title: Angiographic patterns of drug-eluting stent restenosis after treatment with drug-coated balloon versus balloon angioplasty: Late lumen loss subgroup analyses of the PEPCAD-DES study.
abstract: OBJECTIVE
  This report provides the results of additional late lumen loss (LLL) analyses the predefined subgroup of diabetics and post hoc analyses of selected lesion morphologies to further elucidate the efficacy of paclitaxel coated balloon (PCB) angioplasty (clinical trials identifier NCT00998439).
  
  
  BACKGROUND
  The PEPCAD-DES trial revealed that in lesion LLL and the target lesion revascularization rate (TLR) were significantly reduced with PCB angioplasty as compared with plain old balloon angioplasty (POBA) in patients with drug-eluting stent restenosis (DES-ISR).
  
  
  METHODS
  A total of 110 patients with restenosis of Sirolimus- (SES), Everolimus- (EES), or Paclitaxel-eluting (PES) stents in native coronary arteries were randomized 2:1 to receive treatment with PCB (72 patients) or POBA (38 patients).
  
  
  RESULTS
  In the PCB group, LLL did not differ for PES versus non-PES lesions (0.46 ± 0.55 mm vs. 0.41 ± 0.65 mm, P = 0.81). Moreover, there was no difference in LLL when PCB's were used in single and multiple layer DES-ISR (0.35 ± 0.60 mm vs. 0.51 ± 0.63 mm, P = 0.31). In contrast, patients treated with POBA for multilayer DES-ISR were more likely to have significantly higher LLL as compared with single layer DES-ISR (1.29 ± 0.76 mm vs. 0.65 ± 0.60 mm, P = 0.02). There was no LLL difference between diabetics and non-diabetics when treated with PCB angioplasty (0.46 ± 0.76 mm vs. 0.43 ± 0.54 mm, P = 0.83).
  
  
  CONCLUSIONS
  Our hypothesis generating results indicated that there were no differences in terms of LLL when PCB angioplasty was applied in subgroups of single versus multiple layer DES-ISR and PES-ISR versus non-PES ISR. LLL was not higher in diabetic patients as compared with the their non-diabetic counterparts when treated with PCB's. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Medizinische Klinik I, Klinikum Fuerth, Fürth, Germany. harald.rittger@klinikum-fuerth.de.
authors.forename: Harald
authors.initials: H
authors.lastname: Rittger
authors.affiliation: Klinik Für Innere Medizin II, Universitätsklinikum Ulm, Ulm, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.affiliation: Medizinische Klinik II, Klinikum Coburg, Coburg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Brachmann
authors.affiliation: Medizinische Klinik I, Klinikum Fuerth, Fürth, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hohenforst-Schmidt
authors.affiliation: Medizinische Klinik 2, Universitätsklinikum Erlangen, Erlangen, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Schlundt
authors.affiliation: Medizinische Klinik I, Klinikum Fuerth, Fürth, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Lonke
authors.affiliation: Klinik Für Neurologie, Universitätsklinikum Freiburg, Freiburg, Germany.
authors.forename: Moritz
authors.initials: M
authors.lastname: von Cranach
authors.affiliation: Klinik Für Innere Medizin II, Universitätsklinikum Ulm, Ulm, Germany.
authors.forename: Sinisa
authors.initials: S
authors.lastname: Markovic
authors.affiliation: Medizinische Klinik 2, Universitätsklinikum Erlangen, Erlangen, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Achenbach
authors.affiliation: Medical Scientific Affairs, B. Braun Vascular Systems, Berlin, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Waliszewski
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects*; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012307:Risk Factors; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D020099:Coated Materials, Biocompatible
keywords: balloon angioplasty; drug-eluting stent; in-stent restenosis; paclitaxel coated balloon