title: Safety of second-generation drug-eluting stents three years after randomised use in the TWENTE trial.
abstract: OBJECTIVE
  To assess three-year clinical outcome following randomised use of the second-generation Resolute zotarolimus-eluting stent (ZES) and the XIENCE V everolimus-eluting stent (EES). For Resolute ZES and randomised use, outcome data ≥3 years are relatively scarce.
  
  
  RESULTS
  The TWENTE trial examined 1,391 patients with stable angina or non-ST-elevation acute coronary syndromes, of whom 21.6% were diabetics, 70.1% had complex B2 or C lesions and 77.4% had "off-label" indications for DES use. Three-year follow-up data were obtained in 1,381 patients (99.3%; 10 withdrawals). Adverse clinical events were independently adjudicated. The primary endpoint target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction and clinically indicated target vessel revascularisation, was 12.1% for Resolute ZES and 13.4% for XIENCE V EES (p=0.50). Cardiac death rates were 1.9% vs. 3.5% (p=0.06); the other individual components of TVF also showed no significant between-group differences. The rates of definite-or-probable stent thrombosis (1.4% vs. 1.6%, p=0.82) and very late stent thrombosis (0.6% vs. 0.4%, p=1.0) did not differ between the groups.
  
  
  CONCLUSIONS
  Three-year follow-up data of patients included in the randomised TWENTE trial demonstrated similar and sustained safety and efficacy of Resolute ZES and XIENCE V EES.
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Marije M
authors.initials: MM
authors.lastname: Löwik
authors.forename: Ming Kai
authors.initials: MK
authors.lastname: Lam
authors.forename: Hanim
authors.initials: H
authors.lastname: Sen
authors.forename: Kenneth
authors.initials: K
authors.lastname: Tandjung
authors.forename: K Gert
authors.initials: KG
authors.lastname: van Houwelingen
authors.forename: Frits H A F
authors.initials: FH
authors.lastname: de Man
authors.forename: Martin G
authors.initials: MG
authors.lastname: Stoel
authors.forename: J Hans W
authors.initials: JH
authors.lastname: Louwerenburg
authors.forename: Gerard C M
authors.initials: GC
authors.lastname: Linssen
authors.forename: Carine J M
authors.initials: CJ
authors.lastname: Doggen
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy / Q000601:surgery*; D000368:Aged; D060050:Angina, Stable / Q000188:drug therapy / Q000601:surgery*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000401:mortality; D023921:Coronary Stenosis / Q000188:drug therapy / Q000601:surgery*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation; D012086:Reoperation; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013927:Thrombosis / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus