title: One-year clinical outcomes of percutaneous treatment with drug-eluting balloons: results from a multicenter registry.
abstract: OBJECTIVE
  Percutaneous coronary intervention (PCI) with paclitaxel drug-eluting balloons (DEBs) is used mainly for treatment of in-stent restenosis (ISR) and small vessel disease. Our objective was to evaluate the clinical efficacy of this strategy in a multicenter registry.
  
  
  METHODS
  Between 2009 and 2010 a prospective registry from two centers enrolled 156 consecutive patients undergoing PCI with at least one DEB. A primary composite endpoint of major adverse cardiac events (MACE) (all-cause death, myocardial infarction [MI] and target lesion revascularization [TLR]) was assessed at one-year follow-up. Stepwise Cox regression was used to determine independent predictors of outcome.
  
  
  RESULTS
  DEBs (n=206) were used to treat 184 lesions. Procedural success was obtained in 98% of patients (n=150). At one-year follow-up, 86% (n=134) were free of the primary endpoint (6% death, 6% non-procedure related MI and 5% TLR). The independent predictors of MACE at one year were index PCI in the left anterior descending artery (HR 2.81, 95% CI 1.21-6.51; p=0.02) and a history of MI (HR 3.46, 95% CI 1.35-8.84; p=0.01). ISR and DEB diameter or length were not predictors of events.
  
  
  CONCLUSIONS
  PCI with DEBs in real-world patients with complex lesions is effective, with a low rate of MACE, including TLR, at one-year follow-up. The results are equally good whether the intervention is for ISR or for native coronary disease.
authors.affiliation: Unidade de Cardiologia de Intervenção, Hospital Garcia de Orta, Almada, Portugal. ritacale@hotmail.com
authors.forename: Rita
authors.initials: R
authors.lastname: Calé
authors.forename: Pedro Jerónimo
authors.initials: PJ
authors.lastname: Sousa
authors.forename: Ernesto
authors.initials: E
authors.lastname: Pereira
authors.forename: Pedro
authors.initials: P
authors.lastname: Araújo Gonçalves
authors.forename: Sílvia
authors.initials: S
authors.lastname: Vitorino
authors.forename: Hugo
authors.initials: H
authors.lastname: Vinhas
authors.forename: Luís
authors.initials: L
authors.lastname: Raposo
authors.forename: Cristina
authors.initials: C
authors.lastname: Martins
authors.forename: Henrique
authors.initials: H
authors.lastname: Mesquita Gabriel
authors.forename: Rui
authors.initials: R
authors.lastname: Campante Teles
authors.forename: Manuel
authors.initials: M
authors.lastname: Sousa Almeida
authors.forename: Hélder
authors.initials: H
authors.lastname: Pereira
authors.forename: Miguel
authors.initials: M
authors.lastname: Mendes
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D003324:Coronary Artery Disease / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel