title: Five-year follow-up of polymer-free sirolimus- and probucol-eluting stents versus new generation zotarolimus-eluting stents in patients presenting with st-elevation myocardial infarction.
abstract: BACKGROUND
  Patients with ST-segment elevation myocardial infarction (STEMI) undergoing drug-eluting stent (DES) implantation are at increased risk of late adverse events, partly explained by an exaggerated inflammatory reaction to durable-polymer stent coatings.
  
  
  OBJECTIVE
  We sought to investigate whether implantation of polymer-free DES would reduce this risk.
  
  
  METHODS
  In the ISAR-TEST 5 (the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol- and Zotarolimus-Eluting Stents) trial, patients were randomly allocated to receive a polymer-free sirolimus- and probucol-eluting stent or a new generation durable-polymer zotarolimus-eluting stent. We analyzed late clinical outcomes in the subgroup of patients presenting with STEMI. The primary endpoint was the combined incidence of cardiac death, target vessel-related myocardial infarction or target lesion revascularization at 5 years.
  
  
  RESULTS
  311 patients with STEMI were randomized to receive sirolimus- and probucol-eluting stents (n = 215) or zotarolimus-eluting stents (n = 96). At 5 years, there was no difference in the incidence of the primary endpoint in patients treated with sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents (18.3% versus 20.1% respectively, hazard ratio = 0.87, 95% CI, 0.50-1.51; P = 0.62). Rates of the individual components of the primary endpoint were also comparable in both groups. The incidence of definite/probable stent thrombosis was 1.4% versus 1.0% respectively (hazard ratio = 1.35, 95% CI, 0.14-12.94, P = 0.80).
  
  
  CONCLUSIONS
  Long-term outcomes of patients with STEMI treated with polymer-free sirolimus- and probucol-eluting stents versus durable-polymer zotarolimus-eluting stents were similar. Stent thrombosis rates were low and comparable in both treatment groups, with no events beyond 12 months.
  
  
  BACKGROUND
  Registered at ClinicalTrials.gov (Identifier NCT 00598533) © 2016 Wiley Periodicals, Inc.
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Roisin
authors.initials: R
authors.lastname: Colleran
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Kufner
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Harada
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Daniele
authors.initials: D
authors.lastname: Giacoppo
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cassese
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Janika
authors.initials: J
authors.lastname: Repp
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Wiebe
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Raphaela
authors.initials: R
authors.lastname: Lohaus
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Annalena
authors.initials: A
authors.lastname: Lahmann
authors.affiliation: I. Medizinische Klinik, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.
authors.forename: Simon
authors.initials: S
authors.lastname: Schneider
authors.affiliation: I. Medizinische Klinik, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.
authors.forename: Tareq
authors.initials: T
authors.lastname: Ibrahim
authors.affiliation: I. Medizinische Klinik, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.|DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Laugwitz
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.|DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003328:Coronary Thrombosis / Q000209:etiology; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers / Q000737:chemistry*; D011341:Probucol / Q000008:administration & dosage* / Q000009:adverse effects; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012008:Recurrence; D012307:Risk Factors; D000072657:ST Elevation Myocardial Infarction / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; C489443:zotarolimus; D011341:Probucol; D020123:Sirolimus
keywords: STEMI; drug-eluting stent; long-term follow-up; probucol; randomized controlled trial; sirolimus; zotarolimus