The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot study
Abstract
Abstract Background: Percutaneous coronary intervention (PCI) is one of the most performed well-succeeded therapeutic procedures worldwide, reducing symptoms and improving quality of life. Lidocaine associated with gelatinase neutrophilic acid (NGAL) is a biomarker of acute kidney injury (AKI) produced early after an ischemic renal insult. Osmotic diuresis and the vasoconstriction of the afferent arteriole promoted by SGLT2i generate a concern regarding the possibility of dehydration and consequent AKI. There is no consensus on the maintenance or discontinuation of SGTL2i in patients who will undergo PCI. This study aimed to evaluate the safety of SLGT2i in diabetic patients submitted to elective PCI regarding kidney function Methods: SAFE-PCI trial is a single-center, prospective, open-label, randomized (1:1) pilot study with 42 randomized patients and a follow-up of 30 days. The SGLT2i empagliflozin 25mg daily was initiated at least 15 days before PCI in the intervention group and maintained until the end of the follow-up period. Serum NGAL was collected 6 hours after PCI and creatinine before PCI, 24 hours, and 48 hours after the procedure. As per protocol, both groups received optimal medical treatment and standard protocol of nephroprotection. Results: A total of 42 patients were randomized (22 patients in the iSGLT-2 group and 20 patients in the control group). There was no difference between-group baseline data. The primary outcome (NGAL and creatinine values post…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 42 participants or records.
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