title: Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty.
abstract: BACKGROUND
  This study investigated p aclitaxel-induced luminal changes following drug-coated balloon (DCB) angioplasty to treat coronary de novo lesions without additional stenting. DCB-mediated local drug delivery reduces late lumen loss in de novo coronary artery lesions. We performed a retrospective clinical assessment based on a pre-specified quantitative coronary angiography (QCA) protocol.
  
  
  METHODS
  QCA was performed for each centre to assess the primary endpoint late lumen changes, i.e. the difference between in-lesion minimal lumen diameter (MLD) at the routine angiographic follow-up as compared to post-procedural in-lesion MLDs. These MLD changes were compared to corresponding reference vessel diameter changes as an intra-patient control.
  
  
  RESULTS
  We evaluated 58 consecutive native coronary artery lesions directly after DCB angioplasty and at a routine target follow-up angiography of 4 months by QCA. Target lesion MLD increased significantly within the 4.1 ± 2.1 month observation period (1.75 ± 0.55 vs. 1.91 ± 0.55 mm, p < 0.001, diameter stenosis 33.8 ± 12.3 vs. 26.9 ± 13.8 %, p < 0.001), while there were no changes in non-target reference vessel diameters (2.33 ± 0.60 vs. 2.34 ± 0.61 mm, p = ns). A total of 69 % of patients showed luminal enlargement whereas 29 % had minor luminal loss.
  
  
  CONCLUSIONS
  Local application of paclitaxel by DCB angioplasty to native coronary arteries after pre-dilatation without major dissection and recoil leads to late lumen increase.
authors.affiliation: Cardio Centrum Berlin, Academic Teaching Institution, Charité Universitätsmedizin, Unter den Linden 21, 10117, Berlin, Germany, fxkleber@gmx.eu.
authors.forename: Franz X
authors.initials: FX
authors.lastname: Kleber
authors.forename: Antonia
authors.initials: A
authors.lastname: Schulz
authors.forename: Matthias
authors.initials: M
authors.lastname: Waliszewski
authors.forename: Telse
authors.initials: T
authors.lastname: Hauschild
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.forename: Ulrich
authors.initials: U
authors.lastname: Dietz
authors.forename: Bodo
authors.initials: B
authors.lastname: Cremers
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
authors.forename: Yvonne P
authors.initials: YP
authors.lastname: Clever
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000517:prevention & control*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000503:physiopathology; D005260:Female; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D058426:Neointima; D017239:Paclitaxel / Q000008:administration & dosage*; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D066253:Vascular Remodeling / Q000187:drug effects*
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel