What is the clinical evidence from this study?

Study design: Observational. Population: Atrial fibrillation (n=89). Intervention: Rivaroxaban. Primary outcome: Stroke recurrence.

October 29, 2015Future Neurology

Efficacy, Safety and Tolerability of Rivaroxaban for the Secondary Prevention of Stroke in Patients with Atrial Fibrillation in Clinical Practice

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Key result

Early treatment with rivaroxaban for secondary prevention of stroke in atrial fibrillation patients resulted in an annual stroke recurrence rate of 0.82% and a major bleeding rate of 1.64%.

Why the study?

Does early treatment with rivaroxaban prevent stroke recurrence and is it safe in patients with atrial fibrillation in clinical practice?

Study Design

Type

Observational (n=89)

Structured PICO

Does early treatment with rivaroxaban prevent stroke recurrence and is it safe in patients with atrial fibrillation in clinical practice?

Population

89 patients (median age 77 years) with atrial fibrillation treated with rivaroxaban for secondary prevention of stroke or TIA, followed for 15 months.

Exposure

Rivaroxaban started early after cerebrovascular event (median 5 days for stroke and 3 days for transient ischemic attack)

Outcome

Stroke recurrence and clinically significant bleedinghard clinical

Early initiation of rivaroxaban for secondary stroke prevention in real-world atrial fibrillation patients appears safe and effective with low rates of recurrent stroke.

Implication

May support early rivaroxaban post-stroke in AF; leaves open randomized confirmation of benefit.

Abstract

Aim: To evaluate the efficacy, safety and tolerability of rivaroxaban for the secondary prevention of stroke in patients with atrial fibrillation in clinical practice. Methods: Patients treated with rivaroxaban for secondary prevention of stroke/transient ischemic attack attended at a cerebrovascular disease unit were consecutively included in a noninterventional and prospective study. Results: 89 patients (median age 77 years, CHADS2 = 4, HAS-BLED = 3, follow-up = 15 months) were included. Rivaroxaban was started early after the cerebrovascular event (median 5 days for stroke and 3 days for transient ischemic attack). Stroke recurrence occurred in only one patient (annual rate, 0.82%). Eight cases of clinically significant bleeding were recorded (annual rate, 6.58%), of which two were major (annual rate, 1.64%) and one intracranial (annual rate, 0.82%). Medication persistence was very good. Conclusion: Our data show that the early treatment with rivaroxaban is well tolerated, efficacious and safe for secondary prevention of real-life atrial fibrillation patients.

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Cite This Study

Monteagudo et al. (2015) conducted an observational in Atrial fibrillation (n=89). Rivaroxaban was evaluated on Stroke recurrence. Early treatment with rivaroxaban for secondary prevention of stroke in atrial fibrillation patients resulted in an annual stroke recurrence rate of 0.82% and a major bleeding rate of 1.64%.

synapsesocial.com/papers/6a22ac1a54bc213887d2cc78 https://doi.org/10.2217/fnl.15.43