Efficacy of drug-eluting balloon in patients with bare-metal or drug-eluting stent restenosis.

Berta, Balázs and Jambrik, Zoltán and Kohar, K. and Szabó, G. and Ruzsa, Zoltán and Molnár, Levente Domonkos and Bárczi, György and Gellér, László Alajos and Becker, Dávid and Merkely, Béla Péter (2014) Efficacy of drug-eluting balloon in patients with bare-metal or drug-eluting stent restenosis. HELLENIC JOURNAL OF CARDIOLOGY, 55 (5). pp. 369-377. ISSN 1109-9666

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Abstract

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.

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