title: Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: development and internal validation of the PSP score.
abstract: OBJECTIVE
  The aim of the study was to develop a scoring model to evaluate the quality of bioresorbable vascular scaffold (BVS) implantation and determine the model's usefulness in predicting adverse cardiac events.
  
  
  RESULTS
  The implantation technique and clinical outcomes of 1,736 lesions treated with BVS were analysed using the GHOST-EU registry. Predilation, scaffold sizing, and post-dilation (PSP) were scored according to the hazard model derived from the weight of these variables. The primary endpoint was a one-year device-oriented composite endpoint (DoCE) composed of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation. Definite/probable scaffold thrombosis was also evaluated as defined by the Academic Research Consortium. The PSP model performance was evaluated by internal validation. Predilation, correct scaffold sizing, and post-dilation with a non-compliant balloon were performed in 95.7%, 50.2%, and 26.2% of the cases and scored 0.63, 1.96 and 1.93 points, respectively, in the PSP-1 model. PSP-1 was an independent predictor of one-year DoCE (HR 0.75, 95% CI: 0.61-0.93; p=0.007), but with poor calibration and discrimination (AUC 0.611, 95% CI: 0.545-0.677). No patient with a maximum PSP-1 score had scaffold thrombosis, compared to those with a non-maximum PSP-1 score (0% vs. 2.3%; p=0.095).
  
  
  CONCLUSIONS
  At one-year follow-up, the PSP-1 score was an independent predictor of DoCE. External validation and prospective studies are needed to determine the clinical usefulness of this score.
authors.affiliation: Cardiovascular Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Ortega-Paz
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: Giuseppe
authors.initials: G
authors.lastname: Caramanno
authors.forename: Carlo
authors.initials: C
authors.lastname: Di Mario
authors.forename: Christoph
authors.initials: C
authors.lastname: Naber
authors.forename: Maciej
authors.initials: M
authors.lastname: Lesiak
authors.forename: Piera
authors.initials: P
authors.lastname: Capranzano
authors.forename: Jens
authors.initials: J
authors.lastname: Wiebe
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Aleksander
authors.initials: A
authors.lastname: Araszkiewicz
authors.forename: Stelios
authors.initials: S
authors.lastname: Pyxaras
authors.forename: Alessio
authors.initials: A
authors.lastname: Mattesini
authors.forename: Salvatore
authors.initials: S
authors.lastname: Geraci
authors.forename: Toru
authors.initials: T
authors.lastname: Naganuma
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Thomas
authors.initials: T
authors.lastname: Münzel
authors.forename: Manel
authors.initials: M
authors.lastname: Sabaté
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.forename: Salvatore
authors.initials: S
authors.lastname: Brugaletta
mesh_terms: D000970:Antineoplastic Agents; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000592:standards*; D000068338:Everolimus; D006801:Humans; D008962:Models, Theoretical; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011183:Postoperative Complications; D012189:Retrospective Studies; D018570:Risk Assessment; D054457:Tissue Scaffolds
chemical_list: D000970:Antineoplastic Agents; D000068338:Everolimus