title: A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial.
abstract: OBJECTIVE
  The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up.
  
  
  BACKGROUND
  Only 1 randomized trial previously compared these stents.
  
  
  METHODS
  This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4% of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100% follow-up data available). Analysis was by intention-to-treat.
  
  
  RESULTS
  Acute coronary syndromes were present in 52% and "off-label" feature in 77% of patients. Of the lesions, 70% were type B2/C; the post-dilation rate was very high (82%). In ZES and EES, TVF occurred in 8.2% and 8.1%, respectively (absolute risk-difference 0.1%; 95% confidence interval: -2.8% to 3.0%, p(noninferiority) = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9% and 1.2%, respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58% and 0%, respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy.
  
  
  CONCLUSIONS
  Resolute ZES were noninferior to Xience V EES in treating "real-world" patients with a vast majority of complex lesions and "off-label" indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; NCT01066650).
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands. c.vonbirgelen@mst.nl
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
authors.forename: Mounir W Z
authors.initials: MW
authors.lastname: Basalus
authors.forename: Kenneth
authors.initials: K
authors.lastname: Tandjung
authors.forename: K Gert
authors.initials: KG
authors.lastname: van Houwelingen
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: Salah A M
authors.initials: SA
authors.lastname: Saïd
authors.forename: Miep A W J
authors.initials: MA
authors.lastname: Kleijne
authors.forename: Hanim
authors.initials: H
authors.lastname: Sen
authors.forename: Marije M
authors.initials: MM
authors.lastname: Löwik
authors.forename: Job
authors.initials: J
authors.lastname: van der Palen
authors.forename: Patrick M J
authors.initials: PM
authors.lastname: Verhorst
authors.forename: Frits H A F
authors.initials: FH
authors.lastname: de Man
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000601:surgery*; D054855:Drug-Eluting Stents; D004562:Electrocardiography; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012189:Retrospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus