Atrial Fibrillation
Conditions
Keywords
oral anticoagulants, apixaban, rivaroxaban, dabigatran, warfarin, non valvular atrial fibrillation
Brief summary
The study aim to assess demographic and clinical characteristics , treatment patterns and as exploratory analysis will descriptively assess the time to clinical events of NVAF patients treated with oral anticoagulants (OACs) in Colombia through observational, descriptive study of a retrospective cohort of adult patients diagnosed with NVAF in selected Health Maintenance Organizations (HMO) of Colombia. The information will be used in the study comes exclusively form secondary sources: claim databases and medical records.
Detailed description
The study has the following primary objectives: * To assess demographic and clinical characteristics of NVAF patients treated with oral anticoagulants (OACs) in Colombia. * To describe treatment patterns (eg OAC usage,dose, concomitant medications, persistance) And as exploratory analysis to descriptively assess the time to clinical events (Effectiveness and Safety Outcomes) among patients persistent on OAC therapy It is an observational, descriptive study of a retrospective cohort of adult patients diagnosed with NVAF in selected Health Maintenance Organizations (HMO) of Colombia. These patients will be identified from the drug claim database, whose index date of the study will be the first prescription with any of the oral anticoagulants, that is, they are patients with NVAF for the first time starting a therapy with any of the NOACs between January 1, 2013 and June 30, 2018 and follow up period will be among January 2013 to July 2019, to ensure that the last patients can provide follow-up for one year. Patients will be required to have an NVAF diagnosis before or on the index date and health plan for 6 months pre-index date (baseline period). Colombia. The information will be used in the study comes exclusively form secondary sources: claim databases and medical records.
Interventions
None listed
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
* Patients with a diagnosis of AF considered according to the following diagnoses as per the 10th revision of the International classification of diseases (ICD-10) I48 codes at some point before or on the index date, without recorded valvular disease; * Patients who have started treatment with apixaban, dabigatran, rivaroxaban and warfarin for the first time during the identification period, understanding as start of drug delivery by insurer, and after the diagnosis of AF between January 1, 2013 to June 30, 2018; * Patients starting apixaban, dabigatran, rivaroxaban from January 1, 2013 to June 30, 2018 in patients previously exposed to warfarin; * Patient had continuous health plan enrolment for 6 months pre-index date (baseline period); * Patients older than 18 years old on the index date; * NVAF diagnosis before or on the index date.
Exclusion criteria
* Patients with any of the following diagnoses prior to the use of the treatments of interest or index date: * Valvular heart disease or valve replacement - ICD-10 codes: I05, I06, I07, I08, I09, I21, I22, I34, I35, I36, I37, I38, I39, I700, I702-I709; Q22, Q23, Q25, T82, Z95 * Pregnancy during the study period. ICD-10 O00-O9A * Diagnosis of venous thromboembolism (VTE) - ICD-10 codes: I26, I80 - I82; * Individuals with a transitory diagnosis of NVAF prior to the use of the treatments of interest or index date; * Exposure to more than one OAC on or after the index date, during the follow-up period; * NOAC doses different from those recommended by the manufacturing laboratories.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Diagnose NVAF by Each OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Comorbidities | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Participants classified according to the comorbidities they had were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. One participant may have more than one comorbidity. |
| Number of Participants With Uncontrolled Hypertension at OAC Prescription Date | At index date (any time between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Use of Aspirin at Start OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Use of Clopidogrel at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. In this study Aspirin was not considered as NSAID due to doses used in Colombia. |
| HAS-BLED Score at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | The risk of bleeding in participants was assessed using Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INR, Elderly, (age \>65 years), Drugs or alcohol (HAS-BLED) score. Score ranged from 0 to 8 with higher scores indicating greater risk of bleeding. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| CHA2DS2-VASc Score at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | The CHA2DS2-VASc scale is an evaluation of stroke risk in participants with atrial fibrillation. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score , with total scores ranging from 0 to 9, with low scores indicating low risk for stroke, and high scores indicating high risk for stroke. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Anemia at Start of OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Stroke | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Duration of Follow-up in Participants With Stroke | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants According to Type of Stroke | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Number of participants with type of stroke classified as either ischemic cerebrovascular event or hemorrhagic cerebrovascular event were reported in this outcome measure. Participants who reported cerebral infarction, stroke: not specified as hemorrhage or infarction in their medical history during the follow-up period were classified under ischemic cerebrovascular event and participants who reported subarachnoid hemorrhage, intracerebral hemorrhage and other nontraumatic intracranial hemorrhage in their medical record were classified under hemorrhagic stroke. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Pulmonary Embolism | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | The number of participants who had pulmonary embolism were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Duration of Follow-up in Participants With Pulmonary Embolism | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Gastrointestinal Bleeding | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | The number of participants who had gastrointestinal bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Duration of Follow-up in Participants With Gastrointestinal Bleeding | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Intracranial Bleeding | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | The number of participants who had intracranial bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Duration of Follow-up in Participants With Intracranial Bleeding | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Deaths | From index date until death or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Duration of Follow-up in Participants Who Died | From index date until death or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Time Under OAC Treatment (Persistence) by Each OAC Treatment | From index date until switch of treatment, discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Persistence was defined as the time under each OAC treatment, calculated as the time in days from the index date to the date of discontinuation or change of treatment. Participants were censored at the end of their follow-up period. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Other Major Bleeding | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | The number of participants who had other major bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Duration of Follow-up in Participants With Other Major Bleeding | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Dose of Initial OAC Prescription by Each OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Doses Dispensed at Initial OAC Treatment by Each OAC Treatment | At index date (anytime between 01-January-2013 to 30-June-2018) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Dose Reduction by Each OAC Treatment | From baseline (index date) until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Baseline was defined as the time of index date which was defined as the first prescription with any of the oral anticoagulants, that is, participants with NVAF for the first time starting a therapy with any of the NOACs between 01-Jan-2013 and 30-Jun-2018. |
| Time to Dose Reduction by Each OAC Treatment | From index date until date of dose reduction or until end of follow-up, anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Treatment Discontinuation | From index date until date of discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Discontinuation was defined as the first day of a period of at least 30 consecutive days in which 0 days' supply for the index OAC was detected. The date of discontinuation was the end date of the last filled prescription before the treatment gap. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Time to Discontinuation | From index date until date of discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Time to discontinuation was defined as the number of days from the date of index oral anticoagulant prescription to the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants According to Reasons for Discontinuation | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Discontinuation was defined as the first day of a period of at least 30 consecutive days in which 0 days' supply for the index OAC was detected. The date of discontinuation was the end date of the last filled prescription before the treatment gap. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | From 1 Month to maximum 6.5 years (Jan 2013 to Jul 2019) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants Who Switched to Another OAC Treatment | From index date until switch of treatment or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Time to Switch to Another OAC Treatment | From index date until switch of treatment or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants According to Reasons for Switching OAC Treatment | From index date until switch of treatment, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants With Concomitant Therapies by OAC Prescription | From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years) | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
| Number of Participants Who Were Previously Exposed to Warfarin (NOACs Group Only) | Up to 6 months prior to index date | Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. |
Countries
Colombia
Participant flow
Recruitment details
Data of participants diagnosed with non-valvular atrial fibrillation (NVAF) who initiated treatment with warfarin and any of new oral anticoagulants (NOACs) \[dabigatran, rivaroxaban, apixaban\] between 01-January-2013 to 30-June-2018,registered in Health Maintenance Organizations(HMO)of Colombia were observed retrospectively. Data was retrieved from claim database and medical records during approximately 2 months of this study.
Pre-assignment details
Baseline for this study was 6 months prior to the index date. The index date was the date of first prescription with any of the oral anticoagulants (OACs).
Participants by arm
| Arm | Count |
|---|---|
| Warfarin Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | 459 |
| NOACs Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. | 1,617 |
| Total | 2,076 |
Baseline characteristics
| Characteristic | Total | Warfarin | NOACs |
|---|---|---|---|
| Age, Continuous | 73.3 Years STANDARD_DEVIATION 10.5 | 71.6 Years STANDARD_DEVIATION 10 | 73.7 Years STANDARD_DEVIATION 10 |
| Body Mass Index (BMI) | 27.3 Kilograms per meter square STANDARD_DEVIATION 4.9 | 27.1 Kilograms per meter square STANDARD_DEVIATION 4.9 | 27.3 Kilograms per meter square STANDARD_DEVIATION 5 |
| Height | 160.8 Centimeters STANDARD_DEVIATION 10 | 160.4 Centimeters STANDARD_DEVIATION 10.2 | 160.9 Centimeters STANDARD_DEVIATION 9.9 |
| Number of Participants According to Geographic Regions Antioquia | 188 Participants | 60 Participants | 128 Participants |
| Number of Participants According to Geographic Regions Atlantic Coast | 521 Participants | 35 Participants | 486 Participants |
| Number of Participants According to Geographic Regions Bogota/center | 672 Participants | 175 Participants | 497 Participants |
| Number of Participants According to Geographic Regions Center-West | 149 Participants | 16 Participants | 133 Participants |
| Number of Participants According to Geographic Regions Coffee belt | 324 Participants | 122 Participants | 202 Participants |
| Number of Participants According to Geographic Regions Eastern plains | 28 Participants | 3 Participants | 25 Participants |
| Number of Participants According to Geographic Regions Santander | 194 Participants | 48 Participants | 146 Participants |
| Number of Participants With Alcohol Intake at OAC Prescription Date | 15 Participants | 5 Participants | 10 Participants |
| Number of Participants With Bleeding History or Predisposition to Bleeding at Start of OAC Treatment | 13 Participants | 1 Participants | 12 Participants |
| Number of Participants With History of Comorbidities at Index Date Gastrointestinal Bleeding | 25 Participants | 5 Participants | 20 Participants |
| Number of Participants With History of Comorbidities at Index Date Intracranial Bleeding | 6 Participants | 0 Participants | 6 Participants |
| Number of Participants With History of Comorbidities at Index Date Ischemic or Hemorrhagic Stroke | 319 Participants | 56 Participants | 263 Participants |
| Number of Participants With History of Comorbidities at Index Date Other bleeding | 13 Participants | 1 Participants | 12 Participants |
| Number of Participants With History of Comorbidities at Index Date Thromboembolism | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants With History of Comorbidities at Index Date Transient Ischemic Attack | 31 Participants | 4 Participants | 27 Participants |
| Number of Participants With International Normalized Ratio(INR)Greater Than(>)60%: Start OAC Therapy | 134 Participants | 134 Participants | 0 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 1184 Participants | 258 Participants | 926 Participants |
| Sex: Female, Male Male | 892 Participants | 201 Participants | 691 Participants |
| Weight | 70.0 Kilograms STANDARD_DEVIATION 14 | 70.0 Kilograms STANDARD_DEVIATION 14 | 70.7 Kilograms STANDARD_DEVIATION 14.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 459 | 5 / 1,617 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 41 / 459 | 44 / 1,617 |
Outcome results
Primary
CHA2DS2-VASc Score at Start of OAC Treatment
The CHA2DS2-VASc scale is an evaluation of stroke risk in participants with atrial fibrillation. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score , with total scores ranging from 0 to 9, with low scores indicating low risk for stroke, and high scores indicating high risk for stroke. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: At index date (anytime between 01-January-2013 to 30-June-2018)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warfarin | CHA2DS2-VASc Score at Start of OAC Treatment | 3.6 Units on a scale | Standard Deviation 1.5 |
| NOACs - Rivaroxaban | CHA2DS2-VASc Score at Start of OAC Treatment | 3.6 Units on a scale | Standard Deviation 1.5 |
Primary
Dose of Initial OAC Prescription by Each OAC Treatment
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: At index date (anytime between 01-January-2013 to 30-June-2018)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warfarin | Dose of Initial OAC Prescription by Each OAC Treatment | 4.5 Milligrams | Standard Deviation 2.6 |
| NOACs - Rivaroxaban | Dose of Initial OAC Prescription by Each OAC Treatment | 17.9 Milligrams | Standard Deviation 2.7 |
| NOACs - Apixaban | Dose of Initial OAC Prescription by Each OAC Treatment | 7.8 Milligrams | Standard Deviation 2.5 |
| NOACs - Dabigatran | Dose of Initial OAC Prescription by Each OAC Treatment | 239 Milligrams | Standard Deviation 48.5 |
Primary
Duration of Follow-up in Participants Who Died
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until death or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warfarin | Duration of Follow-up in Participants Who Died | 881 Days | — |
| NOACs - Rivaroxaban | Duration of Follow-up in Participants Who Died | 722 Days | Standard Deviation 742 |
Primary
Duration of Follow-up in Participants With Gastrointestinal Bleeding
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warfarin | Duration of Follow-up in Participants With Gastrointestinal Bleeding | 501 Days | Standard Deviation 561 |
| NOACs - Rivaroxaban | Duration of Follow-up in Participants With Gastrointestinal Bleeding | 444 Days | Standard Deviation 298 |
Primary
Duration of Follow-up in Participants With Intracranial Bleeding
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warfarin | Duration of Follow-up in Participants With Intracranial Bleeding | 400 Days | Standard Deviation 355 |
| NOACs - Rivaroxaban | Duration of Follow-up in Participants With Intracranial Bleeding | 206 Days | Standard Deviation 228 |
Primary
Duration of Follow-up in Participants With Other Major Bleeding
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warfarin | Duration of Follow-up in Participants With Other Major Bleeding | 233 Days | Standard Deviation 385 |
| NOACs - Rivaroxaban | Duration of Follow-up in Participants With Other Major Bleeding | 585 Days | Standard Deviation 631 |
Primary
Duration of Follow-up in Participants With Pulmonary Embolism
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warfarin | Duration of Follow-up in Participants With Pulmonary Embolism | 25 Days | — |
| NOACs - Rivaroxaban | Duration of Follow-up in Participants With Pulmonary Embolism | 620 Days | Standard Deviation 409 |
Primary
Duration of Follow-up in Participants With Stroke
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warfarin | Duration of Follow-up in Participants With Stroke | 244 Days | Standard Deviation 157 |
| NOACs - Rivaroxaban | Duration of Follow-up in Participants With Stroke | 680 Days | Standard Deviation 559 |
Primary
HAS-BLED Score at Start of OAC Treatment
The risk of bleeding in participants was assessed using Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INR, Elderly, (age \>65 years), Drugs or alcohol (HAS-BLED) score. Score ranged from 0 to 8 with higher scores indicating greater risk of bleeding. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: At index date (anytime between 01-January-2013 to 30-June-2018)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warfarin | HAS-BLED Score at Start of OAC Treatment | 2.25 Units on a scale | Standard Deviation 0.95 |
| NOACs - Rivaroxaban | HAS-BLED Score at Start of OAC Treatment | 1.99 Units on a scale | Standard Deviation 0.9 |
Primary
Number of Deaths
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until death or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Deaths | 1 Participants |
| NOACs - Rivaroxaban | Number of Deaths | 5 Participants |
Primary
Number of Doses Dispensed at Initial OAC Treatment by Each OAC Treatment
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: At index date (anytime between 01-January-2013 to 30-June-2018)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Warfarin | Number of Doses Dispensed at Initial OAC Treatment by Each OAC Treatment | 5 Doses |
| NOACs - Rivaroxaban | Number of Doses Dispensed at Initial OAC Treatment by Each OAC Treatment | 20 Doses |
| NOACs - Apixaban | Number of Doses Dispensed at Initial OAC Treatment by Each OAC Treatment | 10 Doses |
| NOACs - Dabigatran | Number of Doses Dispensed at Initial OAC Treatment by Each OAC Treatment | 220 Doses |
Primary
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From 1 Month to maximum 6.5 years (Jan 2013 to Jul 2019)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. This outcome measure was planned to be analyzed for the warfarin group only.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 0 | 54 Participants |
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 1 | 56 Participants |
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 2 | 53 Participants |
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 3 | 44 Participants |
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 4 | 34 Participants |
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 5 | 21 Participants |
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 6 | 28 Participants |
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 7 | 18 Participants |
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 8 | 16 Participants |
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 9 | 21 Participants |
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 10 | 13 Participants |
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 11 | 12 Participants |
| Warfarin | Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only) | 12 or more | 89 Participants |
Primary
Number of Participants According to Reasons for Discontinuation
Discontinuation was defined as the first day of a period of at least 30 consecutive days in which 0 days' supply for the index OAC was detected. The date of discontinuation was the end date of the last filled prescription before the treatment gap. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Warfarin | Number of Participants According to Reasons for Discontinuation | Adverse drug reaction - not bleeding | 4 Participants |
| Warfarin | Number of Participants According to Reasons for Discontinuation | Adverse drug reaction - any bleeding | 2 Participants |
| Warfarin | Number of Participants According to Reasons for Discontinuation | Bleeding risk | 5 Participants |
| Warfarin | Number of Participants According to Reasons for Discontinuation | Change to rhythm control | 1 Participants |
| Warfarin | Number of Participants According to Reasons for Discontinuation | INR out of goal | 2 Participants |
| Warfarin | Number of Participants According to Reasons for Discontinuation | No identifiable cause | 32 Participants |
| Warfarin | Number of Participants According to Reasons for Discontinuation | NVAF improvement | 13 Participants |
| Warfarin | Number of Participants According to Reasons for Discontinuation | Another event (acute myocardial infarction, worsening of renal failure, worsening of NVAF) | 7 Participants |
| Warfarin | Number of Participants According to Reasons for Discontinuation | Participant preference | 10 Participants |
| Warfarin | Number of Participants According to Reasons for Discontinuation | Problems related with drug access | 2 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Discontinuation | Another event (acute myocardial infarction, worsening of renal failure, worsening of NVAF) | 11 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Discontinuation | Adverse drug reaction - not bleeding | 4 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Discontinuation | No identifiable cause | 73 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Discontinuation | Adverse drug reaction - any bleeding | 3 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Discontinuation | Problems related with drug access | 5 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Discontinuation | Bleeding risk | 12 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Discontinuation | NVAF improvement | 17 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Discontinuation | Change to rhythm control | 2 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Discontinuation | Participant preference | 20 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Discontinuation | INR out of goal | 0 Participants |
Primary
Number of Participants According to Reasons for Switching OAC Treatment
A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Warfarin | Number of Participants According to Reasons for Switching OAC Treatment | Adverse drug reaction - any bleeding | 0 Participants |
| Warfarin | Number of Participants According to Reasons for Switching OAC Treatment | No identifiable cause | 112 Participants |
| Warfarin | Number of Participants According to Reasons for Switching OAC Treatment | Drug interaction | 1 Participants |
| Warfarin | Number of Participants According to Reasons for Switching OAC Treatment | Another event (acute myocardial infarction, worsening of renal failure, worsening of NVAF) | 6 Participants |
| Warfarin | Number of Participants According to Reasons for Switching OAC Treatment | Bleeding risk | 7 Participants |
| Warfarin | Number of Participants According to Reasons for Switching OAC Treatment | Participant preference | 1 Participants |
| Warfarin | Number of Participants According to Reasons for Switching OAC Treatment | INR out of goal | 65 Participants |
| Warfarin | Number of Participants According to Reasons for Switching OAC Treatment | Problems related with drug access | 0 Participants |
| Warfarin | Number of Participants According to Reasons for Switching OAC Treatment | Adverse drug reaction - not bleeding | 2 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Switching OAC Treatment | Problems related with drug access | 7 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Switching OAC Treatment | Adverse drug reaction - not bleeding | 16 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Switching OAC Treatment | Adverse drug reaction - any bleeding | 3 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Switching OAC Treatment | Bleeding risk | 5 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Switching OAC Treatment | Drug interaction | 0 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Switching OAC Treatment | INR out of goal | 0 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Switching OAC Treatment | No identifiable cause | 87 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Switching OAC Treatment | Another event (acute myocardial infarction, worsening of renal failure, worsening of NVAF) | 28 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Reasons for Switching OAC Treatment | Participant preference | 5 Participants |
Primary
Number of Participants According to Type of Stroke
Number of participants with type of stroke classified as either ischemic cerebrovascular event or hemorrhagic cerebrovascular event were reported in this outcome measure. Participants who reported cerebral infarction, stroke: not specified as hemorrhage or infarction in their medical history during the follow-up period were classified under ischemic cerebrovascular event and participants who reported subarachnoid hemorrhage, intracerebral hemorrhage and other nontraumatic intracranial hemorrhage in their medical record were classified under hemorrhagic stroke. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Warfarin | Number of Participants According to Type of Stroke | Ischemic cerebrovascular event | 11 Participants |
| Warfarin | Number of Participants According to Type of Stroke | Hemorrhagic cerebrovascular event | 5 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Type of Stroke | Ischemic cerebrovascular event | 45 Participants |
| NOACs - Rivaroxaban | Number of Participants According to Type of Stroke | Hemorrhagic cerebrovascular event | 2 Participants |
Primary
Number of Participants Who Switched to Another OAC Treatment
A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants Who Switched to Another OAC Treatment | 194 Participants |
| NOACs - Rivaroxaban | Number of Participants Who Switched to Another OAC Treatment | 151 Participants |
Primary
Number of Participants Who Were Previously Exposed to Warfarin (NOACs Group Only)
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: Up to 6 months prior to index date
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. This outcome measure was planned to be analyzed for the NOACs group only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants Who Were Previously Exposed to Warfarin (NOACs Group Only) | 181 Participants |
Primary
Number of Participants With Anemia at Start of OAC Treatment
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: At index date (anytime between 01-January-2013 to 30-June-2018)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants With Anemia at Start of OAC Treatment | 62 Participants |
| NOACs - Rivaroxaban | Number of Participants With Anemia at Start of OAC Treatment | 217 Participants |
Primary
Number of Participants With Comorbidities
Participants classified according to the comorbidities they had were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. One participant may have more than one comorbidity.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Warfarin | Number of Participants With Comorbidities | Diabetes Mellitus | 100 Participants |
| Warfarin | Number of Participants With Comorbidities | Liver Disease | 5 Participants |
| Warfarin | Number of Participants With Comorbidities | Hypertension | 386 Participants |
| Warfarin | Number of Participants With Comorbidities | Rheumatic disease | 23 Participants |
| Warfarin | Number of Participants With Comorbidities | Acquired Immune Deficiency Syndrome (AIDS) | 0 Participants |
| Warfarin | Number of Participants With Comorbidities | Chronic Kidney Disease | 196 Participants |
| Warfarin | Number of Participants With Comorbidities | Moderate Renal Disease | 163 Participants |
| Warfarin | Number of Participants With Comorbidities | Congestive Heart Failure | 86 Participants |
| Warfarin | Number of Participants With Comorbidities | Acute Myocardial Infarction | 70 Participants |
| Warfarin | Number of Participants With Comorbidities | Chronic Obstructive Pulmonary Disease (COPD) | 84 Participants |
| Warfarin | Number of Participants With Comorbidities | Peripheral Vascular Disease | 30 Participants |
| Warfarin | Number of Participants With Comorbidities | Dementia | 11 Participants |
| Warfarin | Number of Participants With Comorbidities | Hemiplegia | 9 Participants |
| Warfarin | Number of Participants With Comorbidities | Connective Tissue Disease | 23 Participants |
| Warfarin | Number of Participants With Comorbidities | Leukemia and Lymphoma | 2 Participants |
| Warfarin | Number of Participants With Comorbidities | Peptic Ulcer Disease | 4 Participants |
| Warfarin | Number of Participants With Comorbidities | Metastatic Solid Tumor (Cancer) | 0 Participants |
| Warfarin | Number of Participants With Comorbidities | Acute myocardial infarction | 70 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Connective Tissue Disease | 58 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Diabetes Mellitus | 370 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Chronic Obstructive Pulmonary Disease (COPD) | 276 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Liver Disease | 25 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Acute myocardial infarction | 308 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Hypertension | 1430 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Peripheral Vascular Disease | 73 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Rheumatic disease | 58 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Leukemia and Lymphoma | 9 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Acquired Immune Deficiency Syndrome (AIDS) | 0 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Dementia | 48 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Chronic Kidney Disease | 892 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Metastatic Solid Tumor (Cancer) | 21 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Moderate Renal Disease | 661 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Hemiplegia | 38 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Congestive Heart Failure | 231 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Peptic Ulcer Disease | 7 Participants |
| NOACs - Rivaroxaban | Number of Participants With Comorbidities | Acute Myocardial Infarction | 308 Participants |
Primary
Number of Participants With Concomitant Therapies by OAC Prescription
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Beta (β)-blockers | 305 Participants |
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Statins | 266 Participants |
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Angiotensin II receptor blockers | 232 Participants |
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Furosemide | 126 Participants |
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Angiotensin converting enzyme inhibitor | 119 Participants |
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Proton pump inhibitor | 116 Participants |
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Calcium channel blockers | 112 Participants |
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Levothyroxine | 96 Participants |
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Thiazide diuretics | 85 Participants |
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Bronchodilators | 76 Participants |
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Potassium sparing diuretic | 75 Participants |
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Antiarrhythmics | 75 Participants |
| Warfarin | Number of Participants With Concomitant Therapies by OAC Prescription | Oral antidiabetics | 72 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Furosemide | 275 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Oral antidiabetics | 159 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Potassium sparing diuretic | 155 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Levothyroxine | 224 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Angiotensin II receptor blockers | 543 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Beta (β)-blockers | 641 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Bronchodilators | 144 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Thiazide diuretics | 159 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Proton pump inhibitor | 242 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Angiotensin converting enzyme inhibitor | 182 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Statins | 598 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Antiarrhythmics | 206 Participants |
| NOACs - Rivaroxaban | Number of Participants With Concomitant Therapies by OAC Prescription | Calcium channel blockers | 260 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Potassium sparing diuretic | 55 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Furosemide | 98 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Angiotensin converting enzyme inhibitor | 71 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Oral antidiabetics | 72 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Proton pump inhibitor | 105 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Calcium channel blockers | 129 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Antiarrhythmics | 65 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Levothyroxine | 81 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Thiazide diuretics | 82 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Bronchodilators | 45 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Beta (β)-blockers | 270 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Statins | 266 Participants |
| NOACs - Apixaban | Number of Participants With Concomitant Therapies by OAC Prescription | Angiotensin II receptor blockers | 247 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Bronchodilators | 33 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Levothyroxine | 52 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Furosemide | 61 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Beta (β)-blockers | 186 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Calcium channel blockers | 89 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Proton pump inhibitor | 63 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Angiotensin II receptor blockers | 164 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Statins | 164 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Angiotensin converting enzyme inhibitor | 50 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Thiazide diuretics | 59 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Oral antidiabetics | 42 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Antiarrhythmics | 55 Participants |
| NOACs - Dabigatran | Number of Participants With Concomitant Therapies by OAC Prescription | Potassium sparing diuretic | 24 Participants |
Primary
Number of Participants With Dose Reduction by Each OAC Treatment
Baseline was defined as the time of index date which was defined as the first prescription with any of the oral anticoagulants, that is, participants with NVAF for the first time starting a therapy with any of the NOACs between 01-Jan-2013 and 30-Jun-2018.
Time frame: From baseline (index date) until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants With Dose Reduction by Each OAC Treatment | 0 Participants |
| NOACs - Rivaroxaban | Number of Participants With Dose Reduction by Each OAC Treatment | 375 Participants |
| NOACs - Apixaban | Number of Participants With Dose Reduction by Each OAC Treatment | 173 Participants |
| NOACs - Dabigatran | Number of Participants With Dose Reduction by Each OAC Treatment | 159 Participants |
Primary
Number of Participants With Gastrointestinal Bleeding
The number of participants who had gastrointestinal bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants With Gastrointestinal Bleeding | 19 Participants |
| NOACs - Rivaroxaban | Number of Participants With Gastrointestinal Bleeding | 23 Participants |
Primary
Number of Participants With Intracranial Bleeding
The number of participants who had intracranial bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants With Intracranial Bleeding | 5 Participants |
| NOACs - Rivaroxaban | Number of Participants With Intracranial Bleeding | 2 Participants |
Primary
Number of Participants With Other Major Bleeding
The number of participants who had other major bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants With Other Major Bleeding | 17 Participants |
| NOACs - Rivaroxaban | Number of Participants With Other Major Bleeding | 19 Participants |
Primary
Number of Participants With Pulmonary Embolism
The number of participants who had pulmonary embolism were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants With Pulmonary Embolism | 1 Participants |
| NOACs - Rivaroxaban | Number of Participants With Pulmonary Embolism | 5 Participants |
Primary
Number of Participants With Stroke
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants With Stroke | 56 Participants |
| NOACs - Rivaroxaban | Number of Participants With Stroke | 263 Participants |
Primary
Number of Participants With Treatment Discontinuation
Discontinuation was defined as the first day of a period of at least 30 consecutive days in which 0 days' supply for the index OAC was detected. The date of discontinuation was the end date of the last filled prescription before the treatment gap. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until date of discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants With Treatment Discontinuation | 78 Participants |
| NOACs - Rivaroxaban | Number of Participants With Treatment Discontinuation | 147 Participants |
Primary
Number of Participants With Uncontrolled Hypertension at OAC Prescription Date
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: At index date (any time between 01-January-2013 to 30-June-2018)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants With Uncontrolled Hypertension at OAC Prescription Date | 19 Participants |
| NOACs - Rivaroxaban | Number of Participants With Uncontrolled Hypertension at OAC Prescription Date | 50 Participants |
Primary
Number of Participants With Use of Aspirin at Start OAC Treatment
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: At index date (anytime between 01-January-2013 to 30-June-2018)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants With Use of Aspirin at Start OAC Treatment | 191 Participants |
| NOACs - Rivaroxaban | Number of Participants With Use of Aspirin at Start OAC Treatment | 660 Participants |
Primary
Number of Participants With Use of Clopidogrel at Start of OAC Treatment
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: At index date (anytime between 01-January-2013 to 30-June-2018)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants With Use of Clopidogrel at Start of OAC Treatment | 37 Participants |
| NOACs - Rivaroxaban | Number of Participants With Use of Clopidogrel at Start of OAC Treatment | 133 Participants |
Primary
Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. In this study Aspirin was not considered as NSAID due to doses used in Colombia.
Time frame: At index date (anytime between 01-January-2013 to 30-June-2018)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin | Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment | 18 Participants |
| NOACs - Rivaroxaban | Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment | 50 Participants |
Primary
Time to Diagnose NVAF by Each OAC Treatment
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: At index date (anytime between 01-January-2013 to 30-June-2018)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warfarin | Time to Diagnose NVAF by Each OAC Treatment | 71 Days | Standard Deviation 230.8 |
| NOACs - Rivaroxaban | Time to Diagnose NVAF by Each OAC Treatment | 324 Days | Standard Deviation 712.2 |
| NOACs - Apixaban | Time to Diagnose NVAF by Each OAC Treatment | 218 Days | Standard Deviation 541.2 |
| NOACs - Dabigatran | Time to Diagnose NVAF by Each OAC Treatment | 406 Days | Standard Deviation 676 |
Primary
Time to Discontinuation
Time to discontinuation was defined as the number of days from the date of index oral anticoagulant prescription to the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until date of discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Warfarin | Time to Discontinuation | 332 Days |
| NOACs - Rivaroxaban | Time to Discontinuation | 463 Days |
Primary
Time to Dose Reduction by Each OAC Treatment
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until date of dose reduction or until end of follow-up, anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Warfarin | Time to Dose Reduction by Each OAC Treatment | 68.5 Days |
| NOACs - Rivaroxaban | Time to Dose Reduction by Each OAC Treatment | 479 Days |
| NOACs - Apixaban | Time to Dose Reduction by Each OAC Treatment | 523 Days |
| NOACs - Dabigatran | Time to Dose Reduction by Each OAC Treatment | 324 Days |
Primary
Time to Switch to Another OAC Treatment
A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Warfarin | Time to Switch to Another OAC Treatment | 2309.0 Days |
| NOACs - Rivaroxaban | Time to Switch to Another OAC Treatment | 1114.0 Days |
Primary
Time Under OAC Treatment (Persistence) by Each OAC Treatment
Persistence was defined as the time under each OAC treatment, calculated as the time in days from the index date to the date of discontinuation or change of treatment. Participants were censored at the end of their follow-up period. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Time frame: From index date until switch of treatment, discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)
Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Warfarin | Time Under OAC Treatment (Persistence) by Each OAC Treatment | 440 Days |
| NOACs - Rivaroxaban | Time Under OAC Treatment (Persistence) by Each OAC Treatment | 491 Days |
| NOACs - Apixaban | Time Under OAC Treatment (Persistence) by Each OAC Treatment | 364 Days |
| NOACs - Dabigatran | Time Under OAC Treatment (Persistence) by Each OAC Treatment | 608 Days |