title: Twelve-month results of a paclitaxel releasing balloon in patients presenting with in-stent restenosis First-in-Man (PEPPER) trial.
abstract: BACKGROUND
  Coronary in-stent restenosis (ISR) continues to be a therapeutic challenge especially after drug eluting stent (DES) implantation. We studied patients with ISR to investigate safety and efficacy of a novel drug coated balloon (DCB) incorporating paclitaxel into a microcrystalline structure by applying the inert excipient butyryltri-n-hexyl citrate (BTHC) in a prospective First-in-Man trial.
  
  
  METHODS
  Eighty-one patients were enrolled at 9 European sites, thereof 43 (53.1%) presenting with bare metal stent (BMS)-ISR and 38 (46.9%) with DES-ISR. The primary study endpoint was in-stent late lumen loss (LLL) independently assessed by a quantitative coronary angiography laboratory at 6 months. A secondary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, non-fatal myocardial infarction, clinically driven target vessel revascularization after 6 and 12 months.
  
  
  RESULTS
  At 6 months, overall LLL was 0.07±0.31 mm showing differences in BMS-ISR and DES-ISR treatment (-0.05±0.28 mm vs. 0.19±0.29 mm, respectively, P=.001). Overall MACE rates at 6 and 12 months were 6.5% and 11.8%. At the 12-month follow-up, one myocardial infarction, and no cardiac death nor stent thrombosis had occurred.
  
  
  CONCLUSIONS
  Application of a novel paclitaxel coated balloon using BTHC as an excipient in patients with ISR is safe and results in very low LLL, revascularization- and MACE-rates at follow-up. (ClinicalTrials.gov: NCT00961181).
authors.affiliation: Medizinische Universitätsklinik, Freiburg i.Br., Germany. christoph.hehrlein@universitaets-herzzentrum.de
authors.forename: Christoph
authors.initials: C
authors.lastname: Hehrlein
authors.forename: Ulrich
authors.initials: U
authors.lastname: Dietz
authors.forename: Jacek
authors.initials: J
authors.lastname: Kubica
authors.forename: Erik
authors.initials: E
authors.lastname: Jørgensen
authors.forename: Ellen
authors.initials: E
authors.lastname: Hoffmann
authors.forename: Christoph
authors.initials: C
authors.lastname: Naber
authors.forename: Maciej
authors.initials: M
authors.lastname: Lesiak
authors.forename: Henrik
authors.initials: H
authors.lastname: Schneider
authors.forename: Marcus
authors.initials: M
authors.lastname: Wiemer
authors.forename: Ralph
authors.initials: R
authors.lastname: Tölg
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002087:Butyrates / Q000737:chemistry; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D023921:Coronary Stenosis / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005060:Europe; D005079:Excipients / Q000737:chemistry; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002087:Butyrates; D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D005079:Excipients; D008670:Metals; C066757:butyryl-n-trihexylcitrate; D017239:Paclitaxel