title: Italian Diffuse/Multivessel Disease ABSORB Prospective Registry (IT-DISAPPEARS). Study design and rationale.
abstract: BACKGROUND
  The Absorb Bioresorbable Vascular Scaffold System (Absorb BVS) is an everolimus-eluting bioresorbable vascular scaffold able to provide temporary scaffolding and antiproliferative drug delivery for the treatment of coronary artery disease. This temporary scaffolding could be the true feature to overcome the limitations of the conventional metallic stents. A growing body of evidence worldwide is supporting its implementation into daily practice as being associated with comparable results as the second-generation everolimus-eluting stent. However, these pieces of evidence come from 'studies in which the majority of the patients had low-risk stenoses', whereas patients with more complex coronary artery disease could benefit the most from the Absorb BVS technology.
  
  
  METHODS
  The aim of the IT-DISAPPEARS is to investigate the procedural and clinical performance of the Absorb BVS in patients with long (>24 mm), single-vessel coronary disease or with multivessel disease. At least 50 centers across the Italian territory will enroll 1000 patients with either stable or acute coronary syndromes. Follow-up will end up at 5 years. Primary endpoint will be the cumulative hierarchical incidence of major adverse cardiac events at 1 year, defined as: cardiac death, nonfatal target vessel myocardial infarction, or clinically driven target lesion revascularization. The efficacy as well as safety parameters will be evaluated along with a detailed evaluation of the dual antiplatelet therapy duration/interruption.
  
  
  CONCLUSIONS
  The IT-DISAPPEARS could provide the first evidence worldwide concerning the performance of Absorb BVS in patients with high-risk diffuse coronary disease.
authors.affiliation: Istituto Clinico S. Ambrogio, Milan, Italy (TL, BF), La Sapienza Univ, Roma, Italy (BZG), European Hospital, Rome (TF), University of Verona, Verona, Italy (RF), Magna Grecia Univ., Catanzaro, Italy (IC); Ferrarotto Hospital, Catania, Italy,(TC), Centro Cardiologico Monzino, Milan, Italy (BA); Pisa Univ, Pisa, Italy (PAS, DCM).
authors.forename: Luca
authors.initials: L
authors.lastname: Testa
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Biondi Zoccai
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Tomai
authors.forename: Flavio
authors.initials: F
authors.lastname: Ribichini
authors.forename: Ciro
authors.initials: C
authors.lastname: Indolfi
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.forename: Antonio
authors.initials: A
authors.lastname: Bartorelli
authors.forename: Anna Sonia
authors.initials: AS
authors.lastname: Petronio
authors.forename: Francesco
authors.initials: F
authors.lastname: Bedogni
authors.forename: Marco
authors.initials: M
authors.lastname: De Carlo
mesh_terms: D020341:Absorbable Implants; D003324:Coronary Artery Disease / Q000601:surgery*; D054855:Drug-Eluting Stents; D006801:Humans; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation; D012042:Registries; D012107:Research Design; D054457:Tissue Scaffolds