1. 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.
- Author
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Abizaid A, Costa RA, Schofer J, Ormiston J, Maeng M, Witzenbichler B, Botelho RV, Costa JR Jr, Chamié D, Abizaid AS, Castro JP, Morrison L, Toyloy S, Bhat V, Yan J, and Verheye S
- Subjects
- 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, Absorbable Implants, Cardiovascular Agents administration & dosage, Coated Materials, Biocompatible, Coronary Angiography, Coronary Artery Disease therapy, Coronary Vessels drug effects, Macrolides administration & dosage, Percutaneous Coronary Intervention instrumentation, Tomography, Optical Coherence, Ultrasonography, Interventional
- 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.)
- Published
- 2016
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