title: Registro Absorb Italiano (BVS-RAI): an investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb™ BVS: study design.
abstract: BACKGROUND
  The Absorb™ BVS is a bioresorbable, everolimus-eluting scaffold approved and marketed for coronary use. Published data on long-term results after treatment are limited to a small number of patients, most of them with elective PCI of simple lesions. The importance of scaffold resorption is variably appreciated among cardiologists, and indications for use from health technology assessment bodies or guidelines are missing. Instruments are needed to collect, share and assess the experience being accumulated with this new device in several centres.
  
  
  METHODS
  The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists in cooperation with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri" Institute, and is not recipient of funding or benefits originating from the BVS manufacturer. It is a prospective registry with 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more coronary BVS following the indications, techniques and protocols used in each of the participating institutions. Outcome measures are BVS target lesion failure within one year and device-oriented major adverse cardiac events within 5years. The registry started in October 2012 and will extend enrolment throughout 2015, with the aim to include about 1000 patients. ClinicalTrials.gov identifier is CT02298413.
  
  
  CONCLUSIONS
  The BVS-RAI Registry will contribute observational knowledge on the long-term safety and efficacy of the Absorb™ BVS as used in a number of Italian interventional centres in a broad spectrum of settings. Unrewarded and undirected consecutive patient enrolments are key-features of this observation, which is therefore likely to reflect common clinical practice in those centres.
authors.affiliation: Azienda Ospedaliera Fatebenefratelli e Oftalmico, Milano. Electronic address: bcortese@gmail.com.
authors.forename: Bernardo
authors.initials: B
authors.lastname: Cortese
authors.affiliation: Azienda Ospedaliera Bolognini, Seriate (BG).
authors.forename: Alfonso
authors.initials: A
authors.lastname: Ielasi
authors.affiliation: Ospedale Monaldi, Napoli.
authors.forename: Attilio
authors.initials: A
authors.lastname: Varricchio
authors.affiliation: Azienda Ospedaliera Universitaria, Padova.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tarantini
authors.affiliation: Azienda Ospedaliera San Bortolo, Vicenza.
authors.forename: Luigi
authors.initials: L
authors.lastname: LaVecchia
authors.affiliation: Ospedale Regionale, Aosta.
authors.forename: Francesco
authors.initials: F
authors.lastname: Pisano
authors.affiliation: Ospedale di Este (PD).
authors.forename: Michela
authors.initials: M
authors.lastname: Facchin
authors.affiliation: Ospedale S.Andrea, La Spezia.
authors.forename: Roberto
authors.initials: R
authors.lastname: Gistri
authors.affiliation: Ospedale di Magenta (MI).
authors.forename: Maurizio
authors.initials: M
authors.lastname: D'Urbano
authors.affiliation: Ospedale di Avezzano (AQ).
authors.forename: Valerio
authors.initials: V
authors.lastname: Lucci
authors.affiliation: Azienda Ospedaliera Brotzu, Cagliari.
authors.forename: Bruno
authors.initials: B
authors.lastname: Loi
authors.affiliation: Ospedale Cardinal Massaia, Asti.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Tumminello
authors.affiliation: Ospedale Sacco, Milano.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Ospedale della Misericordia, Grosseto.
authors.forename: Ugo
authors.initials: U
authors.lastname: Limbruno
authors.affiliation: Ospedale Santa Corona, Pietra Ligure (SV).
authors.forename: Annamaria
authors.initials: A
authors.lastname: Nicolino
authors.affiliation: Azienda Ospedaliera Ca Foncello, Treviso.
authors.forename: Diego
authors.initials: D
authors.lastname: Calzolari
authors.affiliation: Centro di Ricerche Farmacologiche e Biomediche "Mario Negri", Milano.
authors.forename: Gianni
authors.initials: G
authors.lastname: Tognoni
authors.affiliation: Ospedale Cardinal Massaia, Asti.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Defilippi
authors.affiliation: Azienda Ospedaliera Fatebenefratelli e Oftalmico, Milano.
authors.forename: Dario
authors.initials: D
authors.lastname: Buccheri
authors.affiliation: Azienda Ospedaliera Bolognini, Seriate (BG).
authors.forename: Maurizio
authors.initials: M
authors.lastname: Tespili
authors.affiliation: Centro di Ricerche Farmacologiche e Biomediche "Mario Negri", Milano.
authors.forename: Donatella
authors.initials: D
authors.lastname: Corrado
authors.affiliation: Azienda Sanitaria Ospedaliera Santa Croce e Carle, Cuneo.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Steffenino
mesh_terms: D020341:Absorbable Implants / Q000706:statistics & numerical data*; D000368:Aged; D023921:Coronary Stenosis / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data*; D000068338:Everolimus / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007558:Italy; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries / Q000706:statistics & numerical data*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus
keywords: BVS; Coronary artery disease; Long follow up; Prospective registry