title: Evaluation of the short- and long-term safety and therapy outcomes of the everolimus-eluting bioresorbable vascular scaffold system in patients with coronary artery stenosis: Rationale and design of the German-Austrian ABSORB RegIstRy (GABI-R).
abstract: BACKGROUND
  Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2-4years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side effects.
  
  
  METHODS
  The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) in the world-wide greatest all-comers cohort will be evaluated in the prospective, non-interventional, multicenter German-Austrian ABSORB RegIstRy (GABI-R). GABI-R will include over 5000 patients from about 100 study sites in Austria and Germany. Safety endpoints such as cardiac death, myocardial infarction, and clinically driven percutaneous or surgical target lesion and vessel revascularization will be evaluated during hospitalization and in the follow-up period (minimum of 5years).
  
  
  CONCLUSIONS
  Although two randomized controlled trials and several registries have documented safety and efficacy as well as non-inferiority of this everolimus-eluting ABSORB device compared with drug-eluting metal stents, the current knowledge regarding clinical application, treatment success, and long-term safety of using this BRS in daily routine is limited. Thus, the goal of GABI-R is to address this lack of information.
authors.affiliation: University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany. Electronic address: holger.nef@innere.med.uni-giessen.de.
authors.forename: Holger
authors.initials: H
authors.lastname: Nef
authors.affiliation: University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Wiebe
authors.affiliation: University of Erlangen, Medizinische Klinik II, Department of Cardiology, Erlangen, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Achenbach
authors.affiliation: Department of Medicine II, University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Münzel
authors.affiliation: Klinik für Kardiologie und Angiologie, Elisabeth-Krankenhaus, Essen, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Naber
authors.affiliation: Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg, Germany.
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.affiliation: Department of Cardiology, Klinikum Großhadern, Ludwig- Maximilian Universität, Munich, Germany.
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.affiliation: Department of Internal Medicine II, University of Ulm, Ulm, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.affiliation: University of Essen, Department of Cardiology, Essen, Germany.
authors.forename: Till
authors.initials: T
authors.lastname: Neumann
authors.affiliation: University of Essen, Department of Cardiology, Essen, Germany.
authors.forename: Janine
authors.initials: J
authors.lastname: Biermann
authors.affiliation: Abteilung für Kardiologie, Herzzentrum Ludwigshafen, Ludwigshafen, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Zahn
authors.affiliation: Department of Cardiology, University of Vienna Medical School, Vienna, Austria.
authors.forename: Johannes
authors.initials: J
authors.lastname: Kastner
authors.affiliation: CCB, Cardioangiologisches Centrum Bethanien, Frankfurt, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Schmermund
authors.affiliation: Abbott Vascular Deutschland GmbH, Wetzlar, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pfannebecker
authors.affiliation: Institut für Herzinfarktforschung, Ludwigshafen, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Schneider
authors.affiliation: Institut für Herzinfarktforschung, Ludwigshafen, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Limbourg
authors.affiliation: University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany; Kerckhoff Heart and Thorax Center, Department of Cardiology, Bad Nauheim, Germany.
authors.forename: Christian W
authors.initials: CW
authors.lastname: Hamm
mesh_terms: D020341:Absorbable Implants; D001317:Austria; D015331:Cohort Studies; D023921:Coronary Stenosis / Q000601:surgery*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D005858:Germany; D006801:Humans; D011446:Prospective Studies; D012042:Registries; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D000068338:Everolimus
keywords: BVS; Bioresorbable scaffolds; Coronary artery disease; Stenosis