STEMI and Mutlivessels Coronary Artery Stenosis: Effect of Incretin Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- all cause deaths
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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%).
Arms & Interventions
diabetics STEMI
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.
Intervention: PCI and DES stenting (Device)
non diabetics STEMI
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.
Intervention: PCI and DES stenting (Device)
diabetics incretin-users STEMI
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.
Intervention: PCI and DES stenting (Device)
diabetics incretin-users STEMI
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.
Intervention: Incretins (Drug)
diabetics never-incretin-users STEMI
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.
Intervention: PCI and DES stenting (Device)
Outcomes
Primary Outcomes
all cause deaths
Time Frame: 12 months
at 12 months follow up authors monitored and reported all cause mortality
cardiac deaths
Time Frame: 12 months
at 12 months follow up authors monitored and reported mortality events due to cardiac causes
MACE
Time Frame: 12 months
authors monitored and reported at follow up major adverse cardiac events (MACE): re-STEMI, NSTEMI, unstable angina, arrhythmias, stroke etc.
Secondary Outcomes
No secondary outcomes reported
Investigators
Celestino Sardu
MD, MSc, PHD
University of Campania "Luigi Vanvitelli"