Study design and rationale for Optimal aNtiplatelet pharmacotherapy guided by bedSIDE genetic or functional TESTing in elective percutaneous coronary intervention patients (ONSIDE TEST): a prospective, open-label, randomised parallel-group multicentre trial (NCT01930773)

BACKGROUND AND AIM: High platelet reactivity (HPR) and presence of CYP2C19 loss-of-function alleles are associated with higher risk for periprocedural myocardial infarction in clopidogrel-treated patients undergoing percutaneous coronary intervention (PCI). It is unknown whether personalised treatment based on platelet function testing or genotyping can prevent such complications. METHODS: The ONSIDE-TEST is a multicentre, prospective, open-label, randomised controlled clinical trial aiming to assess if optimisation of antiplatelet therapy based on either phenotyping or genotyping is superior to conventional care. Patients will be randomised into phenotyping, genotyping, or control arms. In the phenotyping group, patients will be tested with the VerifyNow P2Y12 assay before PCI, and patients with a platelet reactivity unit greater than 208 will be switched over to prasugrel, while others will continue on clopidogrel therapy. In the genotyping group, carriers of the *2 loss-of-function allele will receive prasugrel for PCI, while wild-type subjects will be treated with clopidogrel. Patients in the control arm will be treated with standard-dose clopidogrel. The primary endpoint of the study is the prevalence of periprocedural myocardial injury within 24 h after PCI in the controls as compared to the phenotyping and genotyping group. Secondary endpoints include cardiac death, myocardial infarction, definite or probable stent thrombosis, or urgent repeat revascularisation within 30 days of PCI. Primary safety outcome is Bleeding Academic Research Consortium (BARC) type 3 and 5 bleeding during 30 days of PCI. SUMMARY: The ONSIDE TEST trial is expected to verify the clinical utility of an individualised antiplatelet strategy in preventing periprocedural myocardial injury by either phenotyping or genotyping

Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial

AIMS: To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence. METHODS AND RESULTS: This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-mo

Place of magnesium sulfate in cardiopulmonary resuscitation. A systematic review and meta-analysis

INTRODUCTION: Sudden cardiac arrest treatment is challenging, And the effectiveness of resuscitation procedures — especially in pre-hospital conditions — is low. The purpose of this meta-analysis is to investigate the effects of magnesium sulfate (MgSO4) in cardiac arrest on the return of spontaneous circulation (ROSC) and survival to hospital discharge. MATERIAL AND METHODS: We searched in MEDLINE, EMBASE, Scopus, and ClinicalTrials.gov, Web of Science up to May 25, 2020, and we conducted a systematic review and meta-analysis. We synthesized results by using mean differences, and odds ratios. The overall incidence and outcome of cardiac arrest were assessed using a random-effects meta-analysis. RESULTS: A total of 5 eligible studies were included in this meta-analysis. Survival to discharge was higher in magnesium sulfate group compared to placebo group (9,5% vs. 8.2% respectively; OR = 1.17; 95% CI: 0.61, 2.23; p = 0.64). Higher survival rate to hospital admission was observed in the placebo group — 26.9% compared to the group where magnesium was administered — 25.7% (OR = 0.93; 95% CI: 0.59, 1.47; p = 0.77. CONCLUSIONS: In conclusion, this meta-analysis indicates no statistically significant benefit of resuscitation with magnesium sulfate compared to the placebo. Thus, due to the low number of studies we recommend future randomized controlled trials to identify which anti-arrhythmic drug we should use on shock-refractory cardiac arrest. Copyright © 2020 Via MedicaEuropean Research Council, ERCAcknowledgments: Study supported by the ERC Research NET and Polish Society of Disaster Medicine

Supplementary Material for: Influence of Exclusive Enteral Nutrition Therapy on Bone Density and Geometry in Newly Diagnosed Pediatric Crohn's Disease Patients

<b><i>Background and Aims:</i></b> Exclusive enteral nutrition (EEN) induces remission in patients with Crohn's disease (CD). We investigated the short-term impact of EEN on bone quality and muscle mass in children with CD. <b><i>Methods:</i></b> Ten newly diagnosed CD patients (7 male, 10.6-17.7 years of age) were assessed by peripheral quantitative computed tomography (pQCT) at the forearm before starting an 8-weeks treatment with EEN, and after 12 and 52 weeks. No steroids or biologicals were applied. Trabecular and cortical bone mineral density, total bone, and muscle cross-sectional area (CSA) were measured by pQCT and expressed as age- and sex-specific z-scores; size-dependent CSAs were corrected for low height for age. Wilcoxon rank sum test was applied. <b><i>Results:</i></b> Remission at week 12 was achieved in 8 patients; 2 still had mild disease. Initially low trabecular density z-scores improved (+0.3; p = 0.006) at week 12; simultaneously, the increased cortical density z-scores normalized (-0.4; p = 0.027). The low z-score for muscle CSA corrected for height (median -2.5, range -3.49 to -0.97) increased within 12 weeks (+1.0; p = 0.002) with no further improvement thereafter. <b><i>Conclusions:</i></b> The results indicate disturbed bone remodeling and severely impaired muscle mass in newly diagnosed CD children. Bone metabolism and muscle mass improved within 3 months after starting EEN with no further normalization thereafter