[Rivaroxaban in high-risk patients]

Blockade of factor Xa becomes a routine part of clinical practice instead of vitamin K blockade with warfarin, providing a more beneficial and safer effect. The main indications are prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation, deep vein thrombosis and pulmonary embolism. Rivaroxaban has the largest number of data across high risk patients. Rivaroxaban is an oral selective anti Xa inhibitor with well predictive pharmacokinetics and pharmacodynamics. It inhibits thrombin formation for 24 hours, is well absorbed and biological availability is 80-100 %. The excretion is mainly renal and the mean elimination time is 5-9 hours in younger and 11-13 hours in elderly. The pharmacokinetics is minimally influenced by sex and age. The ROCKET AF trial has shown in 14 246 high-risk patients a trend to lowering stroke and systemic embolization by rivaroxaban compared to warfarin without a bleeding increase. The number of events per 100 patient-years was 1.71 in group treated with rivaroxaban compared to 2.16 treated with warfarin (p < 0.001 for non inferiority). A sub-analysis of the ROCKET AF trial has shown numerically trend to higher efficacy and safety of rivaroxaban in patients with moderate renal insufficiency compared to warfarin. Mild hepatic impairment did not significantly affect the pharmacokinetics or pharmacodynamics of rivaroxaban, compared with healthy subjects. The effects by age and concomitant diseases are discussed. The X-VeRT trial shows a new indication for rivaroxaban - electric cardioversion.Key words: age - anticoagulation - heart failure - high risk patients - renal insufficiency - thromboembolic disease.