Analysis of the efficacy and safety of new oral anticoagulant drugs in the secondary stroke prevention in patients with AF: single center experience based on 311 patients.

AIM: According to the performed trials, an introduction of the new oral anticoagulant drugs (NOAC) in the chronic anticoagulation in patients with non-valvular AF (NVAF) is an interesting treatment option. In addition to the encouraging results of the randomized controlled trials the efficacy of this treatment modality in the real-world clinical settings should also be confirmed. In the article, the two-year single center experience with NOACs in the secondary prevention of cerebral stroke in patients with NVAF and previous ischemic stroke was presented. The objective of the study was to evaluate the efficacy, safety and tolerability of the NOACs in the secondary stroke prevention in patients with NVAF.

METHODS: Three hundred eleven patients (M/F 98/213) with NVAF (mean age 62.22 years [41-85]) on NOAC in secondary prevention of cardiogenic stroke, were enrolled into a prospective study. All of them started the therapy during the acute period of cerebral ischemia from III to IX day after the stroke onset. The estimated risk of stroke was based on the CHA2DS2VASc and the risk of hemorrhage on the basis of HAS-BLED scale. Patients underwent a long-term follow-up within the period from 12 to 24 months after initiation of NOAC therapy (mean follow up 18.6 months). 230 patients were treated by the means of rivaroxaban, in 78 patients dabigatran was administered and 1 patient received apixaban. The rate of stroke recurrence, bleeding as well as the drug intolerance were evaluated.

RESULTS: Ischemic stroke during NOAC treatment was diagnosed in 6 patients (1.92%); TIA was observed in 3 cases (0.96%). Hemorrhagic complications during follow-up were recorded in 29 patients (9.32%), of which 3 patients had major bleedings (0,96%): intracranial bleeding (1), bleeding from the genital tract (1) and from the urinary tract (1). There were no deaths caused by bleeding associated with the use of medications, 1 patient died after ischemic stroke when taking NOACs. In 59 patients (18.97%) NOAC therapy was discontinued in the course of follow-up, mostly because of bleeding (29 patients) or renal function worsening (10 patients). There were no significant differences in the efficacy and safety between the groups on selective factor II inhibitor (dabigatran) or factor Xa inhibitor (rivaroxaban).

CONCLUSION: Clinical application of NOAC in a real-world clinical setting results in the treatment profile of high efficacy and acceptable safety for patients with non-valvular AF and stroke.