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

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

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 design

Treatments tested in this trial

  • Treatment with SGLT2 inhibitors (flozins)

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Wroclaw Medical University

Lead sponsor

Poznan University of Medical Sciences

Collaborator

Military Institute of Medicine National Research Institute

Collaborator