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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Exposure to Anti-thrombotic treatment agents and glucose lowering therapy
Hospital de Braga, EPE
Braga, Braga District, Portugal
Centro Hospitalar e Universitário de Coimbra - Hospital Geral & Hospital Universitário de Coimbra
Coimbra, Coimbra District, Portugal
Centro Hospitalar Universitário do Algarve - Hospital de Faro
Faro, Faro District, Portugal
Hospital Prof. Doutor Fernando Fonseca
Amadora, Lisbon District, Portugal
Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz
Carnaxide, Lisbon District, Portugal
Centro Hospitalar Lisboa Central - Hospital de Santa Marta
Lisbon, Lisbon District, Portugal
Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria
Lisbon, Lisbon District, Portugal
Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António
Porto, Porto District, Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
Vila Nova de Gaia, Porto District, Portugal
Hospital Garcia de Orta
Almada, Setúbal District, Portugal
...and 2 more locations
Enumeration of the anti-thrombotic agents prescribed to patients
Time frame: Baseline to 24 months follow-up
Planned duration of dual anti-platelet treatment (DAPT) after the PCI.
Time frame: From index admission to 24 months follow-up
Adherence to anti-thrombotic regimen
Classified qualitatively according to the assessment of the attending physician.
Time frame: 6 to 24 months follow-up
Actual duration of DAPT (if different from the planned duration)
Time frame: 6 to 24 months follow-up
Reasons for interrupting DAPT at a time different from the planned duration
Time frame: 6 to 24 months follow-up
Reasons for prolonging DAPT over 1 year
Time frame: 12 to 24 months follow-up
Major Adverse Coronary Events (MACE)
Major Adverse Coronary Events (MACE) (death from any cause, new spontaneous acute myocardial infarction, stroke).
Time frame: 6 to 24 months follow-up
Death rate from any cause
Time frame: 6 to 24 months follow-up
Rate of cardiovascular death
Time frame: 6 to 24 months follow-up
Rate of new spontaneous acute myocardial infarction
Time frame: 6 to 24 months follow-up
Rate of hospital admissions for acute coronary infarction
Time frame: 6 to 24 months follow-up
Rate of unplanned coronary revascularization
Time frame: 6 to 24 months follow-up
Rate of stroke/transient ischemic attack
Time frame: 6 to 24 months follow-up
Death rate from heart failure
Time frame: 6 to 24 months follow-up
Rate of hospital admission due to heart failure
Time frame: 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.
Time frame: 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.
Time frame: 6 to 24 months follow-up
Percentage of patients treated with different glucose-lowering drugs.
Time frame: Before index admission to 24 months follow-up.
Diabetes control (HbA1c values)
Time frame: At baseline to 24 months follow-up
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