Atrial Fibrillation
Conditions
Brief summary
The objectives of this study are, first, to identify select clinical covariates from electronic medical records (EMR) that might be associated with initiation of oral anticoagulant medications (dabigatran or warfarin) in patients with non-valvular atrial fibrillation (NVAF) at risk for stroke; second, to quantify the association between EMR-based clinical characteristics and patterns of insurance claims; third, to assess the potential for unmeasured confounding in dabigatran vs warfarin comparative effectiveness and safety studies based on administrative claims databases.
Interventions
DRUGWarfarin
Observed upto 12 months
DRUGDabigatran etexilate
observed upto 12 months
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* First dispensing of warfarin or dabigatran between October 2010 and December 2014 * Diagnosis of atrial fibrillation * ≥ 12 months enrolment in the database preceding the date of the first dispensing * Age ≥ 18 * Congestive Heart Failure, Hypertension, Age \> 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease (CHA2DS2-VASc) score ≥ 1
Exclusion criteria
* Prior use of oral anticoagulation * Evidence of valvular atrial fibrillation * Missing or ambiguous age or sex information * Patients with a nursing home stay during baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Obesity | Up to 12 months | Percentage of patients with obesity; where obesity is defined as obese, not-obese based on note of obesity or recorded body mass index (BMI) \> 30 in the electronic medical records (EMR). The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Percentage of Patients Smoking | Up to 12 months | Percentage of patients with current/past smoking in the electronic medical records (EMR) are presented. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Percentage of Patients With Alcohol Consumption | Up to 12 months | Percentage of patients with alcohol consumption in the electronic medical records (EMR) are presented. The patients with light to moderate, heavy and unknown quantity of alcohol consumption are considered. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Percentage of Patients With Abnormal Renal Function | Up to 12 months | Percentage of patients with abnormal renal function; defined as Any note of: Dialysis, renal transplant Serum Creatinine \>1.3 Milligrams per Deciliter (mg/dL) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Percentage of Patients With Bleeding History or Predisposition | Up to 12 months | Percentage of patients with bleeding history or predisposition is presented, defined as any note of major bleeding requiring hospitalization or blood transfusion or causing a decrease in hemoglobin level of \> 2 gram per liter (g/L) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR) | Up to 12 months | EMR characteristic: Renal function - Glomerular Filtration Rate (GFR). Estimated GFR closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| EMR Characteristic: Serum Creatinine | Up to 12 months | EMR characteristic: Serum Creatinine closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Percentage of Patients With Abnormal Liver Function | Up to 12 months | Percentage of patients with abnormal liver function; defined as Any note of: Liver disease, cirrhosis, Active hepatitis C, Active hepatitis B, Active hepatitis A, aspartate transaminase/alanine transaminase (AST/ALT) \>3 times upper limit of normal in the electronic medical records (EMR). Absence of any note would be considered as absence of the disease. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score | Up to 12 months | EMR characteristic: HAS-BLED Score. HAS-BLED score is calculated by adding the specified points for each of the conditions listed below. Hypertension (uncontrolled), Abnormal renal and liver function, Stroke, Bleeding history or predisposition (anemia), Labile International Normalized Ratio (INR), Elderly, Drugs or alcohol (1 point each). Labile INR is defined as as the most recent INR \<2 or \>3 prior to cohort entry. Conditions are considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| EMR Characteristic: Duration of Atrial Fibrillation | Up to 12 months | EMR characteristic: Duration of atrial fibrillation (Years / months prior to initiation of Dabigatran / Warfarin). Duration is defined as number of months prior to index date for the earliest note. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs | Up to 1 month | Percentage of patients with use of antiplatelets or non-steroidal anti-inflammatory drugs (NSAIDs). Includes use of aspirin, clopidogrel, prasugrel, ticagrelor or NSAIDs (within 1 month or on the index date) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| EMR Characteristic: History of Adherence: Non-adherent/Adherent | Up to 12 months | EMR characteristic: History of adherence: non-adherent/adherent. |
| EMR Characteristic: History/Duration of Hypertension | Up to 12 months | EMR characteristic: History/duration of hypertension. Any note of: Hypertension systolic blood pressure (SBP) \>120 millimeters of mercury (mmHg) Hypertension drugs. Duration is defined as number of months prior to index date for the earliest note. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Percentage of Patients With Uncontrolled Hypertension | Up to 12 months | Percentage of patients with uncontrolled hypertension; defined as SBP \>160 mmHg using the most recent information prior to index date in the electronic medical records (EMR). The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| EMR Characteristic: History/Duration of Congestive Heart Failure (CHF) | Up to 12 months | EMR characteristic: History/duration of Congestive Heart Failure (CHF). Duration is defined as number of months prior to index date for the earliest note. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Percentage of Patients With Prior Transient Ischemic Attack | Up to 12 months | Percentage of patients with any note of prior transient ischemic attack in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Percentage of Patients With Diabetes | Up to 12 months | Percentage of patients with any note of diabetes type I or II in the electronic medical records (EMR) is presented. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
| Percentage of Patients With Hyperlipidemia | Up to 12 months | Percentage of patients with hyperlipidemia is presented, defined as any note of hyperlipidemia, dyslipidemia or Low Density Lipoprotein (LDL) \>130 mg/dl in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. |
Countries
United States
Participant flow
Recruitment details
A validation study; Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate dabigatran or warfarin between October 2010 and December 2014.
Pre-assignment details
In this non-interventional study based on existing data, no patients were screened.
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran Etexilate Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate dabigatran etexilate between October 2010 and December 2014. | 1,130 |
| Warfarin Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate warfarin between October 2010 and December 2014. | 2,566 |
| Rivaroxaban (Post hoc analysis) Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate rivaroxaban between October 2010 and December 2014. | 1,602 |
| Apixaban (Post hoc analysis) Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate apixaban between October 2010 and December 2014. | 637 |
| Total | 5,935 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Not linked in the EMR | 25,069 | 67,505 | 30,993 | 10,685 |
Baseline characteristics
| Characteristic | Dabigatran Etexilate | Warfarin | Rivaroxaban | Apixaban | Total |
|---|---|---|---|---|---|
| Age, Continuous | 65.1 Years STANDARD_DEVIATION 11.4 | 69.3 Years STANDARD_DEVIATION 11.3 | 66.2 Years STANDARD_DEVIATION 11.1 | 67.3 Years STANDARD_DEVIATION 11.4 | 67.4 Years STANDARD_DEVIATION 11.4 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 432 Participants | 1006 Participants | 600 Participants | 250 Participants | 2288 Participants |
| Sex: Female, Male Male | 698 Participants | 1560 Participants | 1002 Participants | 387 Participants | 3647 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR)
EMR characteristic: Renal function - Glomerular Filtration Rate (GFR). Estimated GFR closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dabigatran Etexilate | EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR) | Before PS matching | 86.5 Milliliter/minute/1.73 square meter | Standard Deviation 21.6 |
| Dabigatran Etexilate | EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR) | After PS matching | 85.4 Milliliter/minute/1.73 square meter | Standard Deviation 21.9 |
| Warfarin | EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR) | Before PS matching | 78.3 Milliliter/minute/1.73 square meter | Standard Deviation 25.1 |
| Warfarin | EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR) | After PS matching | 83.4 Milliliter/minute/1.73 square meter | Standard Deviation 23.5 |
Primary
EMR Characteristic: Serum Creatinine
EMR characteristic: Serum Creatinine closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dabigatran Etexilate | EMR Characteristic: Serum Creatinine | Before PS matching | 1.0 Milligrams per deciliter | Standard Deviation 0.3 |
| Dabigatran Etexilate | EMR Characteristic: Serum Creatinine | After PS matching | 1.0 Milligrams per deciliter | Standard Deviation 0.3 |
| Warfarin | EMR Characteristic: Serum Creatinine | Before PS matching | 1.1 Milligrams per deciliter | Standard Deviation 0.6 |
| Warfarin | EMR Characteristic: Serum Creatinine | After PS matching | 1.0 Milligrams per deciliter | Standard Deviation 0.4 |
Comparison: R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.Regression, Linear
Primary
Percentage of Patients Smoking
Percentage of patients with current/past smoking in the electronic medical records (EMR) are presented. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate | Percentage of Patients Smoking | Before PS matching | 50.0 Percentage of patients |
| Dabigatran Etexilate | Percentage of Patients Smoking | After PS matching | 50.0 Percentage of patients |
| Warfarin | Percentage of Patients Smoking | Before PS matching | 51.8 Percentage of patients |
| Warfarin | Percentage of Patients Smoking | After PS matching | 50.5 Percentage of patients |
Primary
Percentage of Patients With Abnormal Liver Function
Percentage of patients with abnormal liver function; defined as Any note of: Liver disease, cirrhosis, Active hepatitis C, Active hepatitis B, Active hepatitis A, aspartate transaminase/alanine transaminase (AST/ALT) \>3 times upper limit of normal in the electronic medical records (EMR). Absence of any note would be considered as absence of the disease. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate | Percentage of Patients With Abnormal Liver Function | Before PS matching | 0.5 Percentage of patients |
| Dabigatran Etexilate | Percentage of Patients With Abnormal Liver Function | After PS matching | 0.5 Percentage of patients |
| Warfarin | Percentage of Patients With Abnormal Liver Function | Before PS matching | 0.7 Percentage of patients |
| Warfarin | Percentage of Patients With Abnormal Liver Function | After PS matching | 0.0 Percentage of patients |
Primary
Percentage of Patients With Abnormal Renal Function
Percentage of patients with abnormal renal function; defined as Any note of: Dialysis, renal transplant Serum Creatinine \>1.3 Milligrams per Deciliter (mg/dL) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate | Percentage of Patients With Abnormal Renal Function | Before PS matching | 5.5 Percentage of patients |
| Dabigatran Etexilate | Percentage of Patients With Abnormal Renal Function | After PS matching | 6.5 Percentage of patients |
| Warfarin | Percentage of Patients With Abnormal Renal Function | Before PS matching | 11.7 Percentage of patients |
| Warfarin | Percentage of Patients With Abnormal Renal Function | After PS matching | 8.0 Percentage of patients |
Primary
Percentage of Patients With Alcohol Consumption
Percentage of patients with alcohol consumption in the electronic medical records (EMR) are presented. The patients with light to moderate, heavy and unknown quantity of alcohol consumption are considered. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate | Percentage of Patients With Alcohol Consumption | Before PS matching | 47.1 Percentage of patients |
| Dabigatran Etexilate | Percentage of Patients With Alcohol Consumption | After PS matching | 50.0 Percentage of patients |
| Warfarin | Percentage of Patients With Alcohol Consumption | Before PS matching | 50.9 Percentage of patients |
| Warfarin | Percentage of Patients With Alcohol Consumption | After PS matching | 38.9 Percentage of patients |
Primary
Percentage of Patients With Bleeding History or Predisposition
Percentage of patients with bleeding history or predisposition is presented, defined as any note of major bleeding requiring hospitalization or blood transfusion or causing a decrease in hemoglobin level of \> 2 gram per liter (g/L) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate | Percentage of Patients With Bleeding History or Predisposition | Before PS matching | 3.4 Percentage of patients |
| Dabigatran Etexilate | Percentage of Patients With Bleeding History or Predisposition | After PS matching | 3.7 Percentage of patients |
| Warfarin | Percentage of Patients With Bleeding History or Predisposition | Before PS matching | 4.7 Percentage of patients |
| Warfarin | Percentage of Patients With Bleeding History or Predisposition | After PS matching | 4.6 Percentage of patients |
Comparison: The concordance statistic is equal to the area under a receiver operating characteristic (ROC) curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model.Regression, Logistic
Primary
Percentage of Patients With Obesity
Percentage of patients with obesity; where obesity is defined as obese, not-obese based on note of obesity or recorded body mass index (BMI) \> 30 in the electronic medical records (EMR). The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate | Percentage of Patients With Obesity | Before PS matching | 58.2 Percentage of patients |
| Dabigatran Etexilate | Percentage of Patients With Obesity | After PS matching | 57.4 Percentage of patients |
| Warfarin | Percentage of Patients With Obesity | Before PS matching | 51.7 Percentage of patients |
| Warfarin | Percentage of Patients With Obesity | After PS matching | 54.2 Percentage of patients |
Secondary
EMR Characteristic: Duration of Atrial Fibrillation
EMR characteristic: Duration of atrial fibrillation (Years / months prior to initiation of Dabigatran / Warfarin). Duration is defined as number of months prior to index date for the earliest note. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. Duration calculated for patients identified as having condition in EMR.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dabigatran Etexilate | EMR Characteristic: Duration of Atrial Fibrillation | Before PS matching | 22.5 Months | Standard Deviation 33.8 |
| Dabigatran Etexilate | EMR Characteristic: Duration of Atrial Fibrillation | After PS matching | 22.7 Months | Standard Deviation 35.2 |
| Warfarin | EMR Characteristic: Duration of Atrial Fibrillation | Before PS matching | 26.4 Months | Standard Deviation 32.5 |
| Warfarin | EMR Characteristic: Duration of Atrial Fibrillation | After PS matching | 25.4 Months | Standard Deviation 33 |
Comparison: R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.Regression, Linear
Secondary
EMR Characteristic: History/Duration of Congestive Heart Failure (CHF)
EMR characteristic: History/duration of Congestive Heart Failure (CHF). Duration is defined as number of months prior to index date for the earliest note. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dabigatran Etexilate | EMR Characteristic: History/Duration of Congestive Heart Failure (CHF) | Before PS matching | 28.2 Months | Standard Deviation 30.8 |
| Dabigatran Etexilate | EMR Characteristic: History/Duration of Congestive Heart Failure (CHF) | After PS matching | 26.0 Months | Standard Deviation 30.1 |
| Warfarin | EMR Characteristic: History/Duration of Congestive Heart Failure (CHF) | Before PS matching | 38.3 Months | Standard Deviation 38.6 |
| Warfarin | EMR Characteristic: History/Duration of Congestive Heart Failure (CHF) | After PS matching | 33.9 Months | Standard Deviation 38 |
Secondary
EMR Characteristic: History/Duration of Hypertension
EMR characteristic: History/duration of hypertension. Any note of: Hypertension systolic blood pressure (SBP) \>120 millimeters of mercury (mmHg) Hypertension drugs. Duration is defined as number of months prior to index date for the earliest note. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dabigatran Etexilate | EMR Characteristic: History/Duration of Hypertension | Before PS matching | 42.4 Months | Standard Deviation 42.8 |
| Dabigatran Etexilate | EMR Characteristic: History/Duration of Hypertension | After PS matching | 43.6 Months | Standard Deviation 43.7 |
| Warfarin | EMR Characteristic: History/Duration of Hypertension | Before PS matching | 43.8 Months | Standard Deviation 41.5 |
| Warfarin | EMR Characteristic: History/Duration of Hypertension | After PS matching | 40.9 Months | Standard Deviation 40.6 |
Secondary
EMR Characteristic: History of Adherence: Non-adherent/Adherent
EMR characteristic: History of adherence: non-adherent/adherent.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. Although the original intent was to document the patient's history of adherence, no such information was available in the EMR
Secondary
EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score
EMR characteristic: HAS-BLED Score. HAS-BLED score is calculated by adding the specified points for each of the conditions listed below. Hypertension (uncontrolled), Abnormal renal and liver function, Stroke, Bleeding history or predisposition (anemia), Labile International Normalized Ratio (INR), Elderly, Drugs or alcohol (1 point each). Labile INR is defined as as the most recent INR \<2 or \>3 prior to cohort entry. Conditions are considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. Also the patients with data for all HAS-BLED components.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dabigatran Etexilate | EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score | Before PS matching | 1.4 Unit on Scale | Standard Deviation 1 |
| Dabigatran Etexilate | EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score | After PS matching | 1.5 Unit on Scale | Standard Deviation 1 |
| Warfarin | EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score | Before PS matching | 1.6 Unit on Scale | Standard Deviation 1 |
| Warfarin | EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score | After PS matching | 1.5 Unit on Scale | Standard Deviation 1 |
Comparison: R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.Regression, Linear
Secondary
Percentage of Patients With Diabetes
Percentage of patients with any note of diabetes type I or II in the electronic medical records (EMR) is presented. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate | Percentage of Patients With Diabetes | Before PS matching | 13.4 Percentage of patients |
| Dabigatran Etexilate | Percentage of Patients With Diabetes | After PS matching | 14.7 Percentage of patients |
| Warfarin | Percentage of Patients With Diabetes | After PS matching | 14.5 Percentage of patients |
| Warfarin | Percentage of Patients With Diabetes | Before PS matching | 18.2 Percentage of patients |
Comparison: The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model.Regression, Logistic
Secondary
Percentage of Patients With Hyperlipidemia
Percentage of patients with hyperlipidemia is presented, defined as any note of hyperlipidemia, dyslipidemia or Low Density Lipoprotein (LDL) \>130 mg/dl in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate | Percentage of Patients With Hyperlipidemia | Before PS matching | 34.8 Percentage of patients |
| Dabigatran Etexilate | Percentage of Patients With Hyperlipidemia | After PS matching | 35.6 Percentage of patients |
| Warfarin | Percentage of Patients With Hyperlipidemia | Before PS matching | 36.8 Percentage of patients |
| Warfarin | Percentage of Patients With Hyperlipidemia | After PS matching | 34.0 Percentage of patients |
Comparison: The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model.Regression, Logistic
Secondary
Percentage of Patients With Prior Transient Ischemic Attack
Percentage of patients with any note of prior transient ischemic attack in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate | Percentage of Patients With Prior Transient Ischemic Attack | Before PS matching | 1.6 Percentage of patients |
| Dabigatran Etexilate | Percentage of Patients With Prior Transient Ischemic Attack | After PS matching | 1.4 Percentage of patients |
| Warfarin | Percentage of Patients With Prior Transient Ischemic Attack | Before PS matching | 2.1 Percentage of patients |
| Warfarin | Percentage of Patients With Prior Transient Ischemic Attack | After PS matching | 2.4 Percentage of patients |
Secondary
Percentage of Patients With Uncontrolled Hypertension
Percentage of patients with uncontrolled hypertension; defined as SBP \>160 mmHg using the most recent information prior to index date in the electronic medical records (EMR). The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 12 months
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate | Percentage of Patients With Uncontrolled Hypertension | Before PS matching | 0.0 Percentage of patients |
| Dabigatran Etexilate | Percentage of Patients With Uncontrolled Hypertension | After PS matching | 0.0 Percentage of patients |
| Warfarin | Percentage of Patients With Uncontrolled Hypertension | Before PS matching | 0.0 Percentage of patients |
| Warfarin | Percentage of Patients With Uncontrolled Hypertension | After PS matching | 0.0 Percentage of patients |
Secondary
Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs
Percentage of patients with use of antiplatelets or non-steroidal anti-inflammatory drugs (NSAIDs). Includes use of aspirin, clopidogrel, prasugrel, ticagrelor or NSAIDs (within 1 month or on the index date) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Time frame: Up to 1 month
Population: Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate | Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs | Before PS matching | 18.0 Percentage of patients |
| Dabigatran Etexilate | Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs | After PS matching | 17.1 Percentage of patients |
| Warfarin | Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs | Before PS matching | 18.4 Percentage of patients |
| Warfarin | Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs | After PS matching | 18.7 Percentage of patients |