title: Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent: 4-year results of the PROTECT randomized trial.
abstract: OBJECTIVE
  To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour (E-ZES) vs. Cypher (C-SES) Stenting Trial (PROTECT). At 3 years, there was no difference in the primary outcome of definite or probable stent thrombosis or in the other main secondary clinical outcomes consisting of the composite of death or myocardial infarction (MI). Prespecified 4-year clinical follow-up was analysed.
  
  
  RESULTS
  Patient Related OuTcomes with Endeavour vs. Cypher Stenting Trial was a prospective, open-label randomized-controlled superiority trial powered to look at differences in long-term clinical safety, including stent thrombosis. Dual antiplatelet therapy (DAPT) was prescribed for ≥ 3 months and up to 12 months based on current guidelines. Patient Related OuTcomes with Endeavour vs. Cypher Stenting Trial enrolled 8791 patients undergoing elective or emergency PCI to E-ZES or C-SES. There was no difference in DAPT usage between the two groups up to 4 years. At 4-year follow-up, the primary outcome occurred in 1.6% of E-ZES vs. 2.6% of C-SES patients [HR 0.63 (95% CI 0.46-0.85), P = 0.003]. The composite of all-cause death or large MI occurred in 6.7% of E-ZES vs. 8.0% of C-SES-treated patients [HR 0.84 (95% CI 0.71-0.98), P = 0.024].
  
  
  CONCLUSIONS
  Drug-eluting coronary stents with different healing characteristics demonstrated different late safety profiles: after 4 years, compared with C-SES, E-ZES reduced the risk of stent thrombosis and the risk of the composite endpoints of death or MI. Appropriately powered large-scale trials with long-term follow-up are critical to determine clinical safety and efficacy of permanently implanted coronary stents. This trial is registered with ClinicalTrials.gov, number NCT00476957.
authors.affiliation: Cardiovascular Center, OLV Hospital, Aalst, Belgium.
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.affiliation: Département Hospitalo-Universitaire FIRE, INSERM U-1148, F75018 Paris, France Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France AP-HP, Hôpital Bichat, F75018 Paris, France NHLI Imperial College, ICMS, Royal Brompton Hospital, London, UK.
authors.forename: Ph Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.affiliation: Universitätsklinikum Lübeck, Lübeck, Germany.
authors.forename: Volkhard
authors.initials: V
authors.lastname: Kurowski
authors.affiliation: The Heart Care Clinic, Ahmedabad, India.
authors.forename: Keyur
authors.initials: K
authors.lastname: Parikh
authors.affiliation: Cardiovascular Institute and Fuwai Hospital, Beijing, China.
authors.forename: Runlin
authors.initials: R
authors.lastname: Gao
authors.affiliation: University Hospital Freiburg, Freiburg im Breisgau, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Bode
authors.affiliation: Leeds General Infirmary, Leeds, UK.
authors.forename: John P
authors.initials: JP
authors.lastname: Greenwood
authors.affiliation: University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Erik
authors.initials: E
authors.lastname: Lipsic
authors.affiliation: Castle Hill Hospital, Cottingham, UK.
authors.forename: Farqad
authors.initials: F
authors.lastname: Alamgir
authors.affiliation: Cardialysis BV, Rotterdam, The Netherlands.
authors.forename: Tessa
authors.initials: T
authors.lastname: Rademaker-Havinga
authors.affiliation: Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Eric
authors.initials: E
authors.lastname: Boersma
authors.affiliation: Schön Klinik Neustadt, Neustadt, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Radke
authors.affiliation: Medtronic Bakken Research Center, Maastricht, The Netherlands.
authors.forename: Frank
authors.initials: F
authors.lastname: van Leeuwen
authors.affiliation: University of Geneva, 1 rue Micheli-Servet, Geneva, Switzerland CHU Nancy, Institut Lorrain du Coeur et des Vaisseaux, F54511 Vandoeuvre-lès-Nancy, France edoardo@camenzind-cardio.net.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Camenzind
mesh_terms: D023903:Coronary Restenosis / Q000517:prevention & control*; D003328:Coronary Thrombosis / Q000517:prevention & control*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006083:Graft Occlusion, Vascular / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D011475:Prosthesis Failure; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; C489443:zotarolimus; D020123:Sirolimus
keywords: Drug-eluting stent; Endothelialization; Late stent thrombosis; Myocardial infarction; Sirolimus; Zotarolimus