Coronary Artery Healing Process after Bioresorbable Scaffold in Patients with Non-ST-Segment Elevation Myocardial Infarction: Rationale, Design, and Methodology of the HONEST Study.
Coronary healing
Magnesium
Optical coherence tomography
Journal
Cardiology
ISSN: 1421-9751
Titre abrégé: Cardiology
Pays: Switzerland
ID NLM: 1266406
Informations de publication
Date de publication:
2021
2021
Historique:
received:
17
02
2020
accepted:
30
09
2020
pubmed:
2
2
2021
medline:
1
9
2021
entrez:
1
2
2021
Statut:
ppublish
Résumé
Bioresorbable scaffolds (BRSs) is a relatively new approach in treating coronary artery stenosis. The initial results of the first commercially available scaffolds consisting of a backbone of poly-L-lactide raised safety concerns related to delayed resorption and healing. The magnesium alloy-based scaffold degrades via bio-corrosion within months, whereas it often takes several years for polymer scaffolds to degrade. The aim of the study was to assess the healing stage by optical coherence tomography (OCT) after 6 months in patients with non-ST-segment elevation myocardial infarct (NSTEMI) randomized to OCT or angiography-guided percutaneous coronary intervention with implantation of a magnesium sirolimus-eluting Magmaris scaffold (Magmaris; Biotronik, Bülach, Switzerland). We analyzed the healing process by comparing OCT at baseline and after 6 months. Five stages of healing were defined with stage 1 being the least healed and stage 5 demonstrating complete resorption and healing with no visible scaffold/remnant. The primary end point is a calculated healing score that is based on 5 subtypes of healing stage: (1) malapposed, (2) uncovered with no detection of smooth surface tissue on top of struts or remnants, (3) covered protruding, (4) covered embedded, and (5) complete healing with a smooth neointimal surface and no sign of struts or visible remnants assessed by OCT 6 months after the index procedure. The impact of OCT-guided compared to angiography-guided scaffold implantation will be illuminated. The present study will provide new information on midterm healing properties of the magnesium BRS in patients with NSTEMI.
Sections du résumé
BACKGROUND
Bioresorbable scaffolds (BRSs) is a relatively new approach in treating coronary artery stenosis. The initial results of the first commercially available scaffolds consisting of a backbone of poly-L-lactide raised safety concerns related to delayed resorption and healing. The magnesium alloy-based scaffold degrades via bio-corrosion within months, whereas it often takes several years for polymer scaffolds to degrade. The aim of the study was to assess the healing stage by optical coherence tomography (OCT) after 6 months in patients with non-ST-segment elevation myocardial infarct (NSTEMI) randomized to OCT or angiography-guided percutaneous coronary intervention with implantation of a magnesium sirolimus-eluting Magmaris scaffold (Magmaris; Biotronik, Bülach, Switzerland).
METHODS
We analyzed the healing process by comparing OCT at baseline and after 6 months. Five stages of healing were defined with stage 1 being the least healed and stage 5 demonstrating complete resorption and healing with no visible scaffold/remnant. The primary end point is a calculated healing score that is based on 5 subtypes of healing stage: (1) malapposed, (2) uncovered with no detection of smooth surface tissue on top of struts or remnants, (3) covered protruding, (4) covered embedded, and (5) complete healing with a smooth neointimal surface and no sign of struts or visible remnants assessed by OCT 6 months after the index procedure.
RESULTS
The impact of OCT-guided compared to angiography-guided scaffold implantation will be illuminated.
CONCLUSION
The present study will provide new information on midterm healing properties of the magnesium BRS in patients with NSTEMI.
Identifiants
pubmed: 33524985
pii: 000512417
doi: 10.1159/000512417
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
161-171Informations de copyright
© 2021 S. Karger AG, Basel.