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

Wroclaw Medical University

Status: Enrolling

Conditions: Peripheral Arterial Disease(PAD)

Treatments: Drug: Treatment with SGLT2 inhibitors (flozins)

Study type: Observational

Funder types: Other

Identifiers

NCT07157475

BW-24/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Patients after vascular surgery treated with flozins

Description:

Patients aged ≥18 years who have undergone vascular surgery (either open or minimally invasive procedures) and, for any reason, were treated with SGLT2 inhibitors ("flozins") during the one-year follow-up period after the procedure.

Treatment:

Drug: Treatment with SGLT2 inhibitors (flozins)

Patients after vascular surgery with no exposure to flozins (controls)

Description:

Patients aged ≥18 years who have undergone vascular surgery (either open or minimally invasive procedures) and were not exposed to SGLT2 inhibitors ("flozins") during the one-year follow-up period after the procedure.