title: Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting resolute and everolimus-eluting Xience V stents: 2-year follow-up of the randomized TWENTE trial.
abstract: OBJECTIVE
  The aim of this study was to assess the safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) (Medtronic Inc., Santa Rosa, California) and Xience V everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, California) following strict discontinuation of dual antiplatelet therapy (DAPT) after 12 months.
  
  
  BACKGROUND
  Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents.
  
  
  METHODS
  The randomized TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial is an investigator-initiated study performed in a population with many complex patients and lesions and only limited exclusion criteria. Patients were randomly assigned 1:1 to ZES (n = 697) or EES (n = 694).
  
  
  RESULTS
  Two-year follow-up information was available on all patients. The rate of continuation of DAPT beyond 12 months was very low (5.4%). The primary endpoint of target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization, did not differ between ZES and EES (10.8% vs. 11.6, p = 0.65), despite fewer target lesion revascularizations in patients with EES (2.6% vs. 4.9%, p = 0.03). The patient-oriented composite endpoint was similar (16.4% vs. 17.1%, p = 0.75). Two-year rates of definite or probable stent thrombosis were 1.2% and 1.4%, respectively (p = 0.63). Very late definite or probable stent thrombosis occurred only in 2 patients in each study arm (0.3% vs. 0.3%, p = 1.00).
  
  
  CONCLUSIONS
  After 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for drug-eluting stents. (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente [TWENTE]; NCT01066650).
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Tandjung
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: Hanim
authors.initials: H
authors.lastname: Sen
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: Ming Kai
authors.initials: MK
authors.lastname: Lam
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: Mounir W Z
authors.initials: MWZ
authors.lastname: Basalus
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: J Hans W
authors.initials: JHW
authors.lastname: Louwerenburg
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: Martin G
authors.initials: MG
authors.lastname: Stoel
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: K Gert
authors.initials: KG
authors.lastname: van Houwelingen
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: Frits H A F
authors.initials: FHAF
authors.lastname: de Man
authors.affiliation: Department of Cardiology, Ziekenhuisgroep Twente, Almelo, the Netherlands.
authors.forename: Gerard C M
authors.initials: GCM
authors.lastname: Linssen
authors.affiliation: Department of Cardiology, Ziekenhuisgroep Twente, Hengelo, the Netherlands.
authors.forename: Salah A M
authors.initials: SAM
authors.lastname: Saïd
authors.affiliation: Department of Cardiology, Streekziekenhuis Koningin Beatrix, Winterswijk, the Netherlands.
authors.forename: Mark B
authors.initials: MB
authors.lastname: Nienhuis
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: Marije M
authors.initials: MM
authors.lastname: Löwik
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: Patrick M J
authors.initials: PMJ
authors.lastname: Verhorst
authors.affiliation: Department of Epidemiology, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Research Methodology, Measurement and Data Analysis, University of Twente, Enschede, the Netherlands.
authors.forename: Job
authors.initials: J
authors.lastname: van der Palen
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, MIRA-Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, the Netherlands. Electronic address: c.vonbirgelen@mst.nl.
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
mesh_terms: D000368:Aged; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013927:Thrombosis / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus