Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)

Primary outcomes

1. Number of Participants by Their Sociodemographic Characteristics: Smoking Habit

   Time frame: Day 1

   Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.

2. Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit

   Time frame: Day 1

   Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.

3. Number of Participants by Their Sociodemographic Characteristics: MEDEA

   Time frame: Day 1

   Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.

4. Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)

   Time frame: Day 1

   Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2).

5. Number of Participants by Comorbidity

   Time frame: Up to 12 months after date of first prescription

   Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.

6. Risk of Bleeding Events: HAS-BLED Score

   Time frame: Up to 12 months prior to enrollment

   Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and >3 = high risk of bleed per 100 participants-year.

7. Risk of Thromboembolic Events: CHADS2 Score

   Time frame: Up to 12 months prior to enrollment

   Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age >=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke.

8. Risk of Thromboembolic Events: CHA2DS2Vasc Score

   Time frame: Up to 12 months prior to enrollment

   Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, >=65 and <75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age >=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke.

9. Number of Participants by Comedications

   Time frame: Up to 30 days after date of first prescription

   Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.

10. Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR)

    Time frame: Up to 12 months after date of first prescription

    MPR was one of the methods of measuring adherence and was defined as the ratio of all days supply to elapsed days, during the 12-month observation period. All days supply defined as sum of number of days supply between the start date and last prescription dispensed. Elapsed days defined as number of days between the start date and the last prescription dispensed. There were three categories of adherence: poor defined as <80% of MPR, good defined as between 80% and 120% of MPR and over adherence defined as >120% of MPR.

11. Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year

    Time frame: Up to 12 months after date of first prescription

    Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate.

12. Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)

    Time frame: Up to 12 months after date of first prescription

    NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.

13. International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA

    Time frame: Up to 12 months after date of first prescription

    INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (2<INR<3); and risk of hemorrhages (INR>3).

14. Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA

    Time frame: Up to 12 months after date of first prescription

    TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (2<INR<3); and risk of hemorrhages (INR>3).