title: Drug-Coated Balloons Versus Second-Generation Drug-Eluting Stents for the Management of Recurrent Multimetal-Layered In-Stent Restenosis.
abstract: OBJECTIVE
  This study aimed to investigate the clinical outcomes of patients presenting with recurrent drug-eluting stent (DES) in-stent restenosis (ISR) treated with a second-generation DES or with a drug-coated balloon (DCB).
  
  
  BACKGROUND
  To date, there are no reports of DCB treatment and limited data with regard to the efficacy of further DES implantation for recurrent ISR.
  
  
  METHODS
  Between January 2008 and December 2013, 171 lesions were assessed for eligibility (82 lesions in the second-generation DES group and 89 lesions in the DCB group).
  
  
  RESULTS
  Acute gain was greater in the second-generation DES group (second-generation DES, 2.09 ± 0.53 mm vs. DCBs, 1.60 ± 0.62 mm, p < 0.001). The rates of major adverse cardiac events were comparable (at 1 year, DES 14.0% vs. DCBs 12.3%; at 2 years, DES 28.8% vs. DCBs 43.5%, p = 0.21). Major adverse cardiac event rates were mainly driven by target lesion revascularization (at 1 year, DES 12.5% vs. DCBs 10.9%; at 2 years, DES 27.7% vs. DCBs 38.3%; p = 0.40). Definite scaffold thrombosis occurred in 2 patients (1 patient in each group). Multivariable analysis revealed ISR recurrence within 1 year (hazard ratio: 2.43, 95% confidence interval: 1.14 to 5.18, p = 0.02) and lesion length (per 10-mm increase) (hazard ratio: 1.15, 95% confidence interval: 1.00 to 1.32, p = 0.049) to be independent predictors of TLR.
  
  
  CONCLUSIONS
  The results after both treatments were equivalent. ISR recurrence within 1 year of the first reintervention and lesion length were independent predictors of future target lesion revascularization. Larger studies are required to confirm the late (>1 year) differences with regard to clinical outcomes.
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Kawamoto
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Imperial College, London, United Kingdom.
authors.forename: Neil
authors.initials: N
authors.lastname: Ruparelia
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Miyazaki
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Katsumasa
authors.initials: K
authors.lastname: Sato
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Mangieri
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Rachele
authors.initials: R
authors.lastname: Contri
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Stella
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Figini
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Carlino
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Montorfano
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy. Electronic address: info@emocolumbus.it.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D062906:Cardiac Catheters; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D020099:Coated Materials, Biocompatible
keywords: drug-coated balloon; drug-eluting stent; in-stent restenosis