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
Conditions: Peripheral Arterial Disease(PAD)
Sponsor: Wroclaw Medical University

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Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors 
 Poland, Wrocław 01-Jul-2025 
Study Design 
 
 
NCT numer: pending 
 
 
 
Title: Assessment of Vascular Complications in Patients Undergoing Peripheral 
Revascularization: The Impact of SGLT-2 Inhibitors 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Type: Retrospective, observational study 
 

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Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors 
1. Study Objective: To assess the impact of SGLT2 inhibitors on vascular complications 
in patients undergoing peripheral revascularization. 
 
Specific Objective: To evaluate the occurrence of 3-point MACE (Major Adverse Cardiac 
Events) or MALE (Major Adverse Limb Events) after vascular surgery procedures (both open 
and minimally invasive), performed electively or urgently, in patients previously treated with 
SGLT2 inhibitors. 
 
Follow-up period: ONE YEAR: assessment at 30 days, 3 months, and 12 months post-
procedure. 
 
Definition of MACE: 
 
Myocardial infarction (MI) not resulting in death 
 
Stroke affecting the central nervous system (CNS) not resulting in death 
 
Cardiovascular death 
 
*Definition of MALE: 
 
Untreated loss or deterioration of patency in a previously revascularized vessel (decline in 
ABPI) 
 
Repeat intervention in the revascularized segment due to loss of patency 
 
Amputation (above or below the knee) of the revascularized limb 
 
2. Primary Outcome Measures: MALE and MACE 
 
3. Secondary Outcome Measures: Individual components of MALE and MACE 
 
4. Additional Secondary Outcome Measures: 
 

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Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors 
Surgical complications such as surgical site infection (SSI) or major bleeding 
 
Acute kidney injury 
 
Need for reintervention (readmission and procedure in the same segment) 
 
Foot necrosis 
 
“Minor amputation” (defined as amputation within the foot) 
 
Hospitalization due to heart failure 
 
5. Inclusion and Exclusion Criteria 
 
Inclusion Criteria: 
 
Surgical procedure on peripheral vessels due to acute or chronic ischemia 
 
Use of SGLT2 inhibitors (reason for initiation is irrelevant: CKD – chronic kidney disease / 
cardiovascular indications / diabetes) - Condition required only for the drug-exposed group. 
 
Ability to follow up the patient for at least 30 days up to 1 year after the vascular procedure 
 
                 Exclusion Criteria: 
 
Vascular injury as the reason for the procedure 
 
Amputation for reasons other than ischemia (e.g., tumor, neuropathy, trauma without 
concomitant ischemia) 
 
Planned revascularization procedure not involving lower limbs (e.g., coronary or carotid 
vessels) 
 
Planned amputation due to ischemia, partial, in the area of the operated limb 

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Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors 
 
Planned other major surgical procedure with high cardiovascular risk 
 
6. Collected Parameters (at admission to the vascular surgery ward): 
 
Laboratory tests: 
 
Complete blood count 
 
Blood creatinine with eGFR 
 
Urinalysis 
 
Full lipid panel 
 
HbA1c (if patient has diabetes) 
 
Fasting glucose (FG) 
 
Anthropometric data: weight, height – calculation of BMI ( body mass index) 
 
Demographics: age and biological sex 
 
Medical history (structured questions): 
a. Does the patient have diabetes? (If YES: record type 1 or 2; duration in years or <1 year if 
less than one year; medications for diabetes; presence of chronic microvascular 
complications: neuropathy, albuminuria, diabetic eye disease) 
b. Does the patient have a history of: 
 
Myocardial infarction (MI) 
 
Stroke 
 

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Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors 
Diagnosed peripheral arterial occlusive disease (PAD) (if YES: date of diagnosis; date of 
symptom progression that led to current procedure) 
 
Previous interventions on coronary vessels (if YES: date in years, e.g., 5 years ago, or <1 
year if within the past year) 
 
Previous interventions on carotid or other head/neck vessels (if YES: date in years, e.g., 5 
years ago, or <1 year if within the past year) 
Additional Collected Parameters : 
Previous interventions on lower limb vessels (including iliac arteries – e.g., external iliac 
artery): indicate the date in years, e.g., 5 years ago, or <1 year if within the past year 
 
History of aortic aneurysm surgery (thoracic or abdominal); if YES, indicate date 
 
History of heart failure treatment 
 
Hypertension 
 
Hyperlipidemia 
 
History of cardiac arrhythmias (e.g., atrial fibrillation – AF) 
 
Thyroid disease (hypothyroidism/hyperthyroidism only); if YES, provide most recent TSH 
value, if known or measured in hospital 
 
Smoking status: 
 
Current smoker? 
 
If NO, date of cessation in years, <1 year if within the past year 
 
Includes e-cigarettes (if yes, mark YES) 
 
Chronic medications before hospital admission (excluding supplements) – chemical names 

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Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors 
 
Recent interruptions in chronic medications 
 
SGLT2 inhibitor (flozin) used before procedure: type, dose, duration, indication (diabetes, 
cardiology, nephrology) 
 
7. Parameters to collect during follow-up (post-procedure): 
 
Medications prescribed for chronic use: chemical names 
 
Whether prescribed medications were taken regularly during follow-up 
 
Occurrence of any of the following events**: 
a. Myocardial infarction not resulting in death 
b. Stroke (central nervous system) not resulting in death 
c. Cardiovascular death 
d. Deterioration of previously revascularized vessel (ABI decrease) confirmed by visit to 
vascular surgeon/angiologist 
e. Repeat intervention in previously revascularized segment due to deterioration 
f. Amputation (above or below knee) of revascularized limb 
g. Deep surgical site infection (other than skin) 
h. Major bleeding: at surgical site, gastrointestinal, other (specify location) 
i. Acute kidney injury 
j. Necrosis of the foot 
k. “Minor amputation” (foot or toes) 
l. Hospitalization due to heart failure 
 
8. SGLT2 inhibitor (flozin) continuation during follow-up (up to 1 year): 
 
Did the patient continue taking the flozin as before the procedure? 
 
If not, was it discontinued immediately before surgery or during follow-up? Indicate timing. 
9. Hypoglycemia in  patients with diabetes: 

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Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors 
 
Were there any hypoglycemic events? (Symptoms confirmed by blood glucose <70 mg/dL or 
asymptomatic blood glucose <70 mg/dL) 
 
10. Type of procedure performed: 
 
Record the specific vascular intervention. 
 
11. ABI measurements: 
 
Pre-procedure ABI 
 
Post-procedure ABI 
 
ABI if the patient underwent another procedure during follow-up due to restenosis 
 
Notes / Guidelines: 
 
SGLT2 inhibitors (flozins) – include also combination drugs (e.g., Xigduo). If the patient takes 
a combination drug, mark each component in the Excel sheet (e.g., Lonamo Duo → mark 
both metformin and DPP-4i; Dipeptidyl Peptidase-4 inhibitors ). 
 
If information is unavailable, enter “NZ” to confirm it was checked. 
 
For stroke, include TIA (Transient Ischemic Attack) if confirmed. 
 
*MALE definitione, comments: Untreated loss or deterioration of patency in a previously 
revascularized vessel, measured by: ABI decrease (objective), Restenosis on ultrasound 
(objective), Shortening of claudication distance (subjective/clinical). Comment: If ABI is not 
performed at a center, other listed criteria may be used to confirm MALE. ABI is not strictly 
required if another criterion is met. 
 
**For follow-up events (point 7): 
Myocardial infarction not resulting in death, CNS stroke not resulting in death, cardiovascular 
death, or deterioration of previously revascularized vessel. Comment: “Deterioration requiring 

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Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors 
visit and confirmed by physician” is sufficient; ABI measurement is optional but preferred for 
objective confirmation. Record method of confirmation. 
 
For ABI (point 11): If ABI was not measured at any of the time points, mark “not performed.” 
 
The key is that inclusion criteria are met and primary, secondary, and additional endpoints 
are assessed.