Impact of smoking in patients with suspected coronary artery disease in the randomised DISCHARGE trial.

OBJECTIVES: To investigate if the effect of cardiac computed tomography (CT) vs. invasive coronary angiography (ICA) on cardiovascular events differs based on smoking status. MATERIALS AND METHODS: This pre-specified subgroup analysis of the pragmatic, prospective, multicentre, randomised DISCHARGE trial (NCT02400229) involved 3561 patients with suspected coronary artery disease (CAD). The primary endpoint was major adverse cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, or stroke). Secondary endpoints included an expanded MACE composite (MACE, transient ischaemic attack, or major procedure-related complications). RESULTS: Of 3445 randomised patients with smoking data (mean age 59.1 years + / - 9.7, 1151 men), at 3.5-year follow-up, the effect of CT vs. ICA on MACE was consistent across smoking groups (p for interaction = 0.98). The percutaneous coronary intervention rate was significantly lower with a CT-first strategy in smokers and former smokers (p = 0.01 for both). A CT-first strategy reduced the hazard of major procedure-related complications (HR: 0.21, 95% CI: 0.03, 0.81; p = 0.045) across smoking groups. In current smokers, the expanded MACE composite was lower in the CT- compared to the ICA-first strategy (2.3% (8) vs 6.0% (18), HR: 0.38; 95% CI: 0.17, 0.88). The rate of non-obstructive CAD was significantly higher in all three smoking groups in the CT-first strategy. CONCLUSION: For patients with stable chest pain referred for ICA, the clinical outcomes of CT were consistent across smoking status. The CT-first approach led to a higher detection rate of non-obstructive CAD and fewer major procedure-related complications in smokers. CLINICAL RELEVANCE STATEMENT: This pre-specified sub-analysis of the DISCHARGE trial confirms that a CT-first strategy in patients with stable chest pain referred for invasive coronary angiography with an intermediate pre-test probability of coronary artery disease is as effective as and safer than invasive coronary angiography, irrespective of smoking status. TRIAL REGISTRATION: ClinicalTrials.gov NCT02400229. KEY POINTS: • No randomised studies have assessed smoking status on CT effectiveness in symptomatic patients referred for invasive coronary angiography. • A CT-first strategy results in comparable adverse events, fewer complications, and increased coronary artery disease detection, irrespective of smoking status. • A CT-first strategy is safe and effective for stable chest pain patients with intermediate pre-test probability for CAD, including never smokers.

Malnutrition predicts long-term survival in hospitalized patients with gastroenterological and hepatological diseases.

BACKGROUND & AIMS: Malnutrition is a common problem in hospitalized patients, influencing treatment outcomes, length of hospital stay, quality of life and overall survival. However, the association of nutritional status parameters with long-term mortality has not yet been studied systematically in gastroenterological-hepatological patients. The present study aimed to assess the association between nutritional status parameters as characterized by Nutritional Risk Screening (NRS), anthropometry, serum transferrin, bioelectrical impedance analysis (BIA) and long-term overall survival in hospitalized gastroenterological-hepatological patients. METHODS: Nutritional status was assessed in 644 gastroenterological-hepatological patients by NRS score. In addition, body mass index (BMI) and serum transferrin were determined and BIA was performed. Mid-upper arm circumference (MUAC) and triceps skinfold thickness (TST) were measured. Patients were followed for a mean period of 67 months (mean 54.8, range 0-107 months). RESULTS: During malnutrition screening, 475 (73.8%) patients were diagnosed as sufficiently nourished by NRS (NRS 0-2), while an increased risk of malnutrition was found in 169 (26.2%) patients (NRS≤3). Malnutrition was significantly associated with less favourable results for BMI (p < 0.001), serum transferrin (p < 0.001), BIA (p < 0.001), MUAC (p < 0.001) and TST (p < 0.05). Overall 5-year survival rates (YSR) were much shorter in malnourished patients whether with (5-YSR: 43.9%) or without (73.6%) malignancy. Overall 5-year survival rates (YSR) were much shorter in malnourished patients whether with (5-YSR: 43.9%) or without (73.6%) malignancy. By the multivariable analysis the NRS ≥3 and, phase angle (PhA) over the 5th percentile or over the mean of the cohort were found to be associated with long-term survival. CONCLUSIONS: Malnutrition is highly prevalent in hospitalized gastroenterological-hepatological patients and is associated with distinct clinical diagnoses. In the present study we demonstrated that malnutrition characterized by the NRS, anthropometry, serum transferrin and BIA, not only predicts short-term but also significantly poor long-term outcome in these patients.

Age and distress of women--results of a representative population-based study.

Little research has been carried out on prevalence rates of distress (e.g. depression, posttraumatic stress symptoms (PTSS), hopelessness, and burnout) of women in different age groups. The aims of this study were to measure the prevalence rate of depression, posttraumatic stress symptoms, hopelessness, and burnout among women and to clarify the associations between age groups and distress. Cross sectional epidemiological study on women in Sweden (n = 6,000, aged 18-64 years, response rate 64.1%). Measures were questionnaires on socio-economic and work-related characteristics and on depression, posttraumatic stress symptoms, hopelessness, and burnout. Depression was measured with the "General Health Questionnaire" (GHQ), PTSS with the "Posttraumatic Symptom Scale", hopelessness with the "Hopelessness Scale" and burnout with the "Shiron-Melamed Burnout Questionnaire" (SMBQ). The prevalence rate of depression varied from 12.5% to 14.1%; of posttraumatic stress symptoms from 23.5% to 33.3%; of hopelessness from 11.5% to 16%; and of burnout from 22.9% to 17.1%. Depression was not associated with age group. Hopelessness was associated with age group in univariate analysis bur not in multivariate analysis (OR = 0.7, 95% CI = 0.5-1.0). PTSS and burnout were associated with age group. Both symptoms were higher in the youngest age group, compared to the eldest age group (posttraumatic stress symptoms: OR = 1.6, 95% CI = 1.2, 2.1; burnout: OR = 1.5, 95% CI = 1.1-2.1). Younger women show higher prevalence rates of PTSS and burnout compared to elder women. The higher prevalence rates of PTSS and burnout among younger women may be associated with job strain and/or with violent life events.

Bypass materials in vascular surgery.

INTRODUCTION: Arteriosclerotic changes can lead to circulatory disturbances in various areas of the human vascular system. In addition to pharmacological therapy and the management of risk factors (e. g. hypertension, diabetes, lipid metabolism disorders, and lifestyle), surgical interventions also play an important role in the treatment of arteriosclerosis. Long-segment arterial occlusions, in particular, can be treated successfully with bypass sur-gery. A number of different materials are available for this type of operation, such as autologous vein or pros-thetic grafts comprised of polytetrafluoroethylene (PTFE) or Dacron(®). Prosthetic materials are used especially in the treatment of peripheral artery disease, such as in aortoiliac or femoropopliteal bypass surgery. The present report will thus focus on this area in order to examine the effectiveness of different bypass materials. Among the efforts being made to refine the newly introduced DRG system in Germany, analysing the different bypass materials used in vascular surgery is particularly important. Indeed, in its current version the German DRG system does not distinguish between bypass materials in terms of reimbursement rates. Differences in cost structures are thus of especial interest to hospitals in their budget calculations, whereas both private and statutory health insurance funds are primarily interested in long-term results and their costs. OBJECTIVES: The goal of this HTA is to compare the different bypass materials used in vascular surgery in terms of their medical efficiency and cost-effectiveness, as well as with regard to their ethical, social and legal implications. In addition, this report aims to point out the areas in which further medical, epidemiological and health economic research is still needed. METHODS: Relevant publications were identified by means of a structured search of databases accessed through the German Institute of Medical Documentation and Information (DIMDI), as well as by a manual search. The for-mer included the following electronic resources: SOMED (SM78), Cochrane Library - Central (CCTR93), MEDLINE Alert (ME0A), MEDLINE (ME95), CATFILEplus (CATLINE) (CA66), ETHMED (ED93), GeroLit (GE79), HECLINET (HN69), AMED (CB85), CAB Abstracts (CV72), GLOBAL Health (AZ72), IPA (IA70), El-sevier BIOBASE (EB94), BIOSIS Previews (BA93), EMBASE (EM95), EMBASE Alert (EA08), SciSearch (IS90), Cochrane Library - CDSR (CDSR93), NHS-CRD-DARE (CDAR94), NHS-CRD-HTA (INAHTA), and NHS-EED (NHSEED). The present report included German and English literature published between the years 1999 and 2004. A list of the search parameters can be found in the appendix. No limits were placed on the target population, and the methodical quality of the included studies was determined using standardised checklists. RESULTS: THE STUDIES INCLUDED IN THIS HEALTH TECHNOLOGY ASSESSMENT COMPARED THE FOLLOWING BYPASS MATERIALS: autologous vein, human umbilical vein (HUV) and synthetic materials such as PTFE or Dacron(®). Both the systematic reviews and the randomised controlled trials comparing autologous vein grafts to other bypass materials come to the conclusion that autologous vein is superior to all other materials. From a medical viewpoint, there are no clear differences between the various synthetic materials. To date, the subject of bypass materials in vascular surgery has not been addressed comprehensively from an economic point of view. Indeed, we were able to identify only one publication that compared the cost of various bypass materials. The remaining health economic studies did not compare costs, cost effectiveness, or quality of life associated with the use of various bypass materials. DISCUSSION: When deciding which bypass material to use, vascular surgeons take a number of medical considerations into account, including the bypass area, the availability of autologous vein, the amount of operation time available, and the health status of the patient. The studies included in this health technology assessment demonstrate that autologous vein is usually the preferred material for bypass grafts. In contrast, comparisons of various synthetic materials did not show any specific differences. It remains to be seen whether studies on newly developed synthetic materials will show these to have any particular advantages. The randomised controlled trials included in the present report were limited by a number of methodological weaknesses, such as different methods for determining patency rates, sample size and power problems, the interpretation of non-significant results, and a lack of consideration of additional factors. From an economic point of view, there is still great need for further research, and we have attempted to describe a number of pressing questions for health economic studies in the present report.