OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions
Copyright © 2023 Massachusetts Medical Society..
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.).
| Errataetall: |
CommentIn: N Engl J Med. 2024 Jan 11;390(2):187-188. - PMID 38197829 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:389 |
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| Enthalten in: |
The New England journal of medicine - 389(2023), 16 vom: 19. Okt., Seite 1477-1487 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Holm, Niels R [VerfasserIn] |
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| Links: |
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| Themen: |
Comparative Study |
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| Anmerkungen: |
Date Completed 30.10.2023 Date Revised 10.01.2024 published: Print-Electronic ClinicalTrials.gov: NCT03171311 CommentIn: N Engl J Med. 2024 Jan 11;390(2):187-188. - PMID 38197829 Citation Status MEDLINE |
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| doi: |
10.1056/NEJMoa2307770 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 500 | |a Date Completed 30.10.2023 | ||
| 500 | |a Date Revised 10.01.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03171311 | ||
| 500 | |a CommentIn: N Engl J Med. 2024 Jan 11;390(2):187-188. - PMID 38197829 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 Massachusetts Medical Society. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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.) | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 700 | 1 | |a Andreasen, Lene N |e verfasserin |4 aut | |
| 700 | 1 | |a Neghabat, Omeed |e verfasserin |4 aut | |
| 700 | 1 | |a Laanmets, Peep |e verfasserin |4 aut | |
| 700 | 1 | |a Kumsars, Indulis |e verfasserin |4 aut | |
| 700 | 1 | |a Bennett, Johan |e verfasserin |4 aut | |
| 700 | 1 | |a Olsen, Niels T |e verfasserin |4 aut | |
| 700 | 1 | |a Odenstedt, Jacob |e verfasserin |4 aut | |
| 700 | 1 | |a Hoffmann, Pavel |e verfasserin |4 aut | |
| 700 | 1 | |a Dens, Jo |e verfasserin |4 aut | |
| 700 | 1 | |a Chowdhary, Saqib |e verfasserin |4 aut | |
| 700 | 1 | |a O'Kane, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Bülow Rasmussen, Søren-Haldur |e verfasserin |4 aut | |
| 700 | 1 | |a Heigert, Matthias |e verfasserin |4 aut | |
| 700 | 1 | |a Havndrup, Ole |e verfasserin |4 aut | |
| 700 | 1 | |a Van Kuijk, Jan P |e verfasserin |4 aut | |
| 700 | 1 | |a Biscaglia, Simone |e verfasserin |4 aut | |
| 700 | 1 | |a Mogensen, Lone J H |e verfasserin |4 aut | |
| 700 | 1 | |a Henareh, Loghman |e verfasserin |4 aut | |
| 700 | 1 | |a Burzotta, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a H Eek, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Mylotte, Darren |e verfasserin |4 aut | |
| 700 | 1 | |a Llinas, Miquel S |e verfasserin |4 aut | |
| 700 | 1 | |a Koltowski, Lukasz |e verfasserin |4 aut | |
| 700 | 1 | |a Knaapen, Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Calic, Slobodan |e verfasserin |4 aut | |
| 700 | 1 | |a Witt, Nils |e verfasserin |4 aut | |
| 700 | 1 | |a Santos-Pardo, Irene |e verfasserin |4 aut | |
| 700 | 1 | |a Watkins, Stuart |e verfasserin |4 aut | |
| 700 | 1 | |a Lønborg, Jacob |e verfasserin |4 aut | |
| 700 | 1 | |a Kristensen, Andreas T |e verfasserin |4 aut | |
| 700 | 1 | |a Jensen, Lisette O |e verfasserin |4 aut | |
| 700 | 1 | |a Calais, Fredrik |e verfasserin |4 aut | |
| 700 | 1 | |a Cockburn, James |e verfasserin |4 aut | |
| 700 | 1 | |a McNeice, Andrew |e verfasserin |4 aut | |
| 700 | 1 | |a Kajander, Olli A |e verfasserin |4 aut | |
| 700 | 1 | |a Heestermans, Ton |e verfasserin |4 aut | |
| 700 | 1 | |a Kische, Stephan |e verfasserin |4 aut | |
| 700 | 1 | |a Eftekhari, Ashkan |e verfasserin |4 aut | |
| 700 | 1 | |a Spratt, James C |e verfasserin |4 aut | |
| 700 | 1 | |a Christiansen, Evald H |e verfasserin |4 aut | |
| 700 | 0 | |a OCTOBER Trial Group |e verfasserin |4 aut | |
| 700 | 1 | |a Christiansen, Evald Høj |e investigator |4 oth | |
| 700 | 1 | |a Lønborg, Jacob Thomsen |e investigator |4 oth | |
| 700 | 1 | |a Okkels Jensen, Lisette |e investigator |4 oth | |
| 700 | 1 | |a Havndrup, Ole |e investigator |4 oth | |
| 700 | 1 | |a Olsen, Niels Thue |e investigator |4 oth | |
| 700 | 1 | |a Eftekhari, Ashkan |e investigator |4 oth | |
| 700 | 1 | |a Eek, Christian |e investigator |4 oth | |
| 700 | 1 | |a Hoffmann, Pavel |e investigator |4 oth | |
| 700 | 1 | |a Calic, Slobodan |e investigator |4 oth | |
| 700 | 1 | |a Bleie, Øyvind |e investigator |4 oth | |
| 700 | 1 | |a Heigert, Matthias |e investigator |4 oth | |
| 700 | 1 | |a Witt, Nils |e investigator |4 oth | |
| 700 | 1 | |a Santos-Pardo, Irene |e investigator |4 oth | |
| 700 | 1 | |a Henareh, Loghman |e investigator |4 oth | |
| 700 | 1 | |a Odenstedt, Jacob |e investigator |4 oth | |
| 700 | 1 | |a Calais, Fredrik |e investigator |4 oth | |
| 700 | 1 | |a Laanmets, Peep |e investigator |4 oth | |
| 700 | 1 | |a Kajander, Olli |e investigator |4 oth | |
| 700 | 1 | |a McNeice, Andrew |e investigator |4 oth | |
| 700 | 1 | |a Cockburn, James |e investigator |4 oth | |
| 700 | 1 | |a Spratt, James |e investigator |4 oth | |
| 700 | 1 | |a Obaid, Daniel R |e investigator |4 oth | |
| 700 | 1 | |a O'Kane, Peter |e investigator |4 oth | |
| 700 | 1 | |a Chowdhary, Saqib |e investigator |4 oth | |
| 700 | 1 | |a Watkins, Stuart |e investigator |4 oth | |
| 700 | 1 | |a Mylotte, Darren |e investigator |4 oth | |
| 700 | 1 | |a Kumsars, Indulis |e investigator |4 oth | |
| 700 | 1 | |a Kische, Stephan |e investigator |4 oth | |
| 700 | 1 | |a Lutz, Matthias |e investigator |4 oth | |
| 700 | 1 | |a Bergmann, Martin W |e investigator |4 oth | |
| 700 | 1 | |a Clemmensen, Peter |e investigator |4 oth | |
| 700 | 1 | |a Burzotta, Francesco |e investigator |4 oth | |
| 700 | 1 | |a Biscaglia, Simone |e investigator |4 oth | |
| 700 | 1 | |a Knaapen, Paul |e investigator |4 oth | |
| 700 | 1 | |a Timmers, Leo |e investigator |4 oth | |
| 700 | 1 | |a Heestermans, Ton |e investigator |4 oth | |
| 700 | 1 | |a Bennett, Johan |e investigator |4 oth | |
| 700 | 1 | |a Dens, Jo |e investigator |4 oth | |
| 700 | 1 | |a Koltowski, Lukasz |e investigator |4 oth | |
| 700 | 1 | |a Holm, Niels Ramsing |e investigator |4 oth | |
| 700 | 1 | |a Bargsteen, Helle |e investigator |4 oth | |
| 700 | 1 | |a Pagh Pedersen, Helle |e investigator |4 oth | |
| 700 | 1 | |a Winchkler, Hanne |e investigator |4 oth | |
| 700 | 1 | |a Jørgensen, Mona |e investigator |4 oth | |
| 700 | 1 | |a Ottesen, Pia |e investigator |4 oth | |
| 700 | 1 | |a Jørgensen, Lars |e investigator |4 oth | |
| 700 | 1 | |a Neghabat, Omeed |e investigator |4 oth | |
| 700 | 1 | |a Andreasen, Lene Nyhus |e investigator |4 oth | |
| 700 | 1 | |a Mogensen, Lone Juul Hune |e investigator |4 oth | |
| 700 | 1 | |a Madsen, Morten |e investigator |4 oth | |
| 700 | 1 | |a Hjort, Jakob |e investigator |4 oth | |
| 700 | 1 | |a Rahbek, Martin |e investigator |4 oth | |
| 700 | 1 | |a Santos Llinas, Miquel |e investigator |4 oth | |
| 700 | 1 | |a Bülow Rasmussen, Søren-Haldur |e investigator |4 oth | |
| 700 | 1 | |a Nielsen, Kenneth Spure |e investigator |4 oth | |
| 700 | 1 | |a Dieu, Ruthe Storgaard |e investigator |4 oth | |
| 700 | 1 | |a Andreas, Andreas Torp |e investigator |4 oth | |
| 700 | 1 | |a Stycke Ottosen, Pia |e investigator |4 oth | |
| 700 | 1 | |a Ravkilde, Jan |e investigator |4 oth | |
| 700 | 1 | |a Thygesen, Kristian |e investigator |4 oth | |
| 700 | 1 | |a Liu, Tommy |e investigator |4 oth | |
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| 700 | 1 | |a Erlinge, David |e investigator |4 oth | |
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