title: Efficacy of drug-eluting balloon in patients with bare-metal or drug-eluting stent restenosis.
abstract: BACKGROUND
  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.
authors.affiliation: Semmelweis University, Heart Center, Budapest, Hungary.
authors.forename: Balazs
authors.initials: B
authors.lastname: Berta
authors.forename: Zoltan
authors.initials: Z
authors.lastname: Jambrik
authors.forename: Krisztina
authors.initials: K
authors.lastname: Kohar
authors.forename: Gyorgy
authors.initials: G
authors.lastname: Szabo
authors.forename: Zoltan
authors.initials: Z
authors.lastname: Ruzsa
authors.forename: Levente
authors.initials: L
authors.lastname: Molnar
authors.forename: Gyorgy
authors.initials: G
authors.lastname: Barczi
authors.forename: Laszlo
authors.initials: L
authors.lastname: Geller
authors.forename: David
authors.initials: D
authors.lastname: Becker
authors.forename: Bela
authors.initials: B
authors.lastname: Merkely
mesh_terms: D054058:Acute Coronary Syndrome / Q000000981:diagnostic imaging / Q000601:surgery*; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D000972:Antineoplastic Agents, Phytogenic / Q000494:pharmacology; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000494:pharmacology; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000494:pharmacology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus