Clinical Trials

Date: 2016-08-29

Type of information: Presentation of results at a congress

phase: post-authorisation observational

Announcement: presentation of results at ESC Congress 2016

Company: Bayer Healthcare (Germany)

Product: Xarelto® (rivaroxaban)

Action mechanism: anticoagulant agent/oral direct Factor Xa inhibitor

Disease: non-valvular atrial fibrillation

Therapeutic area: Cardiovascular diseases

Country: Japan

Trial details:

• XAPASS is a real-world, prospective, post-authorisation observational study designed by Bayer at the request of the Japanese Authority, as a surveillance study to evaluate the safety and effectiveness of rivaroxaban in routine clinical practice. The study enrolled patients with non-valvular AF newly initiated on rivaroxaban from 1,415 centres across Japan. The attending physician determined the dose regimen and all adverse events (AEs) were recorded as AEs or serious AEs (SAEs).

Latest news:

• • On August 29, 2016, Bayer announced that new real-world data from multiple countries on its oral Factor Xa inhibitor Xarelto® (rivaroxaban) in patients with non-valvular atrial fibrillation (AF) were presented at ESC Congress 2016. Data from XAPASS - a prospective observational post-authorisation study, which enrolled more than 11,000 patients in Japan - confirmed low rates of both stroke and major bleeding in patients with non-valvular AF newly-initiated on rivaroxaban in routine clinical practice. These results were generally consistent with the Phase III J-ROCKET AF randomised clinical trial. Additionally, real-world insights from National Registers of a total of 57,498 patients in Sweden showed similar rates of major bleeding among patients treated with rivaroxaban and warfarin, but significantly lower rates of intracranial bleeding among patients treated with rivaroxaban.
• Data seen from XAPASS to-date reaffirm the positive benefit-risk profile of rivaroxaban that was first established in the Phase III clinical trials ROCKET AF and J-ROCKET AF. In J-ROCKET AF a non-significant 51% reduction in the risk of stroke and non-CNS systemic embolism was observed with rivaroxaban vs. warfarin. While no significant differences in overall bleeding rates were observed in J-ROCKET AF, rivaroxaban use was associated with a non-significant lower major bleeding rate and a slightly higher non-major clinically relevant bleeding rate than warfarin. Patients in J-ROCKET AF had a moderate-to-high risk profile with a mean CHADS2 score of 3.25, whereas patients studied in XAPASS had a lower average risk of stroke, with a mean CHADS2 score of 2.2. In XAPASS, the incidence of any bleeding event was 4.84 per 100 patient-years, of which the incidence of major bleeding was 1.02 per 100 patient-years and the incidence of intracranial haemorrhage was 0.43 per 100 patient-years. The incidence of the composite endpoint of stroke, systemic embolism, or myocardial infarction was 1.35 per 100 patient-years, while the incidence of ischemic stroke was 0.90 per 100 patient-years. These findings were generally consistent with the findings from J-ROCKET AF.
• Additionally, real-world insights from National Swedish Registers compared the incidence rate of major bleeding with rivaroxaban and warfarin in patients with non-valvular AF. Results showed similar rates of major bleeding with rivaroxaban and warfarin (3.40 vs. 3.32 bleeds per 100 patient-years, respectively; HR 0.89; 95% CI 0.73-1.10). However, rates of intracranial bleeding were significantly lower with rivaroxaban compared with warfarin (0.62 vs. 0.88 bleeds per 100 patient-years, respectively; HR 0.63; 95% CI 0.40-0.99).
• Furthermore, updated results from the REVISIT-US study, a retrospective claims database analysis performed using U.S. MarketScan claims data, were also presented at ESC Congress 2016. This study assessed the real-world effectiveness and safety of newly initiated rivaroxaban, apixaban or dabigatran, each in comparison with warfarin, in patients with non-valvular AF. Results from REVISIT-US were initially presented at this year’s congress of the European Cardiac Arrhythmia Society (ECAS) and in this real-world setting showed that rivaroxaban was seen to be associated with a non-significant 29% decrease in ischemic stroke accompanied by a significant 47% reduction in intracranial haemorrhage (ICH) vs. warfarin. Looking at the combined endpoint of ICH or ischemic stroke, rivaroxaban resulted in a significant 39% reduction vs. warfarin in REVISIT-US.

 

Is general: Yes