-ISR lesions. The control group comprised of 64 patients with bare-metal stent restenosis (BMS-ISR) from the seal-wing PEB arm 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, 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 .57 mm; p = 0.008), percent diameter stenosis (% DS; 62.629.2 % vs. 42.427.9 %; p = 0.020) and incidence of repeated binary restenosis (64.3 % vs. 28.1 %; p = 0.014). Differences at the 12-month clinical follow-up (MACE and TVR) did not reach 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.).