Drug-eluting stents in clinical routine: a 1-year follow-up analysis based on German health insurance administrative data from 2008 to 2014.

OBJECTIVES: To describe the use of drug-eluting stents (DESs) in the largest population of statutory health insurance members in Germany, including newly developed bio-resorbable vascular scaffolds (BVSs), and to evaluate 1-year complication rates of DES as compared with bare metal stents (BMSs) in this cohort. DESIGN: Routine data analysis of statutory health insurance claims data from the years 2008 to 2014. SETTING: The German healthcare insurance Allgemeine Ortskrankenkasse covers approximately 30% of the German population and is the largest nationwide provider of statutory healthcare insurance in Germany. PARTICIPANTS AND INTERVENTIONS: We included all patients with a claims record for a percutaneous coronary intervention (PCI) with either DES or BMS and additionally, from 2013, BVS. Patients with acute myocardial infarction (AMI) were excluded. MAIN OUTCOME MEASURE: major adverse cerebrovascular and cardiovascular event (MACCE, defined as mortality, AMI, stroke and transient ischaemic attack), bypass surgery, PCI and coronary angiography) at 1 year after the intervention. RESULTS: A total of 243 581 PCI cases were included (DES excluding BVS: 143 765; BVS: 1440; BMS: 98 376). The 1-year MACCE rate was 7.42% in the DES subgroup excluding BVS and 11.29% in the BMS subgroup. The adjusted OR for MACCE was 0.72 (95% CI 0.70 to 0.75) in patients with DES excluding BVS as compared with patients with BMS. In the BVS group, the proportion of 1-year MACCE was 5.0%. CONCLUSION: The analyses demonstrate a lower MACCE rate for PCI with DES. BVSs are used in clinical routine in selected cases and seem to provide a high degree of safety, but data are still sparse.

Revascularisation of patients with end-stage renal disease on chronic haemodialysis: bypass surgery versus PCI-analysis of routine statutory health insurance data.

OBJECTIVES: We aimed to analyse the short-term and long-term outcome of patients with end-stage renal disease (ESRD) undergoing percutaneous intervention (PCI) as compared to coronary artery bypass surgery (CABG) to evaluate the optimal coronary revascularisation strategy. DESIGN: Retrospective analysis of routine statutory health insurance data between 2010 and 2012. MAIN OUTCOME MEASURES: Primary outcome was adjusted all-cause mortality after 30 days and major adverse cardiovascular and cerebrovascular events at 1 year. Secondary outcomes were repeat revascularisation at 30 days and 1 year and bleeding events within 7 days. RESULTS: The total number of cases was n=4123 (PCI; n=3417), median age was 71 (IQR 62-77), 30.4% were women. The adjusted OR for death within 30 days was 0.59 (95% CI 0.43 to 0.81) for patients undergoing PCI versus CABG. At 1 year, the adjusted OR for major adverse cardiac and cerebrovascular events (MACCE) was 1.58 (1.32 to 1.89) for PCI versus CABG and 1.47 (1.23 to 1.75) for all-cause death. In the subgroup of patients with acute myocardial infarction (AMI), adjusted all-cause mortality at 30 days did not differ significantly between both groups (OR 0.75 (0.47 to 1.20)), whereas in patients without AMI the OR for 30-day mortality was 0.44 (0.28 to 0.68) for PCI versus CABG. At 1 year, the adjusted OR for MACCE in patients with AMI was 1.40 (1.06 to 1.85) for PCI versus CABG and 1.47 (1.08 to 1.99) for mortality. CONCLUSIONS: In this cohort of unselected patients with ESRD undergoing revascularisation, the 1-year outcome was better for CABG in patients with and without AMI. The 30-day mortality was higher in non-AMI patients with CABG reflecting an early hazard with surgery. In cases where the patient's characteristics and risk profile make it difficult to decide on a revascularisation strategy, CABG could be the preferred option.

Clinical correlates of later violence and criminal offences in schizophrenia.

BACKGROUND: Violence and criminality in patients with schizophrenia has been described in several studies but prediction of later criminal behavior is difficult. METHODS: We reviewed the national crime register for records of criminal offences committed by 1662 patients with schizophrenia treated between 1990 and 1995 in the Psychiatric Hospital of the University of Munich. Analyses were performed to determine predictors of later criminal behavior, and the psychopathological syndrome scales in the Association for Methodology and Documentation in Psychiatry (AMDP) system were used to establish possible psychopathological characteristics for such behavior. RESULTS: One hundred and sixty nine (10.2%) of the 1662 patients had been convicted in the 7-12 years after discharge, whereby male patients (117 of 685, 17.1%) outnumbered female patients ( 52 of 977, 5.3%) by more than 3 to 1. The rate of violent crimes was especially high: 62 (3.7%) patients were convicted for physical injury offences. Five cases of manslaughter or murder were recorded. AMDP syndrome scales were found to be predictive for later criminal offences. Significantly higher rates of criminal conviction and recidivism were found for patients with lack of insight at discharge. Analyses also showed a significantly higher risk of non-violent and violent crimes in patients with a hostility syndrome at admission and discharge. There was a significantly lower incidence of criminal behavior in subjects with a depressive syndrome. CONCLUSION: Data indicate a significant rate of minor and serious physical injury offences in former inpatients with schizophrenia. Moreover, results identify risk factors for future non-violent and violent criminal behavior in patients with schizophrenia.

Genotoxic effects of vanadium pentoxide on human peripheral lymphocytes and mucosal cells of the upper aerodigestive tract.

In addition to tobacco and alcohol consumption, pollutants found in certain industries and in the environment play an important role in carcinogenesis in the upper aerodigestive tract. The aim of the present study was to investigate whether vanadium pentoxide may have a genotoxic effect on human mucosal cells and lymphocytes. The single cell microgel electrophoresis assay (Comet assay) was used to detect DNA damage induced by vanadium pentoxide in human nasal epithelia (n = 11) and in lymphocytes (n = 11). Mucosa was harvested from inferior nasal turbinates, while lymphocytes were obtained via venous puncture. Vanadium pentoxide was applied at concentrations of 0.06 mM, 0.12 mM, 0.24 mM, and 0.47 mM. Aqua bidestillata served as solvent and negative control and N-methyl-N'-nitro-N-nitrosoguanidine at 0.07 mM (MNNG) was used as positive control. The trypan blue exclusion test was applied to assess cytotoxicity. Whereas vanadium pentoxide induced dose-dependent DNA migration in lymphocytes, mucosal cells did not show comparable genotoxic effects. Cytotoxic effects allowed for viabilities exceeding 80%. The results indicate that vanadium pentoxide is capable of inducing single-strand-breaks and/or alkali-labile damage in the DNA of human lymphocytes. By contrast, mucosal cells proved not to be sensitive in this setting. Thus, a possible role of vanadium in the tumorigenesis of head and neck cancer appears unrelated to direct genotoxic effects.