Everolimus-eluting SYNERGY Stent Versus Biolimus-eluting Biomatrix NeoFlex Stent - SORT-OUT VIII

Study Overview
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Brief Summary
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The purpose of this study is to perform a randomised comparison between the SYNERGY and the Biomatrix NeoFlex stents in treatment of unselected patients with ischemic heart disease.

Detailed Description
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SORT-OUT VIII is a randomised, multicenter, all-comer, two-arm, non-inferiority trial comparing the everolimus-eluting SYNERGY stent versus the Biomatrix NeoFlex stent in treatment of atherosclerotic coronary artery lesions. Primary Endpoint: Device-related Target Lesion Failure (TLF) hierarchically as cardiac death, non-index procedure related acute myocardial infarction (AMI) not clearly related to another lesion than the target lesion, or target lesion revascularisation (TLR) (new revascularization of target lesion) (significant stenosis in the stent ± 5 mm distal/proximal) by percutaneous coronary intervention (PCI) or coronary artery bypass operation (CABG) within 12 months. Secondary Endpoint: Device-related target lesion failure hierarchically as cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than the target lesion, or new target lesion revascularization by percutaneous coronary intervention or coronary bypass operation at 2-5 years. Patient-related combined endpoint hierarchically as all-cause death, non-index procedure related acute myocardial infarction or all new revascularizations by percutaneous coronary intervention or coronary bypass operation at 12, 24, 36, 48 and 60 months. Individual above mentioned stent- or patient-related endpoints at 12, 24, 36, 48 and 60 months MACE (combined endpoint as cardiac death, acute myocardial infarction or new revascularization of the study vessel) Stent thrombosis defined according to the Academic Research Consortium (ARC) criteria within 24 hours (acute), between 1 and 30 days (subacute), between 30 days and 12 months (late), and after 12, 24, 36, 48 and 60 months (very late). Device success rate defined as the frequency of a successful implantation with residual stenosis < 20% of the study stent in all the stenoses scheduled to be treated. Procedural success rate defined as the frequency of successful implantation with residual stenosis <20% of the study stent in all the stenoses scheduled to be treated and without serious complications (cardiac death, non-index procedure related acute myocardial infarction related to target vessel or new revascularization of target lesion by percutaneous coronary intervention or coronary bypass operation). Inclusion criteria: All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at one of the three heart centers in Odense, Skejby and Aalborg can be included in the study. Exclusion criteria Age < 18 years The patient does not wish to participate The patient is not able to consent to randomization (eg intubated patients) The patient do not live in Western Denmark The patient do not speak Danish The patient is already included in this study The patient is participating in other stent studies Life expectancy <1 year Allergic to Aspirin, clopidogrel, prasugrel or ticagrelor Allergic to everolimus or biolimus Only implanted bare metal stents (BMS) Only performed plain old balloon angioplasty (POBA)

Official Title
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Randomized Clinical Comparison of Everolimus-Eluting SYNERGY® and Biolimus-Eluting BioMatrix NeoFlex® Coronary Stents in Non-Selected Patients With Ischemic Heart Disease

Conditions
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Coronary Artery Disease, Ischemic Heart Disease

Intervention / Treatment
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* Device: Biomatrix NeoFlex coronary stent
* Device: SYNERGY stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at one of the three heart centers in Odense, Skejby and Aalborg can be included in the study. Exclusion Criteria: Age < 18 years The patient does not wish to participate The patient is not able to consent to randomization (eg intubated patients) The patient do not live in West Denmark The patient do not speak Danish The patient is already included in this study The patient is already participating in other stent studies Life expectancy <1 year Allergic to Aspirin, clopidogrel, prasugrel or ticagrelor Allergic to everolimus or biolimus Only implanted BMS Only performed POBA

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: SYNERGY<br>Coronary implantatation of the SYNERGY everolimus-eluting stent | Device: SYNERGY stent<br>* Percutaneous coronary intervention involving use of stent<br>* Other names: Everolimus-eluting SYNERGY coronary stent;|
| Active Comparator: Biomatrix Neoflex<br>Coronary implantation of the biolimus-eluting Biomatrix NeoFlex stent | Device: Biomatrix NeoFlex coronary stent<br>* Percutaneous coronary intervention involving use of stent<br>* Other names: Biolimus-eluting Biomatrix NeoFlex coronary stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related target lesion failure | Hierarchically as cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion, or target lesion revascularisation (new revascularisation of target lesion revascularisation (significant stenosis in the stent =/+ 5 mm distal/proximal) by percutaneous coronary intervention or coronary artery bypass operation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related target lesion failure | Hierarchically as cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion, or target lesion revascularisation (new revascularisation of target lesion revascularisation by percutaneous coronary intervention or coronary artery bypass operation | 2, 3, 4 and 5 years | 
| Patient-related combined endpoint | Hierarchically as all-cause death, non-index procedure related acute myocardial infarction, or all new revascularisation by percutaneous coronary intervention or coronary artery bypass operation | 1, 2, 3, 4 and 5 year | 
| Individual above mentioned stent- or patient-related endpoints |  | 1, 2, 3, 4 and 5 years | 
| MACE | Combined endpoint as cardiac death, acute myocardial infarction or new revascularisation of the study vessel | 1, 2, 3, 4 and 5 years | 
| Stent thrombosis | Stent thrombosis according to the Academic Research Consortium definitions | Within 24 hours, between 1 and 30 days, between 30 days and 12 months and after 1, 2, 3, 4 and 5 years | 
| Device success rate | The frequency of a successful implantation with residual stenosis <20% of the study stent in all stenoses scheduled to be treated | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DES, Stent, Percutaneous coronary intervention, Angina pectoris