Risk Of Adverse Events Research Articles

Glucagon-Like Peptide-1 Receptor Agonists and Major Adverse Cardiovascular Events in Patients With and Without Diabetes: A Meta-Analysis of Randomized-Controlled Trials.

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shown encouraging results regarding cardiovascular outcomes mainly in patients with diabetes. In the present study, we compared the efficacy of GLP-1 RAs in cardiovascular events between patients with and without diabetes. After finding eligible studies assessing the impact of GLP-1 RAs on cardiovascular events in patients with and without diabetes using a systematic search, we performed a meta-analysis on randomized-controlled trials (RCTs) comparing cardiovascular outcomes between patients taking GLP-1 RAs and placebo stratified by the presence or absence of diabetes. Relative risk (RR) and its 95% confidence interval (CI) were set as the reporting effect size using the random-effects model. A total of 24 RCTs (50 033 with GLP-1 RAs and 44 514 with placebo) were included. Patients on GLP-1 RAs had lower risk of major adverse cardiovascular events (MACE) (RR 0.87, 95% CI0.82-0.93), cardiovascular death (RR 0.88, 95% CI0.82-0.94), myocardial infarction (MI) (RR 0.87, 95% CI0.77-0.97), stroke (RR 0.86, 95% CI0.80-0.92), and hospitalization for heart failure (RR 0.90, 95% CI0.83-0.98). Both subgroups were shown to be effective in terms of MACE and mortality. Nondiabetic patients had decreased risk of hospitalization for heart failure and MI, whereas the diabetic subgroup had marginally nonsignificant efficacy. The findings of this meta-analysis indicated that patients who are overweight/obese but do not have diabetes have a comparable reduction in the risk of adverse cardiovascular events as those with diabetes. These results need to be confirmed further by large-scale randomized trials in the future.

Exploring Novel Adverse Events of Nefecon

BackgroundNefecon, the first innovative drug approved by both the US FDA and European EMA for IgA nephropathy, lacked comprehensive real-world assessments of its adverse events (AEs). MethodsWe leveraged post-marketing data of Nefecon from the US FDA Adverse Event Reporting System, employing disproportionate analysis to detect positive signals at the system organ class (SOCs) and preferred terms (PTs) levels. Duplicate AEs related to budesonide and those previously reported in studies were excluded through the use of the Medical Dictionary of Regulatory Activities. Our analysis encompassed time to onset (TTO), Weibull shape parameter (WSP) evaluation, cumulative incidence, clinical prioritization evaluation and subgroup analysis based on gender and age. ResultsA total of 1515 individuals with IgA nephropathy were included. Eight positive SOC signals and 23 positive PT signals were identified, including four PTs (asthenia, malaise, product dose omission issue, and anxiety) representing novel AEs newly identified in this study. None of the positive PTs were classified as high clinical priority, with only acne, hypertension, swelling face, and weight increased considered as moderate clinical priority events. The median time to TTO was 31 days. All WSP test results indicated an early failure type profile. Lastly, subgroup analysis provided further insights into the relative risk of specific AEs. ConclusionsNefecon demonstrates a favorable safety profile, with no high-priority clinical events identified. The identification of novel AEs and subgroup-specific high-risk events fills a gap in existing studies and offers valuable insights for early clinical vigilance.

The antidepressant effect of Shexiang Baoxin Pills on myocardial infarction rats with depression may be achieved through the inhibition of the NLRP3 inflammasome pathway.

Patients with myocardial infarction (MI) frequently experience a heightened incidence of depression, thereby increasing the risk of adverse cardiovascular events. Consequently, early detection and intervention in depressive symptoms among patients with MI are imperative. Shexiang Baoxin Pills (SBP), a Chinese patent medicine employed for the treatment of MI, exhibits diverse mechanisms targeting this condition. Nevertheless, its therapeutic efficacy on postmyocardial infarction depressive symptoms remains unclear. The aim of this study is to investigate the effectiveness and mechanism of SBP in managing depression during acute myocardial infarction (AMI). A rat model combining MI and depression was established, and the rats were randomly divided into four groups: the model (MOD) group, SBP group, Fluoxetine (FLX) group, and Sham group. After 28 days of drug intervention, cardiac function was assessed using echocardiography while behavior was evaluated through sucrose preference test (SPT), forced swimming test (FST), and open-field test (OFT). Additionally, levels of inflammatory factors in serum and hippocampus were measured along with NLRP3 inflammasome-related protein expression via Western blotting and immunofluorescence. SBP can enhance cardiac function in rats with AMI and depression, while significantly ameliorating depressive-like behavior. Compared to the Sham group, levels of IL-1β, IL-18, TNF-α, and other inflammatory factors were markedly elevated in the MOD group. However, expressions of these inflammatory factors were reduced to varying degrees following treatment with SBP or FLX. Analysis of NLRP3 inflammasome-related proteins in the hippocampus revealed a significant upregulation of IL-1β, IL-18, NLRP3, ASC, caspase-1, and GSDMD in the MOD group; conversely, these measures were significantly attenuated after SBP intervention. We have observed a significant amelioration in depression-like behavior upon SBP administration during the treatment of AMI, suggesting that this effect may be attributed to the inhibition of NLRP3-mediated pyroptosis. (The main findings are summarized in the graphical abstract in the supplementary file.).

Once-weekly semaglutide in people with HIV-associated lipohypertrophy: a randomised, double-blind, placebo-controlled phase 2b single-centre clinical trial.

HIV-associated lipohypertrophy, which is characterised by an abnormal accumulation of abdominal visceral adipose tissue, remains problematic in people with HIV. Effective interventions are lacking, despite HIV-associated lipohypertrophy carrying a substantial risk of cardiometabolic comorbidity. The primary aim of this trial was to investigate effects of the GLP-1 receptor agonist, semaglutide, on adipose tissue in HIV-associated lipohypertrophy. This randomised, double-blind, placebo-controlled phase 2b clinical trial was conducted at a single US site. Key inclusion criteria included people with HIV aged 18 years or older with controlled HIV-1, a BMI of 25 kg/m2 or more, and lipohypertrophy but without type 1 or type 2 diabetes. Participants were randomly assigned 1:1 to receive 32 weeks of once-weekly subcutaneous semaglutide (8-week dose titration and 24 weeks at 1·0 mg) or placebo; all research personnel and participants remained masked to treatment assignment. Primary outcomes were changes at 32 weeks in adipose tissue quantity by body compartment. Analyses, including safety, were performed using intention-to-treat principles. This trial was registered ClinicalTrials.gov (NCT04019197) and is complete. Between June 10, 2019, and July 28, 2022, 108 participants were randomly assigned to receive semaglutide (n=54) or placebo (n=54). Eight (15%) in each group withdrew prematurely. Significant effects of semaglutide were seen over the 32-week study period in sex-adjusted multiplicative regression analyses for the primary outcome, abdominal visceral adipose tissue (β -30·82 cm2, 95% CI -50·13 to -11·51; % change -30·6%). Decreases were also seen in other key measures, including abdominal subcutaneous adipose tissue (β -42·01 cm2, 95% CI -75·49 to -8·52; % change -11·2%) and total body fat (natural logarithmic -0·21 kg, 95% CI -0·33 to -0·08; % change -18·9%). There were no statistically significant differences in possibly related or related adverse events (absolute risk difference 0·1111, 95% CI -0·0727 to 0·2869); however, one semaglutide-related grade 4 elevated lipase and two possibly related cases of cholelithiasis (grades 1 and 2) were observed. Semaglutide holds promise as an effective treatment for HIV-associated lipohypertrophy. The potential risk of serious adverse events deserves further scrutiny in large trials in people with HIV. National Institutes of Health.

Association of Hematological Biomarkers of Inflammation with 10-Year Major Adverse Cardiovascular Events and All-Cause Mortality in Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease: The ARIC Study.

Metabolic dysfunction-associated steatotic liver disease (MASLD) increases the risk of cardiovascular disease and existing evidence indicates that MASLD affects the cardiovascular system through systemic inflammation. Our aim was to assess the association of hematological biomarkers of inflammation with the 10-year risk of major adverse cardiovascular events (MACE) and all-cause mortality in MASLD patients. A total of 1858 MASLD participants from the Atherosclerosis Risk in Communities cohort study at visit 2 (1990-1992) were included. A total of 1338 non-MASLD participants were also included in the comparison. At baseline, hematological biomarkers of inflammation such as leukocytes, neutrophils, lymphocytes, monocytes, and C-reactive protein (CRP) were measured. Participants were followed up for MACE and all-cause mortality for a period of 10 years. Multivariate adjusted Cox models were used to estimate hazard ratios (HR). The 10-year MACE was higher in MASLD participants than in non-MASLD participants (20.8% vs 9.3%). Monocytes (HR 1.114, [95% CI, 1.022-1.216] per 1-SD, P=0.015) and CRP (HR 1.109 [95% CI, 1.032-1.190] per 1-SD, P=0.005) were associated with an increased 10-year risk of MACE, independent of other cardiovascular risk factors. This association was specific to the MASLD population. None of these hematological biomarkers demonstrated a significant association with 10-year all-cause mortality. Increased levels of monocytes and CRP were associated with an increased 10-year risk of MACE in the MASLD population. Hematological biomarkers of inflammation may help identify MASLD populations at higher risk for cardiovascular events.

Clinical outcomes of nurse-coordinated interventions for frail older adults discharged from hospital: A systematic review and meta-analysis.

To determine the effects of nurse-coordinated interventions in improving readmissions, cumulative hospital stay, mortality, functional ability and quality of life for frail older adults discharged from hospital. Systematic review with meta-analysis. A systematic search using key search terms of 'frailty', 'geriatric', 'hospital' and 'nurse'. Covidence was used to screen individual studies. Studies were included that addressed frail older adults, incorporated a significant nursing role in the intervention and were implemented during hospital admission with a focus on transition from hospital to home. This review searched MEDLINE (Ovid), CINAHL (EBSCO), PubMed (EBSCO), Scopus, Embase (Ovid) and Cochrane library for studies published between 2000 and September 2023. Of 7945 abstracts screened, a total 16 randomised controlled trials were identified. The 16 randomised controlled trials had a total of 8795 participants, included in analysis. Due to the heterogeneity of the outcome measures used meta-analysis could only be completed on readmission (n = 13) and mortality (n = 9). All other remaining outcome measures were reported through narrative synthesis. A total of 59 different outcome measure assessments and tools were used between studies. Meta-analysis found statistically significant intervention effect at 1-month readmission only. No other statistically significant effects were found on any other time point or outcome. Nurse-coordinated interventions have a significant effect on 1-month readmissions for frail older adults discharged from hospital. The positive effect of interventions on other health outcomes within studies were mixed and indistinct, this is attributed to the large heterogeneity between studies and outcome measures. This review should inform policy around transitional care recommendations at local, national and international levels. Nurses, who constitute half of the global health workforce, are ideally situated to provide transitional care interventions. Nurse-coordinated models of care, which identify patient needs and facilitate the continuation of care into the community improve patient outcomes. Review findings will be useful for key stakeholders, clinicians and researchers to learn more about the essential elements of nurse-coordinated transitional care interventions that are best targeted to meet the needs of frail older adults. When frail older adults experience transitions in care, for example discharging from hospital to home, there is an increased risk of adverse events, such as institutionalisation, hospitalisation, disability and death. Nurse-coordinated transitional care models have shown to be a potential solution to support adults with specific chronic diseases, but there is more to be known about the effectiveness of interventions in frail older adults. This review demonstrated the positive impact of nurse-coordinated interventions in improving readmissions for up to 1 month post-discharge, helping to inform future transitional care interventions to better support the needs of frail older adults. This systematic review was reported in accordance with the Referred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. No Patient or Public Contribution.

NSAID: Current limits to prescription

Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed to alleviate pain and inflammation in conditions like arthritis, migraines, and post-operative recovery. Their mechanism involves inhibiting prostaglandins that contribute to inflammation. NSAIDs are categorized based on their structure, selectivity for COX-1 and COX-2 enzymes, and plasma half-life. They are effective in treating osteoarthritis, spondyloarthritis, and rheumatoid arthritis but might carry an elevated risk of adverse events.".Despite their effectiveness, NSAIDs have limitations and risks that warrant cautious consideration. Extensive research has investigated their side effects, and this review aims to examine the current limitations of oral NSAID therapy, including safety profiles, specific scenarios where their use may not be appropriate, and gaps in knowledge.By critically evaluating these aspects, healthcare practitioners can make informed decisions about prescribing NSAIDs, optimizing patient outcomes while minimizing potential risks. This narrative review summarizes existing knowledge and underscores the importance of risk-benefit assessments in NSAID prescribing. Ultimately, the goal is to enhance the rational use of NSAIDs, maximizing benefits while mitigating adverse effects.

Screening Sportsmen and Sportswomen Over Age 35: The Relevance of an Exercise Electrocardiogram. Data From the SEEPRED Study.

The importance of exercise electrocardiogram (ECG) is still controversial in the prevention of cardiovascular events among sportsmen and sportswomen. The aim of this study was to assess the relevance of exercise ECG as a screening tool to prevent cardiovascular events when any cardiovascular disease (CVD) risk factors are present. The study included leisure time asymptomatic sportsmen and sportswomen over age 35 evaluated from 2011 to 2016 at the University Hospital of Saint-Etienne (France). Major adverse cardiovascular events (MACE) and atrial fibrillation were collected at 3 years. Of the cohort of 2457 sportsmen and sportswomen (mean age 50.2 ± 9.4 years), 50 (2%) had a high-risk SCORE2. A total of 256 exercise ECGs (10%) were defined as positive, most of them due to silent myocardial ischemia (SMI) (n = 196; 8%). These 196 SMI cases led to 33 coronary angiograms (1%), which revealed 23 significant coronary stenoses requiring revascularization. In multivariate logistic regression analysis, having at least two CVD risk factors was independently associated with (1) positive exercise ECG (OR = 1.80 [95% CI: 1.29-2.52], p = 0.0006), with (2) suspected SMI (OR = 2.57 [95% CI: 1.10-6.02], p = 0.0304), with (3) confirmed SMI (OR = 8.20 [95% CI: 3.46-19.46], p < 0.0001) and with (4) cardiovascular events (MACE or atrial fibrillation) (OR = 6.95 [95% CI: 3.49-13.81], p < 0.0001) at 3 years (median). The study supports the European recommendations for the use of exercise ECG in evaluation of asymptomatic leisure time sportsmen over age 35. Having at least two CVD risk factors was the best predictor for presence of coronary artery stenosis that may increase the risk for adverse events. ClinicalTrials.gov Identifier: NCT06024863.

Safety and Risk in Airway Management During Bariatric Air Medical Retrieval

ObjectiveBariatric anatomy and physiology present added clinical challenges to the provision of safe critical care and patient transport. LifeFlight Retrieval Medicine provides air medical retrieval services in Queensland, Australia, and performs over 6,000 retrieval missions annually using rotary wing, fixed wing, and ground ambulance platforms. MethodsBariatric patient retrievals were identified from the LifeFlight Retrieval Medicine electronic patient database. These cases were interrogated to quantify and describe adverse events during patient transport. ResultsOver the study period from July 2019 to December 2021 11,096 patient retrievals were completed. Of these patients, 816 (7.3%) had a body weight ≥ 120 kg (range, 120-246 kg; median = 146 kg). Bariatric patients were more likely to be male (70%) and to require critical care interventions than nonbariatric patients (25.9% vs. 19.9%). There was an absolute 1.5% increase of high-interest events during patient retrieval, corresponding to a 1.9-fold increased relative risk. Five hundred eleven of 11,096 patients were intubated by the retrieval team, and 61 of these weighed ≥ 120 kg. Bariatric patients undergoing intubation were of similar age and sex, weighed significantly more, had nonsignificant trends toward poorer airway visualization by Cormack-Lehane laryngoscopic grade, and tended toward reduced first-attempt success compared with nonbariatric patients. Rates of airway adverse events (AAEs) were significantly increased for the bariatric group (30/61, 49.2%) compared with the nonbariatric group (135/450, 30.0%) (χ2 likelihood ratio, P = .004). Postintubation desaturation was the most common AAE and was the only criterion significantly increased when comparing bariatric (26%) versus nonbariatric (12%) patients (χ2 likelihood ratio, P = .005). Using patient weight as a continuous variable, nominal logistic regression revealed a significant effect of increasing weight on AAEs (χ2 = 12.9, P = .0003) with a threshold of 105 kg providing an optimal 88% sensitivity for predicting AAEs. The odds of AAEs were increased significantly for those weighing 105 to 119 kg versus those weighing < 105 kg (odds ratio [OR] = 3.4; 95% confidence interval [CI], 1.6-7.5) and for those weighing ≥ 120 kg versus those weighing < 105 kg (OR = 2.5; 95% CI, 1.4-4.3). There was no difference between those weighing ≥ 120 kg versus those weighing 105 to 119 kg (OR = 0.73; 95% CI, 0.3-1.8). ConclusionAir medical retrieval of bariatric patients is safe despite an increased risk of adverse events. Strategies to optimize emergency anesthesia should be used to maximize safe intubation in bariatric patients.

Restricting datasets to classifiable samples augments discovery of immune disease biomarkers

Immunological diseases are typically heterogeneous in clinical presentation, severity and response to therapy. Biomarkers of immune diseases often reflect this variability, especially compared to their regulated behaviour in health. This leads to a common difficulty that frustrates biomarker discovery and interpretation – namely, unequal dispersion of immune disease biomarker expression between patient classes necessarily limits a biomarker’s informative range. To solve this problem, we introduce dataset restriction, a procedure that splits datasets into classifiable and unclassifiable samples. Applied to synthetic flow cytometry data, restriction identifies biomarkers that are otherwise disregarded. In advanced melanoma, restriction finds biomarkers of immune-related adverse event risk after immunotherapy and enables us to build multivariate models that accurately predict immunotherapy-related hepatitis. Hence, dataset restriction augments discovery of immune disease biomarkers, increases predictive certainty for classifiable samples and improves multivariate models incorporating biomarkers with a limited informative range. This principle can be directly extended to any classification task.

Assessing the Suitability of CHA2DS2-VASc for Predicting Adverse Limb Events and Cardiovascular Outcomes in Peripheral Artery Disease Patients with Percutaneous Transluminal Angioplasty: A Retrospective Cohort Study.

Patients with peripheral artery disease (PAD) are at high risk of major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs). CHA2DS2-VASc is a prognostic score for atrial fibrillation stroke risk; however, no study has evaluated its predictive ability for MALEs and MACEs in PAD patients who underwent percutaneous transluminal angioplasty. We conducted a retrospective cohort study on patients from Taiwan with PAD. The patients were stratified into four risk groups based on their modified CHA2DS2-VASc score. Cox proportional hazard models, 10-fold cross-validation, and receiver operating characteristic (ROC) analyses were utilized to evaluate the predictive ability of CHA2DS2-VASc for MALEs, MACEs, and MALEs + MACEs. Kaplan-Meier analysis estimated the survival probability of the risk groups. CHA2DS2-VASc was found to be a significant predictor of MACEs (hazard ratio (HR) 3.52 (95% confidence interval (95% CI) 1.00-12.12; p = 0.048), HR 4.18 (95% CI 1.19-14.36; p = 0.023), and HR 5.08 (95% CI 1.49-17.36; p = 0.009), for moderate-, high-, and very high-risk groups, respectively), while for MALEs and MALEs + MACEs, significance was achieved only for the high-risk group using a univariate model. For the multivariate adjusted model, the score was found to be a significant predictor of MACEs for only the very high-risk group, with an HR of 4.67 (95% CI 1.03-21.09; p = 0.045). The score demonstrated an AUC > 0.8, good discrimination (c-index > 0.8), and good calibration for predicting MACEs. However, it failed to achieve good performance for predicting MALEs and MALEs + MACEs. Based on all of the findings, CHA2DS2-VASc could potentially serve as a risk stratification score for predicting MACEs in patients with PAD, but it failed to qualify as a good predictor for MALEs.

A noninferiority randomized open-label pilot study of 3- versus 7-day influenza postexposure prophylaxis with oseltamivir in hospitalized children

Short influenza postexposure prophylaxis (PEP) showed high efficacy in adults, but studies in children are lacking. This randomized open-label pilot trial aimed to verify noninferiority of a 3- versus 7-day prophylaxis with oral oseltamivir in hospitalized children. Influenza contacts were randomized to the 3- or 7-day group and efficacy, relative risk of adverse events (AEs), and the cumulative costs of drugs and AEs management were compared. The intention-to-treat (ITT) analysis included 59 children (n = 28 and n = 31 in the 3- and 7-day group, respectively). The efficacy was 100% (95% CI 87.7–100%) versus 93.6% (95% CI 78.6–99.2%) in the 3- and 7-day group; the differences were statistically insignificant. A per-protocol (PP) analysis including 56 patients (n = 27 and n = 29, respectively) showed 100% (95% CI 87.2–100%) and 93.1% (95% CI 77.2–99.2%) efficacy, respectively, without statistical significance. Differences were within the predefined noninferiority margin with an efficacy difference Δ = 6.45 percentage points (p.p.) with 1-sided 95% CI (− 2.8, − 1.31, p = 0.86; ITT) and Δ = 6.9 p.p. (1-sided 95% CI − 2.83, − 1.27, p = 0.85; PP). Adverse events did not differ significantly, while the cumulative costs of the prophylaxis and AEs management were higher in the 7-day group (median 10.5 euro vs. 4.5 euro, p < 0.01). This pilot study showed the noninferiority of the 3-day versus 7-day PEP, which was associated with lower costs.Trial registration number: NCT04297462, 5th March 2020, restrospectively registered.

Safety Assessment of Concurrent Vaccination with the HPV Vaccine and the COVID-19 Vaccine in Fujian Province, China: A Retrospective Study.

During acute respiratory infections, women may concurrently receive human papillomavirus (HPV) and respiratory vaccines, as observed during the coronavirus disease 2019 (COVID-19) pandemic in China. However, few studies have assessed the safety of such concurrent administration, which could impact HPV vaccination schedules. This study analyzes the safety and optimal sequence of concurrent HPV and COVID-19 vaccinations. For this purpose, we surveyed women with both vaccines from January to October 2023 in Fujian Province, China. During this process, we collected vaccination history and adverse event (AE) data via telephone or interviews. Participants were grouped as Before, Concurrent, or After based on their vaccination sequence. A Chi-squared test, exact Fisher tests, and logistic regression were used to analyze the incidence of AEs and factors influencing vaccine safety. Overall, 1416 eligible participants were included. Although overall AE risk with the HPV vaccine was unaffected by vaccination sequence, individual AEs varied statistically between groups, including pain at the vaccination site (p < 0.001) and prolonged menstruation duration (p = 0.003). Based on the results, the optimal sequence would be to receive the HPV vaccine after the COVID-19 vaccine (After group). This insight may guide future emergency vaccination sequences for HPV and other respiratory infectious diseases.

The impact of triglyceride-glucose index on the prognosis of post-PCI patients–a meta-analysis

BackgroundPrevious research has demonstrated the validity of the triglyceride-glucose (TyG) index as a robust measure of insulin resistance (IR) and its association with coronary artery disease (CAD). The objective of this study is to elucidate the relationship between the TyG index and the prognosis of patients underwent percutaneous coronary intervention (PCI) through a comprehensive systematic review and meta-analysis. Our goal is to provide a thorough analysis of the available evidence to offer more clarity on this association.MethodsA systematic and thorough search was carried out in the PubMed, Embase, Cochrane Library, and Web of Science databases, covering studies published in English from the beginning until October 1, 2023. The focus of the search was to gather relevant studies pertaining to the occurrence of major adverse cardiovascular events (MACE). To address the variability among the included studies, random or fixed effect models were utilized to summarize the hazard ratios (HR). In cases where heterogeneity was detected, subgroup or sensitivity analyses were performed to explore potential sources. To evaluate publication bias, the Egger or Begg test was employed.ResultsThis study incorporated a total of 17 studies. Individuals with the highest TyG index exhibited an elevated risk of major adverse cardiovascular events (MACEs) compared to those with the lowest TyG index (HR = 1.69; 95% CI: 1.47–1.95; P &amp;lt; 0.001). When analyzing the TyG index as a continuous variable, each standard deviation increase was associated with an HR of 1.60 (95% CI: 1.48–1.73; P &amp;lt; 0.001). Moreover, in patients diagnosed with acute coronary syndrome (ACS), higher TyG index levels showed a trend of increased risk of MACE (HR = 1.54; 95% CI: 1.27–1.86; P &amp;lt; 0.001). Furthermore, an elevated TyG index was found to be associated with a higher risk of in-stent restenosis (HR = 1.62; 95% CI: 1.29–2.03; P &amp;lt; 0.001), new-onset atrial fibrillation (HR = 2.97; 95% CI: 2.10–4.06; P = 0.014), and a reduction in quantitative flow ratio (HR = 1.35; 95% CI: 1.101–1.592; P = 0.005). Subgroup analysis indicated the risk of MACE was comparable between varied durations of follow-up (P = 0.11). Furthermore, regression analysis revealed that the positive association between TyG index and the risk of MACE did not differ between individuals with or without diabetes (P = 0.23).ConclusionAn increase in the TyG index may lead to a higher vulnerability to major adverse cardiovascular events (MACE) in patients underwent PCI and there was no significant difference in the risk of major adverse cardiovascular events (MACE) between diabetic and non-diabetic individuals.

Adverse Cardiovascular Outcomes in Patients with Obstructive Sleep Apnea and Obesity: Metabolic Surgery versus Usual Care.

No therapy has been shown to reduce the risk of major adverse cardiovascular events (MACE) and death in patients with obstructive sleep apnea (OSA). To investigate the long-term relationship between metabolic surgery and incident MACE in patients with OSA and obesity. Adult patients with BMI 35-70 kg/m2 and moderate-to-severe OSA at a US health system (2004-2018) were identified. Baseline characteristics of patients who underwent metabolic surgery were balanced with a nonsurgical control group using overlap weighting methods. Multivariable Cox regression analysis estimated time-to-incident MACE. Follow-up ended in September 2022. 13,657 patients (7496 [54.9%] men; mean age, 52.0 years [SD 12.4]; median BMI, 41.0 [IQR, 37.6-46.2]), including 970 patients in the metabolic surgery group and 12,687 patients in the nonsurgical group, with a median follow-up of 5.3 years (IQR, 3.1-8.4 years) were analyzed. The mean between-group difference in body weight at 10 years was 26.6 kg (95% CI, 25.6-27.6) or 19.3% (95% CI, 18.6%-19.9%). The 10-year cumulative incidence of MACE was 27.0% (95% CI, 21.6%-32.0%) in the metabolic surgery group and 35.6% (95% CI, 33.8%-37.4%) in the nonsurgical group (adjusted HR, 0.58 [95% CI, 0.48-0.71], P < .001). The 10-year cumulative incidence of all-cause mortality was 9.1% (95% CI, 5.7%-12.4%) in the metabolic surgery group and 12.5% (95% CI, 11.2%-13.8%) in the nonsurgical group (adjusted HR, 0.63 [95% CI, 0.45-0.89], P = .009). Among patients with moderate-to-severe OSA and obesity, metabolic surgery, compared with nonsurgical management, was associated with a significantly lower risk of incident MACE and death.

Antiplatelet therapy after coronary artery bypass surgery: five year follow-up of randomised DACAB trial

ObjectiveTo assess the effect of different antiplatelet strategies on clinical outcomes after coronary artery bypass grafting.DesignFive year follow-up of randomised Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Grafting (DACAB)...

A dynamic nomogram for predicting in-hospital major adverse cardiovascular and cerebrovascular events in patients with both coronary artery disease and atrial fibrillation: a multicenter retrospective study.

Patients with both coronary artery disease (CAD) and atrial fibrillation (AF) are at a high risk of major adverse cardiovascular and cerebrovascular events (MACCE) during hospitalization. Accurate prediction of MACCE can help identify high-risk patients and guide treatment decisions. This study was to elaborate and validate a dynamic nomogram for predicting the occurrence of MACCE during hospitalization in Patients with CAD combined with AF. A total of 3550 patients with AF and CAD were collected. They were randomly assigned to a training group and a validation group in a ratio of 7 : 3. Univariate and multivariate analyses were utilized to identify risk factors (P < 0.05). To avoid multicollinearity and overfit of the model, the least absolute shrinkage and selection operator was conducted to further screen the risk factors. Calibration curves, receiver operating characteristic curves, and decision curve analyses are employed to assess the nomogram. For external validation, a cohort consisting of 249 patients was utilized from the Medical Information Mart for Intensive Care IV Clinical Database, version 2.2. Eight indicators with statistical differences were screened by univariate analysis, multivariate analysis, and the least absolute shrinkage and selection operator method (P < 0.05). The prediction model based on eight risk factors demonstrated good prediction performance in the training group, with an area under the curve (AUC) of 0.838. This performance was also maintained in the internal validation group (AUC = 0.835) and the external validation group (AUC = 0.806). Meanwhile, the calibration curve indicates that the nomogram was well-calibrated, and decision curve analysis revealed that the nomogram exhibited good clinical utility. The nomogram we constructed may aid in stratifying the risk and predicting the prognosis for patients with CAD and AF.

Cardiovascular medications, high-sensitivity cardiac troponin T concentrations, and long-term outcome in non-ST segment elevation acute coronary syndrome.

Cardiac troponin plays an essential role in the management of non-ST segment elevation acute coronary syndrome (NSTE-ACS). However, it is not clear whether troponin concentrations provide guidance regarding the initiation of prognostically beneficial cardiovascular medications [i.e. betablockers, renin-angiotensin-aldosterone system (RAAS) inhibitors, and statins] in NSTE-ACS. Registry-based study investigating three NSTE-ACS cohorts (n = 43 075, 40 162, and 46 698) with elevated high-sensitivity cardiac troponin concentrations >14 ng/L. Cox proportional regression models with the addition of interaction terms were used to analyse the interrelations of high-sensitivity cardiac troponin T (hs-cTnT) concentrations, new initiated medications with the respective three drug classes, and long-term risk of all-cause mortality and major adverse events (MAE). Betablockers were associated with risk reductions of 8 and 5% regarding all-cause mortality and MAE, respectively. There was no evidence of an interaction with hs-cTnT concentrations. RAAS inhibitors were associated with 13 and 8% risk reductions, respectively, with a weak interaction between hs-cTnT and MAE (Pinteraction = 0.016). However, no increasing prognostic benefit was noted at hs-cTnT concentrations >100 ng/L. Statins were associated with 38 and 32% risk reductions, respectively, with prognostic benefit across the entire range of hs-cTnT concentrations, and with a weak interaction regarding MAE (Pinteraction = 0.011). Cardiovascular medications provide different prognostic benefit in patients with NSTE-ACS with elevated hs-cTnT, and there was some evidence of greater treatment effects regarding MAE along with higher hs-cTnT concentrations. However, hs-cTnT appears only to have limited value overall for customizing such treatments.

Current practices and challenges of outpatient parenteral antimicrobial therapy: a narrative review.

Extended hospitalization for infection management increases inpatient care costs and the risk of healthcare-associated adverse events, including infections. The growing global demand for healthcare, the diminishing availability of hospital beds and an increasing patient preference for care within their own home have been the primary drivers of the expansion of hospital-in-the-home programmes. Such programmes include the use of IV antimicrobials in outpatient settings, known as outpatient parenteral antimicrobial therapy (OPAT). However, OPAT practices vary globally. This review article aims to describe the current OPAT practices and challenges worldwide. OPAT practice begins with patient evaluation and selection using eligibility criteria, which requires collaboration between the interdisciplinary OPAT team, patients and caregivers. Depending on care requirements, eligible patients may be enrolled to various models of care, receiving medication by healthcare professionals at outpatient infusion centres, hospital clinics, home visits or through self-administration. OPAT can be used for the management of many infections where an effective oral treatment option is lacking. Various classes of parenteral antimicrobials, including β-lactams, aminoglycosides, glycopeptides, fluoroquinolones and antifungals such as echinocandins, are used globally in OPAT practice. Despite its benefits, OPAT has numerous challenges, including complications from medication administration devices, antimicrobial side effects, monitoring requirements, antimicrobial instability, patient non-adherence, patient OPAT rejection, and challenges related to OPAT team structure and administration, all of which impact its outcome. A negative outcome could include unplanned hospital readmission. Future research should focus on mitigating these challenges to enable optimization of the OPAT service and thereby maximize the documented benefits for the healthcare system, patients and healthcare providers.

Xylitol is prothrombotic and associated with cardiovascular risk.

The pathways and metabolites that contribute to residual cardiovascular disease risks are unclear. Low-calorie sweeteners are widely used sugar substitutes in processed foods with presumed health benefits. Many low-calorie sweeteners are sugar alcohols that also are produced endogenously, albeit at levels over 1000-fold lower than observed following consumption as a sugar substitute. Untargeted metabolomics studies were performed on overnight fasting plasma samples in a discovery cohort (n = 1157) of sequential stable subjects undergoing elective diagnostic cardiac evaluations; subsequent stable isotope dilution liquid chromatography tandem mass spectrometry (LC-MS/MS) analyses were performed on an independent, non-overlapping validation cohort (n = 2149). Complementary isolated human platelet, platelet-rich plasma, whole blood, and animal model studies examined the effect of xylitol on platelet responsiveness and thrombus formation in vivo. Finally, an intervention study was performed to assess the effects of xylitol consumption on platelet function in healthy volunteers (n = 10). In initial untargeted metabolomics studies (discovery cohort), circulating levels of a polyol tentatively assigned as xylitol were associated with incident (3-year) major adverse cardiovascular event (MACE) risk. Subsequent stable isotope dilution LC-MS/MS analyses (validation cohort) specific for xylitol (and not its structural isomers) confirmed its association with incident MACE risk [third vs. first tertile adjusted hazard ratio (95% confidence interval), 1.57 (1.12-2.21), P < .01]. Complementary mechanistic studies showed xylitol-enhanced multiple indices of platelet reactivity and in vivo thrombosis formation at levels observed in fasting plasma. In interventional studies, consumption of a xylitol-sweetened drink markedly raised plasma levels and enhanced multiple functional measures of platelet responsiveness in all subjects. Xylitol is associated with incident MACE risk. Moreover, xylitol both enhanced platelet reactivity and thrombosis potential in vivo. Further studies examining the cardiovascular safety of xylitol are warranted.