Coronary Artery Disease, Diabetes Mellitus
Conditions
Keywords
Percutaneous coronary intervention, Drug eluting stent, Neointimal hyperplasia, Diabetes Mellitus
Brief summary
This study is a prospective, randomized controlled, single blind, two-arm, multicenter clinical evaluation. Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2) Polymer-Based Everolimus-Eluting Stent. The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as the primary imaging modality.
Detailed description
In patients with diabetes mellitus (DM), drug eluting stents (DES) have been shown to be associated with greater neointimal suppression than bare-metal stents. However, there is an ongoing debate on the optimal drug-eluting stent in diabetic patients. This study is a prospective, randomized controlled, single blind, two-arm, multicenter clinical evaluation. Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2) Polymer-Based Everolimus-Eluting Stent. The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as the primary imaging modality.
Interventions
DEVICEPolymer-Based Everolimus-Eluting Stent
Polymer-Based Everolimus-Eluting Stent
DEVICEPolymer-Free Amphilimus-Eluting Stent
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
Sponsors
Spanish Society of Cardiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: * Subject is eligible for PCI. * Subject has symptomatic coronary artery disease (stable/unstable angina or Non-ST elevation myocardial infarction). * Subject has known DM. Angiographic Inclusion Criteria: * Presence of 1 or 2 de novo native coronary artery lesions (maximum 1 lesion per epicardial coronary artery), with a visual estimation stenosis ≥ 50%. * Target lesion length 12-25mm, reference diameter 2.5-3.5mm. Clinical
Exclusion criteria
* ST-segment elevation myocardial infarction \<48h * Presence of cardiogenic shock pre-procedure * Contra-indications to dual antiplatelet therapy for 12 months * Left Ventricular Ejection Fraction ≤30% * GFR\<30 ml/min/m2 * Target vessel has been treated previously * Platelet count \<75000/mm3 or \>700000/mm3 * Immunosuppressive therapy * Has received or waiting list for any transplant * Life-threatening disease with a life expectancy of \< 12 months * Pregnant or breast feeding patient * Inability to provide informed consent Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neointimal hyperplasia volume obstruction | 9 months | The primary endpoint is assessed by Optical Coherence Tomography. It is defined as neointimal hyperplasia volume (mm3) divided by the stent volume multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of malapposed struts | 9 months | This endpoint is assessed by Optical Coherence Tomography. Apposition is assessed strut by strut by measuring the distance between the strut marker and the lumen contour. Struts with distance to lumen contour larger than the sum of strut + polymer thickness are considered malapposed. This results in incomplete strut apposition thresholds of 89 µm for the Xience Prime and 80 µm for the Cre8 stent. Struts located at the ostium of side branches, with no vessel wall behind, are excluded from the analysis of apposition. |
| Maximum percentage of NIH cross-sectional obstruction | 9 months | This endpoint is assessed by Optical Coherence Tomography. Percentage of NIH cross-sectional obstruction is defined as the NIH area (mm2) divided by the stent area multiplied by 100. |
| Percentage of uncovered struts | 9 months | This endpoint is assessed by Optical Coherence Tomography. Struts are classified as uncovered if any part of the strut is visibly exposed to the lumen, or covered if a layer of tissue is visible over all the reflecting surfaces. |
| Probable or definite stent thrombosis | 12 months | Stent thrombosis is considered according to the Academic Research Consortium definitions |
| Target vessel failure | 12 months | Target vessel failure is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated revascularization of the target vessel. |
| Cardiac death | 12 months | Death related to cardiac causes; if the cause of death cannot be determined, it will be also categorized as cardiac. |
Countries
Spain
Outcome results
None listed