OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions

Niels R. Holm; Lene N. Andreasen; Omeed Neghabat; Peep Laanmets; Indulis Kumsars; Johan Bennett; Niels T. Olsen; Jacob Odenstedt; Pavel Hoffmann; Jo Dens; Saqib Chowdhary; Peter O'Kane; Søren-Haldur Bülow Rasmussen; Matthias Heigert; Ole Havndrup; Jan P. Van Kuijk; Simone Biscaglia; Lone J. H. Mogensen; Loghman Henareh; Francesco Burzotta; Christian H. Eek; Darren Mylotte; Miquel S. Llinas; Lukasz Koltowski; Paul Knaapen; Slobodan Calic; Nils Witt; Irene Santos-Pardo; Stuart Watkins; Jacob Lønborg; Andreas T. Kristensen; Lisette O. Jensen; Fredrik Calais; James Cockburn; Andrew McNeice; Olli A. Kajander; Ton Heestermans; Stephan Kische; Ashkan Eftekhari; James C, Spratt; Evald H. Christiansen; OCTOBER Trial Group

doi:10.1056/NEJMoa2307770

OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions

Niels R. Holm^*, Lene N. Andreasen, Omeed Neghabat, Peep Laanmets, Indulis Kumsars, Johan Bennett, Niels T. Olsen, Jacob Odenstedt, Pavel Hoffmann, Jo Dens, Saqib Chowdhary, Peter O'Kane, Søren-Haldur Bülow Rasmussen, Matthias Heigert, Ole Havndrup, Jan P. Van Kuijk, Simone Biscaglia, Lone J. H. Mogensen, Loghman Henareh, Francesco BurzottaChristian H. Eek, Darren Mylotte, Miquel S. Llinas, Lukasz Koltowski, Paul Knaapen, Slobodan Calic, Nils Witt, Irene Santos-Pardo, Stuart Watkins, Jacob Lønborg, Andreas T. Kristensen, Lisette O. Jensen, Fredrik Calais, James Cockburn, Andrew McNeice, Olli A. Kajander, Ton Heestermans, Stephan Kische, Ashkan Eftekhari, James C, Spratt, Evald H. Christiansen, OCTOBER Trial Group

^*Corresponding author for this work

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

39 Citations (Scopus)

Abstract

Abstract Background Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain. Methods We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years. Results We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P=0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group. Conclusions Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.)

Original language	English
Journal	The New England Journal of Medicine
Volume	389
Issue number	16
Pages (from-to)	1477-1487
Number of pages	11
ISSN	0028-4793
DOIs	https://doi.org/10.1056/NEJMoa2307770
Publication status	Published - 19 Oct 2023

Bibliographical note

Keywords

Coronary Angiography
Coronary Angiography/adverse effects
Coronary Artery Disease/diagnostic imaging
Europe
Humans
Percutaneous Coronary Intervention/adverse effects
Tomography, Optical Coherence/adverse effects
Tomography, Optical Coherence/methods
Treatment Outcome
Coronary Disease/Myocardial Infarction
Cardiology General
Cardiology

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Holm, N. R., Andreasen, L. N., Neghabat, O., Laanmets, P., Kumsars, I., Bennett, J., Olsen, N. T., Odenstedt, J., Hoffmann, P., Dens, J., Chowdhary, S., O'Kane, P., Bülow Rasmussen, S.-H., Heigert, M., Havndrup, O., Van Kuijk, J. P., Biscaglia, S., Mogensen, L. J. H., Henareh, L., ... OCTOBER Trial Group (2023). OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. The New England Journal of Medicine, 389(16), 1477-1487. https://doi.org/10.1056/NEJMoa2307770

@article{3e8a6bc385054a949ef89ad76e21043b,

title = "OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions",

abstract = "Abstract Background Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain. Methods We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years. Results We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P=0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group. Conclusions Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.)",

keywords = "Coronary Angiography, Coronary Angiography/adverse effects, Coronary Artery Disease/diagnostic imaging, Europe, Humans, Percutaneous Coronary Intervention/adverse effects, Tomography, Optical Coherence/adverse effects, Tomography, Optical Coherence/methods, Treatment Outcome, Coronary Disease/Myocardial Infarction, Cardiology General, Cardiology",

author = "Holm, {Niels R.} and Andreasen, {Lene N.} and Omeed Neghabat and Peep Laanmets and Indulis Kumsars and Johan Bennett and Olsen, {Niels T.} and Jacob Odenstedt and Pavel Hoffmann and Jo Dens and Saqib Chowdhary and Peter O'Kane and {B{\"u}low Rasmussen}, S{\o}ren-Haldur and Matthias Heigert and Ole Havndrup and {Van Kuijk}, {Jan P.} and Simone Biscaglia and Mogensen, {Lone J. H.} and Loghman Henareh and Francesco Burzotta and Eek, {Christian H.} and Darren Mylotte and Llinas, {Miquel S.} and Lukasz Koltowski and Paul Knaapen and Slobodan Calic and Nils Witt and Irene Santos-Pardo and Stuart Watkins and Jacob L{\o}nborg and Kristensen, {Andreas T.} and Jensen, {Lisette O.} and Fredrik Calais and James Cockburn and Andrew McNeice and Kajander, {Olli A.} and Ton Heestermans and Stephan Kische and Ashkan Eftekhari and Spratt, {James C,} and Christiansen, {Evald H.} and {OCTOBER Trial Group}",

note = "Copyright {\textcopyright} 2023 Massachusetts Medical Society.",

year = "2023",

month = oct,

day = "19",

doi = "10.1056/NEJMoa2307770",

language = "English",

volume = "389",

pages = "1477--1487",

journal = "The New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "16",

}

Holm, NR, Andreasen, LN, Neghabat, O, Laanmets, P, Kumsars, I, Bennett, J, Olsen, NT, Odenstedt, J, Hoffmann, P, Dens, J, Chowdhary, S, O'Kane, P, Bülow Rasmussen, S-H, Heigert, M, Havndrup, O, Van Kuijk, JP, Biscaglia, S, Mogensen, LJH, Henareh, L, Burzotta, F, Eek, CH, Mylotte, D, Llinas, MS, Koltowski, L, Knaapen, P, Calic, S, Witt, N, Santos-Pardo, I, Watkins, S, Lønborg, J, Kristensen, AT, Jensen, LO, Calais, F, Cockburn, J, McNeice, A, Kajander, OA, Heestermans, T, Kische, S, Eftekhari, A, Spratt, JC, Christiansen, EH & OCTOBER Trial Group 2023, 'OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions', The New England Journal of Medicine, vol. 389, no. 16, pp. 1477-1487. https://doi.org/10.1056/NEJMoa2307770

TY - JOUR

T1 - OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions

AU - Holm, Niels R.

AU - Andreasen, Lene N.

AU - Neghabat, Omeed

AU - Laanmets, Peep

AU - Kumsars, Indulis

AU - Bennett, Johan

AU - Olsen, Niels T.

AU - Odenstedt, Jacob

AU - Hoffmann, Pavel

AU - Dens, Jo

AU - Chowdhary, Saqib

AU - O'Kane, Peter

AU - Bülow Rasmussen, Søren-Haldur

AU - Heigert, Matthias

AU - Havndrup, Ole

AU - Van Kuijk, Jan P.

AU - Biscaglia, Simone

AU - Mogensen, Lone J. H.

AU - Henareh, Loghman

AU - Burzotta, Francesco

AU - Eek, Christian H.

AU - Mylotte, Darren

AU - Llinas, Miquel S.

AU - Koltowski, Lukasz

AU - Knaapen, Paul

AU - Calic, Slobodan

AU - Witt, Nils

AU - Santos-Pardo, Irene

AU - Watkins, Stuart

AU - Lønborg, Jacob

AU - Kristensen, Andreas T.

AU - Jensen, Lisette O.

AU - Calais, Fredrik

AU - Cockburn, James

AU - McNeice, Andrew

AU - Kajander, Olli A.

AU - Heestermans, Ton

AU - Kische, Stephan

AU - Eftekhari, Ashkan

AU - Spratt, James C,

AU - Christiansen, Evald H.

AU - OCTOBER Trial Group

PY - 2023/10/19

Y1 - 2023/10/19

N2 - Abstract Background Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain. Methods We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years. Results We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P=0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group. Conclusions Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.)

AB - Abstract Background Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain. Methods We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years. Results We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P=0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group. Conclusions Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.)

KW - Coronary Angiography

KW - Coronary Angiography/adverse effects

KW - Coronary Artery Disease/diagnostic imaging

KW - Europe

KW - Humans

KW - Percutaneous Coronary Intervention/adverse effects

KW - Tomography, Optical Coherence/adverse effects

KW - Tomography, Optical Coherence/methods

KW - Treatment Outcome

KW - Coronary Disease/Myocardial Infarction

KW - Cardiology General

KW - Cardiology

UR - http://www.scopus.com/inward/record.url?scp=85175119309&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa2307770

DO - 10.1056/NEJMoa2307770

M3 - Journal article

C2 - 37634149

SN - 0028-4793

VL - 389

SP - 1477

EP - 1487

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

IS - 16

ER -

OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions

Abstract

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