Background:Epidemiological studies and feeding trials with supplements suggest that fibre intake is associated with a reduction in cardiovascular risk. However, the effects of changes in dietary ...fibre on risk factor levels have not been evaluated in free-living individuals. Thus, the effects of changes in dietary fibre intake on cardiovascular risk factors were assessed over 3 months in free-living high-risk subjects.Methods:772 high-risk subjects (age 69±5 years) were assigned to a low-fat diet or two Mediterranean-style diets. All participants received behavioural and nutritional education, including recommendations for increasing the consumption of vegetables, fruits, and legumes. Changes in food and nutrient intake, body weight, blood pressure, lipid profiles, glucose control and inflammatory markers were evaluated.Results:Most participants increased consumption of vegetable products, but the increase in dietary fibre exhibited wide between-subject variability (6–65 g/day). Body weight, waist circumference, and mean systolic and diastolic blood pressure decreased across quintiles of fibre intake (p<0.005; all). Reductions in fasting glucose and total cholesterol levels, and increments in HDL cholesterol were highest among participants in the upper 20% of fibre intake (p = 0.04 and 0.02 respectively). Plasma concentrations of C-reactive protein, but not those of inflammatory cytokines, decreased in parallel with increasing dietary fibre (p = 0.04). Significant reductions in LDL cholesterol were observed only among participants with the greatest increases in soluble fibre intake (p = 0.04).Conclusions:Increasing dietary fibre intake with natural foods is associated with reductions in classical and novel cardiovascular risk factors in a high-risk cohort.
Abstract Background and aim Hypertension is one of the main cardiovascular risk factors in the elderly. The aims of this work were to evaluate if a one-year intervention with two Mediterranean diets ...(Med-diet) could decrease blood pressure (BP) due to a high polyphenol consumption, and if the decrease in BP was mediated by plasma nitric oxide (NO) production. Methods and results An intervention substudy of 200 participants at high cardiovascular risk was carried out within the PREDIMED trial. They were randomly assigned to a low-fat control diet or to two Med-diets, one supplemented with extra virgin olive oil (Med-EVOO) and the other with nuts (Med-nuts). Anthropometrics and clinical parameters were measured at baseline and after one year of intervention, as well as BP, plasma NO and total polyphenol excretion (TPE) in urine samples. Systolic and diastolic BP decreased significantly after a one-year dietary intervention with Med-EVOO and Med-nuts. These changes were associated with a significant increase in TPE and plasma NO. Additionally, a significant positive correlation was observed between changes in urinary TPE, a biomarker of TP intake, and in plasma NO (Beta = 4.84; 95% CI: 0.57–9.10). Conclusions TPE in spot urine sample was positively correlated with plasma NO in Med-diets supplemented with either EVOO or nuts. The statistically significant increases in plasma NO were associated with a reduction in systolic and diastolic BP levels, adding to the growing evidence that polyphenols might protect the cardiovascular system by improving the endothelial function and enhancing endothelial synthesis of NO.
Summary Background and aims Epidemiological data have shown an inverse association between the consumption of polyphenol-rich foods and the risk of cardiovascular disease or overall mortality. A ...comprehensive estimation of individual polyphenol intake in nutritional cohorts is needed to gain a better understanding of this association. The aim of this study was to estimate the quantitative intake of polyphenols and the major dietary sources in the PREDIMED (PREvención con DIeta MEDiterránea) cohort using individual food consumption records. Methods and results The PREDIMED study is a large, parallel-group, multicentre, randomised, controlled 5-year feeding trial aimed at assessing the effects of the Mediterranean diet on the primary prevention of cardiovascular disease. A total of 7200 participants, aged 55–80 years, completed a validated 1-year food frequency questionnaire (FFQ) at baseline. Polyphenol consumption was calculated by matching food consumption data from the FFQ with the recently developed Phenol-Explorer database on polyphenol content in foods. The mean total polyphenol intake was 820 ± 323 mg day−1 (443 ± 218 mg day−1 of flavonoids and 304 ± 156 mg day−1 of phenolic acids). Hydroxycinnamic acids were the phenolic group with the highest consumption and 5-caffeoylquinic acid was the most abundantly ingested individual polyphenol. The consumption of olives and olive oil was a differentiating factor in the phenolic profile of this Spanish population compared with other countries. Conclusion In Mediterranean countries, such as Spain, the main dietary source of polyphenols is coffee and fruits, but the most important differentiating factor with respect to other countries is the consumption of polyphenols from olives and olive oil. Clinical trial registry International Standard Randomised Controlled Trial Number (ISRCTN of London, England) 35739639.
Background
The diagnostic strategy for pulmonary embolism (PE) includes a D‐dimer test when PE probability is low or intermediate, but false‐positive D‐dimer results are frequent and can result in an ...unnecessary computed tomography pulmonary angiogram. The PE rule‐out criteria (PERC) rule excludes PE without D‐dimer testing when pretest probability is <15%. The aim of this study was to assess the safety of the PERC rule strategy in patients included in the Registro Informatizado de la Enfermedad TromboEmbolica venosa (RIETE) registry.
Methods
This retrospective cohort study used data from the RIETE registry, an ongoing, international prospective registry of patients with objectively confirmed venous thromboembolism. The primary outcome was the failure rate of the PERC strategy, represented by the proportion of PERC‐negative (PERC‐N) patients with a PE included in the registry. Secondary outcomes were a comparison of the clinical characteristics, treatment strategy, and outcome of PERC‐N versus PERC‐positive (PERC‐P) patients at 3 months.
Results
From 2001 to 2021, a total of 49,793 patients with acute PE were enrolled in the RIETE registry. We included 48,903 in the final analysis after exclusion of 890 patients with an undetermined PERC status. Only 346 patients were PERC‐N with a failure rate of 0.7% (95% confidence interval 0.6%–0.8%). PERC‐N patients presented more frequently with chest pain but less often with dyspnea, syncope, or hypotension. They also had subsegmental or segmental PE more frequently, were more often treated with direct oral anticoagulants, and received mechanical or pharmacological thrombolysis less often. In addition, PERC‐N patients had a lower incidence of recurrent deep vein thrombosis, major bleeding, and death attributed to PE during the 3‐month follow‐up.
Conclusions
A low failure rate of the PERC rule was observed in the RIETE registry, thus supporting its use to safely identify patients with an unlikely probability of PE.
Background
Age is a major risk factor for venous thromboembolism (VTE), yet patients aged ≥90 years are under‐represented in clinical trials of anticoagulant therapy. The objectives were to describe ...and compare patient clinical characteristics, treatments, and outcomes (VTE recurrence, bleeding, and mortality) during the first 3 months of anticoagulation between VTE patients aged ≥90 years and those aged <90 years.
Methods
We analyzed data from the Registro Informatizado Enfermedad TromboEmbὀlica (RIETE), an ongoing global observational registry of patients with objectively confirmed acute VTE.
Results
From January 2001 to October 2022, 96,701 patients were registered in RIETE, of whom 3262 (3.4%) were aged ≥90 years. Patients aged ≥90 years were less likely to be men, and to have experienced cancer or recent surgery, but more likely to manifest immobility, chronic heart failure, anemia, renal insufficiency, or dementia than those aged <90 years. Most (99.6%) patients aged ≥90 years were receiving anticoagulant therapy. During the first 3 months, 26 patients aged ≥90 years developed VTE recurrences, 116 experienced major bleeding, and 564 died. Among patients initially presenting with pulmonary embolism (PE), deaths due to PE exceeded those due to fatal bleeding (76 vs. 19). Among those initially presenting with isolated deep‐vein thrombosis (DVT), it was the reverse (2 vs. 11 deaths).
Conclusions
In patients aged ≥90 years, the difference in the outcome of anticoagulant treatment depending on the initial presentation of VTE could suggest a need for different management approaches. Clinical trials evaluating the optimal duration of anticoagulation according to initial VTE presentation are warranted to limit excess deaths in this particular population.
Background and importanceParenteral nutrition (PN) is a high-risk medication. Its compounding is a complex process that must be controlled and evaluated periodically. Pharmacy staff involved must ...present appropiate technical skills and perfect knowledge of aseptic technique and preparation aspects.Aim and objectivesTo objectively evaluate the PN compounding process by pharmacy staff, using a specifically designed checklist.Material and methodsEach pharmacy technician (PT) was evaluated by an experienced pharmacist through direct visual inspection, using a checklist containing 57 items: 29 related to aseptic technique and 28 regarding compounding. Each item scored 1 point; final evaluation score was calculated on a 0–10 scale.PT were divided in two groups: with experience (PN compounding for >6 months) and without experience.A descriptive analysis was performed using measures of central tendency, dispersion and position for quantitative variables, and frequency distribution for qualitative variables.Results30 operators were examined, 19 with experience and 11 without experience (the results are in Table 1).Abstract 3PC-006 Table 1 Global (average; minimum; maximum) Aseptic technique (average; minimum; maximum) PN compounding (average; minimum; maximum) With experience 7.9±1.09; 5.2; 9.2 8.5±1.14; 5.9; 10 7.3±1.53; 3.6; 9.4 Without experience 7.2±1.0; 5.9; 8 8.9±0.5; 7.9; 9.7 4.8±1.5; 2.3; 7 Total 7.65±1.0; 5.2; 9.2 8.6±0.94; 5.9; 10 6.3±1.92; 2.3; 9.4 Total number of errors was 307. Error prevalence was 18%. The most frequent errors involved: electrolyte addition sequence (10.7%); stable intermediate admixtures (7.8%); mixing after additions (7.2%); renew/disinfect gloves (5.9%); mix glucose and lipids without amino acids (5.5%); inspect intermediate/final admixtures (5.5%); mix incompatible electrolytes (phosphate-calcium, phosphate-magnesium, magnesium-calcium) (4.23%). Most relevant considered errors were related to incompatibilities/correct mixing of components, visual control, use of gloves and disinfection processes.Conclusion and relevanceEvaluation of PN compounding through a checklist containing the key elements allowed us to objectively detect errors and areas of improvement. Our study revealed a lack of training in compounding aspects, more than in aseptic technique, that was greater in those PT without experience. This study enabled us to implement a targeted training plan to improve staff qualifications and therefore quality/safety of PN.References and/or acknowledgementsConflict of interestNo conflict of interest
Improved prediction of the risk of major bleeding in patients with acute pulmonary embolism (
) receiving systemic thrombolysis is crucial to guide the choice of therapy.
The study included ...consecutive patients with acute PE who received systemic thrombolysis in the RIETE registry. We used multivariable logistic regression analysis to create a risk score to predict 30-day major bleeding episodes. We externally validated the risk score in patients from the COMMAND VTE registry. We also compared the newly created risk score against the Kuijer and RIETE scores.
Multivariable logistic regression identified four predictors for major bleeding: recent major
leeding (3 points),
ge >75 years (1 point), active
ancer (1 point), and
yncope (1 point) (
). Among 1172 patients receiving thrombolytic therapy in RIETE, 446 (38%) were classified as having low-risk (none of the variables present, 0 points) of major bleeding according to the BACS score, and the overall 30-day major bleeding rate of this group was 2.9% (95% CI, 1.6-4.9%), compared with 44% (95% CI, 14-79%) in the high-risk group (>3 points). In the validation cohort, 51% (149/290) of patients were classified as having low-risk, and the overall 30-day major bleeding rate of this group was 1.3%. In RIETE, the 30-day major bleeding event rates in the Kuijer and RIETE low-risk stratum were 5.3% and 4.4%, respectively.
The BACS score is an easily applicable aid for prediction of the risk of major bleeding in the population of PE patients who receive systemic thrombolysis.
Abstract Background and aims Dietary factors are critical for the prevention and treatment of hypertension, but data on the effects of specific nutrients on blood pressure (BP) are scarce. The aim of ...this study was to assess the relationship between total polyphenol excretion (TPE) in urine, as an objective measurement of total polyphenol intake and BP in an elderly population at high cardiovascular risk. Methods and results Cross-sectional substudy of 589 high-risk participants entering in the PREDIMED trial. BP was measured and TPE was determined in urine by Folin–Ciocalteu assay. A significant positive association was observed between TPE in urine and daily intake of fruit and vegetables (F&V), coffee or wine after adjusting for potential confounders. The intake of 100 g of F&V (Beta = 0.150; P < 0.001) had a greater contribution to TPE than 100 mL of coffee (Beta = 0.141; P = 0.001), and the latter two foods contributed more than the consumption of 100 mL of wine (Beta = 0.120; P = 0.019). An inverse association was observed between urinary TPE and the prevalence of hypertension. Participants in the highest quartile of urinary TPE had a reduced prevalence of hypertension compared to those in the lowest quartile (Odds Ratio = 0.64; 95% confidence interval 0.45 to 0.92; P = 0.015). Systolic and diastolic BP were inversely associated with urinary TPE after adjustment for potential confounders ( P = 0.024 and P = 0.003, respectively). Conclusions Polyphenol intake, assessed via TPE in urine, was negatively associated with BP levels and prevalence of hypertension in an elderly Mediterranean population at high cardiovascular risk. Participants with the highest intake of polyphenol-rich foods showed the lowest BP measurements.
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