The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot study.

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.

Effect of diabetic kidney disease on therapeutic strategies for coronary artery disease: ten year follow-up.

BACKGROUND: The best treatment for coronary artery disease (CAD) in patients with type 2 diabetes (DM2) and chronic kidney disease is unknown. METHODS: This retrospective study included MASS registry patients with DM2 and multivessel CAD, stratified by kidney function. Primary endpoint was combined of mortality, myocardial infarction, or additional revascularization. RESULTS: Median follow-up was 9.5 years. Primary endpoint occurrences among strata 1 and 2 were 53.4% and 40.7%, respectively (P=.020). Mortality rates were 37.4% and 24.6% in strata 1 and 2, respectively (P<.001). We observed a lower rate of major adverse cardiovascular events (MACE) (P=.027 for stratum 1 and P<.001 for stratum 2) and additional revascularization (P=.001 for stratum 1 and P<.001 for stratum 2) for those in the surgical group. In a multivariate analysis, eGFR was an independent predictor of MACE (P=.034) and mortality (P=.020). CONCLUSIONS: Among subjects with DM2 and CAD the presence of lower eGFR rate was associated with higher rates of MACE and mortality, irrespective of treatment choice. CABG was associated with lower rates of MACE in both renal function strata. eGFR was an independent predictor of MACE and mortality in a 10-year follow-up.

Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF).

BACKGROUND: Ischemic cardiomyopathy and severe left ventricular dysfunction are well established to represent the main determinants of poor survival and premature death compared with preserved ventricular function. However, the role of myocardial revascularization as a therapeutic alternative is not known to improve the long-term prognosis in this group of patients. This study will investigate whether myocardial revascularization contributes to a better prognosis for patients compared with those treated with drugs alone and followed over the long term. METHODS: The study will include 600 patients with coronary artery disease associated with ischemic cardiomyopathy. The surgical or drug therapy option will be randomized, and the events considered for analysis will be all-cause mortality, nonfatal infarction, unstable angina requiring additional revascularization, and stroke. The events will be analyzed according to the intent-to-treat principle. Patients with multivessel coronary disease and left ventricular ejection fraction measurements of less than 35% will be included. In addition, myocardial ischemia will be documented by myocardial scintigraphy. Markers of myocardial necrosis will be checked at admission and after the procedure. DISCUSSION: The role of myocardial revascularization (CABG) in the treatment of patients with coronary artery disease and heart failure is not clearly established. The surgical option of revascularizing the myocardium is a procedure designed to reduce the load of myocardial hibernation in patients with heart failure caused by coronary artery disease. On the other hand, the assessment of myocardial viability is frequently used to identify patients with left ventricular ischemic dysfunction in which CABG may add survival benefit. However, the effectiveness of this option is uncertain. The great difficulty in establishing the efficacy of surgical intervention is based on the understanding of viability without ischemia. Thus, this study will include only patients with viable and truly ischemic myocardium to correct this anomaly. TRIAL REGISTRATION: Evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy submitted to medical or surgical treatment: MASS-VI (HF), ISRCTN77449548, Oct 10th, 2019 (retrospectively registered).

Diabetes and cardiovascular disease: from evidence to clinical practice - position statement 2014 of Brazilian Diabetes Society.

There is a very well known correlation between diabetes and cardiovascular disease but many health care professionals are just concerned with glycemic control, ignoring the paramount importance of controlling other risk factors involved in the pathogenesis of serious cardiovascular diseases. This Position Statement from the Brazilian Diabetes Society was developed to promote increased awareness in relation to six crucial topics dealing with diabetes and cardiovascular disease: Glicemic Control, Cardiovascular Risk Stratification and Screening Coronary Artery Disease, Treatment of Dyslipidemia, Hypertension, Antiplatelet Therapy and Myocardial Revascularization. The issue of what would be the best algorithm for the use of statins in diabetic patients received a special attention and a new Brazilian algorithm was developed by our editorial committee. This document contains 38 recommendations which were classified by their levels of evidence (A, B, C and D). The Editorial Committee included 22 specialists with recognized expertise in diabetes and cardiology.

Tratamento da sca no paciente diabético: o que mostram as evidências / Treatment of acs in the diabetic patient: what the evidence shows

O diabete mellitus (DM) é uma comorbidade muito frequente entre os pacientes com síndrome coronariana aguda (SCA), acometendo, aproximadamente, 20 a 37% desses. Além de ser um preditor de risco independente, também está relacionado a uma maior prevalência de quadros atípicos de SCA. Apesar disso, é importante ressaltar que no caso da SCA, a maioria dos pacientes com DM apresenta o mesmo quadro clínico que os pacientes sem a doença. Assim como para os pacientes não diabéticos, os scores de risco devem ser aplicados. Entretanto, essa comorbidade por si própria já prediz uma maior gravidade. Inclusive é mais aconselhável utilizar para esses pacientes uma estratégia invasiva precoce. Em relação ao tratamento medicamentoso da SCA, não há alterações significativas no tratamento dos pacientes com DM para os pacientes sem DM. Já no que diz respeito à terapia de reperfusão, muito se extrapola dos conhecimentos em angina estável, em que há uma superioridade do tratamento cirúrgico sobre o percutâneo para os pacientes com DM, ainda que haja falta de evidências no contexto agudo. Finalmente, o conjunto de evidências não é definitivo para indicar a melhor estratégia para o controle da hiperglicemia, entretanto, sabe-se que tanto a hiperglicemia quanto à hipoglicemia durante a internação está relacionada aos piores desfechos. Portanto, é importante evitar valores de glicemia superiores a 180 mg/dL e inferiores a 90 mg/dL, ficando a estratégia de controle rigoroso de glicemia com insulina intravenosa restrita aos pacientes selecionados.

Diabetes mellitus (DM) is a frequent comorbidity among patients with acute coronary syndrome (ACS), affecting about 20% to 37% of these patients. Besides being an independent risk predictor, it is also related to a higher prevalence of atypical presentations of ACS. Despite this, it is important to emphasize that in the case of ACS the majority of patients with DM have the same clinical presentation as patients without the disease. Just as for non-diabetic patients, risk scores should be applied. However, this comorbidity per se predicts a greater severity. Also, it is preferable to use an early invasive strategy for these patients. Regarding the medicinal treatment of ACS, there are no significant differences between the treatment of patients with DM and those without DM. In relation to reperfusion therapy, much of it is extrapolated from knowledge of stable angina, in which surgical treatment takes precedence over percutaneous treatment for patients with DM, despite the lack of evidence in the acute context. Finally, there is no definitive body of evidence to indicate the best strategy to control hyperglycemia, but it is known that both hyperglycemia and hypoglycemia during hospitalization are associated with worse outcomes. Thus, it is important to avoid glycemia values above 180 mg/dL and below 90 mg/dL, restricting the strategy of strict glycemic control with intravenous insulin to selected patients.