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| ID | Type | Description | Link |
|---|---|---|---|
| ESR-19-20188 | Other Grant/Funding Number | AstraZeneca |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Cardiovascular Centre of Universidade de Lisboa (CCUL) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic patients with CAD submitted to PCI | Individuals with type 2 Diabetes mellitus (previously diagnosed or diagnosed at index admission) submitted to PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure to Anti-thrombotic treatment agents and glucose lowering therapy | Other | Exposure to Anti-thrombotic treatment agents and glucose lowering therapy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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1000 Type 2 Diabetes mellitus consecutive patients submitted to PCI in 12 interventional Cardiology Portuguese centers
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| Name | Affiliation | Role |
|---|---|---|
| Sérgio B Baptista, PhD | Cardiovascular Centre of the University of Lisbon (CCUL) | Principal Investigator |
| Luís Raposo, MD | Hospital de Santa Cruz, CHLO, EPE, Lisbon, Portugal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Braga, EPE | Braga | Braga District | 4710-243 | Portugal | ||
| Centro Hospitalar e Universitário de Coimbra - Hospital Geral & Hospital Universitário de Coimbra |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40738464 | Derived | Bravo Baptista S, Pires de Morais G, Almeida Morais L, Costa J, Vinhas H, Campos G, Carrilho Ferreira P, Vale N, Seixo F, Santos M, Martins C, Rodrigues Bras D, Alexandre A, Raposo L. Anti-thrombotic and glucose lowering therapy in diabetic patients with coronary artery disease undergoing PCI with stent implantation: A prospective multicenter observational study on prescription patterns and clinical outcomes. Baseline inclusion data of the ARTHEMIS registry. Rev Port Cardiol. 2025 Sep;44(9):537-546. doi: 10.1016/j.repc.2025.03.006. Epub 2025 Jul 28. English, Portuguese. |
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| 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 |
| Coimbra |
| Coimbra District |
| 3000-075 |
| Portugal |
| Centro Hospitalar Universitário do Algarve - Hospital de Faro | Faro | Faro District | 8000-386 | Portugal |
| Hospital Prof. Doutor Fernando Fonseca | Amadora | Lisbon District | 2720-276 | Portugal |
| Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz | Carnaxide | Lisbon District | 2790-134 | Portugal |
| Centro Hospitalar Lisboa Central - Hospital de Santa Marta | Lisbon | Lisbon District | 1159-064 | Portugal |
| Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria | Lisbon | Lisbon District | 1649-035 | Portugal |
| Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António | Porto | Porto District | 4099-001 | Portugal |
| Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE | Vila Nova de Gaia | Porto District | 4434-502 | Portugal |
| Hospital Garcia de Orta | Almada | Setúbal District | 2805-267 | Portugal |
| Centro Hospitalar de Setúbal | Setúbal | Setúbal District | 2910-549 | Portugal |
| Hospital do Espírito Santo de Évora, EPE | Evora | Évora District | 7000-811 | Portugal |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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