Rivaroxaban in secondary cardiogenic stroke prevention: two-year single-centre experience based on follow-up of 209 patients

Abstract

A b s t r a c t Background:The main goal of treatment in patients with atrial fibrillation is to counteract the effects of embolisation, considering the relatively high risk of cerebral embolic events.Aim: An assessment of the efficacy and safety of rivaroxaban in secondary stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Methods:The study concerned 209 NVAF patients (male/female: 117/92; mean age 65.3 years ), who used rivaroxaban as secondary prevention of cardiogenic stroke. The patients were followed up for 24 months: the control visits were performed 12 and 24 months after the onset of the inclusion. The following aspects were analysed: the occurrence of recurrent stroke and/or transient ischaemic attack (TIA) during rivaroxaban treatment, bleeding episodes with their placement and severity assessment, drug tolerance, and evaluation of the patient's medical records including laboratory tests (e.g. creatinine clearance) and concomitant therapy. All patients underwent physical examination as well as neurological assessment. Results:The mean CHA 2 DS 2 -VASc in the study group was 4.16, and the mean HAS-BLED value was 3.31. During the follow-up 13 deaths were noted (6.22%), ischaemic stroke was diagnosed in five (2.39%) subjects, and TIA in three (1.43%) patients. Bleeding complications were reported in 25 (11.96%) patients, two of which were classified as major bleedings (0.95%): an intracranial bleeding (1) and a bleeding from the genital tract (1). Conclusions:For patients with NVAF and cerebrovascular events, the use of rivaroxaban in a real-world clinical setting results in a highly efficacious treatment profile and acceptable safety.

District versus academic hospitals: differences in the clinical characteristics of patients with atrial fibrillation without valvular heart disease treated with oral anticoagulants

“…4,5 The introduction of non-vitamin K antagonist oral anticoagulants (NOACs) has revolutionized stroke prevention in patients with AF because they showed similar efficacy to VKAs, yet with a safer profile, a fixed dose, and no need for frequent laboratory monitoring. 6 The current European Society of Cardiology (ESC) guidelines recommend anticoagulant treatment in AF patients without valvular heart disease (VHD) and a CHA 2 DS 2 VASc score of 2 or higher for men and 3 or higher for women. 7 In these patients, treatment with NOACs should be preferred over VKAs.…”

Evaluation of indications for reduced-dose non-vitamin K antagonist oral anticoagulants in hospitalised patients with atrial fibrillation

“…An exception was observed in the apixaban group, where the dose of 2.5 mg was prescribed more frequently due to the presence of additional indications for dose reduction despite the CHA 2 DS 2 -VASc score of ≥ 2. In a prospective study by Lasek-Bal et al [15] in patients with nonvalvular AF and cerebrovascular events, standard doses of rivaroxaban were also used more frequently than the reduced doses (171 vs. 38), which was due to the high CHA 2 DS 2 -VASc score (the mean CHA 2 DS 2 -VASc in the study group was 4.16) and was associated with high efficacy and safety of therapy. In the study by Yao et al [16], potential overdose of NOACs (e.g.…”

Commentary to the article: “Rivaroxaban in secondary cardiogenic stroke prevention: two-year single-centre experience based on follow-up of 209 patients”

“…It is known that a history of stroke or transient ischaemic attack (TIA) is a major risk factor for recurrent ischaemic events as well as bleeding in atrial fibrillation (AF), so effective anticoagulation is of key importance in this high-risk subgroup. Therefore, I read with interest the paper by Lasek-Bal et al [1]. The authors presented an observational study on Polish patients with AF and previous stroke or TIA, who were treated with rivaroxaban and followed-up for 24 months.…”

“…Moreover, given the slim chance of approving an antidote to factor Xa inhibitors (e.g. andexanet alpha currently tested in a phase III trial) in the near future, a practising Polish physician dealing with patients receiving rivaroxaban would appreciate information on the management of major bleedings in the patient group analysed by Lasek-Bal et al [1]. Did the patients receive prothrombin complex concentrates, platelet concentrates, antifibrinolytics, or recombinant factor VIIa?…”

“…It is advisable to run registries for treatment with rivaroxaban in large clinical centres, to assess the impact of local factors known from everyday practice, for instance reduction of daily dose or its intake every other day, due to high cost of the treatment, which is not reimbursed in Poland. Increasing use of rivaroxaban, like other non-vitamin K oral anticoagulants in Poland, in which no specialised anticoagulation clinics were ever organised by our healthcare system in the whole country, is likely to lower the incidence of dangerous bleeding and thromboembolic complications of long-term anticoagulation in Polish patients with AF, and thus good long-term outcomes of everyday stroke prevention requires collection of data on anticoagulated patients in each outpatient clinic, including the benefits and adverse events of the therapy as presented by Lasek-Bal et al [1]. Initiatives similar to that of Dr Lasek-Bal should be strongly encouraged.…”