title: Clinical Events and Patient-Reported Chest Pain in All-Comers Treated With Resolute Integrity and Promus Element Stents: 2-Year Follow-Up of the DUTCH PEERS (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial (TWENTE II).
abstract: OBJECTIVE
  This study assessed clinical events and patient-reported chest pain 2 years after treatment of all-comers with Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, California) and Promus Element everolimus-eluting stents (Boston Scientific, Natick, Massachusetts).
  
  
  BACKGROUND
  For both drug-eluting stents (DES), no all-comer outcome data from >12 months of follow-up have been published. Although there is increasing interest in patient-reported chest pain following stenting, data with novel DES are scarce.
  
  
  METHODS
  The DUTCH PEERS multicenter trial (TWENTE II) (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial [TWENTE II]) randomized 1,811 all-comer patients to treatment with 1 type of DES. Monitoring and event adjudication were performed by independent contract research organizations.
  
  
  RESULTS
  The 2-year follow-up of 1,810 patients (99.9%) was available. The primary composite endpoint target vessel failure occurred in 8.6% and 7.8% of patients treated with zotarolimus- and everolimus-eluting stents, respectively (p = 0.55). Rates of components of target vessel failure were: cardiac death (2.4% vs. 1.9%, p = 0.42); target vessel-related myocardial infarction (2.4% vs. 1.8%, p = 0.33); clinically-indicated target vessel revascularization (4.6% vs. 4.9%, p = 0.83). At 1- and 2-year follow-up, >80% of patients were free from chest pain (no between-stent difference). In addition, >87% of patients were either free from chest pain or experienced pain only at maximal physical exertion, but not during normal daily activities. Patients with chest pain after 12 months at no more than moderate physical effort had a higher risk of target vessel revascularization during the following year (hazard ratio: 1.89 [95% confidence interval: 1.05 to 3.39], p = 0.03).
  
  
  CONCLUSIONS
  During the second year of follow-up, the incidence of adverse clinical endpoints remained similar and low for both DES. The vast majority of patients were free from chest pain.
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: Marije M
authors.initials: MM
authors.lastname: Löwik
authors.affiliation: Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.
authors.forename: Peter W
authors.initials: PW
authors.lastname: Danse
authors.affiliation: Department of Cardiology, Scheper Hospital, Emmen, the Netherlands.
authors.forename: Gillian A J
authors.initials: GA
authors.lastname: Jessurun
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, Scheper Hospital, Emmen, the Netherlands.
authors.forename: Rutger L
authors.initials: RL
authors.lastname: Anthonio
authors.affiliation: Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.
authors.forename: R Melvyn
authors.initials: RM
authors.lastname: Tjon Joe Gin
authors.affiliation: Department of Cardiology, Medical Center Alkmaar, Alkmaar, the Netherlands.
authors.forename: Raymond W M
authors.initials: RW
authors.lastname: Hautvast
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: J Hans W
authors.initials: JH
authors.lastname: Louwerenburg
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: Frits H A F
authors.initials: FH
authors.lastname: de Man
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: Liefke C
authors.initials: LC
authors.lastname: van der Heijden
authors.affiliation: Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands.
authors.forename: Gerard C M
authors.initials: GC
authors.lastname: Linssen
authors.affiliation: Department of Health Technology and Services Research, University of Twente, Enschede, the Netherlands.
authors.forename: Maarten J
authors.initials: MJ
authors.lastname: IJzerman
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 Health Technology and Services Research, University of Twente, Enschede, the Netherlands.
authors.forename: Carine J M
authors.initials: CJ
authors.lastname: Doggen
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands. Electronic address: c.vonbirgelen@mst.nl.
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
mesh_terms: D000368:Aged; D000787:Angina Pectoris / Q000209:etiology / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus
keywords: DES; EES; Promus Element platinum-chromium everolimus-eluting stent; Resolute Integrity cobalt-chromium zotarolimus-eluting stent; ZES; all-comer/all-comers; drug-eluting-stents; percutaneous coronary intervention; randomized clinical trial