Publication details
Rivaroxaban v léčbě fibrilace síní
| Title in English | Rivaroxaban in the treatment of atrial fibrillation |
|---|---|
| Authors | |
| Year of publication | 2013 |
| Type | Article in Periodical |
| Magazine / Source | Farmakoterapie |
| MU Faculty or unit | |
| Citation | |
| Field | Cardiovascular diseases incl. cardiosurgery |
| Keywords | atrial fibrillation; rivaroxaban; stroke; bleeding |
| Description | Anticoagulant therapy is an indispensable component of atrial fibrillation therapy including all its types. In our country, this treatment relies on the administration of vitamin K antagonists represented by warfarin. Its administration requires rigorous monitoring using INR values, with INR < 2.0 being equivalent with ineffective therapy while INR values > 3.0 are associated with the risk of major bleeding. American Heart Association has described the studies of drugs intended to replace warfarin in patients with atrial fibrillation as one of the ten most significant discoveries in 2010. The studies in question include RELY, ROCKET AF and AVERROES, the drugs being represented by dabigatran, rivaroxaban and apixaban. Rivaroxaban, a direct competitive factor Xa antagonist, was investigated in the ROCKET AF trial. The study included 14,246 patients with atrial fibrillation, with 598 of the participants in the Czech Republic. Rivaroxaban was found to be non-inferior, or more effective in the prevention of stroke over the treatment period compared with warfarin, it did not increase the number of bleedings and reduced the occurrence of the most feared forms of bleeding, such as fatal and intracranial bleeding or critical organ bleeding. In accordance with the statistics plan, non- -inferiority was first determined in the per-protocol on-treatment population. The rate of strokes and embolism were 1.71/100 patient-years for therapy with rivaroxaban and 2.16/100 patient-years for warfarin (p < 0.001 for non-inferiority). The study has also established superiority in safety on-treatment population. The rates of strokes and embolism were 1.7/100patient-years for therapy with rivaroxaban and 2.2/100 patient-years for warfarin (p = 0.02 for superiority). The occurrence of main safety parameters was found to be identical for both groups, but rivaroxaban resulted in a reduced number of the most feared bleeding forms. The ROCKET AF study demonstrated non-inferiority of rivaroxaban compared with warfarin (reducing on-treatment occurrence of strokes and systemic embolism by 21% without increased risk of bleeding) and has shown the alternative to warfarin even in polymorbid patients with atrial fibrillation and high risk, as 87% of patients in this study had CHADS2 score >/- 3! Rivaroxaban reduced the risk of the most feared forms of bleeding such as fatal and intracranial bleeding. Rivaroxaban is approved in the Czech Republic under the name Xarelto, the dose recommended for patients with atrial fibrillation and non-reduced renal function being 20 mg once daily. |