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

Recruiting

• Conditions: Peripheral Arterial Disease(PAD)
• Interventions: Drug: Treatment with SGLT2 inhibitors (flozins)

• Registration Number: NCT07157475
• Lead Sponsor: Wroclaw Medical University

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.

Study Timeline

• Study Start: 2025-07-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-18
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients after vascular surgery treated with flozins	Treatment with SGLT2 inhibitors (flozins)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wroclaw Medical University; 🇵🇱 Wroclaw, Lower Silesian Voivodeship, Poland