title: Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial.
abstract: Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomes of a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesium scaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device.
  
  
  
  The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novo lesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at 6 months, and-if subjects consented-at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42 patients: in-segment late lumen loss 0.20 ± 0.21 mm vs. 0.25 ± 0.22 mm, P = 0.117, Δ 0.05 ± 0.21 mm (95% CI: -0.01;0.12); in-scaffold late lumen loss 0.37 ± 0.25 mm vs. 0.39 ± 0.27 mm, P = 0.446, Δ 0.03 ± 0.22 (95% CI: -0.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroborated the QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause, one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional event occurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienced a definite or probable scaffold thrombosis.
  
  
  
  The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile up to 12 months and stable angiographic parameters between 6 and 12 months.
  
  
  
  NCT01960504.
authors.affiliation: Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Preussenstr. 84, 41464 Neuss, Germany mhaude@lukasneuss.de michael.haude@uni-due.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany.
authors.forename: Hüseyin
authors.initials: H
authors.lastname: Ince
authors.affiliation: Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Toelg
authors.affiliation: Instituto do Coração - HCFMUSP, University of Sao Paulo, São Paulo, Brazil.
authors.forename: Pedro Alves
authors.initials: PA
authors.lastname: Lemos
authors.affiliation: Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, The Netherlands.
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors.forename: Evald Høj
authors.initials: EH
authors.lastname: Christiansen
authors.affiliation: Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium.
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.affiliation: Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.affiliation: Department of Cardiology, University Hospital, Basel, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Kaiser
authors.affiliation: Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland.
authors.forename: Eric
authors.initials: E
authors.lastname: Eeckhout
authors.affiliation: Department of Cardiology, National Heart Center Singapore, Singapore, Singapore.
authors.forename: Soo Teik
authors.initials: ST
authors.lastname: Lim
authors.affiliation: Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Escaned
authors.affiliation: Cardialysis BV, Rotterdam, The Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.affiliation: Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
mesh_terms: D020341:Absorbable Implants; D017023:Coronary Angiography; D003324:Coronary Artery Disease; D054855:Drug-Eluting Stents; D006801:Humans; D008670:Metals; D011446:Prospective Studies; D020123:Sirolimus; D016896:Treatment Outcome
chemical_list: D008670:Metals; D020123:Sirolimus
keywords: Bioresorbable; Coronary artery disease; DREAMS; Magnesium; PLLA; Scaffold