title: Angiographic outcomes with biodegradable polymer and permanent polymer drug-eluting stents.
abstract: BACKGROUND
  In the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) trial, we demonstrated the noninferiority of biodegradable polymer (BP) sirolimus-eluting stent to permanent polymer (PP) sirolimus/everolimus-eluting stent (Cypher/Xience-V) on the basis of clinical outcomes. In this study, we compare the antirestenotic efficacy of these stents in ISAR-TEST-4 patients with paired angiographic studies.
  
  
  METHODS
  Patients with de novo coronary lesions in native vessels (excluding left main lesions) were randomly assigned to receive a BP stent or a PP stent. Endpoints of interest of this study were in-stent late lumen loss, in-segment binary restenosis, and restenosis morphology at 6-8-month follow-up angiogram.
  
  
  RESULTS
  Of the 2,603 patients (3,372 lesions) enrolled in ISAR TEST-4 trial, 2,016 patients (2,637 lesions) underwent repeat angiographic examination 6-8 months after randomization: 1,006 patients (1,323 lesions) treated with BP stents and 1,010 patients (1,314 lesions) treated with PP stents. No difference was observed between BP and PP stents in in-stent late lumen loss (0.24 ± 0.6 vs. 0.26 ± 0.5 mm, respectively, P = 0.49) or in in-segment binary restenosis (11.6% [153 lesions] vs. 11.8% [155 lesions], P = 0.85). Focal pattern of restenosis was observed in the majority of patients receiving either BP or PP stents. The diffuse pattern of restenosis was observed in 26.8% of patients treated with BP stent and 26.5% of patients treated with PP stent (P = 0.79).
  
  
  CONCLUSIONS
  Angiographic characteristics of restenosis after BP-based limus-eluting stents are similar to those of PP-based limus-eluting stents.
authors.affiliation: Department of Cardiology, Deutsches Herzzentrum, Technische Universität, Munich, Germany. Kufners@dhm.mhn.de
authors.forename: Sebastian
authors.initials: S
authors.lastname: Kufner
authors.forename: Steffen
authors.initials: S
authors.lastname: Massberg
authors.forename: Michael
authors.initials: M
authors.lastname: Dommasch
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.forename: Klaus
authors.initials: K
authors.lastname: Tiroch
authors.forename: Sabine
authors.initials: S
authors.lastname: Ranftl
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Fusaro
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000209:etiology / Q000517:prevention & control; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011108:Polymers / Q000737:chemistry*; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus