TY - JOUR
T1 - Coronary Artery Healing Process after Bioresorbable Scaffold in Patients with Non-ST-Segment Elevation Myocardial Infarction
T2 - Rationale, Design, and Methodology of the HONEST Study
AU - Fallesen, Christian Oliver
AU - Maehara, Akiko
AU - Antonsen, Lisbeth
AU - Nørregaard Hansen, Kirstine
AU - Noori, Manijeh
AU - Flensted Lassen, Jens
AU - Junker, Anders
AU - Hansen, Henrik Steen
AU - Okkels Jensen, Lisette
N1 - © 2021 S. Karger AG, Basel.
PY - 2021/3
Y1 - 2021/3
N2 - 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.
AB - 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.
KW - Absorbable Implants
KW - Coronary Angiography
KW - Coronary Vessels/diagnostic imaging
KW - Drug-Eluting Stents
KW - Humans
KW - Non-ST Elevated Myocardial Infarction/diagnostic imaging
KW - Percutaneous Coronary Intervention
KW - Prosthesis Design
KW - Tomography, Optical Coherence
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85100648927&partnerID=8YFLogxK
U2 - 10.1159/000512417
DO - 10.1159/000512417
M3 - Journal article
C2 - 33524985
SN - 0008-6312
VL - 146
SP - 161
EP - 171
JO - Cardiology
JF - Cardiology
IS - 2
ER -