Optical Coherence Tomography- Versus Angiography-Guided Magnesium Bioresorbable Scaffold Implantation in NSTEMI Patients. 2022

Christian Oliver Fallesen, and Lisbeth Antonsen, and Akiko Maehara, and Manijeh Noori, and Mikkel Hougaard, and Kirstine Nørregaard Hansen, and Julia Ellert, and Ole Ahlehoff, and Karsten Tange Veien, and Jens Flensted Lassen, and Anders Bo Junker, and Henrik Steen Hansen, and Lisette Okkels Jensen
Department of Cardiology, Odense University Hospital, Odense, Denmark. Electronic address: christian.fallesen@rsyd.dk.

The purpose of a bioresorbable scaffold (BRS) is to provide radial support during coronary healing. In this study, coronary artery healing after optical coherence tomography (OCT)- versus angiography-guided magnesium BRS (MBRS) implantation in patients with non-ST-segment-elevation myocardial infarction (NSTEMI) is compared. 75 patients were randomized 1:1 to OCT- or angiography-guided implantation of a MBRS with protocolled pre- and post-dilation. In the OCT-guided group, prespecified criteria indicating additional intervention were (1) scaffold under-expansion, (2) strut malapposition, (3) edge dissection, and (4) residual stenosis at distal or proximal reference segments. The primary endpoint was OCT-derived healing stage at 6 months. At 6 months, there was no difference in average healing stage between OCT- and angiography-guided intervention (4.6 [interquartile range (IQR): 4.5-4.7] versus 4.5 [IQR: 4.3-4.7]; p = 0.54). The MBRSs were completely resolved in 77.0% [IQR: 68.5-85.5] versus 76.5% [IQR: 67.9-85.5]; (p = 0.97). Minimal lumen area (MLA) was reduced at 6 months in both the OCT- (32.3%; p < 0.01) and the angiography-guided group (21.3%; p < 0.01), however OCT-guided implantation was associated with a greater reduction of total lumen volume (-27.1 ± 32.5 mm3 versus -5.0 ± 32.9 mm3; p < 0.01) and MLA (-2.3 ± 1.6 mm2 vs. -1.4 ± 1.4 mm2; p = 0.02). In NSTEMI patients, OCT-guidance with protocolled pre- and post-dilation of MBRS implantation showed similar healing pattern at 6 months compared to angiography-guidance alone. The Coronary Artery Healing Process after Optical Coherence Tomography Guided Percutaneous Coronary Intervention with Magmaris Bioresorbable Scaffold in Patients with Non-ST-Segment-Elevation Myocardial Infarction: (HONEST) trial is registered with ClinicalTrials.gov, NCT03016624.

UI MeSH Term Description Entries
D008274 Magnesium A metallic element that has the atomic symbol Mg, atomic number 12, and atomic weight 24.31. It is important for the activity of many enzymes, especially those involved in OXIDATIVE PHOSPHORYLATION.
D011474 Prosthesis Design The plan and delineation of prostheses in general or a specific prosthesis. Design, Prosthesis,Designs, Prosthesis,Prosthesis Designs
D003331 Coronary Vessels The veins and arteries of the HEART. Coronary Arteries,Sinus Node Artery,Coronary Veins,Arteries, Coronary,Arteries, Sinus Node,Artery, Coronary,Artery, Sinus Node,Coronary Artery,Coronary Vein,Coronary Vessel,Sinus Node Arteries,Vein, Coronary,Veins, Coronary,Vessel, Coronary,Vessels, Coronary
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000072657 ST Elevation Myocardial Infarction A clinical syndrome defined by MYOCARDIAL ISCHEMIA symptoms; persistent elevation in the ST segments of the ELECTROCARDIOGRAM; and release of BIOMARKERS of myocardial NECROSIS (e.g., elevated TROPONIN levels). ST segment elevation in the ECG is often used in determining the treatment protocol (see also NON-ST ELEVATION MYOCARDIAL INFARCTION). ST Elevated Myocardial Infarction,ST Segment Elevation Myocardial Infarction,STEMI
D000072658 Non-ST Elevated Myocardial Infarction A myocardial infarction that does not produce elevations in the ST segments of the ELECTROCARDIOGRAM. ST segment elevation of the ECG is often used in determining the treatment protocol (see also ST Elevation Myocardial Infarction). NSTEMI,Non-ST-Elevation Myocardial Infarction,Infarction, Non-ST-Elevation Myocardial,Infarctions, Non-ST-Elevation Myocardial,Myocardial Infarction, Non-ST-Elevation,Myocardial Infarctions, Non-ST-Elevation,Non ST Elevated Myocardial Infarction,Non ST Elevation Myocardial Infarction,Non-ST-Elevation Myocardial Infarctions
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D017023 Coronary Angiography Radiography of the vascular system of the heart muscle after injection of a contrast medium. Angiography, Coronary,Angiographies, Coronary,Coronary Angiographies
D062645 Percutaneous Coronary Intervention A family of percutaneous techniques that are used to manage CORONARY OCCLUSION, including standard balloon angioplasty (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY), the placement of intracoronary STENTS, and atheroablative technologies (e.g., ATHERECTOMY; ENDARTERECTOMY; THROMBECTOMY; PERCUTANEOUS TRANSLUMINAL LASER ANGIOPLASTY). PTCA was the dominant form of PCI, before the widespread use of stenting. Percutaneous Coronary Revascularization,Coronary Intervention, Percutaneous,Coronary Interventions, Percutaneous,Coronary Revascularization, Percutaneous,Coronary Revascularizations, Percutaneous,Intervention, Percutaneous Coronary,Interventions, Percutaneous Coronary,Percutaneous Coronary Interventions,Percutaneous Coronary Revascularizations,Revascularization, Percutaneous Coronary,Revascularizations, Percutaneous Coronary
D020341 Absorbable Implants Implants constructed of materials designed to be absorbed by the body without producing an immune response. They are usually composed of plastics and are frequently used in orthopedics and orthodontics. Bioabsorbable Implants,Biodegradable Implants,Implants, Absorbable,Absorbable Implant,Bioabsorbable Implant,Biodegradable Implant,Implant, Absorbable,Implant, Bioabsorbable,Implant, Biodegradable,Implants, Bioabsorbable,Implants, Biodegradable

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