title: Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and Xience V drug-eluting stents.
abstract: OBJECTIVE
  The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial population in baseline characteristics and one-year outcome.
  
  
  RESULTS
  Characteristics of 1,709 eligible patients were analysed. Independent external adjudication of clinical events was likewise performed for non-enrolled (n=318) and randomised patients (n=1,391). Non-enrolled and randomised patients did not differ in gender distribution, diabetes mellitus, and clinical presentation, but differed significantly in age and cardiovascular history. Nevertheless, clinical outcome after one year did not differ in the primary composite endpoint target-vessel failure (TVF; 9.8% vs. 8.1%; p=0.34), and its components cardiac death (1.6% vs. 1.2%; p=0.61), target vessel-related myocardial infarction (4.7% vs. 4.6%; p=0.92), and target-vessel revascularisation (3.8% vs. 3.0%; p=0.48). Previous bypass surgery predicted TVF in non-enrolled patients (p=0.001); removal of these patients resulted in identical TVF rates for non-enrolled and randomised patients (7.3% vs. 7.3%; p=0.99).
  
  
  CONCLUSIONS
  Despite some differences in baseline characteristics, non-enrolled and randomised patients did not differ in one-year outcome, which was favourable for both populations and may be related to the drug-eluting stents used.
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Hanim
authors.initials: H
authors.lastname: Sen
authors.forename: Kenneth
authors.initials: K
authors.lastname: Tandjung
authors.forename: Mounir W Z
authors.initials: MW
authors.lastname: Basalus
authors.forename: Marije M
authors.initials: MM
authors.lastname: Löwik
authors.forename: Gert K
authors.initials: GK
authors.lastname: van Houwelingen
authors.forename: Martin G
authors.initials: MG
authors.lastname: Stoel
authors.forename: Hans W
authors.initials: HW
authors.lastname: Louwerenburg
authors.forename: Frits H A F
authors.initials: FH
authors.lastname: de Man
authors.forename: Gerard C M
authors.initials: GC
authors.lastname: Linssen
authors.forename: Rogier
authors.initials: R
authors.lastname: Nijhuis
authors.forename: Mark B
authors.initials: MB
authors.lastname: Nienhuis
authors.forename: Patrick M J
authors.initials: PM
authors.lastname: Verhorst
authors.forename: Job
authors.initials: J
authors.lastname: van der Palen
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D004608:Eligibility Determination; D000068338:Everolimus; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology; D009426:Netherlands; D016017:Odds Ratio; D018579:Patient Selection; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus