title: Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial.
abstract: OBJECTIVE
  Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI.
  
  
  RESULTS
  ABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90% CI) -1.06 (-1.96, -0.16); Pnon-inferiority < 0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1% Absorb vs. 0% EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1% vs. 0% EES; P = ns).
  
  
  CONCLUSIONS
  Stenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials.
authors.affiliation: Thorax Institute, University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.
authors.forename: Manel
authors.initials: M
authors.lastname: Sabaté
authors.affiliation: Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Meixoeiro Hospital, Vigo, Spain.
authors.forename: Andres
authors.initials: A
authors.lastname: Iñiguez
authors.affiliation: Odense University Hospital, Odense, Denmark.
authors.forename: Lisette
authors.initials: L
authors.lastname: Okkels-Jensen
authors.affiliation: Bellvitge University Hospital, Barcelona, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Cequier
authors.affiliation: Thorax Institute, University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Brugaletta
authors.affiliation: Medical Center Leeuwarden, The Netherlands.
authors.forename: Sjoerd H
authors.initials: SH
authors.lastname: Hofma
authors.affiliation: Bern University Hospital, Bern, Switzerland.
authors.forename: Lorenz
authors.initials: L
authors.lastname: Räber
authors.affiliation: Aarhus University Hospital, Skejby, Denmark.
authors.forename: Evald Høi
authors.initials: EH
authors.lastname: Christiansen
authors.affiliation: St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: Maarten
authors.initials: M
authors.lastname: Suttorp
authors.affiliation: Bern University Hospital, Bern, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
authors.affiliation: Cardialysis B.V., Rotterdam, The Netherlands European Cardiovascular Research Institute (ECRI), Rotterdam, The Netherlands.
authors.forename: Gerrit
authors.initials: G
authors.lastname: Anne van Es
authors.affiliation: The Heart Center, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Sotomi
authors.affiliation: Cardialysis B.V., Rotterdam, The Netherlands.
authors.forename: Hector M
authors.initials: HM
authors.lastname: García-García
authors.affiliation: Cardialysis B.V., Rotterdam, The Netherlands Thorax Centre, Erasmus MC, PO Box 2125, 3000 CC Rotterdam, The Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: European Cardiovascular Research Institute (ECRI), Rotterdam, The Netherlands International Center for Circulatory Health, NHLI, Imperial College, London, UK patrick.w.j.c.serruys@gmail.com.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D020341:Absorbable Implants; D017023:Coronary Angiography / Q000379:methods; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008670:Metals; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011108:Polymers; D011474:Prosthesis Design; D000072657:ST Elevation Myocardial Infarction / Q000000981:diagnostic imaging / Q000628:therapy*; D016037:Single-Blind Method; D054457:Tissue Scaffolds; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology
chemical_list: D007166:Immunosuppressive Agents; D008670:Metals; D011108:Polymers; D000068338:Everolimus
keywords: Bioresorbable scaffold; Optical coherence tomography; Randomized control study; ST elevation myocardial infarction