Optical coherence tomography versus angiography guided magnesium bioresorbable scaffold implantation in NSTEMI patients

Christian Oliver Fallesen; Lisbeth Antonsen; Akiko Maehara; Manijeh Noori; Mikkel Hougaard; Kirstine Nørregaard Hansen; Julia Ellert; Ole Ahlehoff; Karsten Tange Veien; Jens Flensted Lassen; Anders Bo Junker; Henrik Steen Hansen; Lisette Okkels Jensen

doi:10.1016/j.carrev.2021.12.003

Optical coherence tomography versus angiography guided magnesium bioresorbable scaffold implantation in NSTEMI patients

Christian Oliver Fallesen, Lisbeth Antonsen, Akiko Maehara, Manijeh Noori, Mikkel Hougaard, Kirstine Nørregaard Hansen, Julia Ellert, Ole Ahlehoff, Karsten Tange Veien, Jens Flensted Lassen, Anders Bo Junker, Henrik Steen Hansen, Lisette Okkels Jensen

4 Citations (Scopus)

Abstract

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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).

CONCLUSIONS: 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.

CLINICAL TRIAL REGISTRATION: 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.

Original language	English
Journal	Cardiovascular revascularization medicine : including molecular interventions
Volume	40
Pages (from-to)	101-110
Number of pages	10
ISSN	1553-8389
DOIs	https://doi.org/10.1016/j.carrev.2021.12.003
Publication status	Published - Jul 2022
Externally published	Yes

Keywords

Absorbable Implants
Coronary Angiography/methods
Coronary Vessels/diagnostic imaging
Humans
Magnesium
Non-ST Elevated Myocardial Infarction/diagnostic imaging
Percutaneous Coronary Intervention/adverse effects
Prosthesis Design
ST Elevation Myocardial Infarction
Tomography, Optical Coherence/methods
Treatment Outcome

Access to Document

10.1016/j.carrev.2021.12.003

Cite this

Fallesen, C. O., Antonsen, L., Maehara, A., Noori, M., Hougaard, M., Hansen, K. N., Ellert, J., Ahlehoff, O., Veien, K. T., Lassen, J. F., Junker, A. B., Hansen, H. S., & Jensen, L. O. (2022). Optical coherence tomography versus angiography guided magnesium bioresorbable scaffold implantation in NSTEMI patients. Cardiovascular revascularization medicine : including molecular interventions, 40, 101-110. https://doi.org/10.1016/j.carrev.2021.12.003

Optical coherence tomography versus angiography guided magnesium bioresorbable scaffold implantation in NSTEMI patients. / Fallesen, Christian Oliver; Antonsen, Lisbeth; Maehara, Akiko et al.
In: Cardiovascular revascularization medicine : including molecular interventions, Vol. 40, 07.2022, p. 101-110.

Research output: Contribution to journal › Journal article › Research › peer-review

Fallesen, CO, Antonsen, L, Maehara, A, Noori, M, Hougaard, M, Hansen, KN, Ellert, J, Ahlehoff, O, Veien, KT, Lassen, JF, Junker, AB, Hansen, HS & Jensen, LO 2022, 'Optical coherence tomography versus angiography guided magnesium bioresorbable scaffold implantation in NSTEMI patients', Cardiovascular revascularization medicine : including molecular interventions, vol. 40, pp. 101-110. https://doi.org/10.1016/j.carrev.2021.12.003

@article{dbadd9ab2ecf4370a45a3150dfe93d15,

title = "Optical coherence tomography versus angiography guided magnesium bioresorbable scaffold implantation in NSTEMI patients",

abstract = "BACKGROUND: 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.METHODS: 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.RESULTS: 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).CONCLUSIONS: 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.CLINICAL TRIAL REGISTRATION: 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.",

keywords = "Absorbable Implants, Coronary Angiography/methods, Coronary Vessels/diagnostic imaging, Humans, Magnesium, Non-ST Elevated Myocardial Infarction/diagnostic imaging, Percutaneous Coronary Intervention/adverse effects, Prosthesis Design, ST Elevation Myocardial Infarction, Tomography, Optical Coherence/methods, Treatment Outcome",

author = "Fallesen, {Christian Oliver} and Lisbeth Antonsen and Akiko Maehara and Manijeh Noori and Mikkel Hougaard and Hansen, {Kirstine N{\o}rregaard} and Julia Ellert and Ole Ahlehoff and Veien, {Karsten Tange} and Lassen, {Jens Flensted} and Junker, {Anders Bo} and Hansen, {Henrik Steen} and Jensen, {Lisette Okkels}",

year = "2022",

month = jul,

doi = "10.1016/j.carrev.2021.12.003",

language = "English",

volume = "40",

pages = "101--110",

journal = "Cardiovascular revascularization medicine : including molecular interventions",

issn = "1553-8389",

publisher = "Elsevier Inc",

}

TY - JOUR

T1 - Optical coherence tomography versus angiography guided magnesium bioresorbable scaffold implantation in NSTEMI patients

AU - Fallesen, Christian Oliver

AU - Antonsen, Lisbeth

AU - Maehara, Akiko

AU - Noori, Manijeh

AU - Hougaard, Mikkel

AU - Hansen, Kirstine Nørregaard

AU - Ellert, Julia

AU - Ahlehoff, Ole

AU - Veien, Karsten Tange

AU - Lassen, Jens Flensted

AU - Junker, Anders Bo

AU - Hansen, Henrik Steen

AU - Jensen, Lisette Okkels

PY - 2022/7

Y1 - 2022/7

N2 - BACKGROUND: 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.METHODS: 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.RESULTS: 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).CONCLUSIONS: 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.CLINICAL TRIAL REGISTRATION: 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.

AB - BACKGROUND: 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.METHODS: 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.RESULTS: 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).CONCLUSIONS: 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.CLINICAL TRIAL REGISTRATION: 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.

KW - Absorbable Implants

KW - Coronary Angiography/methods

KW - Coronary Vessels/diagnostic imaging

KW - Humans

KW - Magnesium

KW - Non-ST Elevated Myocardial Infarction/diagnostic imaging

KW - Percutaneous Coronary Intervention/adverse effects

KW - Prosthesis Design

KW - ST Elevation Myocardial Infarction

KW - Tomography, Optical Coherence/methods

KW - Treatment Outcome

UR - http://www.scopus.com/inward/record.url?scp=85121613979&partnerID=8YFLogxK

U2 - 10.1016/j.carrev.2021.12.003

DO - 10.1016/j.carrev.2021.12.003

M3 - Journal article

C2 - 34949544

SN - 1553-8389

VL - 40

SP - 101

EP - 110

JO - Cardiovascular revascularization medicine : including molecular interventions

JF - Cardiovascular revascularization medicine : including molecular interventions

ER -

Optical coherence tomography versus angiography guided magnesium bioresorbable scaffold implantation in NSTEMI patients

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Cite this