Clinical impact of gastrointestinal bleeding in patients undergoing percutaneous coronary interventions.

BACKGROUND The risk factors and clinical sequelae of gastrointestinal bleeding (GIB) in the current era of drug-eluting stents, prolonged dual antiplatelet therapy, and potent P2Y12 inhibitors are not well established. We determined the frequency, predictors, and clinical impact of GIB after percutaneous coronary interventions (PCIs) in a contemporary cohort of consecutive patients treated with unrestricted use of drug-eluting stents. METHODS AND RESULTS Between 2009 and 2012, all consecutive patients undergoing PCI were prospectively included in the Bern PCI Registry. Bleeding Academic Research Consortium (BARC) GIB and cardiovascular outcomes were recorded within 1 year of follow-up. Among 6212 patients, 84.1% received new-generation drug-eluting stents and 19.5% received prasugrel. At 1 year, GIB had occurred in 65 patients (1.04%); 70.8% of all events and 84.4% of BARC ≥3B events were recorded >30 days after PCI. The majority of events (64.4%) were related to upper GIB with a more delayed time course compared with lower GIB. Increasing age, previous GIB, history of malignancy, smoking, and triple antithrombotic therapy (ie, oral anticoagulation plus dual antiplatelet therapy) were independent predictors of GIB in multivariable analysis. GIB was associated with increased all-cause mortality (adjusted hazard ratio, 3.40; 95% confidence interval, 1.67-6.92; P=0.001) and the composite of death, myocardial infarction, or stroke (adjusted hazard ratio, 3.75; 95% confidence interval, 1.99-7.07; P<0.001) and was an independent predictor of all-cause mortality during 1 year. CONCLUSIONS Among unselected patients undergoing PCI, GIB has a profound effect on prognosis. Triple antithrombotic therapy emerged as the single drug-related predictor of GIB in addition to patient-related risk factors within 1 year of PCI. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT02241291.

Age- and Gender-related Disparities in Primary Percutaneous Coronary Interventions for Acute ST-segment elevation Myocardial Infarction.

BACKGROUND Previous analyses reported age- and gender-related differences in the provision of cardiac care. The objective of the study was to compare circadian disparities in the delivery of primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) according to the patient's age and gender. METHODS We investigated patients included into the Acute Myocardial Infarction in Switzerland (AMIS) registry presenting to one of 11 centers in Switzerland providing primary PCI around the clock, and stratified patients according to gender and age. FINDINGS A total of 4723 patients presented with AMI between 2005 and 2010; 1319 (28%) were women and 2172 (54%) were ≥65 years of age. More than 90% of patients <65 years of age underwent primary PCI without differences between gender. Elderly patients and particularly women were at increased risk of being withheld primary PCI (males adj. HR 4.91, 95% CI 3.93-6.13; females adj. HR 9.31, 95% CI 7.37-11.75) as compared to males <65 years of age. An increased risk of a delay in door-to-balloon time >90 minutes was found in elderly males (adj HR 1.66 (95% CI 1.40-1.95), p<0.001) and females (adj HR 1.57 (95% CI 1.27-1.93), p<0.001), as well as in females <65 years (adj HR 1.47 (95% CI 1.13-1.91), p = 0.004) as compared to males <65 years of age, with significant differences in circadian patterns during on- and off-duty hours. CONCLUSIONS In a cohort of patients with AMI in Switzerland, we observed discrimination of elderly patients and females in the circadian provision of primary PCI.

Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary.

The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.

The American Myth of Markets in Social Policy: Ideological Roots of Inequality

The American Myth of Markets in Social Policy examines how implementing American tropes in policy design inadvertently frustrates policy goals. It investigates multiple market-oriented designs including funding for private organizations to deliver public services, funding for individuals to buy services, and policies incentivizing or mandating private actors to provide social policy. The author shows that these solutions often not only fail to achieve social goals, but, in fact, actively undermine them, for example saddling the poor with debt or encouraging discrimination. The book carefully details the mechanisms through which this occurs, for example a mismatch between program goals and either contract terms or individual preferences. The author examines several policies in depth, covering universal social insurance programs like healthcare and pensions, as well as smaller interventions like programs for the homeless. The author builds the argument using detailed empirical evidence as well as anecdote, keeping the book accessible and entertaining.

Social exclusion and shame in obesity

Weight bias often results in the social exclusion of individuals with obesity. The direct, short-term psychological effects of social exclusion in obesity have not been investigated yet. This study experimentally tests whether social exclusion elicits stronger negative emotions in individuals with obesity compared to normal-weight controls. Specifically, we test whether social exclusion has a specific impact on shame. In total, N = 299 individuals (n = 130 with body mass index [BMI] ≤ 30 and n = 169 with BMI N 30) were randomly assigned to a social exclusion condition or a control condition that was implemented with an online Cyberball paradigm. Before and after, they filled out questionnaires assessing state emotionality. Social exclusion increased negative emotionality in both groups compared to the control condition (p b 0.001) according to a multivariate ANOVA. However, the interaction of group and social exclusion was also significant (p = 0.035) and arose from a significant, specific increase of shame in the group with obesity during social exclusion (p b 0.001, Cohen's d = 0.7). When faced with social exclusion, individuals with obesity do not respond with more intensive negative emotions in general compared to controls, but with a specific increase in shame. As social exclusion is frequent in individuals with obesity, psychological interventions focussing shame-related emotional distress could be crucial.

A sorrow shared is a sorrow halved? Internet-based group therapy versus individual therapy for social anxiety disorder: A randomized controlled trial

Purpose: Social anxiety disorder is one of the most researched conditions in the field of Internet-based self-help. Various studies have shown that cognitive-behavioral treatments can be efficacious to reduce social phobic symptoms. Most of the interventions tested include some form of support, whereas the efficacy of a web-based group format has yet to be investigated. The present study aims at investigating the possible added value of therapist-guided group support in an Internet-based guided self-help treatment for SAD. Methods: A total of 150 adults with a diagnosis of SAD are randomly assigned to either a wait-list control group or one of two active treatment conditions. Participants in the two active conditions use the same Internet-based self-help program, either with individual guidance by a therapist or with the support of a therapist-guided group of 6 individuals. In the group condition, participants communicate with each other via an integrated, protected discussion forum. The primary outcome variables are symptoms of SAD and diagnostic status immediately after the intervention (12 weeks) and at 6-month follow-up. Secondary endpoints are general symptomatology, depression, quality of life and adherence to treatment. Furthermore, process variables such as group processes and the working alliance are studied. Results: Results are currently being analyzed. Results at post-treatment will be presented and discussed. Potential moderating and mediating variables of treatment success will be addressed. Conclusion: The results of this study should indicate whether therapist-guided group support could enhance the efficacy of an internet based self-help treatment for SAD. This novel treatment format, if shown efficacious, could represent a cost-effective option and could be further modified to treat other conditions.