title: Incidence and Potential Mechanism(s) of Post-Procedural Rise of Cardiac Biomarker in Patients With Coronary Artery Narrowing After Implantation of an Everolimus-Eluting Bioresorbable Vascular Scaffold or Everolimus-Eluting Metallic Stent.
abstract: OBJECTIVE
  This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation.
  
  
  BACKGROUND
  A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury.
  
  
  METHODS
  In 501 patients with stable or unstable angina randomized to either Absorb (335 patients) or EES (n = 166) in the ABSORB II trial, 3 types of CB (creatine kinase, creatine kinase-myocardial band, and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as creatine kinase rise >2× the upper limit of normal with creatine kinase-myocardial band rise.
  
  
  RESULTS
  Incidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% vs. Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% vs. EES: 19.9%, p = 0.39). Fourteen patients who presented with recent myocardial infarction at entry with normalized creatine kinase-myocardial band according to the protocol were excluded for post-CB analysis. The overall compliance for CB was 97.8%. The CB rise subcategorized in 7 different ranges was comparable between the 2 treatment arms. PMI rate was numerically higher in the Absorb arm according to the per-protocol definitions, and treatment with overlapping devices was the only independent determinant of per-protocol PMI (odds ratio: 5.07, 95% confidence interval: 1.78 to 14.41, p = 0.002).
  
  
  CONCLUSIONS
  There were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury. (ABSORB II Randomized Clinical Trial: A Clinical Evaluation to Compare the Safety, Efficacy, and Performance of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System Against Xience Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by De Novo Native Coronary Artery Lesions [ABSORB II]; NCT01425281).
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Ishibashi
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Muramatsu
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Shimpei
authors.initials: S
authors.lastname: Nakatani
authors.affiliation: The Heart Center, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Sotomi
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Pannipa
authors.initials: P
authors.lastname: Suwannasom
authors.affiliation: The Heart Center, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Maik J
authors.initials: MJ
authors.lastname: Grundeken
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Yun-Kyeong
authors.initials: YK
authors.lastname: Cho
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.affiliation: Medical Center Leeuwarden, Leeuwarden, the Netherlands.
authors.forename: Ad J
authors.initials: AJ
authors.lastname: van Boven
authors.affiliation: The Heart Center, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Jan J
authors.initials: JJ
authors.lastname: Piek
authors.affiliation: Thorax Institute, Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
authors.forename: Manel
authors.initials: M
authors.lastname: Sabaté
authors.affiliation: Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Steffen
authors.initials: S
authors.lastname: Helqvist
authors.affiliation: Bristol Heart Institute, Bristol, United Kingdom.
authors.forename: Andreas
authors.initials: A
authors.lastname: Baumbach
authors.affiliation: Christchurch Hospital, Christchurch, New Zealand.
authors.forename: Dougal
authors.initials: D
authors.lastname: McClean
authors.affiliation: Hospital Santa Cruz, Carnaxide, Portugal.
authors.forename: Manuel
authors.initials: M
authors.lastname: de Sousa Almeida
authors.affiliation: Abbott Vascular, Diegem, Belgium.
authors.forename: Luc
authors.initials: L
authors.lastname: Wasungu
authors.affiliation: Abbott Vascular, Diegem, Belgium.
authors.forename: Karine
authors.initials: K
authors.lastname: Miquel-Hebert
authors.affiliation: Jagiellonian University, Krakow, Poland.
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.affiliation: Institut Jacques Cartier, Massy, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: International Centre for Cardiovascular Health, Imperial College, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D015415:Biomarkers / Q000097:blood; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D052279:Creatine Kinase, MB Form / Q000097:blood*; D054855:Drug-Eluting Stents; D005060:Europe; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D008670:Metals; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000097:blood / Q000175:diagnosis / Q000453:epidemiology*; D009520:New Zealand; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000295:instrumentation*; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014336:Troponin / Q000097:blood*; D015854:Up-Regulation
chemical_list: D015415:Biomarkers; D002317:Cardiovascular Agents; D008670:Metals; D014336:Troponin; D000068338:Everolimus; D052279:Creatine Kinase, MB Form
keywords: bioresorbable scaffold; cardiac biomarker; device overlap; periprocedural myocardial infarction