Efficacy and Safety of Coronary Amphilimus-ELuting Stent in diAbeTic patiEnts: a Cross-sectional Multicentre Consecutive Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Ospedale S. Giovanni Bosco
- Enrollment
- 3400
- Locations
- 1
- Primary Endpoint
- Incidence of the composite endpoint of cardiac death, definite and probable stent thrombosis, re-PCI, Target Vessel Revascularization and bleeding in the two groups of study
- Last Updated
- 7 years ago
Overview
Brief Summary
More recently a polymer-free drug eluting stent (Amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. However, to date there are no direct comparisons of these two type of drug eluting stents.
Detailed Description
Drug eluting stent is the cornerstone of treatment in diabetic patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, there are a considerable number of patients who continue to have major adverse event despite this treatment. More recently a polymer-free drug eluting stent (Amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. These more favorable effects translate into reduced event rates, but to date there are no existing data comparing directly the mid-long term effect of this new polymer-free drug eluting stent with the other drug eluting stents in a larger cohort of patients.
Investigators
Salvatore Colangelo MD
Interventional Cardiologist
Ospedale S. Giovanni Bosco
Eligibility Criteria
Inclusion Criteria
- •diagnosis of insulin or non-insulin dependent diabetes mellitus treated from at least 1 month
- •if basal blood sugar at the admission is above 200 mg / dl or hemoglobin levels glycated\> 6.5% (\> 48 mmol / mol)
Exclusion Criteria
- •inability to provide informed consent or unable to guarantee the possibility of be contacted in the following 12 months;
- •age under 18 years or over 80 years
Outcomes
Primary Outcomes
Incidence of the composite endpoint of cardiac death, definite and probable stent thrombosis, re-PCI, Target Vessel Revascularization and bleeding in the two groups of study
Time Frame: 1 year
Evaluation and comparison of the composite endpont of cardiac death, definite and probable stent thrombosis according with Academic Research Consortium criteria, Re-PCI, Target Vessel Revascularization, Type III and V bleeding complications according with Bleeding Academic Research Consortium criteria in the two groups of study
Secondary Outcomes
- Incidence of every single adverse event (cardiac death, definite and probable stent thrombosis, re-PCI, Target Vessel Revascularization and bleeding) in the two groups of study(1 year)