STEMI and Incretins Treatment

Study Overview
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Brief Summary
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ST elevation myocardial infarction (STEMI) patients affected by multivessels coronary artery stenosis, represent a clinical relevant problem. The management and prognosis of these patents are supported by few literature data. Therefore, in this study authors enrolled real world diabetic vs. non diabetic patients admitted for STEMI and associated to multi vessels coronary disease. Then these diabetics were divided in incretin users (6 months of incretin treatment before study enrollment) vs. never incretin users. In these patients authors studied all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months follow up.

Detailed Description
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ST elevation myocardial infarction (STEMI) patients affected by multivessels coronary artery stenosis represent a class of patients really challenging to treat. In fact, treatment, clinical management, and prognosis are supported by few literature data. Therefore, in this study authors enrolled real world patients admitted for STEMI and associated to multi vessels coronary disease. Multivessels (Mv) coronary stenosis were characterized by non obstructive coronary stenosis (NOCS) as coronary lesions <50% with fractional flow reserve > 0.8. Therefore, STEMI was treated by percutaneous coronary intervention by primary angioplasty and direct stenting (DES stenting) of culprit vessel lesion. Then these STEMI-Mv-NOCS patients were divided in diabetics vs. non diabetics, and received conventional full medical therapy for STEMI. Then these diabetics were divided in incretin users (6 months of incretin treatment before study enrollment) vs. never incretin users. Study outcomes were all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months follow up. Authors studied these study outcomes comparing diabetics vs. non diabetics at 12 moths follow up, and diabetics incretin-users vs. never-incretin-users.

Official Title
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STEMI and Mutlivessels Coronary Artery Stenosis: Effect of Incretin Treatment

Conditions
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STEMI, Coronary Artery Disease, Coronary Syndrome, Coronary Arteriosclerosis, Diabetes

Intervention / Treatment
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* Device: PCI and DES stenting
* Drug: Incretins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged >18, first STEMI, STEMI with multi vessels coronary stenosis. Exclusion Criteria: aged < 18, renal impairment, mono vessel STEMI, severe depression of left ventricle ejection fraction (LVEF <35%).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| diabetics STEMI<br>Diabetics patients admitted for ST elevation myocardial infarction (STEMI) and associated with multi vessels (Mv) non obstructive coronary artery stenosis (NOCS). These patients received percutaneous coronary intervention (PCI), and primary stenting (DES) of culprit lesion. Then these patients received full medical STEMI therapy. | Device: PCI and DES stenting<br>* Percutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel.<br>|
| non diabetics STEMI<br>Non diabetics patients admitted for ST elevation myocardial infarction (STEMI) and associated with multi vessels coronary artery stenosis(Mv) non obstructive coronary artery stenosis (NOCS). These patients received percutaneous coronary intervention (PCI), and primary stenting (DES) of culprit lesion. Then these patients received full medical STEMI therapy. | Device: PCI and DES stenting<br>* Percutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel.<br>|
| diabetics incretin-users STEMI<br>Diabetics patients admitted for ST elevation myocardial infarction (STEMI) and associated with multi vessels coronary artery stenosis (Mv) non obstructive coronary artery stenosis (NOCS). These patients received percutaneous coronary intervention (PCI), and primary stenting (DES) of culprit lesion. Then these patients received full medical STEMI therapy. These patients were treated by incretin therapy at last 6 months before study enrollment. | Device: PCI and DES stenting<br>* Percutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel.<br>Drug: Incretins<br>* Patients treated before study enrollment by incretin drugs (6 months drugs exposure)<br>|
| diabetics never-incretin-users STEMI<br>Diabetics patients admitted for ST elevation myocardial infarction (STEMI) and associated with multi vessels coronary artery stenosis (Mv) non obstructive coronary artery stenosis (NOCS). These patients received percutaneous coronary intervention (PCI), and primary stenting (DES) of culprit lesion. Then these patients received full medical STEMI therapy. These diabetic patients were never treated by incretin therapy before study enrollment. | Device: PCI and DES stenting<br>* Percutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause deaths | at 12 months follow up authors monitored and reported all cause mortality | 12 months | 
| cardiac deaths | at 12 months follow up authors monitored and reported mortality events due to cardiac causes | 12 months | 
| MACE | authors monitored and reported at follow up major adverse cardiac events (MACE): re-STEMI, NSTEMI, unstable angina, arrhythmias, stroke etc. | 12 months |