Abstract
INTRODUCTION
Atrial fibrillation (AF) is one the most common disturbance of cardiac rhythm in adults and it is a major healthcare problem as it is associated with the risk of ischemic stroke. The prevalence of AF is estimated to affect at least 1% of the population in developed countries. In patients with AF, the risk of stroke is higher, according to the stroke risk stratification schemes CHADS2 and CHA2DS2-VASc. Oral anticoagulation therapy is a well-established treatment to prevent strokes in patients with AF who are at moderate to high risk of stroke, and the non-vitamin K antagonist oral anticoagulants have been recommended as alternatives to warfarin for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) in various treatment guidelines.
Edoxaban (Lixiana®, Daiichi-Sankyo) is an oral, reversible, direct factor Xa inhibitor with a linear and predictable pharmacokinetic. The edoxaban dose regimen consisted of 60 mg/24h, that was reduced to 30 mg/24h for estimated creatinine clearance of 15-50mL/min, body weight <60 kg or concomitant use of potent P-glycoprotein inhibitors. It was found not to be inferior to warfarin for prevention of stroke or systemic embolic events (SEE) in patients with AF and to reduce major bleeding, including a signicant reduction of intracranial haemorrhage and cardiovascular death.
OBJECTIVE
The primary objective of the study is to evaluate the efficacy of Edoxaban in the prevention of stroke and Embolism Systemic. Besides, the secondary objective is to assess its safety, in function of the major bleeding defined according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH).
METHODS
This is a descriptive study. We have included a total of 102 patients with NVAF and venous thromboembolic disease (TED). The indication for anticoagulation was NVFA with 97 cases and 5 patients for secondary prevention of TED.
The risk of stroke is assessed according to the scale CHA2DS2-VASc (average 3,83). Figure 1.
We also evaluated the risk of bleeding according to the scale HAS-BLED (average 2.85). Figure 2.
We have included 85 cases with doses of 60 mg/24h and 17 cases at a dose of 30 mg/24h. According to sex, it was about 56 women and 46 men, aged between 51 and 88 years old (average 72.2).
All patients had received prior treatment with Anti-Vitamin K (AVK). The main reason of suspension of Anti-Vitamin K and its replacement with Edoxaban was because therapeutic time in range (TTR) was <65% (88 patients) and bleeding diathesis caused by anti-vitamin K (AVK) (14 patients). Of the patients included, 18 had presented previous stroke under treatment with AVK.
We have evaluated complications in both bleeding and thrombosis during the treatment.
The treatment time has been between 1 and 6 months (average of 4 months). Figure 3.
RESULTS
It has not been reported any case of Stroke, Systemic Embolism, or Major Bleeding (criteria of ISTH) during the follow-up time of the patients treated.
The only complications described were:
- 1 case of small bruise on the thigh in a patient treated at a dose of 60 mg/24h. In the follow-up visit we performed a new evaluation of the Creatinine Clearance and we found that the figures were 44 ml/min, which was reduced at the dose of 30 mg/24h, as indicated in the Technical Data Sheet.
- 1 patient attended the emergency department due to Delirium, which, after ruling out pathology-related (stroke, ischaemic or haemorrhagic, and TED by means of the relevant studies), or cause-effect relationship with the drug continued with the treatment with Edoxaban.
- 1 patient presented self-limited Hemoptysis that did not require suspension of the treatment.
During the study, a patient was diagnosed with lung cancer and the anticoagulant treatment was suspended. The patient died later by this oncology pathology.
CONCLUSION
The results obtained confirm the efficacy and safety of using Edoxaban in the prevention of stroke in the NVAF and in the few cases of TED.
This is a small sample and with a short time of follow-up, due to the fact that the drug was approved in our country a few months ago.
Our experience support the results of the trials. We believe that there is a good alternative to oral anticoagulation in patients with NVAF, being effective in the prevention of stroke and Systemic Embolism. It has a good safety profile with a clinical net benefit mainly at the expense of absence of bleeding.
Subsequent studies will provide data confirmation.
No relevant conflicts of interest to declare.
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