title: Safety and feasibility of a PAclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one-year clinical outcome of a pilot study.
abstract: OBJECTIVE
  In primary percutaneous coronary intervention (PPCI), stenting has been shown to reduce the need for repeat target lesion revascularisation (TLR) compared to balloon angioplasty alone, but did not result in a reduction of recurrent myocardial infarction (MI) or cardiac death. Meanwhile, stent-related adverse events such as stent thrombosis continue to be of concern. Our aim was to evaluate the safety and feasibility of drug- coated balloon (DCB) angioplasty without stenting in PPCI.
  
  
  RESULTS
  One hundred patients presenting with ST-elevation MI were prospectively enrolled in this pilot study. They underwent PPCI with DCB angioplasty; additional stenting was allowed only in case of type C to F coronary dissection or residual stenosis >50%. All patients were treated with i.v. bivalirudin. The primary endpoint was the composite of cardiac death, recurrent MI and TLR. A total of 59 patients received treatment with DCB angioplasty alone, whereas additional stenting was required in 41 patients. One-year clinical follow-up was completed in 98 patients. A total of five major adverse cardiac events were reported (5%). Cardiac death was seen in two patients, while three patients underwent TLR.
  
  
  CONCLUSIONS
  This first study of a DCB angioplasty-only strategy in the setting of PPCI showed good one-year clinical results.
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Nicola S
authors.initials: NS
authors.lastname: Vos
authors.forename: Maurits T
authors.initials: MT
authors.lastname: Dirksen
authors.forename: Maarten A
authors.initials: MA
authors.lastname: Vink
authors.forename: Ferdinand C
authors.initials: FC
authors.lastname: van Nooijen
authors.forename: Giovanni
authors.initials: G
authors.lastname: Amoroso
authors.forename: Jean-Paul R
authors.initials: JP
authors.lastname: Herrman
authors.forename: Ferdinand
authors.initials: F
authors.lastname: Kiemeneij
authors.forename: Mark S
authors.initials: MS
authors.lastname: Patterson
authors.forename: Ton
authors.initials: T
authors.lastname: Slagboom
authors.forename: Rene J
authors.initials: RJ
authors.lastname: van der Schaaf
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D017239:Paclitaxel / Q000008:administration & dosage*; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel