Clinical trial NCT03171311: The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Official title: European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction - The OCTOBER Trial -
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ischaemic Heart Disease
Ischemic Heart Disease
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2017-05-31
Enrollment: 1201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation

Detailed description: Coronary bifurcation lesions with stenosis in a large side branch may require complex stent implantation techniques with an elevated risk of suboptimal treatment results. Intra vascular optical coherence tomography (OCT) enables improved procedural control of correctable factors and may lead to optimized implantation results.

It is unknown if routine, systematic use of OCT scans during complex bifurcation stenting improves clinical outcome but present available evidence indicates advantages of OCT guidance that could translate into improved clinical outcome.

Hypothesis: Systematic OCT guided revascularization of patients with bifurcation lesions requiring complex stent implantation provides superior two-year clinical outcome compared to standard revascularization by PCI.

Methods: Investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective, multicenter, superiority trial. Randomization is stratified for 1) Left main or non-Left main artery disease, and 2) up-front planned one-stent technique with kissing balloon inflation, or a two-stent technique.

Systematic OCT guidance is detailed for five complex stent implantation techniques. Standard treatment is angiographic based with optional use of intravascular ultrasound (IVUS).

Eligibility criteria: Inclusion Criteria:

* Stable angina pectoris, unstable angina pectoris, clinically stable non-STEMI.
* Age ≥18 yrs.
* Abel to provide written Informed consent and willing to comply with the specified follow-up contacts.

Angiographic inclusion criteria:

* Native coronary bifurcation de novo lesion
* More than 50% diameter stenosis in the main vessel (MV)
* More than 50% diameter stenosis in the side branch (SB) within 5 mm of the ostium.
* Reference size at least 2.75 mm in the main vessel (MV) and ≥2.5 mm in the SB.

Functional inclusion criteria:

Functional significance of the main vessel lesion or documented ischemia of the main vessel territory or other objective documentation of lesion significance. Objective evidence of ischemia is required for all treated lesions except for lesions with more than 80% diameter stenosis that may be considered significant.

Procedural inclusion criteria:

Indication for two-stent technique or one-stent technique with kissing balloon inflation

Exclusion Criteria:

* STEMI within 72 hours
* Cardiogenic shock
* Prior coronary artery bypass grafting (CABG) or planned CABG
* Renal failure with glomerular filtration rate (GFR) \<50 mL/min per 1.73 m2
* Active bleeding or coagulopathy
* Life expectancy \< 2 years
* Ejection fraction \< 30%
* New York Heart Association (NYHA) class \> II
* Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds, everolimus).

Angiographic exclusion criteria:

* Severe tortuosity around target bifurcation
* Chronic total occlusions
* Massive thrombus in Left main coronary artery
* Medina 0.0.1 lesions

Primary outcomes:
measure: Combined endpoint of major adverse cardiac events (MACE)
timeFrame: 24 months
Secondary outcomes:
measure: Study bifurcation oriented composite endpoint
timeFrame: 1 month
measure: Study bifurcation oriented composite endpoint
timeFrame: 12 months
measure: Study bifurcation oriented composite endpoint
timeFrame: 24 months
measure: Study bifurcation oriented composite endpoint
timeFrame: 36 months
measure: Study bifurcation oriented composite endpoint
timeFrame: 48 months
measure: Study bifurcation oriented composite endpoint
timeFrame: 60 months
measure: Patient oriented composite endpoint
timeFrame: 1 month
measure: Patient oriented composite endpoint
timeFrame: 12 months
measure: Patient oriented composite endpoint
timeFrame: 24 months
measure: Patient oriented composite endpoint
timeFrame: 36 months
measure: Patient oriented composite endpoint
timeFrame: 48 months
measure: Patient oriented composite endpoint
timeFrame: 60 months
measure: All-cause mortality
timeFrame: 1 month
measure: All-cause mortality
timeFrame: 12 months
measure: All-cause mortality
timeFrame: 24 months
measure: All-cause mortality
timeFrame: 36 months
measure: All-cause mortality
timeFrame: 48 months
measure: All-cause mortality
timeFrame: 60 months
measure: All-cause mortality
timeFrame: 120 months
measure: Cardiac death
timeFrame: 1 month
measure: Cardiac death
timeFrame: 12 months
measure: Cardiac death
timeFrame: 24 months
measure: Cardiac death
timeFrame: 36 months
measure: Cardiac death
timeFrame: 48 months
measure: Cardiac death
timeFrame: 60 months
measure: Myocardial infarction
timeFrame: 1 month
measure: Myocardial infarction
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 24 months
measure: Myocardial infarction
timeFrame: 36 months
measure: Myocardial infarction
timeFrame: 48 months
measure: Myocardial infarction
timeFrame: 60 months
measure: Stent Thrombosis
timeFrame: 1 month
measure: Stent Thrombosis
timeFrame: 12 months
measure: Stent Thrombosis
timeFrame: 24 months
measure: Stent Thrombosis
timeFrame: 36 months
measure: Stent Thrombosis
timeFrame: 48 months
measure: Stent Thrombosis
timeFrame: 60 months
measure: Target lesion myocardial infarction
timeFrame: 1 month
measure: Target lesion myocardial infarction
timeFrame: 12 months
measure: Target lesion myocardial infarction
timeFrame: 24 months
measure: Target lesion myocardial infarction
timeFrame: 36 months
measure: Target lesion myocardial infarction
timeFrame: 48 months
measure: Target lesion myocardial infarction
timeFrame: 60 months
measure: Target lesion revascularisation
timeFrame: 1 month
measure: Target lesion revascularisation
timeFrame: 12 months
measure: Target lesion revascularisation
timeFrame: 24 months
measure: Target lesion revascularisation
timeFrame: 36 months
measure: Target lesion revascularisation
timeFrame: 48 months
measure: Target lesion revascularisation
timeFrame: 60 months
measure: Target bifurcation myocardial infarction
timeFrame: 1 month
measure: Target bifurcation myocardial infarction
timeFrame: 12 months
measure: Target bifurcation myocardial infarction
timeFrame: 24 months
measure: Target bifurcation myocardial infarction
timeFrame: 36 months
measure: Target bifurcation myocardial infarction
timeFrame: 48 months
measure: Target bifurcation myocardial infarction
timeFrame: 60 months
measure: Target bifurcation revascularisation
timeFrame: 1 month
measure: Target bifurcation revascularisation
timeFrame: 12 months
measure: Target bifurcation revascularisation
timeFrame: 24 months
measure: Target bifurcation revascularisation
timeFrame: 36 months
measure: Target bifurcation revascularisation
timeFrame: 48 months
measure: Target bifurcation revascularisation
timeFrame: 60 months
measure: Target vessel revascularisation
timeFrame: 1 month
measure: Target vessel revascularisation
timeFrame: 12 months
measure: Target vessel revascularisation
timeFrame: 24 months
measure: Target vessel revascularisation
timeFrame: 36 months
measure: Target vessel revascularisation
timeFrame: 48 months
measure: Target vessel revascularisation
timeFrame: 60 months
measure: Any revascularisation
timeFrame: 1 month
measure: Any revascularisation
timeFrame: 12 months
measure: Any revascularisation
timeFrame: 24 months
measure: Any revascularisation
timeFrame: 36 months
measure: Any revascularisation
timeFrame: 48 months
measure: Any revascularisation
timeFrame: 60 months
measure: CCS angina class
timeFrame: 1 month
measure: CCS angina class
timeFrame: 12 months
measure: CCS angina class
timeFrame: 24 months
measure: CCS angina class
timeFrame: 36 months
measure: CCS angina class
timeFrame: 48 months
measure: CCS angina class
timeFrame: 60 months
measure: Post-PCI minimal lumen diameter in the stented proximal main vessel segment
timeFrame: 1 day
measure: Post-PCI minimal lumen diameter in the stented distal main vessel segment
timeFrame: 1 day
measure: Post-PCI minimal lumen diameter in the treated side branch vessel segment
timeFrame: 1 day
measure: Post-PCI minimal lumen diameter in the proximal main vessel edge segment
timeFrame: 1 day
measure: Post-PCI minimal lumen diameter in the distal main vessel edge segment
timeFrame: 1 day
measure: Post-PCI minimal lumen diameter in the side branch vessel edge segment
timeFrame: 1 day
measure: Post-PCI minimal lumen diameter in the stented bifurcation core segment
timeFrame: 1 day
measure: Post-PCI minimal lumen diameter in the stented distal main vessel ostium segment
timeFrame: 1 day
measure: Post-PCI minimal lumen diameter in the treated side branch vessel ostium segment
timeFrame: 1 day
measure: Post-PCI diameter stenosis in the stented proximal main vessel segment
timeFrame: 1 day
measure: Post-PCI diameter stenosis in the stented distal main vessel segment
timeFrame: 1 day
measure: Post-PCI diameter stenosis in the treated side branch vessel segment
timeFrame: 1 day
measure: Post-PCI diameter stenosis in the proximal main vessel edge segment
timeFrame: 1 day
measure: Post-PCI diameter stenosis in the distal main vessel edge segment
timeFrame: 1 day
measure: Post-PCI diameter stenosis in the side branch vessel edge segment
timeFrame: 1 day
measure: Post-PCI diameter stenosis in the stented bifurcation core segment
timeFrame: 1 day
measure: Post-PCI diameter stenosis in the stented distal main vessel ostium segment
timeFrame: 1 day
measure: Post-PCI diameter stenosis in the treated side branch ostium segment
timeFrame: 1 day
measure: Post-PCI minimal lumen diameter in non-bifurcation target stented segment
timeFrame: 1 day
measure: Post-PCI minimal lumen diameter in non-bifurcation target proximal edge segment
timeFrame: 1 day
measure: Post-PCI minimal lumen diameter in non-bifurcation target distal edge segment
timeFrame: 1 day
measure: Post-PCI diameter stenosis in non-bifurcation target stented segment
timeFrame: 1 day
measure: Post-PCI diameter stenosis in non-bifurcation target proximal edge segment
timeFrame: 1 day
measure: Post-PCI diameter stenosis in non-bifurcation target distal edge segment
timeFrame: 1 day
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg (ZOL) Genk
city: Leuven
country: Belgium
facility: Leuven University Hospital
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital Skejby
city: Gentofte
country: Denmark
facility: Gentofte Hospital
city: København Ø
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital, Roskilde Sygehus
city: Tallinn
country: Estonia
facility: Estonia Medical Centre
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: Galway
country: Ireland
facility: University Hospital Galway
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara
state: Cona
city: Rome
country: Italy
facility: Gemelli General Hospital, Catholic University of the Sacred Heart
city: Riga
country: Latvia
facility: Latvia Centre of Cardiology
city: Alkmaar
country: Netherlands
facility: Northwest Hospital Alkmaar
city: Amsterdam
country: Netherlands
facility: VU University Medical Center (VUMC)
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Arendal
country: Norway
facility: Hospital of Southern Norway, Arendal
city: Bergen
country: Norway
facility: Haukeland University Hospital, Bergen
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
city: Oslo
country: Norway
facility: Oslo University Hospital - Ullevål
city: Trondheim
country: Norway
facility: Trondheim University Hospital
city: Warsaw
country: Poland
facility: Medical University of Warsaw
city: Huddinge
country: Sweden
facility: Karolinska University Hospital Huddinge
state: Stockholm
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Orebro
country: Sweden
facility: Örebro University Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Brighton
country: United Kingdom
facility: Sussex Cardiac Centre
city: Glasgow
country: United Kingdom
facility: Golden Jubilee Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: Manchester
country: United Kingdom
facility: University Hospital South Manchester, Wythenshawe Hospital
city: Swansea
country: United Kingdom
facility: Morriston Hospital
Study officials:
affiliation: Aarhus University Hospital, Denmark
name: Evald H Christiansen, MD, PhD
role: STUDY_CHAIR
References:
citation: Holm NR, Andreasen LN, Walsh S, Kajander OA, Witt N, Eek C, Knaapen P, Koltowski L, Gutierrez-Chico JL, Burzotta F, Kockman J, Ormiston J, Santos-Pardo I, Laanmets P, Mylotte D, Madsen M, Hjort J, Kumsars I, Ramunddal T, Christiansen EH. Rational and design of the European randomized Optical Coherence Tomography Optimized Bifurcation Event Reduction Trial (OCTOBER). Am Heart J. 2018 Nov;205:97-109. doi: 10.1016/j.ahj.2018.08.003. Epub 2018 Aug 16.