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OBJECTIVE: We aimed to evaluate the safety and efficacy of antithrombotic strategies by age in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention in AUGUSTUS. METHODS: Patients were stratified into 3 age groups: <65, 65-74, and ≥75 years. Outcomes of interest were major or clinically relevant non-major bleeding, major bleeding, death or rehospitalization, and ischemic events. Treatment effects of apixaban vs. vitamin K antagonist (VKA) and aspirin vs. placebo were assessed across age groups using Cox models. RESULTS: Of 4614 patients, 1267 (27.5%) were <65, 1802 (39.0%) were 65-74, and 1545 (33.5%) were ≥75 years. Apixaban was associated with lower rates of major or clinically relevant non-major bleeding than VKA (<65: HR 0.69 [0.47-1.00]; 65-74: HR 0.57 [0.43-0.75]; ≥75: HR 0.81 [0.63-1.04]). Death or hospitalization occurred less often with apixaban, regardless of age. No differences were observed in rates of ischemic events between apixaban and VKA according to age. Aspirin was associated with higher rates of bleeding than placebo (<65: HR 1.67 [1.15-2.43]; 65-74: HR 2.32 [1.73-3.10]; ≥75: HR 1.69 [1.31-2.19]). Rates of death or rehospitalization and ischemic events were similar among patients receiving aspirin or placebo across age groups. CONCLUSIONS: Apixaban was associated with greater absolute reduction in bleeding than VKA in older age groups, reflecting their higher hemorrhagic risk. Aspirin increased bleeding in all age groups vs. placebo. Our findings support the use of apixaban plus a purinergic receptor P2Y12(P2Y12) inhibitor without aspirin in patients with atrial fibrillation and recent acute coronary syndrome/percutaneous coronary intervention, regardless of age.

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BACKGROUND: Women, in comparison to men, experience worse outcomes after acute coronary syndrome (ACS). However, whether the female sex per se is an independent predictor of such adverse events remains unclear. OBJECTIVE: This study aims to assess the association between the female sex and in-hospital mortality after ST-elevation myocardial infarction (STEMI). METHODS: We conducted a retrospective cohort study by enrolling consecutive STEMI patients admitted to a tertiary hospital from January 2018 to February 2019. All patients were treated per current guideline recommendations. Multivariable logistic regression models were applied to evaluate in-hospital mortality using GRACE variables. Model accuracy was evaluated using c-index. A p-value < 0.05 was statistically significant. RESULTS: Out of the 1678 ACS patients, 709 presented with STEMI. The population consisted of 36% women, and the median age was 61 years. Women were older (63.13 years vs. 60.53 years, p = 0.011); more often presented with hypertension (75.1% vs. 62.4%, p = 0.001), diabetes (42.2% vs. 27.8%, p < 0.001), and hyperlipidemia (34.1% vs. 23.9%, p = 0.004); and were less likely to undergo percutaneous coronary intervention (PCI) via radial access (23.7% vs. 46.1%, p < 0.001). In-hospital mortality rate was significantly higher in women (13.2% vs. 5.6%, p = 0.001), and the female sex remained at higher risk for in-hospital mortality (OR 2.79, 95% CI 1.15-6.76, p = 0.023). A multivariate model including age, sex, systolic blood pressure, cardiac arrest, and Killip class was 94.1% accurate in predicting in-hospital mortality, and the c-index was 0.85 (95% CI 0.77-0.93). CONCLUSION: After adjusting for the risk factors in the GRACE prediction model, women remain at higher risk for in-hospital mortality.

FUNDAMENTO: As mulheres, em comparação aos homens, apresentam piores resultados após a síndrome coronariana aguda (SCA). No entanto, ainda não está claro se o sexo feminino em si é um preditor independente de tais eventos adversos. OBJETIVO: Este estudo tem como objetivo avaliar a associação entre o sexo feminino e a mortalidade hospitalar após infarto do miocárdio com supradesnivelamento do segmento ST (IAMCSST). MÉTODOS: Conduzimos um estudo de coorte retrospectivo, recrutando pacientes consecutivos com IAMCSST, internados em um hospital terciário de janeiro de 2018 a fevereiro de 2019. Todos os pacientes foram tratados de acordo com as recomendações das diretrizes atuais. Modelos de regressão logística multivariada foram aplicados para avaliar a mortalidade hospitalar utilizando variáveis de GRACE. A precisão do modelo foi avaliada usando o índice c. Um valor de p < 0,05 foi estatisticamente significativo. RESULTADOS: Dos 1.678 pacientes com SCA, 709 apresentaram IAMCSST. A população era composta por 36% de mulheres e a idade média era de 61 anos. As mulheres tinham maior idade (63,13 anos vs. 60,53 anos, p = 0,011); apresentavam hipertensão (75,1% vs. 62,4%, p = 0,001), diabetes (42,2% vs. 27,8%, p < 0,001) e hiperlipidemia (34,1% vs. 23,9%, p = 0,004) mais frequentemente; e apresentaram menor probabilidade de serem submetidas a intervenção coronária percutânea (ICP) por acesso radial (23,7% vs. 46,1%, p < 0,001). A taxa de mortalidade hospitalar foi significativamente maior em mulheres (13,2% vs. 5,6%, p = 0,001), e o sexo feminino permaneceu em maior risco de mortalidade hospitalar (OR 2,79, IC de 95% 1,15­6,76, p = 0,023). Um modelo multivariado incluindo idade, sexo, pressão arterial sistólica, parada cardíaca e classe de Killip atingiu 94,1% de precisão na previsão de mortalidade hospitalar, e o índice c foi de 0,85 (IC de 95% 0,77­0,93). CONCLUSÃO: Após ajuste para os fatores de risco no modelo de previsão do GRACE, as mulheres continuam em maior risco de mortalidade hospitalar.

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Resumo Fundamento As mulheres, em comparação aos homens, apresentam piores resultados após a síndrome coronariana aguda (SCA). No entanto, ainda não está claro se o sexo feminino em si é um preditor independente de tais eventos adversos. Objetivo Este estudo tem como objetivo avaliar a associação entre o sexo feminino e a mortalidade hospitalar após infarto do miocárdio com supradesnivelamento do segmento ST (IAMCSST). Métodos Conduzimos um estudo de coorte retrospectivo, recrutando pacientes consecutivos com IAMCSST, internados em um hospital terciário de janeiro de 2018 a fevereiro de 2019. Todos os pacientes foram tratados de acordo com as recomendações das diretrizes atuais. Modelos de regressão logística multivariada foram aplicados para avaliar a mortalidade hospitalar utilizando variáveis de GRACE. A precisão do modelo foi avaliada usando o índice c. Um valor de p < 0,05 foi estatisticamente significativo. Resultados Dos 1.678 pacientes com SCA, 709 apresentaram IAMCSST. A população era composta por 36% de mulheres e a idade média era de 61 anos. As mulheres tinham maior idade (63,13 anos vs. 60,53 anos, p = 0,011); apresentavam hipertensão (75,1% vs. 62,4%, p = 0,001), diabetes (42,2% vs. 27,8%, p < 0,001) e hiperlipidemia (34,1% vs. 23,9%, p = 0,004) mais frequentemente; e apresentaram menor probabilidade de serem submetidas a intervenção coronária percutânea (ICP) por acesso radial (23,7% vs. 46,1%, p < 0,001). A taxa de mortalidade hospitalar foi significativamente maior em mulheres (13,2% vs. 5,6%, p = 0,001), e o sexo feminino permaneceu em maior risco de mortalidade hospitalar (OR 2,79, IC de 95% 1,15-6,76, p = 0,023). Um modelo multivariado incluindo idade, sexo, pressão arterial sistólica, parada cardíaca e classe de Killip atingiu 94,1% de precisão na previsão de mortalidade hospitalar, e o índice c foi de 0,85 (IC de 95% 0,77-0,93). Conclusão Após ajuste para os fatores de risco no modelo de previsão do GRACE, as mulheres continuam em maior risco de mortalidade hospitalar.

Abstract Background Women, in comparison to men, experience worse outcomes after acute coronary syndrome (ACS). However, whether the female sex per se is an independent predictor of such adverse events remains unclear. Objective This study aims to assess the association between the female sex and in-hospital mortality after ST-elevation myocardial infarction (STEMI). Methods We conducted a retrospective cohort study by enrolling consecutive STEMI patients admitted to a tertiary hospital from January 2018 to February 2019. All patients were treated per current guideline recommendations. Multivariable logistic regression models were applied to evaluate in-hospital mortality using GRACE variables. Model accuracy was evaluated using c-index. A p-value < 0.05 was statistically significant. Results Out of the 1678 ACS patients, 709 presented with STEMI. The population consisted of 36% women, and the median age was 61 years. Women were older (63.13 years vs. 60.53 years, p = 0.011); more often presented with hypertension (75.1% vs. 62.4%, p = 0.001), diabetes (42.2% vs. 27.8%, p < 0.001), and hyperlipidemia (34.1% vs. 23.9%, p = 0.004); and were less likely to undergo percutaneous coronary intervention (PCI) via radial access (23.7% vs. 46.1%, p < 0.001). In-hospital mortality rate was significantly higher in women (13.2% vs. 5.6%, p = 0.001), and the female sex remained at higher risk for in-hospital mortality (OR 2.79, 95% CI 1.15-6.76, p = 0.023). A multivariate model including age, sex, systolic blood pressure, cardiac arrest, and Killip class was 94.1% accurate in predicting in-hospital mortality, and the c-index was 0.85 (95% CI 0.77-0.93). Conclusion After adjusting for the risk factors in the GRACE prediction model, women remain at higher risk for in-hospital mortality.

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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.

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BACKGROUND. Despite the potential benefits of percutaneous procedures for the assessment and treatment of coronary artery disease, these interventions require the use of iodine contrast, which might lead to contrast-induced nephropathy (CIN) and increased risk of dialysis and major adverse cardiac events (MACE). Aims. We sought to compare two different iodine contrasts (low vs. iso-osmolar) for the prevention of CIN among high-risk patients. METHODS. This is a single-center, randomized (1:1) trial comparing consecutive patients at high risk for CIN referred to percutaneous coronary diagnostic and/or therapeutic procedures with low (ioxaglate) vs iso-osmolarity (iodixanol) iodine contrast. High risk was defined by the presence of at least one of the following conditions: age >70 years, diabetes mellitus, non-dialytic chronic kidney disease, chronic heart failure, cardiogenic shock, and acute coronary syndrome (ACS). The primary endpoint was the occurrence of CIN, defined as a >25% relative increase and/or >0.5 mg/dL absolute increase in creatinine (Cr) levels compared with baseline between the 2nd and 5th day after contrast media administration. RESULTS. A total of 2268 patients were enrolled. Mean age was 67 years. Diabetes mellitus (53%), non-dialytic chronic kidney disease (31%), and ACS (39%) were highly prevalent. The mean volume of contrast media was 89 ml ± 48.6. CIN occurred in 15% of all patients, with no significant difference regarding the type of contrast used (iso = 15.2% vs low = 15.1%, P>.99). Differences were not observed in specific subgroups such as diabetics, elderly, and ACS patients. At 30-day follow-up, 13 patients in the iso-osmolarity group and 11 in low-osmolarity group required dialysis (P=.8). There were 37 (3.3%) deaths in the iso-osmolarity cohort vs 29 (2.6%) in the low-osmolarity group (P=.4). CONCLUSION. Among patients at high risk for CIN, the incidence of this complication was 15%, and independent of the use of low- or iso-osmolar contrast.

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AIMS: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients at high bleeding risk (HBR) is still debated. The current study, using the totality of existing evidence, evaluated the impact of an abbreviated DAPT regimen in HBR patients. METHODS AND RESULTS: A systematic review and meta-analysis was performed to search randomized clinical trials comparing abbreviated [i.e. very-short (1 month) or short (3 months)] with standard (≥6 months) DAPT in HBR patients without indication for oral anticoagulation. A total of 11 trials, including 9006 HBR patients, were included. Abbreviated DAPT reduced major or clinically relevant non-major bleeding [risk ratio (RR): 0.76, 95% confidence interval (CI): 0.61-0.94; I2 = 28%], major bleeding (RR: 0.80, 95% CI: 0.64-0.99, I2 = 0%), and cardiovascular mortality (RR: 0.79, 95% CI: 0.65-0.95, I2 = 0%) compared with standard DAPT. No difference in all-cause mortality, major adverse cardiovascular events, myocardial infarction, or stent thrombosis was observed. Results were consistent, irrespective of HBR definition and clinical presentation. CONCLUSION: In HBR patients undergoing PCI, a 1- or 3-month abbreviated DAPT regimen was associated with lower bleeding and cardiovascular mortality, without increasing ischaemic events, compared with a ≥6-month DAPT regimen.

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AIM: The win ratio can incorporate different types of outcomes and enhance statistical power, making it a useful method for analysing composite outcomes in cardiovascular trials. The application of this approach to the PARADISE-MI trial provides an additional perspective into understanding the effects of sacubitril/valsartan in patients with acute myocardial infarction. METHODS AND RESULTS: We conducted a post-hoc analysis of the PARADISE-MI trial, which randomly assigned patients with acute myocardial infarction complicated by a reduced left ventricular ejection fraction, pulmonary congestion, or both to receive either sacubitril/valsartan (97 mg of sacubitril and 103 mg of valsartan twice daily) or ramipril (5 mg twice daily) in addition to guideline-recommended therapy. The principal composite outcome was analysed in the hierarchical order of death due to cardiovascular causes, first hospitalization for heart failure, and first outpatient episode of symptomatic heart failure. We included events confirmed by the clinical events classification (CEC) committee as well as events identified by investigators that did not meet study definitions. Results were analysed by the unmatched win-ratio method. A win ratio that exceeds 1.00 reflects a better outcome. A total of 5661 patients underwent randomization; 2830 were assigned to receive sacubitril/valsartan and 2831 to receive ramipril. The hierarchical analysis of the principal composite outcome demonstrated a larger number of wins (1 265 767 [15.7%]) than losses (1 079 502 [13.4%]) in the sacubitril/valsartan group (win ratio of 1.17, 95% confidence interval [CI] 1.03-1.33; p = 0.015). Sensitivity analyses using alternative definitions of the composite outcome showed results similar to those of the principal analysis, except for analysis restricted to events that met CEC definitions (win ratio of 1.11, 95% CI 0.96-1.30; p = 0.16). CONCLUSION: In this post-hoc analysis of the PARADISE-MI trial using the win ratio and including investigator-identified events not having CEC confirmation, sacubitril/valsartan was superior to ramipril among high-risk survivors of acute myocardial infarction.

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BACKGROUND: Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation conveys an inherent risk for short- and long-term complications, including in-stent restenosis and stent thrombosis. Drug-coated balloons are emerging as an alternative approach to fulfill the "leaving nothing behind" principle and avoid long-term DES-related complications. DESIGN: TRANSFORM II is an investigator-initiated, multicenter, noninferiority, randomized clinical trial, testing a sirolimus-coated balloon (SCB) versus the standard of care for native coronary vessels with a 2-3 mm diameter, in terms of 12-month target lesion failure (TLF; primary endpoint) and net adverse cardiovascular events (coprimary endpoint). Patients undergoing PCI will be randomized to be treated with either SCB or new-generation everolimus-eluting stent and will be followed up clinically for up to 60 months. Assuming a TLF rate of 8% at 12 months with DES, a sample size of 1325 patients was chosen to ensure an 80% power to detect a 1.5% lower incidence in the SCB group with a type I error rate of 0.05. The TRANSFORM II trial is registered on clinicaltrials.gov (identification number NCT04893291). Several substudies, including an optical coherence tomography assessment at 9 months (intracoronary imaging substudy), will investigate the study device in different clinical and lesion settings.

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