title: Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry.
abstract: OBJECTIVE
  Safety and efficacy of percutaneous coronary interventions using the Pantera Lux paclitaxel-coated balloon have been demonstrated in the PEPPER first-in-man trial. This prospective, multicentre, clinical registry aims to evaluate its safety and efficacy in an international real-world setting in a larger cohort of patients.
  
  
  RESULTS
  Between April 2010 and April 2011, 1,064 patients were treated for predominantly diffuse and proliferative in-stent restenosis of bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR), or for de novo lesions. Clinical device success was obtained in 98.2% of the patients. The study endpoint was major adverse cardiac events (MACE), defined as a composite of all-cause mortality, non-fatal myocardial infarction and clinically driven target vessel revascularisation, and was 8.5% in the overall, 6.0% in the BMS-ISR, 11.5% in the DES-ISR and 7.0% in the de novo population at six months, and 15.1%, 11.6%, 20.6% and 9.4% at 12 months, respectively. Definitive stent thrombosis occurred in 0.4% of the patients within 12 months.
  
  
  CONCLUSIONS
  Safety and efficacy of the Pantera Lux paclitaxel-coated balloon was confirmed in a real-world setting with low major adverse cardiac event rates in patients with in-stent restenosis or de novo lesions. (ClinicalTrials.gov: NCT01081366).
authors.affiliation: Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Toelg
authors.forename: Béla
authors.initials: B
authors.lastname: Merkely
authors.forename: Andrejs
authors.initials: A
authors.lastname: Erglis
authors.forename: Stefan
authors.initials: S
authors.lastname: Hoffman
authors.forename: Huret
authors.initials: H
authors.lastname: Bruno
authors.forename: Ran
authors.initials: R
authors.lastname: Kornowski
authors.forename: Ton
authors.initials: T
authors.lastname: Slagboom
authors.forename: Christoph
authors.initials: C
authors.lastname: Naber
authors.forename: Bernhard
authors.initials: B
authors.lastname: Witzenbichler
authors.forename: Kristof
authors.initials: K
authors.lastname: Graf
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.forename: Christoph
authors.initials: C
authors.lastname: Hehrlein
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000706:statistics & numerical data*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D002087:Butyrates / Q000008:administration & dosage*; D023903:Coronary Restenosis / Q000628:therapy*; D005079:Excipients; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D012042:Registries
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D002087:Butyrates; D005079:Excipients; C066757:butyryl-n-trihexylcitrate; D017239:Paclitaxel