The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot study
Abstract Background Percutaneous coronary intervention (PCI) is one of the most performed well-succeeded therapeutic procedures worldwide, reducing symptoms and improving quality of life. Neutrophil Gelatinase-associated Lipocalin (NGAL) is a biomarker of acute kidney injury (AKI) produced early aft...
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| Format: | Article |
| Language: | English |
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BMC
2023-06-01
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| Series: | Diabetology & Metabolic Syndrome |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13098-023-01107-9 |
| _version_ | 1797789670662209536 |
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| author | Mateus Paiva Marques Feitosa Eduardo Gomes Lima Alexandre Antônio Cunha Abizaid Roxana Mehran Neuza Helena Moreira Lopes Thiago de Assis Fischer Ramos Alexandre Hideo-Kajita Roberto Kalil Filho Carlos Vicente Serrano Junior |
| author_facet | Mateus Paiva Marques Feitosa Eduardo Gomes Lima Alexandre Antônio Cunha Abizaid Roxana Mehran Neuza Helena Moreira Lopes Thiago de Assis Fischer Ramos Alexandre Hideo-Kajita Roberto Kalil Filho Carlos Vicente Serrano Junior |
| author_sort | Mateus Paiva Marques Feitosa |
| collection | DOAJ |
| description | Abstract Background Percutaneous coronary intervention (PCI) is one of the most performed well-succeeded therapeutic procedures worldwide, reducing symptoms and improving quality of life. Neutrophil Gelatinase-associated Lipocalin (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 Sodium-glucose Cotransporter-2 Inhibitors (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 empagliflozin in diabetic patients submitted to elective PCI regarding kidney function. Methods SAFE-PCI trial is a prospective, open-label, randomized (1:1), single-center pilot study and a follow-up of 30 days. The SGLT2i empagliflozin 25 mg 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 h after PCI and creatinine before PCI, 24 h, and 48 h 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 PCI) did not differ in both groups: the mean NGAL value was 199 ng/dL in the empagliflozin group and 150 ng/dL in the control group (p = 0.249). Although there was an initial increase in creatinine in the SGLT-2i group compared to the control group between baseline creatinine and pre-PCI and 24 h post-PCI creatinine, no difference was detected in creatinine 48 h post-PCI (p = 0.065). The incidence of CI-AKI, determined by KDIGO criteria, in the iSGLT2-group was 13.6% and 10.0% in the control group without statistical difference. Conclusion The present study showed that the use of empagliflozin is safe regarding kidney function during elective PCI in patients with T2D when compared with no use of SGLT2i. Trial registration Our clinical study is registered on ClinicalTrials.gov with the following number: NCT05037695. |
| first_indexed | 2024-03-13T01:53:58Z |
| format | Article |
| id | doaj.art-ec4c054445134bf89f2872352696621e |
| institution | Directory Open Access Journal |
| issn | 1758-5996 |
| language | English |
| last_indexed | 2024-03-13T01:53:58Z |
| publishDate | 2023-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Diabetology & Metabolic Syndrome |
| spelling | doaj.art-ec4c054445134bf89f2872352696621e2023-07-02T11:21:49ZengBMCDiabetology & Metabolic Syndrome1758-59962023-06-011511810.1186/s13098-023-01107-9The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot studyMateus Paiva Marques Feitosa0Eduardo Gomes Lima1Alexandre Antônio Cunha Abizaid2Roxana Mehran3Neuza Helena Moreira Lopes4Thiago de Assis Fischer Ramos5Alexandre Hideo-Kajita6Roberto Kalil Filho7Carlos Vicente Serrano Junior8Instituto Do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São PauloInstituto Do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São PauloInstituto Do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São PauloIcahn School of Medicine at Mount SinaiInstituto Do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São PauloInstituto Do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São PauloInstituto Do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São PauloInstituto Do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São PauloInstituto Do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São PauloAbstract Background Percutaneous coronary intervention (PCI) is one of the most performed well-succeeded therapeutic procedures worldwide, reducing symptoms and improving quality of life. Neutrophil Gelatinase-associated Lipocalin (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 Sodium-glucose Cotransporter-2 Inhibitors (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 empagliflozin in diabetic patients submitted to elective PCI regarding kidney function. Methods SAFE-PCI trial is a prospective, open-label, randomized (1:1), single-center pilot study and a follow-up of 30 days. The SGLT2i empagliflozin 25 mg 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 h after PCI and creatinine before PCI, 24 h, and 48 h 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 PCI) did not differ in both groups: the mean NGAL value was 199 ng/dL in the empagliflozin group and 150 ng/dL in the control group (p = 0.249). Although there was an initial increase in creatinine in the SGLT-2i group compared to the control group between baseline creatinine and pre-PCI and 24 h post-PCI creatinine, no difference was detected in creatinine 48 h post-PCI (p = 0.065). The incidence of CI-AKI, determined by KDIGO criteria, in the iSGLT2-group was 13.6% and 10.0% in the control group without statistical difference. Conclusion The present study showed that the use of empagliflozin is safe regarding kidney function during elective PCI in patients with T2D when compared with no use of SGLT2i. Trial registration Our clinical study is registered on ClinicalTrials.gov with the following number: NCT05037695.https://doi.org/10.1186/s13098-023-01107-9SGLT2 inhibitorsCoronary artery diseasePercutaneous coronary interventionAcute kidney injuryContrast-induced nephropathy |
| spellingShingle | Mateus Paiva Marques Feitosa Eduardo Gomes Lima Alexandre Antônio Cunha Abizaid Roxana Mehran Neuza Helena Moreira Lopes Thiago de Assis Fischer Ramos Alexandre Hideo-Kajita Roberto Kalil Filho Carlos Vicente Serrano Junior The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot study Diabetology & Metabolic Syndrome SGLT2 inhibitors Coronary artery disease Percutaneous coronary intervention Acute kidney injury Contrast-induced nephropathy |
| title | The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot study |
| title_full | The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot study |
| title_fullStr | The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot study |
| title_full_unstemmed | The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot study |
| title_short | The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot study |
| title_sort | safety of sglt 2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function safe pci pilot study |
| topic | SGLT2 inhibitors Coronary artery disease Percutaneous coronary intervention Acute kidney injury Contrast-induced nephropathy |
| url | https://doi.org/10.1186/s13098-023-01107-9 |
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