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.

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  • Additional Information
    • Source:
      Publisher: Elsevier Country of Publication: United States NLM ID: 101467004 Publication Model: Print Cited Medium: Internet ISSN: 1876-7605 (Electronic) Linking ISSN: 19368798 NLM ISO Abbreviation: JACC Cardiovasc Interv Subsets: MEDLINE
    • Publication Information:
      Original Publication: New York : Elsevier
    • Subject Terms:
      Absorbable Implants* ; Coated Materials, Biocompatible* ; Coronary Angiography* ; Tomography, Optical Coherence* ; Ultrasonography, Interventional*; Cardiovascular Agents/*administration & dosage ; Coronary Artery Disease/*therapy ; Coronary Vessels/*drug effects ; Macrolides/*administration & dosage ; Percutaneous Coronary Intervention/*instrumentation; Aged ; Brazil ; Cardiovascular Agents/adverse effects ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/mortality ; Coronary Vessels/diagnostic imaging ; Europe ; Female ; Humans ; Hyperplasia ; Macrolides/adverse effects ; Male ; Middle Aged ; Neointima ; New Zealand ; Percutaneous Coronary Intervention/adverse effects ; Percutaneous Coronary Intervention/mortality ; Predictive Value of Tests ; Prospective Studies ; Time Factors ; Treatment Outcome
    • Abstract:
      Objectives: 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).
      (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
    • Comments:
      Comment in: JACC Cardiovasc Interv. 2016 Mar 28;9(6):575-7. (PMID: 27013156)
    • Contributed Indexing:
      Keywords: bioresorbable scaffold; multimodality imaging
    • Molecular Sequence:
      ClinicalTrials.gov NCT02086045
    • Accession Number:
      0 (Cardiovascular Agents)
      0 (Coated Materials, Biocompatible)
      0 (Macrolides)
      2719UAHUA8 (novolimus)
    • Publication Date:
      Date Created: 20160326 Date Completed: 20170104 Latest Revision: 20220310
    • Publication Date:
      20221213
    • Accession Number:
      10.1016/j.jcin.2015.12.004
    • Accession Number:
      27013155