Contributions
Abstract: PB2515
Type: Publication Only
Background
Atrial fibrillation (AF) is associated with the risk of ischemic stroke. Oral anticoagulation therapy is a well-established treatment for preventing strokes in patients with moderate to high risk. Non-vitamin K antagonist oral anticoagulants (NOACs) have been recommended as alternatives to Anti-Vitamin K (AVK) for stroke prevention in patients with non-valvular AF (NVAF) and Deep Vein Thrombosis (DVT). Edoxaban (Lixiana®, Daiichi-Sankyo) is an oral, reversible, direct factor Xa. The dose consists of 60 mg / 24h and 30 mg/24h (reduced dose) for estimated creatinine clearance of 15–50mL/min, body weight <60 kg or concomitant use of P-glycoprotein inhibitors.
Aims
Primary Objective: To evaluate the efficacy of Edoxaban in the prevention of stroke and Embolism Systemic. Secondary objective: To assess the safety, in function of the major bleeding largest defined according to the criteria of the International Society of Thrombosis and Hemostasis.
Methods
This is a descriptive study. We have included a total of 211 patients with NVAF (199 patients) and DVT (12 patients). The mean CHA2DS2-VASc (risk of stroke) of patients studied was of 3.74 in the total population and 4.18 in reduced dosage population. The mean HAS-BLED (risk of bleeding) of the studied patients was 3.01 in the total population and 3.25 in the reduced dosage population. We have included 163 cases with doses of 60 mg/24h and 48 cases at a dose of 30 mg / 24h (22,7% of total patients. It was about 109 women (51,66%) and 102 men (48,34%), aged between 42 and 95 years old (mean age 72.5). The main reason of suspension of AVK and replacement by Edoxaban was poor control of INR (199 patients) and diathesis bleeding (12 patients). Of the total number of included patients, 41 had presented a previous stroke under treatment with AVK. The treatment time has been between 3 and 13 months, with an average of 7.65 months of follow-up.
Results
It has not been reported any case of Stroke, Systemic Embolism, or Major during the follow-up time of the patients treated. Only one case of non-major clinically relevant bleeding (rectal bleed) which required changing to another NOAC. One case of small bruise in a patient treated with a 60 mg dose /24h which had a creatinine clearance of 44 ml/min, so the dose was reduced to 30 mg/24h. One patient presented self-limited hemoptysis that did not require suspension of the treatment. One patient with a subdural hematoma, after traumatic brain injury, which treatment was suspended. During the study, a patient was diagnosed with lung cancer and was discontinued anticoagulant treatment, and replaced by low molecular weight heparin. The patient died later by this pathology oncology. Three patients died due to respiratory disease (Influenza and respiratory insufficiency), not being related to the anticoagulant medication.
Conclusion
The results obtained confirm the efficacy and safety of Edoxaban in the prevention of stroke in the NVAF and DVT. This is a good sample of 211 patients and more than seven months of follow-up, despite the short period of time since the use approval of the drug in our country (18 months). The results support the results of the trials. We believe that there is a good alternative to oral anticoagulation in patients with NVAF with efficacy in the prevention of stroke and Systemic Embolism, and with a good safety profile with a clinical benefit net at the expense of mainly absence of bleeding. Subsequent studies will provide data confirmation.
Session topic: 35. Thrombosis and vascular biology & translational Research
Keyword(s): Anticoagulants, Anticoagulation, Stroke, Thromboembolic events
Abstract: PB2515
Type: Publication Only
Background
Atrial fibrillation (AF) is associated with the risk of ischemic stroke. Oral anticoagulation therapy is a well-established treatment for preventing strokes in patients with moderate to high risk. Non-vitamin K antagonist oral anticoagulants (NOACs) have been recommended as alternatives to Anti-Vitamin K (AVK) for stroke prevention in patients with non-valvular AF (NVAF) and Deep Vein Thrombosis (DVT). Edoxaban (Lixiana®, Daiichi-Sankyo) is an oral, reversible, direct factor Xa. The dose consists of 60 mg / 24h and 30 mg/24h (reduced dose) for estimated creatinine clearance of 15–50mL/min, body weight <60 kg or concomitant use of P-glycoprotein inhibitors.
Aims
Primary Objective: To evaluate the efficacy of Edoxaban in the prevention of stroke and Embolism Systemic. Secondary objective: To assess the safety, in function of the major bleeding largest defined according to the criteria of the International Society of Thrombosis and Hemostasis.
Methods
This is a descriptive study. We have included a total of 211 patients with NVAF (199 patients) and DVT (12 patients). The mean CHA2DS2-VASc (risk of stroke) of patients studied was of 3.74 in the total population and 4.18 in reduced dosage population. The mean HAS-BLED (risk of bleeding) of the studied patients was 3.01 in the total population and 3.25 in the reduced dosage population. We have included 163 cases with doses of 60 mg/24h and 48 cases at a dose of 30 mg / 24h (22,7% of total patients. It was about 109 women (51,66%) and 102 men (48,34%), aged between 42 and 95 years old (mean age 72.5). The main reason of suspension of AVK and replacement by Edoxaban was poor control of INR (199 patients) and diathesis bleeding (12 patients). Of the total number of included patients, 41 had presented a previous stroke under treatment with AVK. The treatment time has been between 3 and 13 months, with an average of 7.65 months of follow-up.
Results
It has not been reported any case of Stroke, Systemic Embolism, or Major during the follow-up time of the patients treated. Only one case of non-major clinically relevant bleeding (rectal bleed) which required changing to another NOAC. One case of small bruise in a patient treated with a 60 mg dose /24h which had a creatinine clearance of 44 ml/min, so the dose was reduced to 30 mg/24h. One patient presented self-limited hemoptysis that did not require suspension of the treatment. One patient with a subdural hematoma, after traumatic brain injury, which treatment was suspended. During the study, a patient was diagnosed with lung cancer and was discontinued anticoagulant treatment, and replaced by low molecular weight heparin. The patient died later by this pathology oncology. Three patients died due to respiratory disease (Influenza and respiratory insufficiency), not being related to the anticoagulant medication.
Conclusion
The results obtained confirm the efficacy and safety of Edoxaban in the prevention of stroke in the NVAF and DVT. This is a good sample of 211 patients and more than seven months of follow-up, despite the short period of time since the use approval of the drug in our country (18 months). The results support the results of the trials. We believe that there is a good alternative to oral anticoagulation in patients with NVAF with efficacy in the prevention of stroke and Systemic Embolism, and with a good safety profile with a clinical benefit net at the expense of mainly absence of bleeding. Subsequent studies will provide data confirmation.
Session topic: 35. Thrombosis and vascular biology & translational Research
Keyword(s): Anticoagulants, Anticoagulation, Stroke, Thromboembolic events