Angina Pectoris, Coronary Artery Disease, Myocardial Infarction
Conditions
Keywords
DES, Angina pectoris, Stent, Optical coherence tomography, Stent thrombosis
Brief summary
The purpose of this study is to compare early vessel healing after implantation of SYNERGY drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.
Detailed description
Prospective, open label, single blind, randomized study with inclusion of 160 patients in two equal sized cohorts (A and B). Angiographic follow-up with optical coherence tomography (OCT) is performed at 1 month (Cohort A) and 3 months (Cohort B). Randomization 1:1 to SYNERGY or BioMatrix Neoflex. The Cohorts are included consecutively, Cohort A first.
Interventions
DEVICEEverolimus eluting bioresorbable polymer stent
DEVICEBiolimus eluting bioresorbable polymer stent
Sponsors
Biosensors International
Boston Scientific Corporation
Aarhus University Hospital Skejby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>18 years to be treated with one or more drug-eluting stents in a coronary artery at Aarhus University Hospital or Odense University Hospital
Exclusion criteria
* Age \<18 years * Do not wish to participate * Unable to provide written informed consent * Domicile outside Denmark * Do not speak Danish * Inclusion in the SORT-OUT VIII study * Inclusion in other stent studies * Expected survival \<1 year * Allergy to aspirin, clopidogrel, prasugrel or ticagrelor * Hypersensitivity to everolimus or biolimus * The operator wishes to use other DES * Reduced renal function; creatinine\> 120 mmol / L * Only bare metal stent (BMS) implantation * Only plain old balloon angioplasty (POBA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronary Stent Healing Index | 1 or 3 months | Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT) |
| Uncovered stent struts | 1 or 3 months | Uncovered stent struts 2%=1, 5%=2, 10%=3, 15%=4, 20%=5, 25%=6, 30%=7, 35%=8, 40%=9 |
| Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts | 1 and 3 months | Uncovered stent struts in front of side branchs (SB), on acquired or persistent malapposed struts10%=1, 20%=2, 30%=3 etc to 100%=0 |
| Persistent malapposition | 1 and 3 months | Persistent malapposition: \>2 adjacent struts of at least 1 mm length =1; \>2 mm=2; \>3 mm=3 |
| Neointimal thickness in one frame or lumen mean diameter stenosis | 1 and 3 months | Neointimal thickness in one frame or lumen mean diameter stenosis \>200=1; \>300=2; \>400=3 or diameter stenosis \>50%=4; \>75%=5 |
| Acquired malapposition | 1 and 3 months | Acquired malapposition: \>2 adjacent struts of at least 1 mm length =2; \> 2 mm=4; \> 3 mm=6 |
| Cumulated extra stent lumen increase in matched cross sectional analysis | 1 and 3 months | Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lumen area | Baseline, 1 and 3 months | Area of lumen in cross section |
| Stent area | Baseline, 1 and 3 months | Area of stent in cross section |
| Area stenosis (AS) % | Baseline, 1 and 3 months | Minimal luminal area/reference area (interpolated) |
| Minimum expansion of the stent | Baseline, 1 and 3 months | Expressed as absolute area and percentage of the closest reference area |
| Late recoil | Baseline, 1 and 3 months | Loss in stent area from baseline to follow-up |
| Lumen late loss | Baseline, 1 and 3 months | Loss in minimal lumen area from baseline to follow-up |
| Acute expansion and late recoil | Baseline, 1 and 3 months | In segments with; 1)calcified plaque, 2)lipid plaque, 3)area after predilatation \<30% of reference area, 4)stenosed segments (\>50% AS) with no dissections after predilatation |
| Extra stent lumen | Baseline, 1 and 3 months | Area outside stent boarder limited by lumen boarder |
| Cardiac death | Baseline, 12, 24, 36, 48 and 60 months | Stent related, major adverse cardiac events (MACE), serious complication at procedure |
| Non-index procedure related acute myocardial infarction (AMI) | Baseline and within 12, 24, 36, 48 and 60 months | Defined as AMI not clearly related to another lesion than the target lesion |
| Target Lesion Revascularisation (TLR) | Baseline and within 12, 24, 36, 48 and 60 months | New revascularisation of TLR by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) (TLR if significant stenosis += 5 mm distal/proximal) |
| All-cause death | 12, 24, 36, 48 and 60 months | — |
| Stent thrombosis | Baseline, 1, 12, 24, 36, 48 and 60 months | According to ARC criteria |
| Device success rate | Baseline | Defined as the frequency of successful implantation with residual stenosis \<20% of the study stent in all the stenoses scheduled to be treated |
| Procedural success rate | Baseline | 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 |
| Target Lesion Failure (TLF) | Within 12 months | Stent related combined endpoint of Target Lesion Failure (TLF) hierarchically as cardiac death, non-index procedure related AMI (defined as AMI not clearly related to another lesion than the target lesion), or Target Lesion Revascularisation (TLR) (by PCI or CABG - TLR if significant stenosis + 5mm distal/proximal) |
| Evaginations | Baseline, 1 and 3 months | Counts and descriptive by size (volume and depth) |
| Thrombus on struts | Baseline, 1 and 3 months | In final OCT after implantation and at follow-up |
| Malapposition | Baseline, 1 and 3 months | Detectable separation between the vessel wall and strut in a cross section. |
| Coverage | Baseline, 1 and 3 months | Detectable tissue covering the strut |
| Fracture | Baseline, 1 and 3 months | Discontinuity of a strut evaluated by 3D reconstruction |
| Neointimal thickness (NIT) | Baseline, 1 and 3 months | Thickness of intima from leading strut surface to lumen boarder |
Countries
Denmark
Outcome results
None listed