Anti-thrombotic and Glucose Lowering Therapy in Diabetic Patients Undergoing PCI

Study Overview
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Brief Summary
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Diabetes mellitus (DM) is one of the main risk factors for ischemic events in patients with coronary artery disease (CAD) and diabetes is a factor in several post-PCI (Percutaneous Coronary Intervention) risk scores. However, until recently, there were almost no studies performed specifically in the diabetic population of patients undergoing PCI. This study aims to describe the anti-thrombotic regimens, clinical outcomes and current diabetes medical treatment in an unselected consecutive population of patients with DM undergoing PCI.

Detailed Description
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Diabetes is one of the main risk factors for ischemic events in patients with coronary artery disease and diabetes is a factor in several post-PCI risk scores (including the commonly used DAPT score). However, until recently, there were almost no studies performed specifically in the diabetic population of patients undergoing PCI. At large, results from randomized trials assessing the duration of DAPT have produced conflicting results and there is uncertainty about the best anti-thrombotic strategy in patients with diabetes. Further assessment of the patterns of use and their clinical effects, including those related to prolonged DAPT is needed, in diabetic patients, especially in less selected real world populations.

Official Title
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Anti-thrombotic and Glucose loweRing THerapy in diabEtics With CAD Undergoing PCI: a Prospective Multicenter observatIonal Study on Their Use and Implications for Clinical Outcomes - The ARTHEMIS Registry

Conditions
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Type2 Diabetes Mellitus, Coronary Heart Disease

Intervention / Treatment
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* Other: Exposure to Anti-thrombotic treatment agents and glucose lowering therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PCI with stent implantation, performed in at least one major coronary artery in the context of stable coronary artery disease or acute coronary syndrome Type 2 Diabetes mellitus (previously diagnosed or diagnosed at the index admission) Informed consent signed Patient not simultaneously participating in any interventional study Exclusion Criteria: Patients with Type 1 Diabetes mellitus Patients whose survival is expected to be lower than 1 year at hospital discharge Patients not whiling to participate

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic patients with CAD submitted to PCI<br>Individuals with type 2 Diabetes mellitus (previously diagnosed or diagnosed at index admission) submitted to PCI | Other: Exposure to Anti-thrombotic treatment agents and glucose lowering therapy<br>* Exposure to Anti-thrombotic treatment agents and glucose lowering therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enumeration of the anti-thrombotic agents prescribed to patients |  | Baseline to 24 months follow-up | 
| Planned duration of dual anti-platelet treatment (DAPT) after the PCI. |  | From index admission to 24 months follow-up | 
| Adherence to anti-thrombotic regimen | Classified qualitatively according to the assessment of the attending physician. | 6 to 24 months follow-up | 
| Actual duration of DAPT (if different from the planned duration) |  | 6 to 24 months follow-up | 
| Reasons for interrupting DAPT at a time different from the planned duration |  | 6 to 24 months follow-up | 
| Reasons for prolonging DAPT over 1 year |  | 12 to 24 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Coronary Events (MACE) | Major Adverse Coronary Events (MACE) (death from any cause, new spontaneous acute myocardial infarction, stroke). | 6 to 24 months follow-up | 
| Death rate from any cause |  | 6 to 24 months follow-up | 
| Rate of cardiovascular death |  | 6 to 24 months follow-up | 
| Rate of new spontaneous acute myocardial infarction |  | 6 to 24 months follow-up | 
| Rate of hospital admissions for acute coronary infarction |  | 6 to 24 months follow-up | 
| Rate of unplanned coronary revascularization |  | 6 to 24 months follow-up | 
| Rate of stroke/transient ischemic attack |  | 6 to 24 months follow-up | 
| Death rate from heart failure |  | 6 to 24 months follow-up | 
| Rate of hospital admission due to heart failure |  | 6 to 24 months follow-up | 
| Rate of bleeding events of type 3-5 of BARC (Bleeding Academic Research Consortium) scale | The BARC (Bleeding Academic Research Consortium) scale will be used. The minimum and maximum scores of the scale are, respectively, type 0 (no bleeding) and type 5 (fatal). There will only be collected the events corresponding to type 3-5 of BARC scale. | 6 to 24 months follow-up | 
| Rate of bleeding events of type 1-5 of BARC (Bleeding Academic Research Consortium) scale | The BARC (Bleeding Academic Research Consortium) scale will be used. The minimum and maximum scores of the scale are, respectively, type 0 (no bleeding) and type 5 (fatal). There will be collected the events corresponding to type 1-5 of BARC scale. | 6 to 24 months follow-up | 
| Percentage of patients treated with different glucose-lowering drugs. |  | Before index admission to 24 months follow-up. | 
| Diabetes control (HbA1c values) |  | At baseline to 24 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI-Percutaneous Coronary Intervention, Diabetes Mellitus, Dual Antiplatelet Therapy, Anti-diabetic drugs