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Coronary Vasoreactivity after Complete Bioresorption of Absorb BVS at 5-Year Follow-Up

Keywords
Absorbable Implants/standards; Percutaneous Coronary Intervention/methods; Tissue Scaffolds/standards; Coronary Artery Disease; Myocardial Infarction; Recovery of Function

Introduction

Bioresorbable coronary scaffolds have been designed to prevent long-term complications related to permanent implantation of metallic stents. Everolimus-eluting bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, California) was one of the first bioresorbable vascular scaffolds (BVS) to be developed. Absorb BVS is a backbone of Poly-L-lactic acid coated with Poly-DL-lactic polymer, which elutes antiproliferative drug everolimus.11. Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, et al. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008;371(9616):899-907. BVS received CE Mark for the treatment of coronary artery disease in January 2011 and it was marketed in most European countries by 2012.22. Byrne RA, Stefanini GF, Capodanno D, Onuma Y, Baumbach A, Escaned J, et al. Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary. EuroIntervention. 2018;39(18):1591-601. Although good outcomes were initially described,33. Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009;373(9667):897-910.,44. Onuma Y, Dudek D, Thuesen L, Webster M, Nieman K, Garcia-Garcia HM, et al. Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial. JACC Cardiovasc Interv. 2013;6(10):999-1009. recent studies have questioned the safety of the device, suggesting a higher incidence of thrombosis and myocardial infarction.55. Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, et al. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015;373(20):1905-15.,66. Serruys PW, Chevalier B, Dudek D, Cequier A, Carrie D, Iniguez A, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385(9962):43-54. Beyond this, structural and functional recovery of scaffolded coronary segments after BVS resorption has not been systematically searched in a consecutive real-world series.77. Serruys PW, Onuma Y, Garcia-Garcia HM, Muramatsu T, van Geuns RJ, de Bruyne B, et al. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24, 36 months. EuroIntervention.2014;9(11):1271-84. We describe a case of a patient who was studied by coronary angiography, optical coherence tomography (OCT) and coronary vasoreactivity test 5-year after BVS implantation.

Case Report

A 39-year-old man, ex-smoker, presented with atypical chest pain and non-conclusive ischemia test. Past history included a ST-segment elevation myocardial infarction (STEMI) 5 years ago, in relation to a single-vessel disease treated with a 3.5×28mm Absorb BVS into mid left anterior descending (LAD). Now, the patient underwent a new coronary catheterization and there was no evidence of new lesions or restenosis. Then, an optical coherence tomography (OCT) was performed over the scaffolded segment of LAD showing fully reabsorbed Absorb BVS with development of a well-organized neointimal layer (Figure 1, Video 1).

Figure 1
(A, B, C) Absorb-BVS implantation time-point by OCT. (A´, B´, C´) OCT findings at 5-year follow-up (same cross-section). White arrows point radiopaque markers of scaffolds.
Video 1
Optical coherence tomography performed over the scaffolded segment of LAD showing fully reabsorbed Absorb BVS and a well-organized neointimal layer. Access the video at the link: http://abccardiol.org/supplementary-material/2021/11601/2019-0783-video1.mp4

Coronary vasoreactivity was assessed with administration of intracoronary acetylcholine. Incremental bolus of acetylcholine were infused (2µg-20µg-100µg) for 3 minutes each followed by electrocardiographic, hemodynamic, angiographic and OCT evaluation of the functional response. At peak dose of acetylcholine the patient developed chest pain and LAD spasm -including the scaffolded segment- as observed by both, angiography and OCT Figure 2, Video 2. Finally, an intracoronary bolus (200µg) of nitroglycerin was administered in order to relieve coronary spasm and symptoms. Repeated angiography and OCT confirmed the vasodilator response.

Figure 2
(A, B, C) Baseline images obtained by angiography and OCT. (A´, B´, C´) Angiography and OCT findings at the same cross-section after maximum dose of acetylcholine. Color arrows point side-branches before and after testing.
Video 2
Coronary angiography showing a LAD spasm -including the scaffolded segment- after peak dose of acetylcholine. Access the video at the link: http://abccardiol.org/supplementary-material/2021/11601/2019-0783-video2.mp4

Discussion

BVS technologies are currently in the spotlight worldwide due to a higher than expected rate of long-term adverse events and growing questions regarding the full resorption of the device.88. Serruys PW, Chevalier B, Sotomi Y, Cequier A, Carrie D, Piek JJ, et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016;388(10059):2479-91. Moreover, evidence-based data of long-term functional outcomes of the vessels treated with BVS are still scarce.99. Goncalves-Ramírez LR, Gutiérrez H, Cortés C, Gómez I, San Román JA, Amat-Santos IJ. Functional and structural coronary recovery at the 5-year follow-up after bioresorbable vascular scaffold implantation. An optical coherence tomography analysis. RevEspCardiol.2019;72(4):357-9. Indeed, whether in vivo normal vasomotion is recovered or not remains unanswered.

To the best of our knowledge, this is the first case that shows both morphological and functional recovery of scaffolded coronary segments after 5-year of Absorb BVS implantation in a real-life patent. As it has been previously described, Absorb BVS is finally reabsorbed by the vessel 5-year after implantation, with a development of a signal-rich layer seen by OCT into the scaffolded segment, which corresponds to neointima and underlying tissue.99. Goncalves-Ramírez LR, Gutiérrez H, Cortés C, Gómez I, San Román JA, Amat-Santos IJ. Functional and structural coronary recovery at the 5-year follow-up after bioresorbable vascular scaffold implantation. An optical coherence tomography analysis. RevEspCardiol.2019;72(4):357-9.,1010. Goncalves-Ramírez LR, Gutiérrez H, Rojas P, Cortés C, Serrador A, Ramos B, et al. Fully bioresorption of an Absorb bioresorbable vascular scaffold after scaffold restenosis. Cardiol J. 2019;26(2):209-211. On the other hand, paradoxical vasoconstriction induced by acetylcholine and corrected by nitroglycerin adds unique information regarding functional recovery of scaffolded coronary arteries, suggesting that the endothelial from the neointima is sensitive to chemical stimuli but might present paradoxical response in certain cases.

Conclusion

Fully resorption of Absorb BVS was found at 5-year follow-up. After scaffold resorption, there seems to be an adequate healing process of the vascular endothelium with restoration of the morphological and functional properties.

  • Sources of Funding
    There were no external funding sources for this study.
  • Study Association
    This study is not associated with any thesis or dissertation work.
  • Ethics Approval and Consent to Participate
    This study was approved by the Ethics Committee of the Hospital Clinico Universitario de Valladolid under the protocol number PI 18-994. All the procedures in this study were in accordance with the 1975 Helsinki Declaration, updated in 2013. Informed consent was obtained from all participants included in the study.

Referências

  • 1
    Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, et al. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008;371(9616):899-907.
  • 2
    Byrne RA, Stefanini GF, Capodanno D, Onuma Y, Baumbach A, Escaned J, et al. Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary. EuroIntervention. 2018;39(18):1591-601.
  • 3
    Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009;373(9667):897-910.
  • 4
    Onuma Y, Dudek D, Thuesen L, Webster M, Nieman K, Garcia-Garcia HM, et al. Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial. JACC Cardiovasc Interv. 2013;6(10):999-1009.
  • 5
    Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, et al. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015;373(20):1905-15.
  • 6
    Serruys PW, Chevalier B, Dudek D, Cequier A, Carrie D, Iniguez A, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385(9962):43-54.
  • 7
    Serruys PW, Onuma Y, Garcia-Garcia HM, Muramatsu T, van Geuns RJ, de Bruyne B, et al. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24, 36 months. EuroIntervention.2014;9(11):1271-84.
  • 8
    Serruys PW, Chevalier B, Sotomi Y, Cequier A, Carrie D, Piek JJ, et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016;388(10059):2479-91.
  • 9
    Goncalves-Ramírez LR, Gutiérrez H, Cortés C, Gómez I, San Román JA, Amat-Santos IJ. Functional and structural coronary recovery at the 5-year follow-up after bioresorbable vascular scaffold implantation. An optical coherence tomography analysis. RevEspCardiol.2019;72(4):357-9.
  • 10
    Goncalves-Ramírez LR, Gutiérrez H, Rojas P, Cortés C, Serrador A, Ramos B, et al. Fully bioresorption of an Absorb bioresorbable vascular scaffold after scaffold restenosis. Cardiol J. 2019;26(2):209-211.

Publication Dates

  • Publication in this collection
    05 Feb 2021
  • Date of issue
    Feb 2021

History

  • Received
    07 Nov 2019
  • Reviewed
    22 Jan 2020
  • Accepted
    22 Jan 2020
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