title: Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial.
abstract: BACKGROUND
  Newer-generation drug-eluting stents that release zotarolimus or everolimus have been shown to be superior to the first-generation drug-eluting stents. However, data comparing long-term safety and efficacy of zotarolimus- (ZES) and everolimus-eluting stents (EES) are limited. RESOLUTE all-comers (Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) trial compared these 2 stents and has shown that ZES was noninferior to EES at 12-month for the primary end point of target lesion failure. We report the secondary clinical outcomes at the final 5-year follow-up of this trial.
  
  
  RESULTS
  RESOLUTE all-comer clinical study is a prospective, multicentre, randomized, 2-arm, open-label, noninferiority trial with minimal exclusion criteria. Patients (n=2292) were randomly assigned to treatment with either ZES (n=1140) or EES (n=1152). Patient-oriented composite end point (combination of all-cause mortality, myocardial infarction, and any revascularizations), device-oriented composite end point (combination of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization), and major adverse cardiac events (combination of all-cause death, all myocardial infarction, emergent coronary bypass surgery, or clinically indicated target lesion revascularization) were analyzed at 5-year follow-up. The 2 groups were well-matched at baseline. Five-year follow-up data were available for 98% patients. There were no differences in patient-oriented composite end point (ZES 35.3% versus EES 32.0%, P=0.11), device-oriented composite end point (ZES 17.0% versus EES 16.2%, P=0.61), major adverse cardiac events (ZES 21.9% versus EES 21.6%, P=0.88), and definite/probable stent thrombosis (ZES 2.8% versus EES 1.8%, P=0.12).
  
  
  CONCLUSIONS
  At 5-year follow-up, ZES and EES had similar efficacy and safety in a population of patients who had minimal exclusion criteria.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00617084.
authors.affiliation: From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
authors.forename: Javaid
authors.initials: J
authors.lastname: Iqbal
authors.affiliation: From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.). patrick.w.j.c.serruys@gmail.com.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.affiliation: From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
authors.forename: Henning
authors.initials: H
authors.lastname: Kelbaek
authors.affiliation: From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.affiliation: From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
authors.forename: Marie-Angele
authors.initials: MA
authors.lastname: Morel
authors.affiliation: From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
authors.forename: Manuela
authors.initials: M
authors.lastname: Negoita
authors.affiliation: From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
authors.forename: Pawel E
authors.initials: PE
authors.lastname: Buszman
authors.affiliation: From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data*; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus
keywords: drug-eluting stent; everolimus; percutaneous coronary interventions; zotarolimus