INTRODUCTION: In spite of improving results, the treatment of in-stent restenosis (ISR) of bare-metal stents (BMS), and particularly drug-eluting stents (DES), is a challenging clinical problem. There are promising but limited follow-up data concerning drug-eluting balloons in the treatment of BMS and DES restenosis. The goal of this real-world registry was to assess the long-term safety and efficacy of drug-eluting balloons in the treatment of BMS and DES restenosis. METHODS: In this prospective registry, 82 patients with BMS or DES restenosis treated with paclitaxel-eluting balloons were enrolled. The primary endpoint was ischemia-driven target lesion revascularization (TLR); a secondary endpoint was the rate of major adverse cardiac events (MACE) at 28 months. RESULTS: Thirty-five patients (42.7%) had DES ISR and 16 patients (19.5%) presented with an acute coronary syndrome. The success rate of drug-eluting balloon inflation was 97.6%. The median (interquartile range) duration of follow up was 28.0 (25.0-30.3) months. The rate of TLR was 24.5%, and was not significantly higher in the DES-ISR group than in the BMS-ISR group: 29.0% vs. 21.1%, respectively (p=0.687). There were two cases of definite stent thrombosis in the BMS-ISR group and one probable subacute stent thrombosis in the DES-ISR group. The overall MACE rate was 37.0% and did not differ between the DES-ISR and BMS-ISR group (40.8% vs. 34.7%, respectively; p=0.994). CONCLUSIONS: This real-world registry provided less favorable long-term results for drug-eluting balloons in the treatment of BMS restenosis and in DES restenosis, compared to the promising mid-term results of previous studies. The TLR rate was slightly but not significantly higher after DES restenosis compared to BMS restenosis treatment.
INTRODUCTION: In spite of improving results, the treatment of in-stent restenosis (ISR) of bare-metal stents (BMS), and particularly drug-eluting stents (DES), is a challenging clinical problem. There are promising but limited follow-up data concerning drug-eluting balloons in the treatment of BMS and DES restenosis. The goal of this real-world registry was to assess the long-term safety and efficacy of drug-eluting balloons in the treatment of BMS and DES restenosis. METHODS: In this prospective registry, 82 patients with BMS or DES restenosis treated with paclitaxel-eluting balloons were enrolled. The primary endpoint was ischemia-driven target lesion revascularization (TLR); a secondary endpoint was the rate of major adverse cardiac events (MACE) at 28 months. RESULTS: Thirty-five patients (42.7%) had DES ISR and 16 patients (19.5%) presented with an acute coronary syndrome. The success rate of drug-eluting balloon inflation was 97.6%. The median (interquartile range) duration of follow up was 28.0 (25.0-30.3) months. The rate of TLR was 24.5%, and was not significantly higher in the DES-ISR group than in the BMS-ISR group: 29.0% vs. 21.1%, respectively (p=0.687). There were two cases of definite stent thrombosis in the BMS-ISR group and one probable subacute stent thrombosis in the DES-ISR group. The overall MACE rate was 37.0% and did not differ between the DES-ISR and BMS-ISR group (40.8% vs. 34.7%, respectively; p=0.994). CONCLUSIONS: This real-world registry provided less favorable long-term results for drug-eluting balloons in the treatment of BMS restenosis and in DES restenosis, compared to the promising mid-term results of previous studies. The TLR rate was slightly but not significantly higher after DES restenosis compared to BMS restenosis treatment.