title: Stent coverage and neointimal proliferation in bare metal stents postdilated with a Paclitaxel-eluting balloon versus everolimus-eluting stents: prospective randomized study using optical coherence tomography at 6-month follow-up.
abstract: BACKGROUND
  In this randomized trial, strut coverage and neointimal proliferation of a therapy of bare metal stents (BMSs) postdilated with the paclitaxel drug-eluting balloon (DEB) was compared with everolimus drug-eluting stents (DESs) at 6-month follow-up using optical coherence tomography. We hypothesized sufficient stent coverage at follow-up.
  
  
  RESULTS
  A total of 105 lesions in 90 patients were treated with either XIENCE V DES (n=51) or BMS postdilated with the SeQuent Please DEB (n=54). At follow-up, comparable results on the primary optical coherence tomography end point (percentage uncovered struts 5.64±9.65% in BMS+DEB versus 4.93±9.29% in DES; P=0.366) were found. Thus, BMS+DEB achieved the prespecified noninferiority margin of 5% uncovered struts versus DES (difference between treatment means, 0.71%; one-sided upper 95% confidence interval, 4.14%; noninferiority P=0.04). Optical coherence tomography analysis showed significantly more global neointimal proliferation in the BMS+DEB group (15.7±7.8 versus 11.0±5.2 mm(3) proliferation volume/cm stent length; P=0.002). No significant focal in-stent stenosis analyzed with angiography (percentage diameter stenosis at follow-up, 22.8±11.9 versus 16.9±10.4; P=0.014) and optical coherence tomography (peak local area stenosis, 39.5±13.8% versus 36.8±15.6%; P=0.409) was found.
  
  
  CONCLUSIONS
  Good stent strut coverage of >94% was found in both therapy groups. Despite greater suppression of global neointimal growth in DES, both DES and BMS+DEB effectively prevented clinically relevant focal restenosis at 6-month follow-up.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT01056744.
authors.affiliation: From the 1st Department of Medicine, Division of Cardiology, University Hospital of Jena, Jena, Germany (T.C.P., S.O., J.G., K.N., F.J., B.G., C.J., H.R.F.); and Clinical and Experimental Interventional Cardiology, Internal Medicine III, University of Saarland, Saarbrücken, Germany (B.S.).
authors.forename: Tudor C
authors.initials: TC
authors.lastname: Poerner
authors.affiliation: From the 1st Department of Medicine, Division of Cardiology, University Hospital of Jena, Jena, Germany (T.C.P., S.O., J.G., K.N., F.J., B.G., C.J., H.R.F.); and Clinical and Experimental Interventional Cardiology, Internal Medicine III, University of Saarland, Saarbrücken, Germany (B.S.). sylvia.otto@med.uni-jena.de.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Otto
authors.affiliation: From the 1st Department of Medicine, Division of Cardiology, University Hospital of Jena, Jena, Germany (T.C.P., S.O., J.G., K.N., F.J., B.G., C.J., H.R.F.); and Clinical and Experimental Interventional Cardiology, Internal Medicine III, University of Saarland, Saarbrücken, Germany (B.S.).
authors.forename: Johannes
authors.initials: J
authors.lastname: Gassdorf
authors.affiliation: From the 1st Department of Medicine, Division of Cardiology, University Hospital of Jena, Jena, Germany (T.C.P., S.O., J.G., K.N., F.J., B.G., C.J., H.R.F.); and Clinical and Experimental Interventional Cardiology, Internal Medicine III, University of Saarland, Saarbrücken, Germany (B.S.).
authors.forename: Kristina
authors.initials: K
authors.lastname: Nitsche
authors.affiliation: From the 1st Department of Medicine, Division of Cardiology, University Hospital of Jena, Jena, Germany (T.C.P., S.O., J.G., K.N., F.J., B.G., C.J., H.R.F.); and Clinical and Experimental Interventional Cardiology, Internal Medicine III, University of Saarland, Saarbrücken, Germany (B.S.).
authors.forename: Florian
authors.initials: F
authors.lastname: Janiak
authors.affiliation: From the 1st Department of Medicine, Division of Cardiology, University Hospital of Jena, Jena, Germany (T.C.P., S.O., J.G., K.N., F.J., B.G., C.J., H.R.F.); and Clinical and Experimental Interventional Cardiology, Internal Medicine III, University of Saarland, Saarbrücken, Germany (B.S.).
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
authors.affiliation: From the 1st Department of Medicine, Division of Cardiology, University Hospital of Jena, Jena, Germany (T.C.P., S.O., J.G., K.N., F.J., B.G., C.J., H.R.F.); and Clinical and Experimental Interventional Cardiology, Internal Medicine III, University of Saarland, Saarbrücken, Germany (B.S.).
authors.forename: Björn
authors.initials: B
authors.lastname: Goebel
authors.affiliation: From the 1st Department of Medicine, Division of Cardiology, University Hospital of Jena, Jena, Germany (T.C.P., S.O., J.G., K.N., F.J., B.G., C.J., H.R.F.); and Clinical and Experimental Interventional Cardiology, Internal Medicine III, University of Saarland, Saarbrücken, Germany (B.S.).
authors.forename: Christian
authors.initials: C
authors.lastname: Jung
authors.affiliation: From the 1st Department of Medicine, Division of Cardiology, University Hospital of Jena, Jena, Germany (T.C.P., S.O., J.G., K.N., F.J., B.G., C.J., H.R.F.); and Clinical and Experimental Interventional Cardiology, Internal Medicine III, University of Saarland, Saarbrücken, Germany (B.S.).
authors.forename: Hans R
authors.initials: HR
authors.lastname: Figulla
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D049109:Cell Proliferation / Q000187:drug effects; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000517:prevention & control*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D058426:Neointima; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D015607:Stents; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D062666:Vascular Access Devices
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D008670:Metals; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus
keywords: coronary stenosis; drug-eluting stents; percutaneous coronary intervention; tomography, optical coherence; transluminal coronary balloon dilation