Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, apixaban, stroke
Brief summary
Apixaban is a direct anticoagulant, which inhibits the factor Xa. Its clinical efficiency in prevention of stroke and systemic embolism in adult patients with NVAF (non/valvular atrial fibrillation) was demonstrated as well as has shown better safety profile compared with warfarin. A Drug Utilization study will evaluate whether this drug has been used in accordance with the approved indication and recommendations described in the summary of product characteristics (SmPC) and estimate possible misuse or overuse apixaban.
Detailed description
The primary research question is to evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA. In addition a comparison with a cohort of NVAF patients treated with VKA, dabigatran and rivaroxaban for the SPAF indication will also be performed. Objective 1: To characterize patients using apixaban according to demographics, comorbidity, risk of thromboembolic events (CHADS2 and CHA2DS2-Vasc scores), risk of bleeding events (HAS-BLED score), comedications and compare it with the profile of patients treated with VKA, dabigatran and rivaroxaban. Objective 2: Describe the level of appropriate usage according to the posology recommended in the apixaban SmPC. Objective 3: Describe the potential interactions with other drugs prescribed concomintatly according with the SmPC recommendations. Objective 4: Estimate the level of apixaban adherence by the medication possession ratio (MPR) and discontinuation rates and compare it with VKA, dabigatran and rivaroxaban cohort. Objective 5: To analyze INR (International Normalized Ratio) values during the last 12 months and to obtain TTR (Time in Therapeutic Range) values in patients previously treated with VKA, and during the whole study period for those in the cohort treated with VKA.
Interventions
DRUGapixaban
current or new medication
DRUGdabigatran
current or new medication
DRUGVKA
current or new medication
DRUGrivaroxaban
current or new medication
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients more than 18 years-old. 2. Patients diagnosed with NVAF registered in primary care according to ICD-10. 3. Patients initiating apixaban (naïve or VKA experienced), VKA (naïve or VKA experienced), dabigatran or rivaroxaban for the SPAF indication. 4. Continuous enrolment in the 12 months pre-index.
Exclusion criteria
1. Patients with valvular heart disease (ICD 10: I05.0-I05.09, I08.0-I08.9) including patients with mitral prosthetic valves. 2. Lost to follow-up (e.g. transfer to primary care center non-ICS).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Day 1 | Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit. |
| Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Day 1 | Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit. |
| Number of Participants by Their Sociodemographic Characteristics: MEDEA | 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. |
| Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 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). |
| Number of Participants by Comorbidity | 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. |
| Risk of Bleeding Events: HAS-BLED Score | 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. |
| Risk of Thromboembolic Events: CHADS2 Score | 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. |
| Risk of Thromboembolic Events: CHA2DS2Vasc Score | 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. |
| Number of Participants by Comedications | 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. |
| Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | 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. |
| Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year | 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. |
| Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) | 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. |
| International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA | 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). |
| Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA | 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). |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Apixaban: Naive Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. | 4,712 |
| Apixaban: Non Naive Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. | 1,423 |
| Acenocoumarol: Naive Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. | 32,212 |
| Acenocoumarol: Non-Naive Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. | 192 |
| Warfarin: Naive Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. | 2,286 |
| Warfarin: Non Naive Participants who were treated with warfarin with prior prescription of different VKA, apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. | 363 |
| Dabigatran: Naive Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. | 2,855 |
| Dabigatran: Non-Naive Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. | 953 |
| Rivaroxaban: Naive Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. | 5,132 |
| Rivaroxaban: Non-Naive Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician. | 1,562 |
| Total | 51,690 |
Baseline characteristics
| Characteristic | Apixaban: Naive | Apixaban: Non Naive | Acenocoumarol: Naive | Acenocoumarol: Non-Naive | Warfarin: Naive | Warfarin: Non Naive | Dabigatran: Naive | Dabigatran: Non-Naive | Rivaroxaban: Naive | Rivaroxaban: Non-Naive | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 71.8 years STANDARD_DEVIATION 11.1 | 78.1 years STANDARD_DEVIATION 8.7 | 73.5 years STANDARD_DEVIATION 12.3 | 74.6 years STANDARD_DEVIATION 10.7 | 69.7 years STANDARD_DEVIATION 13.4 | 74.9 years STANDARD_DEVIATION 12.9 | 69.9 years STANDARD_DEVIATION 12.3 | 76.5 years STANDARD_DEVIATION 9.5 | 69.3 years STANDARD_DEVIATION 13.2 | 76.4 years STANDARD_DEVIATION 10.5 | 72.8 years STANDARD_DEVIATION 12.3 |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 2661 Participants | 751 Participants | 15531 Participants | 94 Participants | 979 Participants | 205 Participants | 1399 Participants | 479 Participants | 2649 Participants | 811 Participants | 25559 Participants |
| Sex: Female, Male Male | 2051 Participants | 672 Participants | 16681 Participants | 98 Participants | 1307 Participants | 158 Participants | 1456 Participants | 474 Participants | 2483 Participants | 751 Participants | 26131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)
NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.
Time frame: Up to 12 months after date of first prescription
Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here N signifies number of participants evaluable for the specified outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Apixaban: Naive | Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) | 15.0 milligrams per day |
| Apixaban: Non Naive | Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) | 30.0 milligrams per day |
| Acenocoumarol: Naive | Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) | 16.0 milligrams per day |
| Acenocoumarol: Non-Naive | Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) | 16.0 milligrams per day |
| Warfarin: Naive | Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) | 53.0 milligrams per day |
| Warfarin: Non-Naive | Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) | 16.0 milligrams per day |
| Dabigatran: Naive | Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) | 22.0 milligrams per day |
| Dabigatran: Non-Naive | Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) | 22.0 milligrams per day |
| Rivaroxaban: Naive | Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) | 21.0 milligrams per day |
| Rivaroxaban: Non-Naive | Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) | 28.0 milligrams per day |
Comparison: Dabigatran vs. Apixaban in naive participants (NDDDs)p-value: 095% CI: [3.02, 4.24]ANOVA
Comparison: Dabigatran vs. Apixaban in non-naive participants (NDDDs)p-value: 095% CI: [-0.77, 0.98]ANOVA
Comparison: Rivaroxaban vs. Apixaban in naive participants (NDDDs)p-value: 095% CI: [0.84, 2.17]ANOVA
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (NDDDs)p-value: 095% CI: [1.16, 2.8]ANOVA
Comparison: Acenocumarol vs. Apixaban in naive participants (NDDDs)p-value: 095% CI: [0.41, 1.39]ANOVA
Comparison: Acenocumarol vs. Apixaban in non-naive participants (NDDDs)p-value: 095% CI: [-4.32, -0.18]ANOVA
Comparison: Warfarin vs. Apixaban in naive participants (NDDDs)p-value: 095% CI: [27.56, 29.48]ANOVA
Comparison: Warfarin vs. Apixaban in non-naive participants (NDDDs)p-value: 095% CI: [-1.05, 4.9]ANOVA
Primary
International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
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).
Time frame: Up to 12 months after date of first prescription
Population: Study population included all participants with a first-recorded prescription of VKA for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here N signifies number of participants evaluable for the specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban: Naive | International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA | 2.5 ratio | Standard Deviation 0.4 |
| Apixaban: Non Naive | International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA | 2.5 ratio | Standard Deviation 0.4 |
| Acenocoumarol: Naive | International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA | 2.5 ratio | Standard Deviation 0.3 |
| Acenocoumarol: Non-Naive | International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA | 2.6 ratio | Standard Deviation 0.4 |
Primary
Number of Participants by Comedications
Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.
Time frame: Up to 30 days after date of first prescription
Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Apixaban: Naive | Number of Participants by Comedications | 4712 Participants |
| Apixaban: Non Naive | Number of Participants by Comedications | 1406 Participants |
| Acenocoumarol: Naive | Number of Participants by Comedications | 32212 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Comedications | 188 Participants |
| Warfarin: Naive | Number of Participants by Comedications | 2286 Participants |
| Warfarin: Non-Naive | Number of Participants by Comedications | 352 Participants |
| Dabigatran: Naive | Number of Participants by Comedications | 2855 Participants |
| Dabigatran: Non-Naive | Number of Participants by Comedications | 947 Participants |
| Rivaroxaban: Naive | Number of Participants by Comedications | 5132 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Comedications | 1532 Participants |
Comparison: Dabigatran vs. Apixaban in non-naive participantsp-value: 0.00895% CI: [0.77, 5.3]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participantsp-value: 0.00895% CI: [0.33, 1.12]Chi-squared
Comparison: Acenocumarol vs. Apixaban in non-naive participantsp-value: 0.00895% CI: [0.2, 1.99]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participantsp-value: 0.00895% CI: [0.18, 0.86]Chi-squared
Primary
Number of Participants by Comorbidity
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.
Time frame: Up to 12 months after date of first prescription
Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Apixaban: Naive | Number of Participants by Comorbidity | 3695 Participants |
| Apixaban: Non Naive | Number of Participants by Comorbidity | 1316 Participants |
| Acenocoumarol: Naive | Number of Participants by Comorbidity | 26450 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Comorbidity | 173 Participants |
| Warfarin: Naive | Number of Participants by Comorbidity | 1819 Participants |
| Warfarin: Non-Naive | Number of Participants by Comorbidity | 318 Participants |
| Dabigatran: Naive | Number of Participants by Comorbidity | 2030 Participants |
| Dabigatran: Non-Naive | Number of Participants by Comorbidity | 870 Participants |
| Rivaroxaban: Naive | Number of Participants by Comorbidity | 3731 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Comorbidity | 1417 Participants |
Comparison: Dabigatran vs. Apixaban in naive participantsp-value: 095% CI: [0.61, 0.75]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participantsp-value: 0.05295% CI: [0.63, 1.15]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participantsp-value: 095% CI: [0.67, 0.8]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participantsp-value: 0.05295% CI: [0.61, 1.03]Chi-squared
Comparison: Acenocumarol vs. Apixaban in naive participantsp-value: 095% CI: [1.17, 1.36]Chi-squared
Comparison: Acenocumarol vs. Apixaban in non-naive participantsp-value: 0.05295% CI: [0.45, 1.27]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participantsp-value: 095% CI: [0.95, 1.21]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participantsp-value: 0.05295% CI: [0.4, 0.84]Chi-squared
Primary
Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.
Time frame: Day 1
Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Missing | 2162 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | No intake | 1749 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Moderate intake | 765 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Risk consumption | 36 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | No intake | 810 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Missing | 353 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Risk consumption | 13 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Moderate intake | 247 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | No intake | 14337 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Missing | 11299 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Moderate intake | 6241 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Risk consumption | 335 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Missing | 40 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | No intake | 111 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Moderate intake | 39 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Risk consumption | 2 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Moderate intake | 447 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | No intake | 984 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Risk consumption | 16 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Missing | 839 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Moderate intake | 58 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | No intake | 212 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Missing | 91 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Risk consumption | 2 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | No intake | 1054 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Moderate intake | 505 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Risk consumption | 33 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Missing | 1263 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Missing | 211 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Risk consumption | 5 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | No intake | 550 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Moderate intake | 187 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Risk consumption | 46 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Missing | 2475 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Moderate intake | 915 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | No intake | 1696 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Moderate intake | 255 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Missing | 366 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | Risk consumption | 18 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit | No intake | 923 Participants |
Comparison: Dabigatran vs. Apixaban in naive participants (No intake)p-value: 095% CI: [0.9, 1.09]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (Moderate intake)p-value: 095% CI: [0.98, 1.25]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (Risk consumption)p-value: 0.16495% CI: [0.94, 2.45]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (No intake)p-value: 0.82695% CI: [0.87, 1.22]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Moderate intake)p-value: 0.1995% CI: [0.94, 1.43]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Risk consumption)p-value: 0.52695% CI: [0.18, 1.57]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (No intake)p-value: 095% CI: [0.77, 0.91]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Moderate intake)p-value: 095% CI: [1.01, 1.24]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Risk consumption)p-value: 0.16495% CI: [0.76, 1.83]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (No intake)p-value: 0.82695% CI: [0.95, 1.26]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Moderate intake)p-value: 0.1995% CI: [0.77, 1.13]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Risk consumption)p-value: 0.52695% CI: [0.62, 2.65]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (No intake)p-value: 095% CI: [1.28, 1.45]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (Moderate intake)p-value: 095% CI: [1.14, 1.35]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (Risk consumption)p-value: 0.16495% CI: [0.98, 1.95]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (No intake)p-value: 0.82695% CI: [0.76, 1.41]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (Moderate intake)p-value: 0.1995% CI: [0.82, 1.76]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (Risk consumption)p-value: 0.52695% CI: [0.17, 4.5]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (No intake)p-value: 095% CI: [1.16, 1.42]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Moderate intake)p-value: 095% CI: [1.1, 1.43]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Risk consumption)p-value: 0.16495% CI: [0.49, 1.64]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (No intake)p-value: 0.82695% CI: [0.84, 1.34]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Moderate intake)p-value: 0.1995% CI: [0.66, 1.23]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Risk consumption)p-value: 0.52695% CI: [0.09, 2.36]Chi-squared
Primary
Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)
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).
Time frame: Day 1
Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Less than (<) 18.5 kg per m^2 (Underweight) | 12 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 25 - 30 kg per m^2 (Overweight) | 1229 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Missing | 1424 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 18.5 - 25 kg per m^2 (Normal) | 423 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Greater than (>) 30 kg per m^2 (Obese) | 1624 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Less than (<) 18.5 kg per m^2 (Underweight) | 6 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 18.5 - 25 kg per m^2 (Normal) | 253 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Greater than (>) 30 kg per m^2 (Obese) | 410 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Missing | 261 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 25 - 30 kg per m^2 (Overweight) | 493 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 18.5 - 25 kg per m^2 (Normal) | 4471 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Greater than (>) 30 kg per m^2 (Obese) | 10628 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 25 - 30 kg per m^2 (Overweight) | 10074 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Missing | 6898 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Less than (<) 18.5 kg per m^2 (Underweight) | 141 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Greater than (>) 30 kg per m^2 (Obese) | 60 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Less than (<) 18.5 kg per m^2 (Underweight) | 0 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 25 - 30 kg per m^2 (Overweight) | 68 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 18.5 - 25 kg per m^2 (Normal) | 30 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Missing | 34 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 18.5 - 25 kg per m^2 (Normal) | 295 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Missing | 509 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Greater than (>) 30 kg per m^2 (Obese) | 764 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 25 - 30 kg per m^2 (Overweight) | 712 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Less than (<) 18.5 kg per m^2 (Underweight) | 6 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 25 - 30 kg per m^2 (Overweight) | 119 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Missing | 87 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Less than (<) 18.5 kg per m^2 (Underweight) | 2 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 18.5 - 25 kg per m^2 (Normal) | 78 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Greater than (>) 30 kg per m^2 (Obese) | 77 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Less than (<) 18.5 kg per m^2 (Underweight) | 10 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 25 - 30 kg per m^2 (Overweight) | 735 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Missing | 960 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 18.5 - 25 kg per m^2 (Normal) | 272 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Greater than (>) 30 kg per m^2 (Obese) | 878 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Missing | 178 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Less than (<) 18.5 kg per m^2 (Underweight) | 8 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 25 - 30 kg per m^2 (Overweight) | 306 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Greater than (>) 30 kg per m^2 (Obese) | 317 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 18.5 - 25 kg per m^2 (Normal) | 144 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 18.5 - 25 kg per m^2 (Normal) | 464 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 25 - 30 kg per m^2 (Overweight) | 1289 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Less than (<) 18.5 kg per m^2 (Underweight) | 16 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Missing | 1746 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Greater than (>) 30 kg per m^2 (Obese) | 1617 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Greater than (>) 30 kg per m^2 (Obese) | 498 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 25 - 30 kg per m^2 (Overweight) | 482 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | 18.5 - 25 kg per m^2 (Normal) | 271 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Less than (<) 18.5 kg per m^2 (Underweight) | 0 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) | Missing | 311 Participants |
Comparison: Dabigatran vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)p-value: 095% CI: [0.91, 1.25]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)p-value: 0.20295% CI: [0.58, 3.23]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)p-value: 095% CI: [0.88, 1.09]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)p-value: 0.00395% CI: [0.76, 0.93]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)p-value: 0.08395% CI: [0.66, 1.03]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)p-value: 0.01195% CI: [0.68, 6.18]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)p-value: 0.22795% CI: [0.75, 1.06]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)p-value: 095% CI: [1.03, 1.47]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)p-value: 095% CI: [0.88, 1.16]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)p-value: 0.20295% CI: [0.58, 2.66]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)p-value: 095% CI: [0.87, 1.04]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)p-value: 0.00395% CI: [0.8, 0.95]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)p-value: 0.08395% CI: [0.8, 1.17]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)p-value: 0.01195% CI: [0.02, 1.05]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)p-value: 0.22795% CI: [0.72, 0.98]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)p-value: 095% CI: [0.99, 1.35]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)p-value: 095% CI: [1.47, 1.82]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)p-value: 0.20295% CI: [0.98, 3.25]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)p-value: 095% CI: [1.2, 1.38]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)p-value: 0.00395% CI: [0.88, 1]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)p-value: 0.08395% CI: [0.56, 1.28]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)p-value: 0.01195% CI: [0.13, 8.58]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)p-value: 0.22795% CI: [0.75, 1.42]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)p-value: 095% CI: [0.81, 1.55]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)p-value: 095% CI: [1.28, 1.76]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)p-value: 0.20295% CI: [0.36, 2.73]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)p-value: 095% CI: [1.15, 1.43]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)p-value: 0.00395% CI: [0.86, 1.06]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)p-value: 0.08395% CI: [0.95, 1.68]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)p-value: 0.01195% CI: [0.18, 6.21]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)p-value: 0.22795% CI: [0.72, 1.17]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)p-value: 095% CI: [0.5, 0.87]Chi-squared
Primary
Number of Participants by Their Sociodemographic Characteristics: MEDEA
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.
Time frame: Day 1
Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here, Overall Number of Participants Analyzed (N) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 2 - Urban area | 754 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 4 - Urban area | 807 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 1 - Urban area | 716 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 3 - Urban area | 825 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 5 - Urban area | 735 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Missing - Urban area | 190 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Missing - Urban area | 90 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 1 - Urban area | 224 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 2 - Urban area | 216 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 3 - Urban area | 256 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 4 - Urban area | 231 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 5 - Urban area | 193 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 2 - Urban area | 4753 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 1 - Urban area | 4735 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 4 - Urban area | 4744 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 3 - Urban area | 4801 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Missing - Urban area | 1754 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 5 - Urban area | 4690 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Missing - Urban area | 16 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 5 - Urban area | 27 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 3 - Urban area | 27 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 4 - Urban area | 28 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 1 - Urban area | 31 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 2 - Urban area | 25 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 3 - Urban area | 606 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 1 - Urban area | 149 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 5 - Urban area | 338 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Missing - Urban area | 120 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 2 - Urban area | 315 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 4 - Urban area | 635 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 4 - Urban area | 55 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 2 - Urban area | 73 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Missing - Urban area | 28 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 5 - Urban area | 41 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 1 - Urban area | 73 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 3 - Urban area | 52 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 3 - Urban area | 447 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 1 - Urban area | 558 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Missing - Urban area | 110 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 2 - Urban area | 461 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 4 - Urban area | 429 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 5 - Urban area | 388 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 2 - Urban area | 148 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 5 - Urban area | 139 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 1 - Urban area | 156 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 3 - Urban area | 137 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Missing - Urban area | 57 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 4 - Urban area | 152 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 1 - Urban area | 973 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 2 - Urban area | 803 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 5 - Urban area | 683 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 4 - Urban area | 837 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Missing - Urban area | 230 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 3 - Urban area | 904 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 1 - Urban area | 230 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Missing - Urban area | 145 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 5 - Urban area | 250 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 4 - Urban area | 300 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 2 - Urban area | 234 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: MEDEA | Quintile 3 - Urban area | 230 Participants |
Comparison: Dabigatran vs. Apixaban in naive participants (Quintile 1 - Urban area)p-value: 095% CI: [1.2, 1.53]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (Quintile 2 - Urban area)p-value: 0.01495% CI: [0.89, 1.15]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (Quintile 3 - Urban area)p-value: 095% CI: [0.77, 0.99]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (Quintile 4 - Urban area)p-value: 095% CI: [0.75, 0.97]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (Quintile 5 - Urban area)p-value: 0.01395% CI: [0.74, 0.97]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Quintile 1 - Urban area)p-value: 0.15795% CI: [0.84, 1.31]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Quintile 2 - Urban area)p-value: 0.12495% CI: [0.82, 1.29]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Quintile 3 - Urban area)p-value: 0.06295% CI: [0.61, 0.96]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Quintile 4 - Urban area)p-value: 0.07995% CI: [0.78, 1.22]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Quintile 5 - Urban area)p-value: 0.1495% CI: [0.86, 1.38]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Quintile 1 - Urban area)p-value: 095% CI: [1.17, 1.45]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Quintile 2 - Urban area)p-value: 0.01495% CI: [0.87, 1.09]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Quintile 3 - Urban area)p-value: 095% CI: [0.91, 1.12]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Quintile 4 - Urban area)p-value: 095% CI: [0.85, 1.05]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Quintile 5 - Urban area)p-value: 0.01395% CI: [0.74, 0.93]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Quintile 1 - Urban area)p-value: 0.15795% CI: [0.76, 1.13]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Quintile 2 - Urban area)p-value: 0.12495% CI: [0.81, 1.2]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Quintile 3 - Urban area)p-value: 0.06295% CI: [0.65, 0.96]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Quintile 4 - Urban area)p-value: 0.07995% CI: [1.02, 1.48]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Quintile 5 - Urban area)p-value: 0.1495% CI: [0.99, 1.49]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (Quintile 1 - Urban area)p-value: 095% CI: [0.88, 1.05]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (Quintile 2 - Urban area)p-value: 0.01495% CI: [0.84, 0.99]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (Quintile 3 - Urban area)p-value: 095% CI: [0.76, 0.9]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (Quintile 4 - Urban area)p-value: 095% CI: [0.77, 0.91]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (Quintile 5 - Urban area)p-value: 0.01395% CI: [0.85, 1]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (Quintile 1 - Urban area)p-value: 0.15795% CI: [0.68, 1.54]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (Quintile 2 - Urban area)p-value: 0.12495% CI: [0.53, 1.29]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (Quintile 3 - Urban area)p-value: 0.06295% CI: [0.48, 1.13]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (Quintile 4 - Urban area)p-value: 0.07995% CI: [0.57, 1.33]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (Quintile 5 - Urban area)p-value: 0.1495% CI: [0.67, 1.59]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Quintile 1 - Urban area)p-value: 095% CI: [0.32, 0.47]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Quintile 2 - Urban area)p-value: 0.01495% CI: [0.73, 0.97]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Quintile 3 - Urban area)p-value: 095% CI: [1.51, 1.91]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Quintile 4 - Urban area)p-value: 095% CI: [1.65, 2.1]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Quintile 5 - Urban area)p-value: 0.01395% CI: [0.82, 1.08]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Quintile 1 - Urban area)p-value: 0.15795% CI: [1, 1.8]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Quintile 2 - Urban area)p-value: 0.12495% CI: [1.04, 1.88]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Quintile 3 - Urban area)p-value: 0.06295% CI: [0.55, 1.05]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Quintile 4 - Urban area)p-value: 0.07995% CI: [0.67, 1.26]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Quintile 5 - Urban area)p-value: 0.1495% CI: [0.56, 1.15]Chi-squared
Primary
Number of Participants by Their Sociodemographic Characteristics: Smoking Habit
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.
Time frame: Day 1
Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Smoker | 942 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Ex-smoker | 459 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Missing | 207 Participants |
| Apixaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Non-smoker | 3104 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Smoker | 371 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Ex-smoker | 83 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Non-smoker | 946 Participants |
| Apixaban: Non Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Missing | 23 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Ex-smoker | 3676 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Non-smoker | 19440 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Smoker | 7252 Participants |
| Acenocoumarol: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Missing | 1844 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Non-smoker | 119 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Smoker | 50 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Missing | 7 Participants |
| Acenocoumarol: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Ex-smoker | 16 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Non-smoker | 1166 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Ex-smoker | 320 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Smoker | 688 Participants |
| Warfarin: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Missing | 112 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Missing | 14 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Non-smoker | 234 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Ex-smoker | 26 Participants |
| Warfarin: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Smoker | 89 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Ex-smoker | 355 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Non-smoker | 1684 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Smoker | 591 Participants |
| Dabigatran: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Missing | 225 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Missing | 23 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Non-smoker | 623 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Smoker | 235 Participants |
| Dabigatran: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Ex-smoker | 72 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Ex-smoker | 608 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Missing | 354 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Smoker | 1091 Participants |
| Rivaroxaban: Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Non-smoker | 3079 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Non-smoker | 1030 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Smoker | 392 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Ex-smoker | 102 Participants |
| Rivaroxaban: Non-Naive | Number of Participants by Their Sociodemographic Characteristics: Smoking Habit | Missing | 38 Participants |
Comparison: Dabigatran vs. Apixaban in naive participants (Non-smoker)p-value: 095% CI: [0.68, 0.82]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (Ex-smoker)p-value: 095% CI: [1.14, 1.52]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (Smoker)p-value: 095% CI: [0.93, 1.17]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Non-smoker)p-value: 0.75595% CI: [0.8, 1.13]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Ex-smoker)p-value: 0.42695% CI: [0.95, 1.83]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Smoker)p-value: 0.9395% CI: [0.77, 1.12]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Non-smoker)p-value: 095% CI: [0.72, 0.84]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Ex-smoker)p-value: 095% CI: [1.1, 1.42]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Smoker)p-value: 095% CI: [0.98, 1.19]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Non-smoker)p-value: 0.75595% CI: [0.84, 1.14]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Ex-smoker)p-value: 0.42695% CI: [0.84, 1.52]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Smoker)p-value: 0.9395% CI: [0.81, 1.12]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (Non-smoker)p-value: 095% CI: [0.74, 0.84]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (Ex-smoker)p-value: 095% CI: [1.08, 1.32]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in naive participants (Smoker)p-value: 095% CI: [1.08, 1.26]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (Non-smoker)p-value: 0.75595% CI: [0.6, 1.13]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (Ex-smoker)p-value: 0.42695% CI: [0.82, 2.52]Chi-squared
Comparison: Acenocoumarol vs. Apixaban in non-naive participants (Smoker)p-value: 0.9395% CI: [0.7, 1.4]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Non-smoker)p-value: 095% CI: [0.49, 0.6]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Ex-smoker)p-value: 095% CI: [1.29, 1.76]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Smoker)p-value: 095% CI: [1.54, 1.93]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Non-smoker)p-value: 0.75595% CI: [0.72, 1.17]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Ex-smoker)p-value: 0.42695% CI: [0.78, 1.95]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Smoker)p-value: 0.9395% CI: [0.7, 1.2]Chi-squared
Primary
Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year
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.
Time frame: Up to 12 months after date of first prescription
Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here N signifies number of participants evaluable for the specified outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Apixaban: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year | 881 Participants |
| Apixaban: Non Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year | 236 Participants |
| Acenocoumarol: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year | 11326 Participants |
| Acenocoumarol: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year | 85 Participants |
| Warfarin: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year | 1009 Participants |
| Warfarin: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year | 127 Participants |
| Dabigatran: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year | 1002 Participants |
| Dabigatran: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year | 248 Participants |
| Rivaroxaban: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year | 1191 Participants |
| Rivaroxaban: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year | 322 Participants |
Comparison: Dabigatran vs. Apixaban in naive participants (Discontinuation first year)p-value: 095% CI: [0.92, 1.27]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Discontinuation first year)p-value: 095% CI: [1.15, 1.83]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Discontinuation first year)p-value: 095% CI: [0.93, 1.27]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Discontinuation first year)p-value: 095% CI: [0.96, 1.47]Chi-squared
Comparison: Acenocumarol vs. Apixaban in naive participants (Discontinuation first year)p-value: 095% CI: [0.79, 1.01]Chi-squared
Comparison: Acenocumarol vs. Apixaban in non-naive participants (Discontinuation first year)p-value: 095% CI: [3.14, 7.55]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Discontinuation first year)p-value: 095% CI: [1.19, 1.67]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Discontinuation first year)p-value: 095% CI: [2.12, 4.05]Chi-squared
Primary
Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR)
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.
Time frame: Up to 12 months after date of first prescription
Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here N signifies number of participants evaluable for the specified outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apixaban: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Poor adherence | 162 Participants |
| Apixaban: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Good adherence | 259 Participants |
| Apixaban: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Over adherence | 3 Participants |
| Apixaban: Non Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Good adherence | 276 Participants |
| Apixaban: Non Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Over adherence | 3 Participants |
| Apixaban: Non Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Poor adherence | 151 Participants |
| Acenocoumarol: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Over adherence | 14 Participants |
| Acenocoumarol: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Poor adherence | 5634 Participants |
| Acenocoumarol: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Good adherence | 460 Participants |
| Acenocoumarol: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Over adherence | 1 Participants |
| Acenocoumarol: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Poor adherence | 31 Participants |
| Acenocoumarol: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Good adherence | 0 Participants |
| Warfarin: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Over adherence | 90 Participants |
| Warfarin: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Good adherence | 151 Participants |
| Warfarin: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Poor adherence | 103 Participants |
| Warfarin: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Over adherence | 9 Participants |
| Warfarin: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Poor adherence | 57 Participants |
| Warfarin: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Good adherence | 13 Participants |
| Dabigatran: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Poor adherence | 241 Participants |
| Dabigatran: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Over adherence | 0 Participants |
| Dabigatran: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Good adherence | 206 Participants |
| Dabigatran: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Poor adherence | 177 Participants |
| Dabigatran: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Good adherence | 133 Participants |
| Dabigatran: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Over adherence | 1 Participants |
| Rivaroxaban: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Over adherence | 2 Participants |
| Rivaroxaban: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Poor adherence | 147 Participants |
| Rivaroxaban: Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Good adherence | 378 Participants |
| Rivaroxaban: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Poor adherence | 131 Participants |
| Rivaroxaban: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Over adherence | 4 Participants |
| Rivaroxaban: Non-Naive | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) | MPR: Good adherence | 360 Participants |
Comparison: Dabigatran vs. Apixaban in naive participants (Poor adherence)p-value: 095% CI: [1.14, 1.75]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (Good adherence)p-value: 095% CI: [0.55, 0.82]Chi-squared
Comparison: Dabigatran vs. Apixaban in naive participants (Over adherence)p-value: 095% CI: [0.03, 2.01]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Poor adherence)p-value: 095% CI: [1.23, 2.04]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Good adherence)p-value: 095% CI: [0.34, 0.57]Chi-squared
Comparison: Dabigatran vs. Apixaban in non-naive participants (Over adherence)p-value: 095% CI: [0.02, 3.73]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Poor adherence)p-value: 095% CI: [0.52, 0.84]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Good adherence)p-value: 095% CI: [0.95, 1.36]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in naive participants (Over adherence)p-value: 095% CI: [0.06, 3.41]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Poor adherence)p-value: 095% CI: [0.5, 0.85]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Good adherence)p-value: 095% CI: [0.9, 1.37]Chi-squared
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (Over adherence)p-value: 095% CI: [0.22, 5.85]Chi-squared
Comparison: Acenocumarol vs. Apixaban in naive participants (Poor adherence)p-value: 095% CI: [2.86, 3.99]Chi-squared
Comparison: Acenocumarol vs. Apixaban in naive participants (Good adherence)p-value: 095% CI: [0.09, 0.13]Chi-squared
Comparison: Acenocumarol vs. Apixaban in naive participants (Over adherence)p-value: 095% CI: [0.11, 1.52]Chi-squared
Comparison: Acenocumarol vs. Apixaban in non-naive participants (Poor adherence)p-value: 095% CI: [0.78, 1.91]Chi-squared
Comparison: Acenocumarol vs. Apixaban in non-naive participants (Good adherence)p-value: 095% CI: [0, 0.09]Chi-squared
Comparison: Acenocumarol vs. Apixaban in non-naive participants (Over adherence)p-value: 095% CI: [0.07, 18]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Poor adherence)p-value: 095% CI: [0.45, 0.75]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Good adherence)p-value: 095% CI: [0.41, 0.63]Chi-squared
Comparison: Warfarin vs. Apixaban in naive participants (Over adherence)p-value: 095% CI: [11.01, 123.8]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Poor adherence)p-value: 095% CI: [0.91, 1.86]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Good adherence)p-value: 095% CI: [0.05, 0.17]Chi-squared
Comparison: Warfarin vs. Apixaban in non-naive participants (Over adherence)p-value: 095% CI: [2.81, 46.5]Chi-squared
Primary
Risk of Bleeding Events: HAS-BLED Score
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.
Time frame: Up to 12 months prior to enrollment
Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban: Naive | Risk of Bleeding Events: HAS-BLED Score | 1.7 bleed per 100 participants-year | Standard Deviation 1 |
| Apixaban: Non Naive | Risk of Bleeding Events: HAS-BLED Score | 2.7 bleed per 100 participants-year | Standard Deviation 1.1 |
| Acenocoumarol: Naive | Risk of Bleeding Events: HAS-BLED Score | 2.2 bleed per 100 participants-year | Standard Deviation 1.1 |
| Acenocoumarol: Non-Naive | Risk of Bleeding Events: HAS-BLED Score | 2.5 bleed per 100 participants-year | Standard Deviation 1 |
| Warfarin: Naive | Risk of Bleeding Events: HAS-BLED Score | 1.9 bleed per 100 participants-year | Standard Deviation 1.1 |
| Warfarin: Non-Naive | Risk of Bleeding Events: HAS-BLED Score | 2.4 bleed per 100 participants-year | Standard Deviation 1.2 |
| Dabigatran: Naive | Risk of Bleeding Events: HAS-BLED Score | 1.5 bleed per 100 participants-year | Standard Deviation 1 |
| Dabigatran: Non-Naive | Risk of Bleeding Events: HAS-BLED Score | 2.6 bleed per 100 participants-year | Standard Deviation 1 |
| Rivaroxaban: Naive | Risk of Bleeding Events: HAS-BLED Score | 1.6 bleed per 100 participants-year | Standard Deviation 1 |
| Rivaroxaban: Non-Naive | Risk of Bleeding Events: HAS-BLED Score | 2.6 bleed per 100 participants-year | Standard Deviation 1.1 |
Comparison: Dabigatran vs. Apixaban in naive participants (HAS - BLED)p-value: 095% CI: [-0.26, -0.17]ANOVA
Comparison: Dabigatran vs. Apixaban in non-naive participants (HAS - BLED)p-value: 0.00195% CI: [-0.18, -0.01]ANOVA
Comparison: Rivaroxaban vs. Apixaban in naive participants (HAS - BLED)p-value: 095% CI: [-0.23, -0.15]ANOVA
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (HAS - BLED)p-value: 0.00195% CI: [-0.19, -0.04]ANOVA
Comparison: Acenocumarol vs. Apixaban in naive participants (HAS - BLED)p-value: 095% CI: [0.47, 0.53]ANOVA
Comparison: Acenocumarol vs. Apixaban in non-naive participants (HAS - BLED)p-value: 0.00195% CI: [-0.32, -0.02]ANOVA
Comparison: Warfarin vs. Apixaban in naive participants (HAS - BLED)p-value: 095% CI: [0.12, 0.23]ANOVA
Comparison: Warfarin vs. Apixaban in non-naive participants (HAS - BLED)p-value: 0.00195% CI: [-0.37, -0.1]ANOVA
Primary
Risk of Thromboembolic Events: CHA2DS2Vasc Score
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.
Time frame: Up to 12 months prior to enrollment
Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban: Naive | Risk of Thromboembolic Events: CHA2DS2Vasc Score | 3.0 stroke risk per year | Standard Deviation 1.7 |
| Apixaban: Non Naive | Risk of Thromboembolic Events: CHA2DS2Vasc Score | 4.4 stroke risk per year | Standard Deviation 1.6 |
| Acenocoumarol: Naive | Risk of Thromboembolic Events: CHA2DS2Vasc Score | 3.2 stroke risk per year | Standard Deviation 1.7 |
| Acenocoumarol: Non-Naive | Risk of Thromboembolic Events: CHA2DS2Vasc Score | 3.7 stroke risk per year | Standard Deviation 1.6 |
| Warfarin: Naive | Risk of Thromboembolic Events: CHA2DS2Vasc Score | 2.9 stroke risk per year | Standard Deviation 1.8 |
| Warfarin: Non-Naive | Risk of Thromboembolic Events: CHA2DS2Vasc Score | 3.9 stroke risk per year | Standard Deviation 1.9 |
| Dabigatran: Naive | Risk of Thromboembolic Events: CHA2DS2Vasc Score | 2.7 stroke risk per year | Standard Deviation 1.8 |
| Dabigatran: Non-Naive | Risk of Thromboembolic Events: CHA2DS2Vasc Score | 4.0 stroke risk per year | Standard Deviation 1.7 |
| Rivaroxaban: Naive | Risk of Thromboembolic Events: CHA2DS2Vasc Score | 2.7 stroke risk per year | Standard Deviation 1.7 |
| Rivaroxaban: Non-Naive | Risk of Thromboembolic Events: CHA2DS2Vasc Score | 4.1 stroke risk per year | Standard Deviation 1.7 |
Comparison: Dabigatran vs. Apixaban in naive participants (CHA2DS2Vasc)p-value: 095% CI: [-0.42, -0.26]ANOVA
Comparison: Dabigatran vs. Apixaban in non-naive participants (CHA2DS2Vasc)p-value: 095% CI: [-0.46, -0.19]ANOVA
Comparison: Rivaroxaban vs. Apixaban in naive participants (CHA2DS2Vasc)p-value: 095% CI: [-0.45, -0.32]ANOVA
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (CHA2DS2Vasc)p-value: 095% CI: [-0.39, -0.15]ANOVA
Comparison: Acenocumarol vs. Apixaban in naive participants (CHA2DS2Vasc)p-value: 095% CI: [0.14, 0.24]ANOVA
Comparison: Acenocumarol vs. Apixaban in non-naive participants (CHA2DS2Vasc)p-value: 095% CI: [-0.86, -0.37]ANOVA
Comparison: Warfarin vs. Apixaban in naive participants (CHA2DS2Vasc)p-value: 095% CI: [-0.18, -0.01]ANOVA
Comparison: Warfarin vs. Apixaban in non-naive participants (CHA2DS2Vasc)p-value: 095% CI: [-0.64, -0.21]ANOVA
Primary
Risk of Thromboembolic Events: CHADS2 Score
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.
Time frame: Up to 12 months prior to enrollment
Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban: Naive | Risk of Thromboembolic Events: CHADS2 Score | 1.7 stroke risk per year | Standard Deviation 1.3 |
| Apixaban: Non Naive | Risk of Thromboembolic Events: CHADS2 Score | 2.8 stroke risk per year | Standard Deviation 1.4 |
| Acenocoumarol: Naive | Risk of Thromboembolic Events: CHADS2 Score | 1.9 stroke risk per year | Standard Deviation 1.3 |
| Acenocoumarol: Non-Naive | Risk of Thromboembolic Events: CHADS2 Score | 2.3 stroke risk per year | Standard Deviation 1.3 |
| Warfarin: Naive | Risk of Thromboembolic Events: CHADS2 Score | 1.8 stroke risk per year | Standard Deviation 1.3 |
| Warfarin: Non-Naive | Risk of Thromboembolic Events: CHADS2 Score | 2.5 stroke risk per year | Standard Deviation 1.5 |
| Dabigatran: Naive | Risk of Thromboembolic Events: CHADS2 Score | 1.5 stroke risk per year | Standard Deviation 1.3 |
| Dabigatran: Non-Naive | Risk of Thromboembolic Events: CHADS2 Score | 2.6 stroke risk per year | Standard Deviation 1.4 |
| Rivaroxaban: Naive | Risk of Thromboembolic Events: CHADS2 Score | 1.5 stroke risk per year | Standard Deviation 1.2 |
| Rivaroxaban: Non-Naive | Risk of Thromboembolic Events: CHADS2 Score | 2.6 stroke risk per year | Standard Deviation 1.4 |
Comparison: Dabigatran vs. Apixaban in naive participants (CHADS2)p-value: 095% CI: [-0.24, -0.12]ANOVA
Comparison: Dabigatran vs. Apixaban in non-naive participants (CHADS2)p-value: 095% CI: [-0.35, -0.12]ANOVA
Comparison: Rivaroxaban vs. Apixaban in naive participants (CHADS2)p-value: 095% CI: [-0.28, -0.18]ANOVA
Comparison: Rivaroxaban vs. Apixaban in non-naive participants (CHADS2)p-value: 095% CI: [-0.31, -0.11]ANOVA
Comparison: Acenocumarol vs. Apixaban in naive participants (CHADS2)p-value: 095% CI: [0.17, 0.25]ANOVA
Comparison: Acenocumarol vs. Apixaban in non-naive participants (CHADS2)p-value: 095% CI: [-0.7, -0.3]ANOVA
Comparison: Warfarin vs. Apixaban in naive participants (CHADS2)p-value: 095% CI: [0.01, 0.14]ANOVA
Comparison: Warfarin vs. Apixaban in non-naive participants (CHADS2)p-value: 095% CI: [-0.54, -0.2]ANOVA
Primary
Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
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).
Time frame: Up to 12 months after date of first prescription
Population: Study population included all participants with a first-recorded prescription of VKA for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here N signifies number of participants evaluable for the specified outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Apixaban: Naive | Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA | 60.2 days |
| Apixaban: Non Naive | Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA | 59.6 days |
| Acenocoumarol: Naive | Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA | 66.2 days |
| Acenocoumarol: Non-Naive | Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA | 58.9 days |