Reduced anticoagulation variability in patients on warfarin monitored with Fiix-prothrombin time associates with reduced thromboembolism: The Fiix-trial.

Fiix-prothrombin time (Fiix-PT) differs from traditional PT in being affected by reduced factor (F) II or FX only. In the randomized controlled Fiix-trial, patients on warfarin monitored with Fiix-PT (Fiix-warfarin patients) had fewer thromboembolisms (TE), similar major bleeding (MB) and more stable anticoagulation than patients monitored with PT (PT-warfarin patients). In the current Fiix-trial report we analyzed how reduced anticoagulation variability during Fiix-PT monitoring was reflected in patients with TE or bleeding. Data from 1143 randomized patients was used. We analyzed the groups for anticoagulation intensity (time within target range; TTR), international normalized ratio (INR) variability (variance growth rate B1; VGR) and dose adjustment frequency. We assessed how these parameters associated with clinically relevant vascular events (CRVE), ie TE or MB or clinically relevant non-MB. TTR was highest in Fiix-warfarin patients without CRVE (median 82%;IQR 72-91) and lowest in PT-warfarin patients with TE (62%;56-81). VGR was lowest in Fiix-warfarin patients without CRVE (median VGR B1 0.17; 95% CI 0.08-0.38) and with TE (0.20;0.07-0.26) and highest in PT-warfarin patients with TE (0.50;0.27-0.90) or MB (0.59;0.07-1.36). The mean annual dose adjustment frequency was lowest in Fiix-warfarin patients with TE (mean 5.4;95% CI 3.9-7.3) and without CRVE (mean 6.0; 5.8-6.2) and highest in PT-warfarin patients with TE (14.2;12.2-16.3). Frequent dose changes predicted MB in both study arms. Compared to patients monitored with PT, high anticoagulation stability in Fiix-warfarin patients coincided with their low TE rate. Those with bleeding had high variability irrespective of monitoring method. Thus, although further improvements are needed to reduce bleeding, stabilization of anticoagulation by Fiix-PT monitoring associates with reduced TE.

[European outbreak of Hepatitis A in Iceland in 2017. Common radiological changes of the gallbladder].

IAim The incidence of hepatitis A (HAV) in Iceland is low with about one case per year in the last decades. Since 2016, there has been an ongoing outbreak of HAV in men who have sex with men (MSM). The aim of this study was to inves-tigate whether cases diagnosed in Iceland during 2017 had any link to the HAV outbreak in Europe. Methods All cases of HAV in Iceland during 2017 were reviewed retrospectively. Results Four of five cases diagnosed during 2017 were MSM and one was a female. Three cases presented the same week in the summer 2017. The age of the patients was between 25 and 39 years. All the male patients had had sex with men from Europe and/or had travelled to Europe prior to admission. All cases had typical signs and symptoms of HAV infection and in all cases recent infection was confirmed by positive serology and exclusion of other causes of acute hepatitis. Four of five patients had radiological signs of changes in the gallbladder with thickening of the wall and oedema and one underwent later an elective cholecystectomy. Conclusion The outbreak of HAV in MSM Europe reached Iceland in the summer 2017, emphasizing the importance of vaccination in this risk group as recommended by the Icelandic Health Authorities. The review of these cases indicate that changes such as thickening of the gallbladder wall without gallstones in patients with HAV are common. It is important to discrimi-nate patients with these changes associated with HAV from patients with acute acalculus cholecystitis.