Short Term Outcomes After Primary PCI in Diabetic Patients Treated With Insulin Versus Oral Anti-diabetic Drugs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, PCI. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
• This study aims to compare the short-term clinical and echocardiographic outcomes of primary PCI in diabetic patients treated with insulin versus OADs.
Detailed description
1. Diabetes mellitus (DM) is a major risk factor for cardiovascular disease (CVD), significantly increasing the risk of myocardial infarction (MI), heart failure, and mortality. Among patients with ST-segment elevation myocardial infarction (STEMI), diabetes is associated with higher rates of multi vessel disease, impaired coronary microcirculation, and poorer outcomes following percutaneous coronary intervention (PCI) compared to non-diabetic patients (1.2.3.4) 2. Diabetes is an independent risk factor for the development of CAD. Coronary arteries in diabetic patients present extensive and diffuse atherosclerosis, longer and more complex lesions than in non-diabetic patients \[5\]. The relative risk of myocardial infarction (MI) is 50% higher in diabetic men and 150% higher in diabetic women \[6\]. Patients with type 2 DM have similar risk for cardiac events as subjects with a prior MI \[7\]. The risk of recurrence of MI in diabetic patients is more than 40% \[8\]. Due to high prevalence of acute MI in diabetic patients, adults with diabetes will lose 30 quality-adjusted life years compared to those without DM \[9\]. 3. Primary PCI is the gold-standard treatment for STEMI, offering superior outcomes compared to fibrinolysis. However, diabetic patients exhibit higher rates of in-stent restenosis, stent thrombosis, and recurrent ischemic events, making optimal glycemic control and choice of anti-diabetic therapy critical in improving post-PCI outcomes (10) 4. Cardiac remodeling refers to a spectrum of structural and functional changes that occur in the heart in response to myocardial injury or increased hemodynamic load, such as after myocardial infarction, chronic hypertension, or valvular heart disease. These changes may include alterations in ventricular size, shape, wall thickness, and overall function, and they are strongly associated with adverse cardiovascular outcomes including heart failure and sudden cardiac death.
Echocardiography is a cornerstone non-invasive imaging modality that plays a vital role in the assessment and monitoring of cardiac remodeling. It offers real-time evaluation of cardiac chamber dimensions, wall thickness, ventricular volumes, ejection fraction, myocardial deformation (strain), and diastolic function. These echocardiographic parameters not only reflect the extent of remodeling but also have prognostic significance in various cardiac conditions.(11) 5. Impact of Diabetes Treatment on Cardiovascular Outcomes
The choice of anti-diabetic therapy may influence cardiovascular outcomes in STEMI patients undergoing PCI. There are two main therapeutic strategies for diabetes management:
Insulin therapy: Often used in patients with long-standing or poorly controlled diabetes, but is associated with increased risks of hypoglycemia, weight gain, and potential pro-inflammatory effects, which may contribute to worse cardiovascular outcomes (12.13)
Oral anti-diabetic drugs (OADs): Certain newer agents, such as SGLT2 inhibitors and GLP-1 receptor agonists, have demonstrated cardio protective effects, while others like sulfonylureas may be associated with an increased risk of adverse cardiovascular events (14)
Despite these differences, data on the impact of insulin versus OADs on PCI outcomes remain inconclusive, necessitating further research
Primary outcome measures
- Short Term Outcomes after Primary PCI in Diabetic Patients Treated with Insulin Versus Oral Anti-diabetic Drugs [Time frame: baseline]
Secondary outcome measures (1)
- Echocardiography [Time frame: baseline]
Eligibility criteria
Inclusion criteria
- Patients with DM (type 2) undergoing primary PCI for STEMI.1-
Treated with either insulin or OADs prior to admission.2-
3- Age ≥18 year
Exclusion criteria
- Type 1 DM.1- Patients on both insulin and OADs.2- 3-Prior coronary artery bypass graft (CABG) surgery. 4-Severe renal impairment (eGFR <30 mL/min/1.73m²). 5-Hemodynamically unstable patients 6-moderate to severe VHD 7-Patients who were shifted from OADs to insulin during Follow-up
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Egypt · 1 center
- Assuit — Asyut
Publications
- Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. PMID 30415602
- Abizaid A, Kornowski R, Mintz GS, Hong MK, Abizaid AS, Mehran R, Pichard AD, Kent KM, Satler LF, Wu H, Popma JJ, Leon MB. The influence of diabetes mellitus on acute and late clinical outcomes following coronary stent implantation. J Am Coll Cardiol. 1998 Sep;32(3):584-9. doi: 10.1016/s0735-1097(98)00286-1. PMID 9741497
- Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998 Jul 23;339(4):229-34. doi: 10.1056/NEJM199807233390404. PMID 9673301
Identifiers
NCT: NCT06992466 · Diabetic patients after PPCI