title: Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry.
abstract: OBJECTIVE
  Clinical data on the early and midterm outcomes of bioresorbable vascular scaffolds (BVS) in routine clinical practice are limited. To fill this gap, we report on the early and midterm clinical outcomes of PCI with everolimus-eluting BVS from the large multicentre GHOST-EU registry.
  
  
  RESULTS
  Between November 2011 and January 2014, 1,189 patients underwent percutaneous coronary intervention with one or more BVS (Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) at 10 European centres. The primary outcome of interest was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation (TLR). A total of 1,731 Absorb BVS were implanted at a mean of 12.3±3.4 atm. Technical success was achieved in 99.7% of cases. TLF was recorded in 67 of 1,189 patients at a median of 109 (interquartile range 8-227) days after implantation. The cumulative incidence of TLF was 2.2% at 30 days and 4.4% at six months. The annualised rate of TLF was 10.1%. At six months, the rate of cardiac death was 1.0%, target vessel myocardial infarction was 2.0%, TLR was 2.5%, and target vessel revascularisation was 4.0%. Diabetes mellitus was the only independent predictor of TLF (hazard ratio 2.41, 95% confidence interval: 1.28-4.53; p=0.006). The cumulative incidence of definite/probable scaffold thrombosis was 1.5% at 30 days and 2.1% at six months, with 16 of 23 cases occurring within 30 days.
  
  
  CONCLUSIONS
  "Real-world" outcomes of BVS showed acceptable rates of TLF at six months, although the rates of early and midterm scaffold thrombosis, mostly clustered within 30 days, were not negligible.
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Capodanno
authors.forename: Tommaso
authors.initials: T
authors.lastname: Gori
authors.forename: Holger
authors.initials: H
authors.lastname: Nef
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Maciej
authors.initials: M
authors.lastname: Lesiak
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Caramanno
authors.forename: Christoph
authors.initials: C
authors.lastname: Naber
authors.forename: Carlo
authors.initials: C
authors.lastname: Di Mario
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Piera
authors.initials: P
authors.lastname: Capranzano
authors.forename: Jens
authors.initials: J
authors.lastname: Wiebe
authors.forename: Aleksander
authors.initials: A
authors.lastname: Araszkiewicz
authors.forename: Salvatore
authors.initials: S
authors.lastname: Geraci
authors.forename: Stelios
authors.initials: S
authors.lastname: Pyxaras
authors.forename: Alessio
authors.initials: A
authors.lastname: Mattesini
authors.forename: Toru
authors.initials: T
authors.lastname: Naganuma
authors.forename: Thomas
authors.initials: T
authors.lastname: Münzel
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
mesh_terms: D020341:Absorbable Implants; D054058:Acute Coronary Syndrome / Q000188:drug therapy / Q000601:surgery*; D000368:Aged; D000787:Angina Pectoris / Q000188:drug therapy / Q000601:surgery*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000401:mortality; D015897:Comorbidity; D003324:Coronary Artery Disease / Q000188:drug therapy / Q000601:surgery*; D003920:Diabetes Mellitus / Q000453:epidemiology; D054855:Drug-Eluting Stents; D005060:Europe; D000068338:Everolimus / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000453:epidemiology / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation; D016016:Proportional Hazards Models; D012086:Reoperation; D012307:Risk Factors; D013927:Thrombosis / Q000453:epidemiology; D054457:Tissue Scaffolds; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000068338:Everolimus