Background There is a lack of evidence regarding the benefits of β-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF). Methods and results TREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fraction (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of β-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to β-blocker therapy (agent and dose according to treating physician) or no β-blocker therapy. The primary endpoint is a composite of all-cause death, nonfatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analyzed according to the intention-to-treat principle. Conclusion The REBOOT trial will provide robust evidence to guide the prescription of β-blockers to patients discharged after MI without reduced LVEF.
Sodium-glucose cotransporter-2 inhibitors (SGLT-2 inhibitors) are new glucose-lowering drugs (GLDs) with demonstrated cardiovascular benefits in patients with heart disease and type-2 diabetes mellitus (T2DM). However, their safety and efficacy when prescribed at hospital discharge are unexplored. This prospective, observational, longitudinal cohort study included 104 consecutive T2DM patients discharged from the cardiology department between April 2018 and February 2019. Patients were classified based on SGLT-2 inhibitor prescription and adjusted by propensity-score matching. The safety outcomes included discontinuation of GLDs; worsening renal function; and renal, hepatic, or metabolic hospitalization. The efficacy outcomes were death from any cause, cardiovascular death, cardiovascular readmission, and combined clinical outcome (cardiovascular death or readmission). The results showed that, the incidence rates of safety outcomes were similar in the SGLT-2 inhibitor or non-SGLT-2 inhibitor groups. Regarding efficacy, the SGLT-2 inhibitors group resulted in a lower rate of combined clinical outcomes (18% vs. 42%; hazard ratio (HR), 0.35; p = 0.02), any cause death (0% vs. 24%; HR, 0.79; p = 0.001) and cardiovascular death (0% vs. 17%; HR, 0.83; p = 0.005). No significant differences were found in cardiovascular readmissions. SGLT-2 inhibitor prescription at hospital discharge in patients with heart disease and T2DM was safe, well tolerated, and associated with a reduction in all-cause and cardiovascular deaths.
Background In recent years, the paradigm of glycemic treatment has changed due to the cardiovascular impact of newer glucose-lowering drugs (GLD) (sodium-glucosa cotransporter 2 inhibitor (SGLT2i) and GLP-1 receptor agonist (GLP1a)). The cardiological patient with type 2 diabetes (2DM) is a very high cardiovascular risk patient in which the benefit of these therapies is greater. However, to date, different studies have demonstrated the efficacy and safety of newer GLD only in the outpatient setting. So its impact when they are initiated to discharge after a cardiovascular event is unknown. Objective To evaluate the efficacy and safety of the onset of these newer GLD in 2DM patients at discharge from cardiology hospitalization. And to compare mortality and readmissions among patients treated with or without newer GLD. Methods Prospective, it includes patients admitted to cardiology at a 3er level hospital between April/2018 and February/2019 with a history of 2DM or diagnosed with 2DM during hospitalization. They were followed at 6, 12 and 18 months. The evolution of anthropometric parameters, glycemic profile, renal function and blood pressure were analyzed; renal events, readmissions, mortality and combined clinical outcome (mortality or readmission) were collected during follow-up. Quantitative variables are expressed in mean/SD and categorical variables in number of patients (%). For the comparison between the parameters at discharge and thefollow-up, a T student was used for paired data. Survival analysis by K-M was performed crude and adjusted data by propensity score matching (PSM). Results Population: Diagnoses at discharge: Acute coronary syndrome 66 (64%), Heart failure 22 (21%), Arrhythmias 16 (15%). 104 diabetic patients, 39 of them (38%) were treated on discharge with newer GLD. 35 Patients with SGLT2i without GLP1a, 3 patients with SGLT2i and GLP1a and 1 patient with GLP1a without SGLT2i. The mean follow-up was 16±2 months. Regarding the subgroup of patients with newer GLD: mean age was 65±21 y, male 26 (67%). A significant decrease was observed in glycated hemoglobin (7.6 to 6.9%, p=0.04) and weight (81 to 78 kg, p<0.01) without significant changes in blood pressure or glomerular filtration rate (GFR). Only 1 patient presented deterioration of their GFR that forced the transient suspension of newer GLD. 10 deaths were registered in the classical GLD group (15%) and none in the newer GLD group (HR 0.81 [0.71–0.92] p=0.002, Figure 1A, HR adjusted by PSM 0.9 [0.82–0.99], p=0.04), Figure 1B. The combined clinical outcome appeared in 38 patients (58%) in the the classical GLD group and in 9 (23%) in the newer GLD group (HR 0.70 [0.58–0.85] p<0.001, Figure 1C, PSM adjusted HR 0.75 [0.61–0.92], p=0.001), Figure 1D. Conclusion The use of newer GLD at discharge from cardiology hospitalization reduce mortality and readmissions. Newer GLD were safe and showed significant reduction in weigth and glycated hemoglobin. Figure 1. Kaplan-Meier survival analysis crude and adjusted Funding Acknowledgement Type of funding source: None
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