title: Comparison of the Efficacy of Paclitaxel-Eluting Balloon Catheters and Everolimus-Eluting Stents in the Treatment of Coronary In-Stent Restenosis: The Treatment of In-Stent Restenosis Study.
abstract: BACKGROUND
  The aim of this prospective randomized noninferiority study was to compare the efficacy of paclitaxel-eluting balloon (PEB) catheters and everolimus-eluting stents (EES) in the treatment of bare metal stent restenosis.
  
  
  RESULTS
  A total of 136 patients were enrolled in the study. Each treatment group included 68 patients with 74 in-stent restenotic lesions. The primary end point was in-segment late lumen loss (LLL) at 12 months. Secondary end points were the incidence of binary in-stent restenosis and 12-month major adverse cardiac events. The 2-sided 95% confidence interval of LLL difference between treatments (0.149-0.558) was greater than noninferiority margin (0.12), which demonstrates both noninferiority and superiority of PEB treatment. Furthermore, the PEB group had significantly less 12-month LLL than the EES group (0.02 versus 0.19 mm; P=0.0004). The difference in the incidence of repeated binary restenosis (8.7% versus 19.12%; P=0.078) and 12-month major adverse cardiac events (10.29% versus 19.12%; P=0.213) was not significant. The 12-month LLL was significantly less in the PEB group and also in subgroups with in-stent restenosis >10 mm (0.05 versus 0.26 mm; P=0.0002) and artery diameter <3 mm (0.05 versus 0.16 mm; P=0.003) compared with the EES groups, but not in the subgroup of patients with diabetes mellitus (P=0.254). In the EES group, repetitive binary restenosis had a significantly greater chance of occurring (odds ratio=3.132; 95% confidence interval, 1.058-9.269; P=0.039), even when adjusting for other risk factors.
  
  
  CONCLUSIONS
  Treatment of bare metal stent restenosis using PEB led to significantly less 12-month LLL than the implantation of second-generation EES.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01735825.
authors.affiliation: From the Department of Cardiovascular Diseases (L.P., P.K.) and Department of Laboratory Medicine (P.K.), University Hospital Ostrava, Czech Republic; Department of Biomedical Sciences, Medical Faculty, University of Ostrava, Ostrava, Czech Republic (P.K.); Department of Medical Biophysics, Palacky University, Olomouc, Czech Republic (J.Z.); Department of Cardioangiology, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czech Republic (O.H.); and International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic (O.H.). leos.pleva@volny.cz.
authors.forename: Leos
authors.initials: L
authors.lastname: Pleva
authors.affiliation: From the Department of Cardiovascular Diseases (L.P., P.K.) and Department of Laboratory Medicine (P.K.), University Hospital Ostrava, Czech Republic; Department of Biomedical Sciences, Medical Faculty, University of Ostrava, Ostrava, Czech Republic (P.K.); Department of Medical Biophysics, Palacky University, Olomouc, Czech Republic (J.Z.); Department of Cardioangiology, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czech Republic (O.H.); and International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic (O.H.).
authors.forename: Pavel
authors.initials: P
authors.lastname: Kukla
authors.affiliation: From the Department of Cardiovascular Diseases (L.P., P.K.) and Department of Laboratory Medicine (P.K.), University Hospital Ostrava, Czech Republic; Department of Biomedical Sciences, Medical Faculty, University of Ostrava, Ostrava, Czech Republic (P.K.); Department of Medical Biophysics, Palacky University, Olomouc, Czech Republic (J.Z.); Department of Cardioangiology, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czech Republic (O.H.); and International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic (O.H.).
authors.forename: Pavlina
authors.initials: P
authors.lastname: Kusnierova
authors.affiliation: From the Department of Cardiovascular Diseases (L.P., P.K.) and Department of Laboratory Medicine (P.K.), University Hospital Ostrava, Czech Republic; Department of Biomedical Sciences, Medical Faculty, University of Ostrava, Ostrava, Czech Republic (P.K.); Department of Medical Biophysics, Palacky University, Olomouc, Czech Republic (J.Z.); Department of Cardioangiology, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czech Republic (O.H.); and International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic (O.H.).
authors.forename: Jana
authors.initials: J
authors.lastname: Zapletalova
authors.affiliation: From the Department of Cardiovascular Diseases (L.P., P.K.) and Department of Laboratory Medicine (P.K.), University Hospital Ostrava, Czech Republic; Department of Biomedical Sciences, Medical Faculty, University of Ostrava, Ostrava, Czech Republic (P.K.); Department of Medical Biophysics, Palacky University, Olomouc, Czech Republic (J.Z.); Department of Cardioangiology, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czech Republic (O.H.); and International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic (O.H.).
authors.forename: Ota
authors.initials: O
authors.lastname: Hlinomaz
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D018153:Czech Republic; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D017239:Paclitaxel / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D000068338:Everolimus; D017239:Paclitaxel
keywords: coronary restenosis; diabetes mellitus; drug-eluting stents; paclitaxel; stents