Significant Reduction In Overall Mortality Research Articles

Abstract 4138553: Sodium-Glucose Cotransporter-2 Inhibitors After Acute Myocardial Infarction: A Meta-analysis of Randomized Controlled Trials

Background: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) were initially developed to treat type 2 diabetes mellitus, but they have also shown benefits in mitigating cardiovascular risk. Given the increasing evidence of their efficacy in diverse disease states and their proposed mechanisms of action, it is plausible that SGLT2i could improve outcomes in patients with acute myocardial infarction (AMI) if administered early after presentation. However, the efficacy and safety of these therapies when used early in the course of acute coronary heart disease remain largely unexplored. Objective: The aim of this current study was to assess the benefit of early initiation of SGLT2i after AMI. Methods: We searched the Cochrane Central Registry of Controlled Trials, PubMed, Embase, Web of Science, and clinicalTrials.gov databases for all randomized controlled trials (RCTs) published up to May 2024 comparing SGLT2 inhibitors to placebo. The primary clinical endpoints included overall mortality, cardiovascular (CV) death, heart failure (HF) hospitalization, and adverse effects. Data were analyzed using a random-effects model to account for potential heterogeneity among the included studies. Significant heterogeneity was defined as an I-squared statistic ≥ 50%; a fixed-effects model was employed if heterogeneity was not significant. The odds ratio (OR) with a 95% confidence interval (CI) was calculated for each endpoint. Results: Four RCTs were included in the analysis, comprising 11,108 patients (SGLT2i, n = 5,561; placebo, n = 5,547) who enrolled with a mean age of 63±9 years and 77% males. SGLT2i were associated with a 28% reduction in risk of HF hospitalization (OR: 0.72 [95% CI, 0.59-0.88]; p = 0.001; I 2 = 0%). However, there was no significant reduction in overall mortality (OR: 1.01 [95% CI, 0.83-1.23]; p = 0.93; I 2 = 27%), CV mortality (OR: 1.04 [95% CI, 0.83-1.30]; p = 0.74; I 2 = 0%), and serious adverse effects (OR: 1.06 [95% CI, 0.87-1.28]; p = 0.59; I 2 = 62%). Conclusion: In patients with AMI, early initiation of SGLT2i was associated with a lower risk of HF hospitalization without increasing the incidence of serious adverse effects when compared to placebo. However, no significant difference was observed in overall mortality and CV deaths.

Efficacy and safety of dinutuximab in the management of high-risk neuroblastoma: A systematic review and meta-analysis.

e22000 Background: Neuroblastoma (NB) is a malignant tumor of the sympathetic nervous system that usually occurs in children below 5 years of age. High-risk neuroblastoma (HR-NB) has a poor prognosis despite a number of treatment strategies. Dinutuximab, an anti-GD2 monoclonal antibody, has been recently added to the standard of care due to its improved prognosis. We aimed to systematically assess the outcomes of HR-NB patients treated with dinutuximab and compare them with those on other treatment regimens. Methods: A comprehensive search strategy was used to search PubMed and the Cochrane Library for articles investigating the effect of dinutuximab on the outcomes of patients with HR-NB. Eligibility criteria included: 1) Diagnosis of HR-NB based on INRG and INSS staging and MYCN status 2) Dinutuximab as the primary agent used in the intervention group 3) Mean/median follow-up time greater than 6 months. Three investigators independently reviewed and extracted relevant articles. Any disagreements were addressed through consultation with other authors. The risk of bias assessment of the selected articles was conducted using the Cochrane Risk of Bias Tool for randomized controlled trials (RCTs) and the Newcastle-Ottawa scale for observational studies. Review Manager software was used to obtain and display the meta-analysis estimates in forest plots. Random effects models were used to calculate the mean difference and overall estimated effects for continuous variables. The primary outcomes were all-cause mortality and 5-year event-free survival (5-year-EFS). Results: Five studies, including two RCTs, two secondary analyses of clinical trials, and one retrospective cohort study, comprising 1,393 participants, were included in the analysis. 686 of the patients received dinutuximab, while the remaining 707 patients were assigned to other therapies as controls. Dinutuximab was associated with lower all-cause mortality as compared to control [pooled RR, 0.41; 95% CI, 0.22-0.75, P = 0.004, I2 = 31%]. 5-year-EFS was also greater for patients treated with dinutuximab [MD: 0.12; 95% CI, 0.09-0.16; P < 0.001, I2= 98%]. Conclusions: Our findings suggest that dinutuximab is linked to a significant reduction in overall mortality and a noteworthy improvement in the 5-Year-EFS for patients with HR-NB, when compared to other treatment options.

Balanced crystalloids versus isotonic saline in pediatric sepsis: a comprehensive systematic review and meta-analysis

Purpose We conducted a comprehensive meta-analysis to compare the effects of balanced crystalloids (BC) and isotonic saline (IS) in pediatric sepsis. Methods A systematic search was performed for studies comparing BC and IS in pediatric sepsis. Outcomes included mortality, acute kidney injury (AKI), need for renal replacement therapy (RRT), hospital length of stay (LOS), and pediatric intensive care unit (PICU) LOS. A random-effect models was used to calculated pooled odds ratios (OR) and mean differences (MD) with 95% confidence intervals (CIs). Results The analysis included six studies with 8753 children. BC demonstrated significant reductions in overall mortality (OR 0.84, 95% CI 0.71 to 0.98, P = 0.03, I2 = 0%) and AKI (OR 0.74, 95% CI 0.57 to 0.96, P = 0.03, I2 = 37%) compared to IS. RRT need was similar between the BC and IS groups (OR 0.79, 95% CI 0.60 to 1.02, P = 0.07, I2 = 0%). Hospital and PICU LOS did not differ significantly. However, subgroup analysis of randomized controlled trials revealed significantly shorter hospital LOS in the BC group (mean difference −0.66 days, 95% CI −1.10 to −0.23, P = 0.003, I2 = 0%). Conclusion Our meta-analysis demonstrates that using BC in pediatric sepsis is associated with reduced mortality, AKI, and hyperchloremia rates compared to IS, while maintaining similar hospital and PICU LOS. Large-scale randomized controlled trials are needed to validate these findings.

Efficacy of SGLT2 inhibitors for anthracycline-induced cardiotoxicity: a meta-analysis in cancer patients.

Aim: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) lower anthracycline-induced cardiotoxicity.Methods: PubMed and Google Scholar were searched until September 2023 for studies regarding SGLT2i for treating anthracycline-induced cardiotoxicity. Overall mortality and cardiovascular events were considered. Using a random-effects model, data pooled RR and HR at a 95% confidence interval (CI).Results: 3 cohort studies were identified, analyzing 2817 patients. Results display a significant reduction in overall mortality [RR=0.52 (0.33-0.82); p=0.005; I2= 32%], HF hospitalization [RR=0.20 (0.04-1.02); p=0.05; I2= 0%] and no significant reduction in HF incidence [RR=0.50 (0.20-1.16); p=0.11, I2= 0%].Conclusion: SGLT2i mitigates mortality and hospitalization due to heart failure, improving cancer patient's chances of survival by undergoing anthracycline treatment.

Fractional flow reserve versus angiography guided revascularization for patients with multivessel coronary artery disease: a systematic review and meta-analysis of randomized controlled trials

Abstract Background Recently published randomized controlled trials (RCT) have questioned the utility of Fraction Flow Reserve (FFR) to guide revascularization in patients with multivessel coronary artery disease (CAD) as compared to Angiography Purpose This current analysis aimed to compare the clinical outcomes associated with FFR guided versus standard angiography-guided revascularization for patients with multivessel CAD using a large number of randomized patients with stable CAD and acute coronary syndrome (ACS) Methods We conducted an electronic database search of all published data for RCT that compared FFR versus Angiography for patients with multivessel CAD and reported on subsequent mortality, cardiac death, myocardial infarction, revascularization, and other outcomes of interest. Event rates were compared using a forest plot of odds ratios using a fixed-effects model assuming interstudy heterogeneity. Results Eleven RCT (n=6052; FFR = 3043, Angiography = 3027) were included in the final analysis. Mean follow-up period was 1.7 years. In our analysis, FFR guided revascularization as compared to angiography guided revascularization alone was not associated with any significant reduction in overall mortality (OR = 1.10, 95% CI = 0.83–1.47, P=0.47, I2=0), cardiac mortality (OR = 0.95, 95% CI = 0.63–1.45, P=0.42, I2=0), all revascularization (OR = 0.96, 95% CI = 0.80–1.14, P=0.17, I2=31%) or myocardial infarction (OR = 0.99, 95% CI = 0.79–1.23, P=0.33, I2=12%). There was also no difference between two groups in terms of major adverse cardiac or cerebrovascular event [MACCE] (OR = 1.13, 95% CI = 0.90–1.42, P=0.39, I2=5%), major adverse cardiac event [MACE] (OR = 0.86, 95% CI = 0.70–1.07, P=0.55, I2=0), stroke/TIA (OR = 1.61, 95% CI = 0.92–2.82, P=0.36, I2=8%) or target lesion revascularization [TLR] (OR = 0.86, 95% CI = 0.44–1.67, P=0.71, I2=0). Furthermore, sensitivity analysis was conducted to include only studies with ACS patients and studies which used CABG only for revascularization. However, there was no difference between the two groups for any of the above outcomes Conclusion There is no difference in clinical outcomes in patients undergoing FFR-guided versus angiography guided revascularization for multivessel CAD Funding Acknowledgement Type of funding sources: None.

IV Vitamin C in Critically Ill Patients: A Systematic Review and Meta-Analysis.

To conduct a systematic review and meta-analysis to evaluate the impact of IV vitamin C on outcomes in critically ill patients. Systematic search of MEDLINE, EMBASE, CINAHL, and the Cochrane Register of Controlled Trials. Randomized controlled trials testing IV vitamin C in critically ill patients. Two independent reviewers abstracted patient characteristics, treatment details, and clinical outcomes. Fifteen studies involving 2,490 patients were identified. Compared with placebo, IV vitamin C administration is associated with a trend toward reduced overall mortality (relative risk, 0.87; 95% CI, 0.75-1.00; p = 0.06; test for heterogeneity I2 = 6%). High-dose IV vitamin C was associated with a significant reduction in overall mortality (relative risk, 0.70; 95% CI, 0.52-0.96; p = 0.03), whereas low-dose IV vitamin C had no effect (relative risk, 0.94; 95% CI, 0.79-1.07; p = 0.46; test for subgroup differences, p = 0.14). IV vitamin C monotherapy was associated with a significant reduction in overall mortality (relative risk, 0.64; 95% CI, 0.49-0.83; p = 0.006), whereas there was no effect with IV vitamin C combined therapy. No trial reported an increase in adverse events related to IV vitamin C. IV vitamin C administration appears safe and may be associated with a trend toward reduction in overall mortality. High-dose IV vitamin C monotherapy may be associated with improved overall mortality, and further randomized controlled trials are warranted.

Association of Intravenous Tranexamic Acid With Thromboembolic Events and Mortality

Tranexamic acid (TXA) is an efficient antifibrinolytic agent; however, concerns remain about the potential adverse effects, particularly vascular occlusive events, that may be associated with its use. To examine the association between intravenous TXA and total thromboembolic events (TEs) and mortality in patients of all ages and of any medical disciplines. Cochrane Central Register of Controlled Trials and MEDLINE were searched for eligible studies investigating intravenous TXA and postinterventional outcome published between 1976 and 2020. Randomized clinical trials comparing intravenous TXA with placebo/no treatment. The electronic database search yielded a total of 782 studies, and 381 were considered for full-text review. Included studies were published in English, German, French, and Spanish. Studies with only oral or topical tranexamic administration were excluded. Meta-analysis, subgroup and sensitivity analysis, and meta-regression were performed. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Vascular occlusive events and mortality. A total of 216 eligible trials including 125 550 patients were analyzed. Total TEs were found in 1020 (2.1%) in the group receiving TXA and 900 (2.0%) in the control group. This study found no association between TXA and risk for total TEs (risk difference = 0.001; 95% CI, -0.001 to 0.002; P = .49) for venous thrombosis, pulmonary embolism, venous TEs, myocardial infarction or ischemia, and cerebral infarction or ischemia. Sensitivity analysis using the risk ratio as an effect measure with (risk ratio = 1.02; 95% CI, 0.94-1.11; P = .56) and without (risk ratio = 1.03; 95% CI, 0.95-1.12; P = .52) studies with double-zero events revealed robust effect size estimates. Sensitivity analysis with studies judged at low risk for selection bias showed similar results. Administration of TXA was associated with a significant reduction in overall mortality and bleeding mortality but not with nonbleeding mortality. In addition, an increased risk for vascular occlusive events was not found in studies including patients with a history of thromboembolism. Comparison of studies with sample sizes of less than or equal to 99 (risk difference = 0.004; 95% CI, -0.006 to 0.014; P = .40), 100 to 999 (risk difference = 0.004; 95% CI, -0.003 to 0.011; P = .26), and greater than or equal to 1000 (risk difference = -0.001; 95% CI, -0.003 to 0.001; P = .44) showed no association between TXA and incidence of total TEs. Meta-regression of 143 intervention groups showed no association between TXA dosing and risk for venous TEs (risk difference, -0.005; 95% CI, -0.021 to 0.011; P = .53). Findings from this systematic review and meta-analysis of 216 studies suggested that intravenous TXA, irrespective of dosing, is not associated with increased risk of any TE. These results help clarify the incidence of adverse events associated with administration of intravenous TXA and suggest that TXA is safe for use with undetermined utility for patients receiving neurological care.

ОСОБЕННОСТИ СМЕРТНОСТИ В 2020 ГОДУ ЖИТЕЛЕЙ АЛТАЙСКОГО КРАЯ, ПОДВЕРГШИХСЯ РАДИАЦИОННОМУ ВОЗДЕЙСТВИЮ

In the Altai Territory, the Altai Medical Dosimetric Register is functioning, containing information on the health status of the inhabitants of the Territory exposed to radiation. The most numerous contingents are persons exposed to radiation as a result of nuclear tests at the Semipalatinsk testing area. The aim of the study is to obtain up-to-actual data on the health status of persons listed in the register. This research analyzed mortality rates for 2019 and 2020. Preliminary data for 2020 showed significant reductions in overall mortality and mortality from specific causes for the majority of the largest populations in the register.

Why Your Patients' Believing Hydroxychloroquine and Chloroquine Are 90% Effective for COVID-19 Is 100% Dangerous.

Why Your Patients' Believing Hydroxychloroquine and Chloroquine Are 90% Effective for COVID-19 Is 100% Dangerous.

Mitraclip Plus Medical Therapy Versus Medical Therapy Alone for Functional Mitral Regurgitation: A Meta-Analysis.

IntroductionThe purpose of this meta-analysis is to compare the efficacy of MitraClip plus medical therapy versus medical therapy alone in patients with functional mitral regurgitation (FMR). FMR caused by left ventricular dysfunction is associated with poor prognosis. Whether MitraClip improves clinical outcomes in this patient population remains controversial.MethodsWe conducted an electronic database search of PubMed, CINAHL, Cochrane Central, Scopus, Google Scholar, and Web of Science databases for randomized control trials (RCTs) and observational studies with propensity score matching (PSM) that compared MitraClip plus medical therapy with medical therapy alone for patients with FMR and reported on subsequent mortality, heart failure re-hospitalization, and other outcomes of interest. Event rates were compared using a random-effects model with odds ratio as the effect size.ResultsFive studies (n = 1513; MitraClip = 796, medical therapy = 717) were included in the final analysis. MitraClip plus medical therapy compared to medical therapy alone was associated with a significant reduction in overall mortality (OR = 0.66, 95% CI = 0.44–0.99, P = 0.04) and heart failure (HF) re-hospitalization rates (OR = 0.57, 95% CI = 0.36–0.91, P = 0.02). There was reduced need for heart transplantation or mechanical support requirement (OR = 0.48, 95% CI = 0.25–0.91, P = 0.02) and unplanned mitral valve surgery (OR = 0.21, 95% CI = 0.07–0.61, P = 0.004) in the MitraClip group. No effect was observed on cardiac mortality (P = 0.42) between the two groups.ConclusionsMitraClip plus medical therapy improves overall mortality and reduces HF re-hospitalization rates compared to medical therapy alone in patients with FMR.Electronic supplementary materialThe online version of this article (10.1007/s40119-019-00157-3) contains supplementary material, which is available to authorized users.

5 Conservative treatment for PAD - Risk factor management.

5 Conservative treatment for PAD - Risk factor management.

Extended Anticoagulation for VTE: A Systematic Review and Meta-Analysis

The efficacy and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) during extended anticoagulation for a VTE remains largely unknown, especially in terms of potential survival benefit. The goal of this study was to assess the effects of VKAs and DOACs on overall mortality and VTE-related mortality, as well as VTE recurrence and safety. PubMed, EMBASE, and the Cochrane Library were searched from January 1990 through September 2018 for randomized controlled trials evaluating the effect of extended anticoagulants as secondary prevention for VTE compared with placebo. The primary outcome was the specific effects of standard-intensity VKAs and DOACs on overall mortality. Sixteen studies (12,458 patients) were included. DOACs were associated with a reduction in overall (risk ratio [RR], 0.48; 95%CI, 0.27-0.86; P= .01) and VTE-related (RR, 0.36; 95%CI, 0.15-0.89; P= .03) mortality, whereas VKAs were not (P > .50). Although VKAs and DOACs similarly prevented recurrent VTE, only VKAs were associated with an increased risk of major bleeding (RR, 2.67; 95%CI, 1.28-5.60; P< .01), resulting in an improved net clinical benefit for DOACs (RR, 0.25 [95%CI, 0.16-0.39; P< .01] vs0.46 [95%CI, 0.30-0.72; P< .01]; Pinteraction= .05). DOACs for extended anticoagulation were associated with a significant reduction in overall mortality compared with observation alone. PROSPERO; No.: CRD42018088739; URL: https://www.crd.york.ac.uk/prospero/.

Trends in the utilization of radiotherapy for spinal meningiomas: insights from the 2004-2015 National Cancer Database.

OBJECTIVERecent studies have reported on the utility of radiosurgery for local control and symptom relief in spinal meningioma. The authors sought to evaluate national utilization trends in radiotherapy (including radiosurgery), investigate possible factors associated with its use in patients with spinal meningioma, and its impact on survival for atypical tumors.METHODSUsing the ICD-O-3 topographical codes C70.1, C72.0, and C72.1 and histological codes 9530-9535 and 9537-9539, the authors queried the National Cancer Database for patients in whom spinal meningioma had been diagnosed between 2004 and 2015. Patients who had undergone radiation in addition to surgery and those who had received radiation as the only treatment were analyzed for factors associated with each treatment.RESULTSFrom among 10,458 patients with spinal meningioma in the database, the authors found a total of 268 patients who had received any type of radiation. The patients were divided into two main groups for the analysis of radiation alone (137 [51.1%]) and radiation plus surgery (131 [48.9%]). An age > 69 years (p < 0.001), male sex (p = 0.03), and tumor size 5 to < 6 cm (p < 0.001) were found to be associated with significantly higher odds of receiving radiation alone, whereas a Charlson-Deyo Comorbidity Index ≥ 2 (p = 0.01) was associated with significantly lower odds of receiving radiation alone. Moreover, a larger tumor size (2 to < 3 cm, p = 0.01; 3 to < 4 cm, p < 0.001; 4 to < 5 cm, p < 0.001; 5 to < 6 cm, p < 0.001; and ≥ 6 cm, p < 0.001; reference = 1 to < 2 cm), as well as borderline (p < 0.001) and malignant (p < 0.001) tumors were found to be associated with increased odds of undergoing radiation in addition to surgery. Receiving adjuvant radiation conferred a significant reduction in overall mortality among patients with borderline or malignant spinal meningiomas (HR 2.12, 95% CI 1.02-4.1, p = 0.02).CONCLUSIONSThe current analysis of cases from a national cancer database revealed a small increase in the use of radiation for the management of spinal meningioma without a significant increase in overall survival. Larger tumor size and borderline or malignant behavior were found to be associated with increased radiation use. Data in the present analysis failed to show an overall survival benefit in utilizing adjuvant radiation for atypical tumors.

Quality of care and survival of women with uterine cancer by Hispanic origin: An NCDB analysis.

e17120 Background: In cancer research in the US, Hispanic patients are often analyzed as a homogeneous group despite significant diversity within this ethnic classification. Our objective was to assess the impact of place of origin on quality of care and overall survival for Hispanic women with uterine cancer living in the US. Methods: The National Cancer Database (NCDB) was used to identify all patients with uterine cancer from 2004-2015. Hispanic origin was classified based on NCDB subgroups: Mexican, Puerto Rican, Cuban, South or Central American, and Dominican Republic. Multivariable models were used to assess the adjusted relative risk (aRR) of receiving quality of care indicators. Thirty-day mortality and overall 5-year survival were calculated using multivariable log-Poisson and Cox proportional Hazard models. Results: A total of 5,411 Hispanic women and 288,111 non-Hispanic women were identified. Of Hispanic women, Mexican patients comprised the largest subgroup (n = 2,512), and increased from 34.5% to 49.7% over the study period. South or Central American (n = 1,217) and Dominican (n = 218) patients also increased modestly, while the volume of Puerto Rican patients remained unchanged (n = 877), and Cuban patients decreased from 23.3% to 5.6% (n = 587). Compared to non-Hispanic women, there were no significant differences in the rates of use of minimally invasive surgery, chemotherapy in early stage high risk disease, lymph node dissection, or 30-day readmission among the Hispanic subpopulations. Rates of chemotherapy for advanced stage disease were modestly increased for Dominican (aRR 1.37, 95%CI (1.23-1.54)) and South or Central American (aRR 1.16, 95%CI (1.05,1.29)) groups. Dominican patients had a statistically significant reduction in overall mortality at five years for stage III and IV disease with aHR 0.38, 95%CI (0.16-0.90) and aHR 0.28, 95%CI (0.09, 0.87), respectively. For all other Hispanic subgroups, there were no differences in stage-specific survival. Conclusions: The diversity within the Hispanic cohort of women with uterine cancer in NCDB is changing. Overall quality indicators and survival outcomes are comparable between each Hispanic origin group, with the exception of advanced stage Dominican women who are more likely to receive chemotherapy, and have superior survival outcomes.

Overall mortality in men and women in the randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

Objective To assess the secondary outcome of overall mortality in the randomized Prostate, Lung, Colorectal, and Ovarian cancer screening trial. Methods In the Prostate, Lung, Colorectal, and Ovarian trial, subjects were randomized to usual care or intervention. In the intervention arm, men and women received annual chest radiographs and two sigmoidoscopy exams. Men also received annual prostate-specific antigen tests and digital rectal exams, and women also received annual CA125 tests and trans-vaginal ultrasounds. Poisson regression and Cox proportional hazards models were used to assess differences across trial arms in overall mortality and overall mortality excluding deaths from trial cancers (OMEX). Due to slight age imbalances in later trial years, age-adjusted rate ratios and hazard ratios were computed. Results There were 76,678 men and 78,209 women randomized, with median follow-up of 17 years. In men there was a significant reduction in both overall mortality (age-adjusted rate ratio = 0.966; 95% CI: 0.943–0.989; p = 0.004) and OMEX (age-adjusted rate ratio = 0.970, 95% CI: 0.946–0.995; p = 0.02) in the intervention versus usual care arm. In women, no reduction was seen in either overall mortality (age-adjusted rate ratio = 1.002) or OMEX (age-adjusted rate ratio = 1.006). In both sexes combined, there was a significant reduction in overall mortality (age-adjusted rate ratio = 0.980; 95% CI: 0.963–0.999; p = 0.036) but not OMEX (age-adjusted rate ratio = 0.985; 95% CI: 0.965–1.004; p = 0.13). Results were similar using age-adjusted hazard ratios. Conclusion In the Prostate, Lung, Colorectal, and Ovarian trial, there was a small but significant reduction in overall mortality in men, and in both sexes combined, and a small but significant reduction in overall mortality excluding trial cancer deaths in men.

PO-052 Selenium status and survival from colorectal cancer in the european prospective investigation of cancer and nutrition

IntroductionSuboptimal levels of selenium (Se) or selenoprotein P (SELENOP), which is an antioxidant protein that also distributes Se from the liver to target tissues, may contribute to risk of colorectal cancer (CRC) development, as we previously showed using serum samples taken pre-diagnostically in the European Prospective Investigation into Cancer and Nutrition (EPIC) cohortHughes et al, 2015 Int J Cancer 136: 1149–61). However, the relationship between Se and survival outcomes following cancer diagnosis is more uncertain. Here, we examined the association of Se status with mortality from CRC and overall mortality in the same study group.Material and methodsSe was measured by reflection X-ray fluorescence spectrometry and SELENOP by immunoluminometric sandwich assay. Multivariable adjusted Cox proportional hazard models were used to calculate the hazard ratio (HR) and 95% confidence interval (CI) of the association between Se and SELENOP and CRC-death and all-cause mortality.Results and discussionsHigher levels of Se showed non-significant inverse associations with reduction in both CRC and overall mortality: Respective multivariable adjusted HRs for the fifth quintile versus the first quintile (HRQ5 vs. Q1) were 0.76 (95% CI: 0.52–1.11, Ptrend=0.10), and 0.82 (95% CI: 0.56–1.16, Ptrend=0.14). Higher levels of SELENOP were also not associated with a statistically significant reduction in CRC mortality (HRQ5 vs. Q1 = 0.83, 95% CI: 0.57–1.19, Ptrend=0.33). However, higher SELENOP concentrations were associated with a significant reduction in overall mortality (HRQ5 vs. Q1 = 0.70, 95% CI: 0.50–0.98, Ptrend=0.05). Similar results were also obtained by tumour site and sex. Possible interactions of potential effect modifiers and sensitivity analyses showed no considerable change in these estimates, although CRC stage data sensitivity analyses were significant for the association between Se and overall mortality (HRQ5 vs. Q1 = 0.89, 95% CI: 0.80–0.99, Ptrend=0.03).ConclusionWe found no major association of Se status markers with survival after CRC diagnosis, but an association of SELENOP with overall mortality. Detailed investigation of Se metabolism is needed to further explore relevance for CRC prognosis especially for individuals of suboptimal SELENOP status.

Selenium status and survival from colorectal cancer in the European prospective investigation of cancer and nutrition

Introduction Suboptimal levels of selenium (Se) or selenoprotein P (SELENOP), which is an antioxidant protein that also distributes Se from the liver to target tissues, may contribute to risk of colorectal cancer (CRC) development, as we previously showed using serum samples taken pre-diagnostically in the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort [1] . However, the relationship between Se and survival outcomes following cancer diagnosis is more uncertain. Here, we examined the association of Se status with mortality from CRC and overall mortality in the same study group. Methods Se was measured by total reflection X-ray fluorescence and SELENOP by immunoluminometric sandwich assay. Multivariable-adjusted Cox proportional hazard models were used to calculate the hazard ratio (HR) and 95% confidence interval (CI) of the association between Se and SELENOP and CRC death and all-cause mortality. Results Higher levels of Se showed non-significant inverse associations with reduction in both CRC and overall mortality: respective multivariable-adjusted HRs for the fifth quintile versus the first quintile (HRQ5 vs. Q1) were 0.76 (95% CI: 0.52–1.11, Ptrend = 0.10), and 0.82 (95% CI: 0.56–1.16, Ptrend = 0.14). Higher levels of SELENOP were also not associated with a statistically significant reduction in CRC mortality (HRQ5 vs. Q1 = 0.83, 95% CI: 0.57–1.19, Ptrend = 0.33). However, higher SELENOP concentrations were associated with a significant reduction in overall mortality (HRQ5 vs. Q1 = 0.70, 95% CI: 0.50–0.98, Ptrend = 0.05). Similar results were also obtained by tumour site and sex. Possible interactions of potential effect modifiers and sensitivity analyses showed no considerable change in these estimates, although CRC stage data sensitivity analyses were significant for the association between Se and overall mortality (HRQ5 vs. Q1 = 0.89, 95% CI: 0.80–0.99, Ptrend = 0.03). Conclusions We found no major association of Se status markers with survival after CRC diagnosis, but an association of SELENOP with overall mortality. Detailed investigation of Se metabolism is needed to further explore relevance for CRC prognosis especially for individuals of suboptimal SELENOP status.

Coaching Patients Saves Lives and Money

BackgroundThe Coaching On Achieving Cardiovascular Health (COACH) Program has been proven to improve biomedical and lifestyle cardiovascular disease (CVD) risk factors. The objective of this study was to evaluate the long-term impact of The COACH Program on overall survival, hospital utilization, and costs from the perspective of a private health insurer (payor), in patients with CVD. MethodsA prospective parallel-group case-control study design with controls randomly matched to patients based on propensity score. There were 512 participants with CVD engaged in a structured disease management program of 6 months duration (The COACH Program) who were matched to 512 patients with CVD who were allocated to the control group. The independent variables that estimated the propensity score were preprogram hospital admissions, age, and sex. The primary outcome was overall survival with secondary outcomes, including hospital utilization and cost incurred by the private health insurer. Mean follow-up was 6.35 years. Difference in overall survival between the 2 groups was estimated using a Cox proportional hazard ratio (HR) with difference in total cost estimated using a generalized linear model. ResultsThe COACH Program achieved a significant reduction in overall mortality (HR 0.70; 95% confidence interval [CI], 0.53-0.93; P = .014). There was an apparent dose-response effect: those who received up to 3 coaching sessions had no decrease in mortality (HR 1.02; 95% CI, 0.69-1.49; P = .926); those who received 4 or more coaching sessions had a substantial decrease in mortality (HR 0.58; 95% CI, 0.42-0.81; P = .001). Total cost to the health insurer was substantially lower in the intervention group ($12,707 per person lower; P = .078). The reduction in total cost was significantly greater in those who received 4 or more sessions ($19,418 per person; P = .006) and in males ($18,947 per person; P = .029). ConclusionsThose enrolled in The COACH program achieved a statistically significant decrease in overall mortality compared with usual care at 6.35 years. A substantive reduction in hospital costs was also observed among those who received The COACH program compared with those who did not, particularly in those who received 4 or more sessions and in males.

Risk and Benefits of Triple Therapy in Patients Undergoing Coronary Stent Implantation Requiring Oral Anticoagulation: A Meta-Analysis of 16 Studies.

Patients with coronary artery disease who undergo stent implantation and have concomitant indication for long-term oral anticoagulation represent a considerable proportion of the overall population. To date there is still no consensus about the optimal antithrombotic strategy to choose in this kind of patients, due to the difficult balance between an increased risk of bleeding and thromboembolic complications. Therefore, the aim of this study was to perform a meta-analysis to evaluate the risk and benefits of triple antithrombotic therapy versus dual antithrombotic therapy in patients undergoing coronary stent implantation, requiring long-term oral anticoagulation. We performed formal searches of PubMed, EMBASE, Cochrane central register of controlled trials and major international scientific session abstracts from January 1990 to September 2015 regarding the use of triple antithrombotic therapy (TT) versus dual therapy (DT) in patients undergoing percutaneous coronary stent implantation that required chronic oral anticoagulation. Data regarding study design, inclusion/exclusion criteria, number of patients, and selected endpoints was extracted by 2 investigators. Disagreements were resolved by consensus. Sixteen trials with a total of 21716 patients undergoing coronary stent implantation with indication to long term oral anticoagulation, were finally included. A total of 6950 received TT, whereas 14766 received DT alone. The follow-up period ranged from 180 to 730days. Data regarding mortality were available in 21658 patients (99.7%). All cause mortality was observed in 10.4% patients in TT versus 16.3% in DT (OR [95% CI] =0.73 [0.66-0.80], p <0.001; p het <0.001). In addition, TT was associated with a reduced incidence of MI (6.4 versus 9.8%, OR [95% CI] = 0.74 [0.65-0.84], p < 0.001; phet < 0.001) and ischemic stroke (1.8 versus 3.9%, OR [95% CI] = 0.55 [0.45-0.68], p < 0.001; p het = 0.07). As expected, TT was associated with a significant increase in major bleeding events (10.8 versus 8.5%, OR [95% CI] = 1.38 [1.25-1.53], p < 0.001; p het = 0.02). By meta regression analysis we found that benefits in mortality with TT were inversely related with the risk of bleedings (beta [95% CI] = 2.25 (1.55; 2.95), p < 0.00001). The benefits with TT regarding overall mortality, recurrent MI and ischemic stroke were also confirmed in a pre-specified analysis versus DAPT or oral anticoagulation in association with a single antiplatelet agent. This meta-analysis showed that among patients undergoing coronary stent implantation, requiring chronic OAC, the use of a TT is associated with a significant reduction in overall mortality, recurrent MI and ischemic stroke. As expected, we found a higher incidence of bleedings in patients treated with triple therapy. The benefits in mortality were lost in patients at high-risk for bleedings.

N-3 fatty acid-based parenteral nutrition improves postoperative recovery for cirrhotic patients with liver cancer: A randomized controlled clinical trial

A new lipid emulsion enriched in n-3 fatty acid has been reported to prevent hepatic inflammation in patients following major surgery. However, the role of n-3 fatty acid-based parenteral nutrition for postoperative patients with cirrhosis-related liver cancer is unclear. We investigated the safety and efficacy of n-3 fatty acid-based parenteral nutrition for cirrhotic patients with liver cancer followed hepatectomy. A prospective randomized controlled clinical trial (Registered under ClinicalTrials.gov Identifier no. NCT02321202) was conducted for cirrhotic patients with liver cancer that underwent hepatectomy between March 2010 and September 2013 in our institution. We compared isonitrogenous total parenteral nutrition with 20% Structolipid and 10% n-3 fatty acid (Omegaven, Fresenius-Kabi, Germany) (treatment group) to Structolipid alone (control group) for five days postoperatively, in the absence of enteral nutrition. We enrolled 320 patients, and 312 (97.5%) were included in analysis (155 in the control group and 157 in the treatment group). There was a significant reduction of morbidity and mortality in the treatment group, when compared with the control group (total complications 78 [50.32%] vs. 46 [29.30%]; P<0.001, total infective complications, 30 [19.35%] vs. 15 [9.55%]; P=0.014), overall mortality (5 [3.23%] vs. 1 [0.64%]; P=0.210), and hospital stay (12.56±3.21d vs. 10.17±3.15d; P=0.018). We found that addition of n-3 fatty acid-based parenteral nutrition significantly improved postoperative recovery for cirrhotic patients with liver cancer following hepatectomy, with a significant reduction in overall mortality and length of hospital stay.