Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment with SGLT2 inhibitors (flozins).
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease(PAD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ocena powikłań Naczyniowych u pacjentów Poddanych Rewaskularyzacji Obwodowej: wpływ inhibitorów SGLT-2 The Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors
Overview
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
- Drug Treatment 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.
Primary outcome measures
- MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)-Number of Participants Experiencing MACEor MALE [Time frame: 12 months from the vascular intervention]
Secondary outcome measures (6)
- Non-fatal Myocardial Infarction (MI) [Time frame: 12 months from the vascular intervention]
- Non-fatal Stroke Involving the Central Nervous System (CNS) [Time frame: 12 months from the vascular intervention]
- Cardiovascular Death [Time frame: 12 months from the vascular intervention]
- Loss or Deterioration of Patency in a Previously Revascularized Vessel [Time frame: 12 months from the vascular intervention]
- Repeat intervention in a revascularized segment due to impaired patency [Time frame: 12 months from the vascular intervention]
- Amputation of the revascularized limb [Time frame: 12 months from the vascular intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- Wroclaw Medical University — Wroclaw
Identifiers
NCT: NCT07157475 · BW-24/2025