Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors

ConditionPeripheral Arterial Disease(PAD)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorWroclaw Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The analyzed cases will involve patients from three major vascular clinics located in Wrocław, Poznań, and Warsaw.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Treatment with SGLT2 inhibitors (flozins)
Drug
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.

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Patients after vascular surgery treated with flozins1 intervention

Group B: Patients after vascular surgery with no exposure to flozins (controls)0 interventions

Trial outcomes

Primary outcomes

MACE (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