title: Long-Term Outcomes After Treatment With a Paclitaxel-Coated Balloon Versus Balloon Angioplasty: Insights From the PEPCAD-DES Study (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel-Coated Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter).
abstract: OBJECTIVE
  The intention this PEPCAD-DES (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter) study update was to demonstrate the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in patients with DES-ISR at 3 years.
  
  
  BACKGROUND
  In the PEPCAD-DES trial late lumen loss and the need for repeat target lesion revascularization (TLR) was significantly reduced with PCB angioplasty compared with plain old balloon angioplasty (POBA) in patients with drug-eluting stent in-stent restenosis (DES-ISR) at 6 months. We evaluated whether the clinical benefit of reduced TLR and major adverse cardiac events (MACE) was maintained up to 3 years.
  
  
  METHODS
  A total of 110 patients with DES-ISR in native coronary arteries with reference diameters ranging from 2.5 mm to 3.5 mm and lesion lengths ≤22 mm were randomized to treatment with either PCB or POBA in a multicenter, randomized, single-blind clinical study. With a 2:1 randomization, 72 patients were randomized to the PCB group and 38 patients to the POBA group. At baseline, there were lesions with at least 2 stent layers in PCB (52.8%, 38 of 72) and POBA (55.3%, 21 of 38) patients.
  
  
  RESULTS
  At 36 months, the TLR rates were significantly lower in the PCB group compared with the POBA control group (19.4% vs. 36.8%; p = 0.046). Multiple TLRs in individual patients were more frequent in the POBA group compared with the PCB group (more than 1 TLR: POBA, 13.2%; PCB, 1.4%; p = 0.021). The 36-month MACE rate was significantly reduced in the PCB group compared with the POBA group (20.8% vs. 52.6%, log-rank p = 0.001).
  
  
  CONCLUSIONS
  PCB angioplasty was superior to POBA for the treatment of DES-ISR patients in terms of MACE and TLR for up to 36 months. There was no late catch-up phenomenon. (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter [PEPCAD-DES]; NCT00998439).
authors.affiliation: Medizinische Klinik I, Klinikum Fuerth, Fuerth, Germany. Electronic address: harald.rittger@klinikum-fuerth.de.
authors.forename: Harald
authors.initials: H
authors.lastname: Rittger
authors.affiliation: Medical Scientific Affairs, B. Braun Vascular Systems, Berlin, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Waliszewski
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, Fuerth, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hohenforst-Schmidt
authors.affiliation: Klinik für Kardiologie, Zentralklinikum Bad Berka, Bad Berka, Germany.
authors.forename: Marc
authors.initials: M
authors.lastname: Ohlow
authors.affiliation: Klinik für Kardiologie, Klinikum Kulmbach, Kulmbach, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Brugger
authors.affiliation: Medizinische Klinik II, Universitätsklinikum Lübeck, Lübeck, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
authors.affiliation: Herzklinik Ulm, Ulm, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Birkemeyer
authors.affiliation: Abteilung für Innere Medizin/Kardiologie, Krankenhaus Mölln-Ratzeburg, Mölln-Ratzeburg, Germany.
authors.forename: Volkhard
authors.initials: V
authors.lastname: Kurowski
authors.affiliation: Medizinische Klinik 2, Universitätsklinikum Erlangen, Erlangen, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Schlundt
authors.affiliation: Klinik für Innere/Medizin Kardiologie, Diakonissenhaus Flensburg, Flensburg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Zimmermann
authors.affiliation: Medizinische Klinik I, Klinikum Fuerth, Fuerth, 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: Werner G
authors.initials: WG
authors.lastname: Daniel
authors.affiliation: Medizinische Klinik 2, Universitätsklinikum Erlangen, Erlangen, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Achenbach
authors.affiliation: Klinik für Innere Medizin II, Universitätsklinikum Ulm, Ulm, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005260:Female; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D019233:Retreatment; D012307:Risk Factors; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: balloon angioplasty; drug-coated balloon; drug-eluting stent(s); in-stent restenosis