The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)

Study Overview
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Brief Summary
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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
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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).

Official Title
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European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction - The OCTOBER Trial -

Conditions
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Ischaemic Heart Disease, Ischemic Heart Disease

Intervention / Treatment
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* Procedure: Angiographic guided PCI
* Procedure: OCT guided PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Angiographic guided PCI<br>Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS). | Procedure: Angiographic guided PCI<br>* Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques<br>* Other names: PCI, percutaneous transluminal coronary angioplasty (PTCA);|
| Experimental: OCT guided PCI<br>OCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT) | Procedure: OCT guided PCI<br>* OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans<br>* Other names: OCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined endpoint of major adverse cardiac events (MACE) | Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study bifurcation oriented composite endpoint | Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation | 1 month | 
| Study bifurcation oriented composite endpoint | Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation | 12 months | 
| Study bifurcation oriented composite endpoint | Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation | 24 months | 
| Study bifurcation oriented composite endpoint | Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation | 36 months | 
| Study bifurcation oriented composite endpoint | Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation | 48 months | 
| Study bifurcation oriented composite endpoint | Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation | 60 months | 
| Patient oriented composite endpoint | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke | 1 month | 
| Patient oriented composite endpoint | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke | 12 months | 
| Patient oriented composite endpoint | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke | 24 months | 
| Patient oriented composite endpoint | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke | 36 months | 
| Patient oriented composite endpoint | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke | 48 months | 
| Patient oriented composite endpoint | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke | 60 months | 
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 1 month | 
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 12 months | 
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 24 months | 
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 36 months | 
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 48 months | 
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 60 months | 
| All-cause mortality | Death of any cause including cardiac deaths and non-natural causes of death | 120 months | 
| Cardiac death | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes | 1 month | 
| Cardiac death | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes | 12 months | 
| Cardiac death | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes | 24 months | 
| Cardiac death | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes | 36 months | 
| Cardiac death | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes | 48 months | 
| Cardiac death | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes | 60 months | 
| Myocardial infarction | Procedure and non-procedure related myocardial infarction | 1 month | 
| Myocardial infarction | Procedure and non-procedure related myocardial infarction | 12 months | 
| Myocardial infarction | Procedure and non-procedure related myocardial infarction | 24 months | 
| Myocardial infarction | Procedure and non-procedure related myocardial infarction | 36 months | 
| Myocardial infarction | Procedure and non-procedure related myocardial infarction | 48 months | 
| Myocardial infarction | Procedure and non-procedure related myocardial infarction | 60 months | 
| Stent Thrombosis | Definite, possible or probable | 1 month | 
| Stent Thrombosis | Definite, possible or probable | 12 months | 
| Stent Thrombosis | Definite, possible or probable | 24 months | 
| Stent Thrombosis | Definite, possible or probable | 36 months | 
| Stent Thrombosis | Definite, possible or probable | 48 months | 
| Stent Thrombosis | Definite, possible or probable | 60 months | 
| Target lesion myocardial infarction | Myocardial infarction related to an index treated lesion | 1 month | 
| Target lesion myocardial infarction | Myocardial infarction related to an index treated lesion | 12 months | 
| Target lesion myocardial infarction | Myocardial infarction related to an index treated lesion | 24 months | 
| Target lesion myocardial infarction | Myocardial infarction related to an index treated lesion | 36 months | 
| Target lesion myocardial infarction | Myocardial infarction related to an index treated lesion | 48 months | 
| Target lesion myocardial infarction | Myocardial infarction related to an index treated lesion | 60 months | 
| Target lesion revascularisation | Coronary artery bypass grafting or PCI of target lesion | 1 month | 
| Target lesion revascularisation | Coronary artery bypass grafting or PCI of target lesion | 12 months | 
| Target lesion revascularisation | Coronary artery bypass grafting or PCI of target lesion | 24 months | 
| Target lesion revascularisation | Coronary artery bypass grafting or PCI of target lesion | 36 months | 
| Target lesion revascularisation | Coronary artery bypass grafting or PCI of target lesion | 48 months | 
| Target lesion revascularisation | Coronary artery bypass grafting or PCI of target lesion | 60 months | 
| Target bifurcation myocardial infarction | Myocardial infarction related to the index bifurcation | 1 month | 
| Target bifurcation myocardial infarction | Myocardial infarction related to the index bifurcation | 12 months | 
| Target bifurcation myocardial infarction | Myocardial infarction related to the index bifurcation | 24 months | 
| Target bifurcation myocardial infarction | Myocardial infarction related to the index bifurcation | 36 months | 
| Target bifurcation myocardial infarction | Myocardial infarction related to the index bifurcation | 48 months | 
| Target bifurcation myocardial infarction | Myocardial infarction related to the index bifurcation | 60 months | 
| Target bifurcation revascularisation | Coronary artery bypass grafting or PCI of target bifurcation | 1 month | 
| Target bifurcation revascularisation | Coronary artery bypass grafting or PCI of target bifurcation | 12 months | 
| Target bifurcation revascularisation | Coronary artery bypass grafting or PCI of target bifurcation | 24 months | 
| Target bifurcation revascularisation | Coronary artery bypass grafting or PCI of target bifurcation | 36 months | 
| Target bifurcation revascularisation | Coronary artery bypass grafting or PCI of target bifurcation | 48 months | 
| Target bifurcation revascularisation | Coronary artery bypass grafting or PCI of target bifurcation | 60 months | 
| Target vessel revascularisation | Coronary artery bypass grafting or PCI of target vessel | 1 month | 
| Target vessel revascularisation | Coronary artery bypass grafting or PCI of target vessel | 12 months | 
| Target vessel revascularisation | Coronary artery bypass grafting or PCI of target vessel | 24 months | 
| Target vessel revascularisation | Coronary artery bypass grafting or PCI of target vessel | 36 months | 
| Target vessel revascularisation | Coronary artery bypass grafting or PCI of target vessel | 48 months | 
| Target vessel revascularisation | Coronary artery bypass grafting or PCI of target vessel | 60 months | 
| Any revascularisation | Any repeat revascularization except staged revascularization planned during the index procedure | 1 month | 
| Any revascularisation | Any repeat revascularization except staged revascularization planned during the index procedure | 12 months | 
| Any revascularisation | Any repeat revascularization except staged revascularization planned during the index procedure | 24 months | 
| Any revascularisation | Any repeat revascularization except staged revascularization planned during the index procedure | 36 months | 
| Any revascularisation | Any repeat revascularization except staged revascularization planned during the index procedure | 48 months | 
| Any revascularisation | Any repeat revascularization except staged revascularization planned during the index procedure | 60 months | 
| CCS angina class | Canadian Cardiovascular Society (CCS) grading of angina pectoris | 1 month | 
| CCS angina class | Canadian Cardiovascular Society (CCS) grading of angina pectoris | 12 months | 
| CCS angina class | Canadian Cardiovascular Society (CCS) grading of angina pectoris | 24 months | 
| CCS angina class | Canadian Cardiovascular Society (CCS) grading of angina pectoris | 36 months | 
| CCS angina class | Canadian Cardiovascular Society (CCS) grading of angina pectoris | 48 months | 
| CCS angina class | Canadian Cardiovascular Society (CCS) grading of angina pectoris | 60 months | 
| Post-PCI minimal lumen diameter in the stented proximal main vessel segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented proximal main vessel segment | 1 day | 
| Post-PCI minimal lumen diameter in the stented distal main vessel segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel segment | 1 day | 
| Post-PCI minimal lumen diameter in the treated side branch vessel segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment | 1 day | 
| Post-PCI minimal lumen diameter in the proximal main vessel edge segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent) | 1 day | 
| Post-PCI minimal lumen diameter in the distal main vessel edge segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent) | 1 day | 
| Post-PCI minimal lumen diameter in the side branch vessel edge segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon) | 1 day | 
| Post-PCI minimal lumen diameter in the stented bifurcation core segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented bifurcation core segment | 1 day | 
| Post-PCI minimal lumen diameter in the stented distal main vessel ostium segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment | 1 day | 
| Post-PCI minimal lumen diameter in the treated side branch vessel ostium segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated side branch vessel ostium segment | 1 day | 
| Post-PCI diameter stenosis in the stented proximal main vessel segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented proximal main vessel segment | 1 day | 
| Post-PCI diameter stenosis in the stented distal main vessel segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel segment | 1 day | 
| Post-PCI diameter stenosis in the treated side branch vessel segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment | 1 day | 
| Post-PCI diameter stenosis in the proximal main vessel edge segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent) | 1 day | 
| Post-PCI diameter stenosis in the distal main vessel edge segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent) | 1 day | 
| Post-PCI diameter stenosis in the side branch vessel edge segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon) | 1 day | 
| Post-PCI diameter stenosis in the stented bifurcation core segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented bifurcation core segment | 1 day | 
| Post-PCI diameter stenosis in the stented distal main vessel ostium segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment | 1 day | 
| Post-PCI diameter stenosis in the treated side branch ostium segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated side branch ostium segment | 1 day | 
| Post-PCI minimal lumen diameter in non-bifurcation target stented segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target stented segment | 1 day | 
| Post-PCI minimal lumen diameter in non-bifurcation target proximal edge segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment (within 5mm fra stent) | 1 day | 
| Post-PCI minimal lumen diameter in non-bifurcation target distal edge segment | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment (within 5mm fra stent) | 1 day | 
| Post-PCI diameter stenosis in non-bifurcation target stented segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target stented segment | 1 day | 
| Post-PCI diameter stenosis in non-bifurcation target proximal edge segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment | 1 day | 
| Post-PCI diameter stenosis in non-bifurcation target distal edge segment | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment | 1 day |