Publication details
Nová éra sekundární prevence: rivaroxaban u pacientů s akutním koronárním syndromem
| Title in English | A new era of secondary prevention: rivaroxaban for patients with acute coronary syndrome |
|---|---|
| Authors | |
| Year of publication | 2013 |
| Type | Article in Periodical |
| Magazine / Source | Farmakoterapie |
| MU Faculty or unit | |
| Citation | |
| Field | Cardiovascular diseases incl. cardiosurgery |
| Keywords | acute coronary syndrome; secondary prevention; rivaroxaban |
| Description | A number of clinical trials have been conducted and published over the last 20 years looking for more effective antiaggregation therapy for patients after acute coronary syndrome. Data have been presented for prasugrel and ticagrelor -both are effective and safe antiaggregation agents. Attempts to add anticoagulation treatment to antiaggregation therapy were not successful in the warfarin era. American Heart Association declared studies investigating drugs intended to replace warfarin in patients with atrial fibrillation as one of the 10 most significant discoveries in 2010. These studies are RE-LY, ROCKET AF and AVEROES. The ROCKET AF study that included a total of 14, 246 patients demonstrated a trend towards reduced occurrence of cerebrovascular events and systemic embolism in patients treated with rivaroxaban in comparison to warfarin, without the observation of increased bleeding risk. The number of events for 100 patient-years was 1.71 for treatment with rivaroxaban and 2.16 for warfarin (p < 0.001 for non-inferiority). The ATLAS ACS 2-TIMI 51 study evaluated the effects of adding a small dose of rivaroxaban as part of the treatment of patients with acute coronary syndrome, compared to standard antiaggregation therapy. The study included 15,526 patients with subacute coronary syndrome treated with rivaroxaban 2.5 mg or 5.0 mg b.i.d., or placebo for 13 months. Rivaroxaban was associated with significantly reduced primary study endpoint compared to placebo - 8.9% vs. 10.7% (p = 0.008), with significant improvement for both doses - 2.5 mg (p = 0.02), 5 mg (p = 0.03) - corresponding to a total reduction by 16%. The administration of rivaroxaban dosed 2.5 mg b.i.d. reduced the occurrence rate of death related to cardiovascular causes (p = 0.002) as well as overall mortality rate (p = 0.002). The comparison of rivaroxaban with placebo showed that the active agent increased the occurrence of bleeding complications unrelated to bypass surgery (p < 0.001), but also that of intracranial bleeding (p = 0.009). The dose 2.5 mg b.i.d. was accompanied by reduced occurrence of fatal bleeding events when compared to 5.0 mg b.i.d. (p = 0.04). Rivaroxaban thus reduced the occurrence rate of a composed endpoint of death from cardiovascular causes, myocardial infarction and stroke in patients with acute coronary syndrome. Rivaroxaban was associated with an increase of both major and intracranial bleeding, but not with increased occurrence of fatal bleeding or fatal intracranial bleeding. |