Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors
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
Wroclaw Medical University
300 participants
Jul 1, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria5
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07157475