BACKGROUND: The efficacy of paclitaxel-eluting balloon catheters (PEB) and drug-eluting stents for treatment of bare-metal stent restenosis (BMS-ISR) have been demonstrated in several studies with follow-up times of 9 to 12 months; however, the long-term outcomes of ISR treatment are less defined. OBJECTIVES: We aimed to compare the long-term efficacy of PEB and everolimus-eluting stents (EES) for the treatment of BMS-ISR. METHODS: We analyzed 3-year clinical follow-up data from patients included in the TIS randomized clinical study. A total of 136 patients with BMS-ISR were allocated to receive treatment with either PEB or EES (68 patients with 74 ISR lesions per group). RESULTS: The PEB and EES groups did not significantly differ in major adverse cardiac events-free survival (MACE; P = .211; including individual events: CV death: P = .622; myocardial infarction: P = .650 or target vessel revascularization: P = .286) at 3-year clinical follow-up. No event-free survival differences were found between the groups regarding overall mortality (P = .818), definite stent thrombosis (P = .165) or the second MACE (P = .270). CONCLUSIONS: At the 3-year follow-up, no significant differences in clinical outcomes were found between iopromide-coated PEB and EES for the treatment of BMS-ISR. (ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825).

Department of Cardioangiology St Anne's University Hospital and Faculty of Medicine Masaryk University Brno Czech Republic

Department of Cardiovascular Diseases University Hospital Ostrava Czech Republic

Department of Medical Biophysics Palacky University Olomouc Czech Republic

International Clinical Research Center St Anne's University Hospital Brno Czech Republic

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ClinicalTrials.gov
NCT01735825