Peripheral Arterial Disease(PAD)
Conditions
Keywords
flozins, SGLT2i, peripheral arterial disease, revascularisation, MACE, MALE
Brief summary
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.
Detailed description
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.
Interventions
DRUGTreatment with SGLT2 inhibitors (flozins)
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.
Sponsors
Wroclaw Medical University
Poznan University of Medical Sciences
Military Institute of Medicine National Research Institute
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Peripheral vascular procedure ( Conventional surgical procedure or minimally invasive procedure) due to acute or chronic ischemia * Use of SGLT2 inhibitors (applies only to the group exposed to flozins) for at least 3 months prior to the vascular procedure (the indication for initiating the drug is irrelevant: chronic kidney disease \[CKD\] / cardiac reasons / diabetes), or immediately after the vascular procedure * Ability to determine the patient's outcomes within a minimum of 30 days up to 1 year following the vascular procedure
Exclusion criteria
* Vascular injury as the reason for the procedure * Amputation due to causes other than ischemia (e.g., cancer, neuropathy, trauma without coexisting ischemia) * Planned revascularization procedure other than for the lower limbs at the time of hospital discharge (e.g., coronary or carotid arteries) * Planned ischemia-related amputation or reoperation of the operated limb at the time of hospital discharge * Planned other major surgical procedure with high cardiovascular risk at the time of hospital discharge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)-Number of Participants Experiencing MACEor MALE | 12 months from the vascular intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-fatal Myocardial Infarction (MI) | 12 months from the vascular intervention | 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 |
| Non-fatal Stroke Involving the Central Nervous System (CNS) | 12 months from the vascular intervention | Non-fatal Stroke Involving the Central Nervous System (CNS), Unit of Measure: Number of participants |
| Cardiovascular Death | 12 months from the vascular intervention | Cardiovascular Death, Unit of Measure: Number of participants |
| Loss or Deterioration of Patency in a Previously Revascularized Vessel | 12 months from the vascular intervention | Loss or Deterioration of Patency in a Previously Revascularized Vessel, Unit of Measure: Number of participants |
| Repeat intervention in a revascularized segment due to impaired patency | 12 months from the vascular intervention | Repeat intervention in a revascularized segment due to impaired patency; Unit of Measure: Number of participants and number of limbs |
| Amputation of the revascularized limb | 12 months from the vascular intervention | Amputation (above or below the knee) of the revascularized limb; Unit of Measure: Number of participants and number of limbs |
Countries
Poland
Contacts
CONTACTEdyta Sutkowska, M.D., Ph.D.
STUDY_CHAIREdyta Sutkowska, Ph.D
Wroclaw Medical University
Outcome results
None listed