Key result
Rivaroxaban and apixaban show similar stroke and bleeding risks in real-world AF.
Why the study?
The study was conducted to evaluate real-world data of patients prescribed rivaroxaban and apixaban for atrial fibrillation and examine differences from randomized controlled trials.
Does rivaroxaban compared to apixaban affect rates of ischemic stroke/TIA and bleeding in real-world patients with atrial fibrillation?
Cohort (n=400)
No
Does rivaroxaban compared to apixaban affect rates of ischemic stroke/TIA and bleeding in real-world patients with atrial fibrillation?
In real-world atrial fibrillation patients, stroke rates with rivaroxaban and apixaban were higher than in landmark clinical trials, driven notably by frequent off-label underdosing and higher stroke rates in patients receiving rivaroxaban 15 mg.
Answers are grounded in this paper and cite their sources.
Supports comparable real-world outcomes with rivaroxaban and apixaban in AF; leaves open dosing adherence and generalizability questions.
BACKGROUND: This study aims to analyze the real-life data of patients who were prescribed rivaroxaban and apixaban and to emphasize the points that we think will make a difference compared to randomized controlled studies. METHODS: The patients who accepted to participate in the study in whom rivaroxaban (15-20 mg) and apixaban (2.5-5 mg) were started with the diagnosis of atrial fibrillation between 01 January 2018 and 31 December 2019 and whose records were fully accessed through the hospital automation system were included in the study. RESULTS: One hundred and ninety-four (48.5%) of a total of 400 patients using rivaroxaban and apixaban were women. The mean age was 73.34 ± 10.45 years, and the age range was 41-98. There was no significant difference in terms of demographic characteristics, background information of the patients, and the medications. Drug-induced complications and mortality rates were also similar. The GFR change rates of the patients in both groups were similar even though the initial GFRs were significantly higher in rivaroxaban group. The mean age and ejection fractions of the patients using rivaroxaban 15 mg were found to be lower than those of patients using rivaroxaban 20 mg whereas the mean systolic blood pressure and HAS-BLED score were found to be higher. Ischemic stroke and mortality rates were higher in patients using 15 mg rivaroxaban than patients using 20 mg rivaroxaban. The rates of nonmajor bleeding in patients using rivaroxaban 15 mg were lower compared to those using 20 mg, and this difference was statistically significant. DISCUSSION: Stroke rates were found to be higher and to have similar bleeding rates compared to major clinical studies in our real-life analysis. However, high ischemic cerebrovascular event and low nonmajor bleeding rates are remarkable in low dose use of rivaroxaban. It is clear that there is a need to consider existing dose reduction criteria in terms of correct prescribing.
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Aslan et al. (2022) conducted a cohort in Atrial fibrillation (n=400). Rivaroxaban (15-20 mg) vs. Apixaban (2.5-5 mg) was evaluated on Ischemic stroke and transient ischemic attack (TIA) (p=0.253). Rivaroxaban and apixaban showed similar rates of ischemic stroke and TIA and major bleeding in real-world atrial fibrillation patients.
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