Paclitaxel-eluting balloon angioplasty or cutting balloon angioplasty for the treatment of restenosis after carotid artery stenting.

BACKGROUND: In-stent restenosis (ISR) is a well-recognized late complication of carotid artery stenting (CAS), but there is no consensus on the optimal endovascular treatment. The aim of this study was to compare the short- and mid-term outcomes of paclitaxel-eluting drug-coated balloon (DEB) and cutting balloon (CB) angioplasty for the treatment of significant carotid ISR. METHODS: Consecutive patients treated for significant (>70%) ISR after CAS at a single tertiary center between January 2022 and June 2023 with either a paclitaxel-coated DEB (ELUTAX™) or a CB (WOLVERINE™) were retrospectively analyzed. Allocation between the two devices was performed at the operator’s discretion in a non-randomized fashion. The primary safety endpoint was the composite of any neurological event, death, and recurrent restenosis >50% at 30 days. The primary efficacy endpoint was freedom from recurrent >70% restenosis at 12 months on duplex ultrasound surveillance. Categorical variables were compared with the Chi-square or Fisher’s Exact Test, continuous variables with Student’s t-test. Freedom from restenosis was estimated by the Kaplan-Meier method and compared with the log-rank test. Statistical significance was set at P<0.05. RESULTS: Thirty patients were included (18 DEB, 12 CB). Baseline demographic and anatomical features were comparable between groups, with the exception of a higher prevalence of chronic obstructive pulmonary disease in the DEB group (38.9% vs. 0%, P=0.02). Procedural technical success was achieved in all 30 cases. At 30 days, no neurological events, deaths or recurrent restenoses >50% were observed in either group. After a mean follow-up of 14.1±8.1 months, freedom from >70% restenosis at 12 months was 100% in the DEB group and 41.7±14.2% in the CB group (log-rank P=0.02). CONCLUSIONS: In this small single-center retrospective experience, both DEB and CB angioplasty proved feasible and safe for the endovascular treatment of carotid ISR after CAS. DEB angioplasty was associated with a significantly lower rate of recurrent restenosis at 12-month follow-up. These hypothesis-generating findings should be confirmed in larger, ideally prospective and randomized studies before any definitive recommendation can be made.