Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

Background Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown. Methods Patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated d-dimer level (cohort 1), patients with an elevated d-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding. Results A total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P=0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P=0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P=0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P=0.55). Conclusions Among acutely ill medical patients with an elevated d-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts. (Funded by Portola Pharmaceuticals; APEX ClinicalTrials.gov number, NCT01583218. opens in new tab.

Cause of Death and Predictors of All-Cause Mortality in Anticoagulated Patients With Nonvalvular Atrial Fibrillation : Data From ROCKET AF

M. Kaste on työryhmän ROCKET AF Steering Comm jäsen.Background-Atrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all-cause mortality may guide interventions. Methods and Results-In the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose-adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all-cause mortality in the 14 171 participants in the intention-to-treat population. The median age was 73 years, and the mean CHADS(2) score was 3.5. Over 1.9 years of median follow-up, 1214 (8.6%) patients died. Kaplan-Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all-cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33-1.70, P= 75 years (hazard ratio 1.69, 95% CI 1.51-1.90, P Conclusions-In a large population of patients anticoagulated for nonvalvular atrial fibrillation, approximate to 7 in 10 deaths were cardiovascular, whereasPeer reviewe

Badanie właściwości dynamicznych tokarki do gwintów falistych

Paper present results of experimental investigations on dynamic properties of rope threading lathe TAE 45N. Prototype of this uniquely designed machine tool was delivered for the tests focused on finding dominant mode shape. Influence of the dominant mode on the cutting process is determined. Significant velocity and acceleration of headstock, during machining, can result in high vibration amplitudes, and its influence was estimated.W artykule przedstawiono wyniki badań doświadczalnych unikatowej tokarki do gwintów falistych TAE 45N. Badania prototypu tej obrabiarki zostały przeprowadzone w celu wyznaczenia dominującej postaci drgań, oddziałujących na realizację procesu skrawania. Przyjęty cel wynika głównie z zastosowanej kinematyki obróbki charakteryzującej się dużą prędkością i przyspieszeniem głowicy narzędziowej, w trakcie jej realizacji

The device for testing the spring mechanisms to a drive of medium voltage switch-disconnectors

Integracja zaawansowanych przetworników pomiarowych, technik cyfrowego sterowania napędami oraz metod bezpiecznego programowania pozwala automatyzować nie tylko procesy wytwórcze, lecz także złożone i czasochłonne procedury testowania i badania wyrobów. Przykładem takiej zintegrowanej aplikacji pomiarowej jest opracowane w PIAP urządzenie testujące mechanizmy sprężynowe do napędu rozłączników średnich napięć, które zostało wdrożone w 2009 r. w firmie ABB Oddział w Przasnyszu. Urządzenie zdejmuje charakterystyki momentu obrotowego w funkcji kąta obrotu, przy załączaniu i wyłączaniu mechanizmu sprężynowego. Uzyskano dokładność i wydajność testowania nieosiągalne przy manualnym zdejmowaniu charakterystyk. Wyeliminowano także zagrożenia dla obsługi przy operowaniu mechanizmami sprężynowymi kumulującymi znaczne energie.The integration of advanced measuring converters, techniques of digital control for drives and methods of safe programming permits to automate not only productive processes, but also complex and time-consuming testing procedures and investigations of products. The example of such integrated measuring application is worked out in PIAP the device for testing spring mechanisms to a drive of medium voltage switch-disconnectors which were implemented in 2009 in the division of ABB in Przasnysz. The device takes off torque characteristics as function of turn angle, when enclosing and disengaging of spring mechanism. The accuracy and testing rate obtained were unattainable using characteristics taken off manually. Risks to service staff by operating the spring mechanisms also were eliminated