Registro Absorb Italiano (BVS-RAI): An investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb™ BVS: Study design

Bernardo Cortese, Alfonso Ielasi, Attilio Varricchio, Giuseppe Tarantini, Luigi LaVecchia, Francesco Pisano, Michela Facchin, Roberto Gistri, Maurizio D'Urbano, Valerio Lucci, Bruno Loi, Gabriele Tumminello, Alessandro Colombo, Ugo Limbruno, Annamaria Nicolino, Diego Calzolari, Gianni Tognoni, Gianfranco Defilippi, Dario Buccheri, Maurizio TespiliDonatella Corrado, Giuseppe Steffenino

Research output: Contribution to journalArticlepeer-review

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/Design: 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 5. years. 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.

Original languageEnglish
Pages (from-to)340-343
Number of pages4
JournalCardiovascular Revascularization Medicine
Volume16
Issue number6
DOIs
Publication statusPublished - Sep 1 2015

Keywords

  • BVS
  • Coronary artery disease
  • Long follow up
  • Prospective registry

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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