Effectiveness of therapeutic heparin versus prophylactic heparin on death, mechanical ventilation, or intensive care unit admission in moderately ill patients with covid-19 admitted to hospital: RAPID randomised clinical trial.

OBJECTIVE: To evaluate the effects of therapeutic heparin compared with prophylactic heparin among moderately ill patients with covid-19 admitted to hospital wards. DESIGN: Randomised controlled, adaptive, open label clinical trial. SETTING: 28 hospitals in Brazil, Canada, Ireland, Saudi Arabia, United Arab Emirates, and US. PARTICIPANTS: 465 adults admitted to hospital wards with covid-19 and increased D-dimer levels were recruited between 29 May 2020 and 12 April 2021 and were randomly assigned to therapeutic dose heparin (n=228) or prophylactic dose heparin (n=237). INTERVENTIONS: Therapeutic dose or prophylactic dose heparin (low molecular weight or unfractionated heparin), to be continued until hospital discharge, day 28, or death. MAIN OUTCOME MEASURES: The primary outcome was a composite of death, invasive mechanical ventilation, non-invasive mechanical ventilation, or admission to an intensive care unit, assessed up to 28 days. The secondary outcomes included all cause death, the composite of all cause death or any mechanical ventilation, and venous thromboembolism. Safety outcomes included major bleeding. Outcomes were blindly adjudicated. RESULTS: The mean age of participants was 60 years; 264 (56.8%) were men and the mean body mass index was 30.3 kg/m2. At 28 days, the primary composite outcome had occurred in 37/228 patients (16.2%) assigned to therapeutic heparin and 52/237 (21.9%) assigned to prophylactic heparin (odds ratio 0.69, 95% confidence interval 0.43 to 1.10; P=0.12). Deaths occurred in four patients (1.8%) assigned to therapeutic heparin and 18 patients (7.6%) assigned to prophylactic heparin (0.22, 0.07 to 0.65; P=0.006). The composite of all cause death or any mechanical ventilation occurred in 23 patients (10.1%) assigned to therapeutic heparin and 38 (16.0%) assigned to prophylactic heparin (0.59, 0.34 to 1.02; P=0.06). Venous thromboembolism occurred in two patients (0.9%) assigned to therapeutic heparin and six (2.5%) assigned to prophylactic heparin (0.34, 0.07 to 1.71; P=0.19). Major bleeding occurred in two patients (0.9%) assigned to therapeutic heparin and four (1.7%) assigned to prophylactic heparin (0.52, 0.09 to 2.85; P=0.69). CONCLUSIONS: In moderately ill patients with covid-19 and increased D-dimer levels admitted to hospital wards, therapeutic heparin was not significantly associated with a reduction in the primary outcome but the odds of death at 28 days was decreased. The risk of major bleeding appeared low in this trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT04362085.

Heparin for Moderately Ill Patients with Covid-19.

BACKGROUND: Heparin, in addition to its anticoagulant properties, has anti-inflammatory and potential anti-viral effects, and may improve endothelial function in patients with Covid-19. Early initiation of therapeutic heparin could decrease the thrombo-inflammatory process, and reduce the risk of critical illness or death. METHODS: We randomly assigned moderately ill hospitalized ward patients admitted for Covid-19 with elevated D-dimer level to therapeutic or prophylactic heparin. The primary outcome was a composite of death, invasive mechanical ventilation, non-invasive mechanical ventilation or ICU admission. Safety outcomes included major bleeding. Analysis was by intention-to-treat. RESULTS: At 28 days, the primary composite outcome occurred in 37 of 228 patients (16.2%) assigned to therapeutic heparin, and 52 of 237 patients (21.9%) assigned to prophylactic heparin (odds ratio, 0.69; 95% confidence interval [CI], 0.43 to 1.10; p=0.12). Four patients (1.8%) assigned to therapeutic heparin died compared with 18 patients (7.6%) assigned to prophylactic heparin (odds ratio, 0.22; 95%-CI, 0.07 to 0.65). The composite of all-cause mortality or any mechanical ventilation occurred in 23 (10.1%) in the therapeutic heparin group and 38 (16.0%) in the prophylactic heparin group (odds ratio, 0.59; 95%-CI, 0.34 to 1.02). Major bleeding occurred in 2 patients (0.9%) with therapeutic heparin and 4 patients (1.7%) with prophylactic heparin (odds ratio, 0.52; 95%-CI, 0.09 to 2.85). CONCLUSIONS: In moderately ill ward patients with Covid-19 and elevated D-dimer level, therapeutic heparin did not significantly reduce the primary outcome but decreased the odds of death at 28 days. Trial registration numbers: NCT04362085 ; NCT04444700.

Music for anxiety reduction in patients undergoing cardiac catheterization: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Medical diagnostic procedures, such as cardiac catheterization, can cause significant patient anxiety. Patient anxiety can have negative implications for compliance with healthcare visits, medical tests, and treatments. Music interventions may have a role in reducing anxiety related to cardiac catheterization procedures. OBJECTIVE: To perform a comprehensive systematic review and meta-analysis evaluating whether musical interventions reduce anxiety in patients undergoing cardiac catheterization. DATA SOURCES: MEDLINE, EMBASE, CENTRAL, AMED, and PsychINFO from inception to May 2015. Reference lists of included articles were further hand searched for additional eligible studies. STUDY SELECTION: Randomized controlled trials evaluating the effectiveness of music interventions for anxiety reduction in patients undergoing cardiac catheterization. DATA EXTRACTION AND SYNTHESIS: Data on trial design, baseline characteristics and outcomes was extracted using a data extraction table. Study quality and risk of bias were assessed using the JADAD scale. MAIN OUTCOMES AND MEASURES: The main outcome was the effectiveness of music interventions in reducing anxiety in this patient population. Meta-analysis was pursued using data from studies that had used the Spielberger state anxiety inventory (STAI-S) to measure anxiety reduction. Other outcomes qualitatively reported include the use of anxiolytic medications and effect on physiological parameters such as blood pressure and heart rate. RESULTS: A total of 15 studies were found to be eligible for inclusion (14 published trials and one conference abstract) in this review. Two-thirds of these studies showed statistically significant reduction in measures of patient anxiety or well-being with musical interventions. Meta-analysis included six studies (n = 695) and showed statistically significant reduction in mean STAI-S scores with music (-3.95 points; 95% confidence -5.53 and -2.37; p value less than 0.005). CONCLUSION AND RELEVANCE: In conclusion, music is a safe and easily administered intervention that can be used for anxiety reduction among patients undergoing cardiac catheterization. Further research is needed to better evaluate the clinical implications associated with the anxiolytic effects of music interventions during cardiac catheterization.

Is the MAdrid Sonographic Enthesitis Index useful for differentiating psoriatic arthritis from psoriasis alone and healthy controls?

OBJECTIVE: To assess the usefulness of the MAdrid Sonographic Enthesitis Index (MASEI) in classifying patients as having psoriatic arthritis (PsA) and comparing entheseal abnormalities between patients with PsA, psoriasis alone (PsC), and healthy controls (HC). METHODS: Patients with PsC were assessed to exclude inflammatory arthritis. The MASEI scoring system was used to quantify the extent of ultrasonographic (US) entheseal abnormalities. The total MASEI score was categorized into items that reflected inflammatory abnormalities (MASEI-inflammatory) and chronic damage (MASEI-damage). Nonparametric tests were used to compare MASEI scores across the groups. A cutoff point of MASEI ≥ 20 was used to calculate the sensitivity and specificity of the MASEI to classify patients as having PsA. RESULTS: Patients with PsA (n = 50), PsC (n = 66), and HC (n = 60) were assessed. Total MASEI scores were higher in patients with PsA than in those with PsC, and both those groups were higher than HC (p < 0.0001). MASEI-inflammatory showed a similar trend (p < 0.0001). MASEI-damage was higher in patients with PsA compared to both patients with PsC and HC (p < 0.0001); however, no difference was observed between patients with PsC and HC. No significant difference in MASEI scores was found across the 3 groups in patients with a body mass index > 30. The sensitivity of the MASEI score to correctly classify patients as having PsA was 30% and the specificity was 95% when compared to HC and 89% when compared to PsC. CONCLUSION: The severity of US entheseal abnormalities is highest in patients with PsA followed by PsC and is lowest in healthy controls. MASEI can specifically classify patients as having PsA.

The burden of carotid artery plaques is higher in patients with psoriatic arthritis compared with those with psoriasis alone.

AIM: To compare the extent of atherosclerosis in patients with psoriatic arthritis (PsA) and patients with cutaneous psoriasis without arthritis (PsC). METHODS: In this cross-sectional study the authors compared patients with PsA with PsC patients. Psoriasis patients underwent a rheumatological assessment to exclude inflammatory arthritis. Ultrasonographic measurements of carotid total plaque area (TPA) and carotid intima-media thickness (cIMT) were performed. t Test was used to compare the imaging findings between the two groups. Multivariate linear regression analysis was used to assess the association between disease status and imaging findings after adjusting for potential confounders. RESULTS: Overall, 125 PsA and 114 PsC patients were compared. There were no significant differences in age, gender or cardiovascular risk factors between the two groups. Patients with PsA exhibited greater TPA than did PsC patients (TPA (square root of area in mm(2)) 3.33±3.34 vs 2.43±2.72, p=0.03). This difference remained statistically significant in the multivariate regression analysis after adjusting for potential confounders (p=0.03). The difference in cIMT between the groups did not achieve statistical significance (p=0.09). The following disease-related variables were associated with increase in TPA in multivariate regression analysis among PsA patients: duration of PsA (p=0.04), highest Psoriasis Area and Severity Index recorded in the first 3 years of follow-up (p=0.02) and erythrocyte sedimentation rate (p=0.005). CONCLUSIONS: PsA patients suffer from more severe subclinical atherosclerosis compared with patients with PsC. This difference is independent of traditional cardiovascular risk factors and correlates with PsA disease duration, more severe skin disease and increased inflammatory markers.

Serum adipokines in patients with psoriatic arthritis and psoriasis alone and their correlation with disease activity.

OBJECTIVE: To compare the prevalence of metabolic syndrome (MetS) and the levels of related biomarkers in patients with psoriatic arthritis (PsA) and psoriasis without arthritis (PsC). METHODS: This study compared patients with PsA and patients with PsC. The presence of MetS was determined. Serum levels of insulin, adiponectin and leptin were measured. The homeostasis model assessment for insulin resistance (HOMA-IR) was calculated. HOMA-IR, adiponectin and leptin were log-transformed. Continuous variables were compared using the t test and the χ(2) test was used for discrete variables. Multivariate regression models were used to investigate the association of MetS and adiponectin with PsA compared to PsC after adjusting for potential confounding variables. RESULTS: 203 PsA and 155 PsC patients were analysed. The prevalence of MetS was higher in PsA patients compared to those with PsC. However, this did not reach statistical significance (36.5% vs 27.1%, p=0.056). The levels of adipokines were significantly higher in PsA compared to PsC: adiponectin (8.8±5.2 vs 7.4±4.5 log (µg/ml), p=0.009) and leptin in women (3.1±0.8 vs 2.8±0.8, log (ng/ml), p=0.04). HOMA-IR was also higher in PsA (0.97±0.63 vs 0.68±0.81, p<0.001). No difference was observed in leptin levels in men. In multivariate regression analysis, PsA (p=0.04) and the psoriasis area and severity index score (p=0.02) were associated with MetS. Adiponectin was significantly associated with PsA (p=0.005), the use of anti-tumour necrosis factor α therapy (p=0.03) and active joint count (p=0.001). CONCLUSIONS: MetS and related adipokines correlated with an increased burden of skin and joint inflammation.