The study is observational and involves patients (pts) with peripheral arterial occlusive disease (PAD) who have undergone lower limb revascularization procedures. Patients who are at least one year post-procedure will be contacted by phone and asked whether any cardiovascular complications occurred during that period, specifically major adverse cardiovascular events (MACE) or major adverse limb events (MALE), and whether they had been taking sodium-glucose co-transporter 2 inhibitors (SGLT2-i, "flozins") during the year following the procedure. The results from the group of pts who, for any reason, received SGLT2-i treatment after the vascular procedure (including those who had initiated treatment before surgery) will be compared to the results from the group of patients who did not receive such treatment, with regard to the occurrence of the aforementioned complications.
Project Objective: To assess the impact of SGLT2 inhibitors (SGLT2-i) on vascular complications in patients undergoing peripheral revascularization. Specific Objective: To evaluate the incidence of 3-point MACE\* (Major Adverse Cardiac Events) and MALE\*\* (Major Adverse Limb Events) following vascular surgical procedures (both open and minimally invasive), performed in patients treated with SGLT2- i vs controls ( non-treated pts). Observation Period: One year - assessment at 30 days, 3 months, and 1 year post-procedure. Definitions for: \* MACE = Non-fatal myocardial infarction (MI),Non-fatal stroke involving the central nervous system (CNS), Cardiovascular death \*\* MALE = Untreated restenosis or deterioration in patency of a previously revascularized vessel , Reintervention in the revascularized segment due to impaired patency, Amputation (either above or below the knee) of the revascularized limb. Demographic and clinical data will be obtained from the medical records of patients hospitalized in three vascular surgery departments (Wrocław, Poznań, Warsaw), while information regarding MACE , MALE, and the use of SGLT2-i will be collected via telephone interviews with the patients (or their family members, if the patient is deceased). The number of MACE and MALE incidents during the year following the procedure will be compared between the two groups.
Study Type
OBSERVATIONAL
Enrollment
300
Patients received SGLT2 inhibitors (empagliflozin, dapagliflozin, canagliflozin) as part of their routine clinical care during the 12-month follow-up period after elective or urgent lower limb revascularization procedures. The study does not assign treatment; medication use occurred independently of the study protocol.
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland
RECRUITINGMACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)-Number of Participants Experiencing MACEor MALE
MACE is defined as a composite of : Non-fatal myocardial infarction (MI); Non-fatal stroke involving the central nervous system (CNS); or Cardiovascular death MALE is defined as a composite of : Untreated loss or deterioration of patency in a previously revascularized vessel; Repeat intervention in a revascularized segment due to impaired patency, or Amputation (above or below the knee) of the revascularized limb Unit of Measure: Number of participants with at least one event
Time frame: 12 months from the vascular intervention
Non-fatal Myocardial Infarction (MI)
Non-fatal myocardial infarction (MI), Unit of Measure: Number of participants Non-fatal stroke involving the central nervous system (CNS) Cardiovascular death Untreated loss or deterioration of patency in a previously revascularized vessel Repeat intervention in a revascularized segment due to impaired patency Amputation (above or below the knee) of the revascularized limb
Time frame: 12 months from the vascular intervention
Non-fatal Stroke Involving the Central Nervous System (CNS)
Non-fatal Stroke Involving the Central Nervous System (CNS), Unit of Measure: Number of participants
Time frame: 12 months from the vascular intervention
Cardiovascular Death
Cardiovascular Death, Unit of Measure: Number of participants
Time frame: 12 months from the vascular intervention
Loss or Deterioration of Patency in a Previously Revascularized Vessel
Loss or Deterioration of Patency in a Previously Revascularized Vessel, Unit of Measure: Number of participants
Time frame: 12 months from the vascular intervention
Repeat intervention in a revascularized segment due to impaired patency
Repeat intervention in a revascularized segment due to impaired patency; Unit of Measure: Number of participants and number of limbs
Time frame: 12 months from the vascular intervention
Amputation of the revascularized limb
Amputation (above or below the knee) of the revascularized limb; Unit of Measure: Number of participants and number of limbs
Time frame: 12 months from the vascular intervention
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