title: Drug-eluting balloon in the treatment of in-stent restenosis and diffuse coronary artery disease: real-world experience from our registry.
abstract: OBJECTIVE
  To report a single-center experience of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) and de novo coronary artery disease.
  
  
  BACKGROUND
  DEB are emerging as an alternative treatment for coronary stenosis especially when metal scaffolding is undesirable (in-stent restenosis and small-vessel de novo disease). Although there are various randomized trials and registry studies, the data from real-world cohorts are lacking.
  
  
  METHODS
  Consecutive patients treated with the In.Pact Falcon™ (Medtronic Inc., Minneapolis, MN, USA) paclitaxel-eluting balloon between January 2009 and December 2011 were retrospectively studied. The measured end-points were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE) defined as combination of cardiac death, MI, and TVR.
  
  
  RESULTS
  A total of 275 lesions were successfully treated in 184 patients. The mean age was 66.2 ± 9.6 years, and 87% were males. The predominant indication for DEB use was ISR (62%), with de novo lesions accounting for the remainder (38%). A mean of 1.48 ± 0.9 DEB were used per patient. Bailout stenting was required in 24% of lesions. The median clinical follow-up was 14.6 months (IQR 12-23). The overall rates of cardiac death, MI, TLR, TVR, and MACE were 3.8%, 1.6%, 16.8%, 17.9%, and 21.7%, respectively. The overall rate of stent thrombosis was 0.5% (n = 1).
  
  
  CONCLUSIONS
  Our results suggests that DEB can be considered in lesions where the use of stents is not desirable, especially restenotic lesions. Further long-term follow-up of these patients will provide us more insights on the long-term outcomes.
authors.affiliation: Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, The Heart of England Trust, Birmingham, United Kingdom; Interventional Cardiology Unit, Imperial College, London, United Kingdom.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Basavarajaiah
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.forename: Joanne
authors.initials: J
authors.lastname: Shannon
authors.forename: Toru
authors.initials: T
authors.lastname: Naganuma
authors.forename: Alessandro
authors.initials: A
authors.lastname: Sticchi
authors.forename: Letizia
authors.initials: L
authors.lastname: Bertoldi
authors.forename: Charis
authors.initials: C
authors.lastname: Costopoulos
authors.forename: Filippo
authors.initials: F
authors.lastname: Figini
authors.forename: Mauro
authors.initials: M
authors.lastname: Carlino
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.forename: Matteo
authors.initials: M
authors.lastname: Montorfano
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D017239:Paclitaxel / Q000008:administration & dosage; D063868:Patient Outcome Assessment; D012042:Registries; D012189:Retrospective Studies; D015607:Stents / Q000009:adverse effects*
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel