Atrial Fibrillation, Stroke
Conditions
Brief summary
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age =\>18 years at enrollment 2. Male or female patient (or legally acceptable representative) willing and able to provide written informed consent 3. Patient newly diagnosed (\< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke. Other inclusion criteria apply.
Exclusion criteria
1. Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention; 2. Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime; 3. AF with a generally reversible cause; 4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) | From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years. | Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate. |
| Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) | From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years. | Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate. |
| Incidence Rate of Stroke or Systemic Embolism | From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years. | Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. |
| Incidence Rate of Stroke | From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years. | Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification. |
| Incidence Rate of Transient Ischaemic Attack (TIA) | From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years. | Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. |
| Incidence Rate of Systemic Embolism (SEE) | From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years. | Incidence rate of systemic embolism (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. |
| Incidence Rate of Pulmonary Embolism (PE) | From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years. | Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. |
| Incidence Rate of Major Bleeding Events | From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years. | Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding. |
| Incidence Rate of Life-threatening Bleeding Events | From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years. | Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding. |
| Incidence Rate of Vascular Death | From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years. | Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. |
| Incidence Rate of Myocardial Infarction | From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years. | Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. |
| Incidence Rate of All-cause Death | From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years. | Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
This study investigated characteristics of patients with non-valvular atrial fibrillation influencing the choice of antithrombotic treatment for the prevention of stroke, and the safety and effectiveness of dabigatran versus Vitamin K Antagonist for up to 3-year follow-up period.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the study. Subjects attended a participating site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran Etexilate - Baseline Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. | 2,066 |
| Vitamin K Antagonist (VKA) - Baseline Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. | 2,758 |
| Rivaroxaban - Baseline Patients who were prescribed Rivaroxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. | 2,008 |
| Apixaban - Baseline Patients who were prescribed Apixaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. | 2,197 |
| Edoxaban - Baseline Patients who were prescribed Edoxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. | 180 |
| Acetylsalicylic Acid (ASA) - Baseline Patients who were prescribed Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. | 507 |
| Antiplts Other Than ASA - Baseline Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. | 79 |
| No Treatment - Baseline Patients who were prescribed no treatment at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. | 507 |
| Combinations With Oral Anticoagulants - Baseline Patients who were prescribed the treatments with combinations with oral anticoagulants at baseline were included in this group. This group of patients were not included in the safety analysis as no specific treatment can be defined.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician. | 2 |
| Total | 10,304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 93 | 142 | 91 | 63 | 7 | 20 | 2 | 28 | 0 |
| Overall Study | No end of study case report form | 3 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Not eligible | 23 | 76 | 25 | 17 | 0 | 6 | 1 | 19 | 0 |
| Overall Study | Other reasons than listed | 166 | 373 | 197 | 228 | 14 | 71 | 17 | 66 | 0 |
| Overall Study | Withdrawal by Subject | 36 | 59 | 53 | 58 | 4 | 15 | 1 | 19 | 0 |
Baseline characteristics
| Characteristic | Total | Dabigatran Etexilate - Baseline | Vitamin K Antagonist (VKA) - Baseline | Rivaroxaban - Baseline | Apixaban - Baseline | Edoxaban - Baseline | Acetylsalicylic Acid (ASA) - Baseline | Antiplts Other Than ASA - Baseline | No Treatment - Baseline | Combinations With Oral Anticoagulants - Baseline |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 72.0 Years STANDARD_DEVIATION 10.1 | 71.3 Years STANDARD_DEVIATION 9.4 | 72.8 Years STANDARD_DEVIATION 9.5 | 71.1 Years STANDARD_DEVIATION 10.1 | 73.3 Years STANDARD_DEVIATION 9.8 | 73.3 Years STANDARD_DEVIATION 9.2 | 70.5 Years STANDARD_DEVIATION 12.4 | 74.2 Years STANDARD_DEVIATION 11.1 | 68.7 Years STANDARD_DEVIATION 12.5 | 71.5 Years STANDARD_DEVIATION 0.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 21 Participants | 5 Participants | 14 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 25 Participants | 4 Participants | 4 Participants | 7 Participants | 7 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/African American | 31 Participants | 4 Participants | 6 Participants | 9 Participants | 9 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Missing | 1141 Participants | 254 Participants | 199 Participants | 253 Participants | 339 Participants | 0 Participants | 71 Participants | 3 Participants | 22 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 31 Participants | 7 Participants | 9 Participants | 4 Participants | 6 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 9055 Participants | 1792 Participants | 2526 Participants | 1735 Participants | 1835 Participants | 178 Participants | 430 Participants | 75 Participants | 482 Participants | 2 Participants |
| Sex: Female, Male Female | 4670 Participants | 942 Participants | 1252 Participants | 894 Participants | 990 Participants | 86 Participants | 234 Participants | 25 Participants | 246 Participants | 1 Participants |
| Sex: Female, Male Male | 5634 Participants | 1124 Participants | 1506 Participants | 1114 Participants | 1207 Participants | 94 Participants | 273 Participants | 54 Participants | 261 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 116 / 2,385 | 264 / 3,258 | 166 / 2,576 | 207 / 2,934 | 17 / 368 | 141 / 1,940 | 33 / 427 |
| other Total, other adverse events | 0 / 2,385 | 0 / 3,258 | 0 / 2,576 | 0 / 2,934 | 0 / 368 | 0 / 1,940 | 0 / 427 |
| serious Total, serious adverse events | 79 / 2,385 | 157 / 3,258 | 92 / 2,576 | 99 / 2,934 | 10 / 368 | 70 / 1,940 | 14 / 427 |
Outcome results
Primary
Incidence Rate of All-cause Death
Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Population: Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate - Baseline | Incidence Rate of All-cause Death | 2.08 Events per 100 person-years |
| Vitamin K Antagonist (VKA) - Baseline | Incidence Rate of All-cause Death | 3.27 Events per 100 person-years |
Comparison: A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.95% CI: [0.6, 1.01]Regression, Cox
Primary
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death)
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Population: Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate - Baseline | Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) | 2.30 Events per 100 person-years |
| Vitamin K Antagonist (VKA) - Baseline | Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) | 3.02 Events per 100 person-years |
Comparison: A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.95% CI: [0.64, 1.08]Regression, Cox
Primary
Incidence Rate of Life-threatening Bleeding Events
Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Population: Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate - Baseline | Incidence Rate of Life-threatening Bleeding Events | 0.50 Events per 100 person-years |
| Vitamin K Antagonist (VKA) - Baseline | Incidence Rate of Life-threatening Bleeding Events | 1.04 Events per 100 person-years |
Primary
Incidence Rate of Major Bleeding Events
Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
Time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Population: Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate - Baseline | Incidence Rate of Major Bleeding Events | 0.73 Events per 100 person-years |
| Vitamin K Antagonist (VKA) - Baseline | Incidence Rate of Major Bleeding Events | 1.42 Events per 100 person-years |
Comparison: A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.95% CI: [0.38, 0.88]Regression, Cox
Primary
Incidence Rate of Myocardial Infarction
Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Population: Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate - Baseline | Incidence Rate of Myocardial Infarction | 0.34 Events per 100 person-years |
| Vitamin K Antagonist (VKA) - Baseline | Incidence Rate of Myocardial Infarction | 0.45 Events per 100 person-years |
Comparison: A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.95% CI: [0.49, 1.84]Regression, Cox
Primary
Incidence Rate of Pulmonary Embolism (PE)
Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Population: Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate - Baseline | Incidence Rate of Pulmonary Embolism (PE) | 0.09 Events per 100 person-years |
| Vitamin K Antagonist (VKA) - Baseline | Incidence Rate of Pulmonary Embolism (PE) | 0.06 Events per 100 person-years |
Primary
Incidence Rate of Stroke
Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Population: Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate - Baseline | Incidence Rate of Stroke | 0.64 Events per 100 person-years |
| Vitamin K Antagonist (VKA) - Baseline | Incidence Rate of Stroke | 0.96 Events per 100 person-years |
Comparison: A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.95% CI: [0.43, 1.09]Regression, Cox
Primary
Incidence Rate of Stroke or Systemic Embolism
Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Population: Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate - Baseline | Incidence Rate of Stroke or Systemic Embolism | 0.69 Events per 100 person-years |
| Vitamin K Antagonist (VKA) - Baseline | Incidence Rate of Stroke or Systemic Embolism | 1.01 Events per 100 person-years |
Comparison: A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.95% CI: [0.43, 1.06]Regression, Cox
Primary
Incidence Rate of Systemic Embolism (SEE)
Incidence rate of systemic embolism (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Population: Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate - Baseline | Incidence Rate of Systemic Embolism (SEE) | 0.07 Events per 100 person-years |
| Vitamin K Antagonist (VKA) - Baseline | Incidence Rate of Systemic Embolism (SEE) | 0.06 Events per 100 person-years |
Primary
Incidence Rate of Transient Ischaemic Attack (TIA)
Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Population: Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate - Baseline | Incidence Rate of Transient Ischaemic Attack (TIA) | 0.30 Events per 100 person-years |
| Vitamin K Antagonist (VKA) - Baseline | Incidence Rate of Transient Ischaemic Attack (TIA) | 0.26 Events per 100 person-years |
Primary
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death)
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Population: Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate - Baseline | Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) | 1.91 Events per 100 person-years |
| Vitamin K Antagonist (VKA) - Baseline | Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) | 2.36 Events per 100 person-years |
Comparison: A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.95% CI: [0.7, 1.27]Regression, Cox
Primary
Incidence Rate of Vascular Death
Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Population: Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate - Baseline | Incidence Rate of Vascular Death | 0.76 Events per 100 person-years |
| Vitamin K Antagonist (VKA) - Baseline | Incidence Rate of Vascular Death | 1.00 Events per 100 person-years |