title: Serial Multimodality Imaging and 2-Year Clinical Outcomes of the Novel DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold System for the Treatment of Single De Novo Coronary Lesions.
abstract: OBJECTIVE
  This study sought to report the late multimodality imaging and clinical outcomes of the novel poly-l-lactic-acid-based DESolve novolimus-eluting bioresorbable coronary scaffold for the treatment of de novo coronary lesions.
  
  
  BACKGROUND
  Bioresorbable scaffolds are an alternative to drug-eluting metallic stents and provide temporary vascular scaffolding, which potentially may allow vessel restoration and reduce the risk of future adverse events.
  
  
  METHODS
  Overall, 126 patients were enrolled at 13 international sites between November 2011 and June 2012. The primary endpoint was in-scaffold late lumen loss at 6 months. Major adverse cardiac events, the main safety endpoint, were defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. All patients underwent angiography at 6 months. Serial intravascular ultrasound and optical coherence tomography were performed in a subset of patients.
  
  
  RESULTS
  The scaffold device success rate was 97% (n = 122 of 126), and procedural success was 100% (n = 122 of 122). The major adverse cardiac event rate was 3.3% (n = 4 of 122) at 6 months and 7.4% (n = 9 of 122) at 24 months, including 1 probable stent thrombosis within the first month. At 6-month angiographic follow-up, in-scaffold late lumen loss was 0.20 ± 0.32 mm. Paired intravascular ultrasound analysis demonstrated a significant increase in vessel, lumen and scaffold dimensions between post-procedure and 6-month follow-up, and strut-level optical coherence tomography analysis showed full strut coverage in 99 ± 1.7%.
  
  
  CONCLUSIONS
  Our results showed favorable performance of the DESolve scaffold, effective inhibition of neointimal hyperplasia, and for the first time, early luminal and scaffold growth at 6 months with sustained efficacy and safety through 2 years. (Elixir Medical Clinical Evaluation of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System-The DESolve Nx Trial; NCT02086045).
authors.affiliation: Instituto Dante Pazzanese, São Paulo, Brazil. Electronic address: aabizaid@uol.com.br.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: Instituto Dante Pazzanese, São Paulo, Brazil.
authors.forename: Ricardo A
authors.initials: RA
authors.lastname: Costa
authors.affiliation: Universitäres Herz-und Gefäβzentrum, Hamburg, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.affiliation: Mercy Angiography Unit, Auckland, New Zealand.
authors.forename: John
authors.initials: J
authors.lastname: Ormiston
authors.affiliation: Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
authors.affiliation: Charite Benjamin Franklin Campus, Med. Klinik II, Berlin, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Witzenbichler
authors.affiliation: Instituto do Coração do Triângulo Mineiro, Uberlândia, Brazil.
authors.forename: Roberto V
authors.initials: RV
authors.lastname: Botelho
authors.affiliation: Cardiovascular Research Center, São Paulo, Brazil.
authors.forename: J Ribamar
authors.initials: JR
authors.lastname: Costa
authors.affiliation: Cardiovascular Research Center, São Paulo, Brazil.
authors.forename: Daniel
authors.initials: D
authors.lastname: Chamié
authors.affiliation: Cardiovascular Research Center, São Paulo, Brazil.
authors.forename: Andrea S
authors.initials: AS
authors.lastname: Abizaid
authors.affiliation: Cardiovascular Research Center, São Paulo, Brazil.
authors.forename: Juliana P
authors.initials: JP
authors.lastname: Castro
authors.affiliation: Elixir Medical Corporation, Sunnyvale, California.
authors.forename: Lynn
authors.initials: L
authors.lastname: Morrison
authors.affiliation: Elixir Medical Corporation, Sunnyvale, California.
authors.forename: Sara
authors.initials: S
authors.lastname: Toyloy
authors.affiliation: Elixir Medical Corporation, Sunnyvale, California.
authors.forename: Vinayak
authors.initials: V
authors.lastname: Bhat
authors.affiliation: Elixir Medical Corporation, Sunnyvale, California.
authors.forename: John
authors.initials: J
authors.lastname: Yan
authors.affiliation: ZNA Middelheim, Antwerp, Belgium.
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D001938:Brazil; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects*; D005060:Europe; D005260:Female; D006801:Humans; D006965:Hyperplasia; D018942:Macrolides / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D058426:Neointima; D009520:New Zealand; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011237:Predictive Value of Tests; D011446:Prospective Studies; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D018942:Macrolides; C534800:novolimus
keywords: bioresorbable scaffold; multimodality imaging