Efficacy and Safety of Coronary Amphilimus-ELuting Stent in diAbeTic patiEnts

Ospedale S. Giovanni Bosco3,400 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

3,400

Conditions

Coronary Artery Disease Diabetes Mellitus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

San Giovanni Bosco Hospital - ASL Città di Torino

Turin, Italy

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

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

Time frame: 1 year

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

Measurements and comparison of the incidence of any single adverse event of the composite endpoint (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

Time frame: 1 year

Data from ClinicalTrials.gov

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