Publication Date:
2014-12-06
Description:
Background: Antithrombotic therapy with Rivaroxaban [RIVA] is increasingly being administered for secondary TE prophylaxis in adults. The objective of the present study was to evaluate efficacy and safety of standard RIVA administered as routine medication in an outpatient cohort of pts with TE. Furthermore, on an explorative basis we investigated the influence of RIVA on coagulation factors and biomarkers, and the impact of RIVA monitoring during routine administration. Methods: In 140 consecutively admitted whiteoutpts (15-82 yrs; male 56%) with TE and standard RIVA medication (2x 15 mg followed by 20 mg absolute) recruited between January 2013 and January 2014, a comprehensive monitoring of RIVA through (24h) and peak levels (2h, 4h; Xa-based chromogenic substrate S-2732; Haemochrom Diagnostica) alongwith anti-factor-Xa-activities [Xa; Xa-based assay, Haemochrom Diagnostica], selected coagulation factors and biomarkers (factors II, V, VIII, von-Willebrand-Ristocetin-cofactor [RICO], antithrombin [AT], protein C [PC], D-Dimer, prothrombin fragment F1+2 [F1+2], dRVVT-ratio) was performed during routine follow-up. Efficacy endpoints were defined as any TE or thrombus progression during treatment, safety endpoints were defined as significant bleeding requiring any medical intervention, such as dose reduction, withdrawal of RIVA or death related to therapy. Blood samples were taken during routine follow-up visits in the study centers on a monthly (RIVA start) to 3-months (maintenance) interval. Apart from descriptive analysis non-parametric statistics was performed. In addition, chi-square or Fisher’s exact test was applied. Results: During the study period of 15 months in 140 pts 210 follow-up visits including analyses of 420 individual blood samples were performed. Median pt age was 49yrs, with no difference between males and females. Median (min-max) body weight [bw] per kg was 85 (50-151). Median (min-max) daily RIVA dose per kgbw was 0.2 mg (0.09-0.51).Due to a significant lower bw the median daily RIVA dose of 0.24 mg (0.1-0.51) in females was significantly higher compared to males with 0.20 mg (0.09-0.4; p
Print ISSN:
0006-4971
Electronic ISSN:
1528-0020
Topics:
Biology
,
Medicine
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