Atrial Fibrillation
Conditions
Brief summary
1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12 months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be collected. At 6 months, patient adherence will be assessed, using the Morisky Score.
Interventions
DRUGDabigatran etexilate
150 mg or 110 mg capsules twice daily
International Normalized Ratio (INR) 2-3
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
* Newly prescribed treatment with Pradaxa® (dabigatran etexilate)/VKA in the indication Stroke prevention in non-valvular atrial fibrillation (AF) respecting the indication and contraindications as described in the respective Summary of Product Characteristics for Pradaxa® 110 mg or 150 mg hard capsules or the appropriate VKA (patients are eligible for both Pradaxa® and VKA therapy). * Treatment with dabigatran etexilate or VKA is given in accordance with the respective Summaries of Product Characteristics. The routine diagnostic procedures and treatment that would be undertaken irrespective of the study are unaffected. * Only patients who are eligible both for therapy with Pradaxa® and for therapy with VKA in accordance with the respective Summaries of Product Characteristics will be documented (patients eligible for VKA and Pradaxa®) * Patients must have signed the patient consent form prior to inclusion in the Non-Interventional Study (NIS).
Exclusion criteria
* Patients with the general and special contraindications mentioned in the packaging leaflet or Summary of Product Characteristics must not be included. * Patients participating at the same time or within the last 30 days in another Non-Interventional Study (NIS) or an interventional clinical trial must not be included. * Patients treated with anticoagulants for a condition other than non-valvular atrial fibrillation must not be included. * Pradaxa® and VKA should not be used during pregnancy and lactation. Pregnant or breastfeeding women must therefore not be included in the NIS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month | 12 month (Visit 5) | Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | 6 month (visit 3) | Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and \> 2, respectively). |
| Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment) | Number of patients with the reason for definitive treatment discontinuation |
Countries
Germany
Participant flow
Recruitment details
In this study 1506 patients were entered, 1421 patients had at least one documented prescription of dabigatran etexilate (DE) or vitamin K antagonists (VKA)and were analyzed in the Treated set. 952 patients were matched 1:1 based on Propensity Score (PS).
Pre-assignment details
The patients were enrolled from 1000 sites from Germany. Approximately 2/3 (about 670) will be community-based primary care internists/general practitioners and approximately 1/3 (about 330) community-based cardiologists across Germany.
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran (Dabigatran vs VKA) Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention. | 771 |
| Vitamin K Antagonists (VKA) Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention. | 650 |
| Total | 1,421 |
Baseline characteristics
| Characteristic | Dabigatran (Dabigatran vs VKA) | Vitamin K Antagonists (VKA) | Total |
|---|---|---|---|
| Age, Continuous Dabigatran vs VKA(matched pop) | 75 Years | 75 Years | 75 Years |
| Age, Continuous Overall | 75 Years | 75 Years | 75 Years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Dabigatran vs VKA(matched pop) Female | 214 Participants | 205 Participants | 419 Participants |
| Sex: Female, Male Dabigatran vs VKA(matched pop) Male | 262 Participants | 271 Participants | 533 Participants |
| Sex: Female, Male Overall Female | 339 Participants | 284 Participants | 623 Participants |
| Sex: Female, Male Overall Male | 432 Participants | 366 Participants | 798 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 771 | 5 / 650 |
| other Total, other adverse events | 0 / 771 | 0 / 650 |
| serious Total, serious adverse events | 45 / 771 | 39 / 650 |
Outcome results
Primary
Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month
Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.
Time frame: 12 month (Visit 5)
Population: Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs VKA) | Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month | 89.5 percentage of participants |
| VKA (Dabigatran vs VKA) | Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month | 89.5 percentage of participants |
Comparison: Persistence in both treatment groups was compared by means of the stratified Log-rank testp-value: 0.8496stratified log-rank test
Secondary
Number of Patients With the Reason for Definitive Treatment Discontinuation
Number of patients with the reason for definitive treatment discontinuation
Time frame: Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)
Population: Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 5 (Month 12) | Patient's wish | 1 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 3 (Month 6) | Other | 1 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 2 (Month 3) | Other | 0 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 4 (Month 9) | Serious adverse event | 0 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 2 (Month 3) | Patient's wish | 1 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 4 (Month 9) | Patient's wish | 0 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 3 (Month 6) | Serious adverse event | 1 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 4 (Month 9) | Decision of physician | 0 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 2 (Month 3) | Serious adverse event | 0 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 4 (Month 9) | Other | 0 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 3 (Month 6) | Patient's wish | 0 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 5 (Month 12) | Serious adverse event | 0 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 5 (Month 12) | Decision of physician | 0 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 2 (Month 3) | Decision of physician | 1 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 5 (Month 12) | Other | 2 Participants |
| Dabigatran (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 3 (Month 6) | Decision of physician | 1 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 5 (Month 12) | Other | 0 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 5 (Month 12) | Patient's wish | 0 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 2 (Month 3) | Serious adverse event | 0 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 2 (Month 3) | Patient's wish | 1 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 2 (Month 3) | Decision of physician | 0 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 2 (Month 3) | Other | 1 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 3 (Month 6) | Serious adverse event | 1 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 3 (Month 6) | Patient's wish | 1 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 3 (Month 6) | Decision of physician | 1 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 3 (Month 6) | Other | 1 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 4 (Month 9) | Serious adverse event | 0 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 4 (Month 9) | Patient's wish | 0 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 4 (Month 9) | Decision of physician | 2 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 4 (Month 9) | Other | 1 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 5 (Month 12) | Decision of physician | 2 Participants |
| VKA (Dabigatran vs VKA) | Number of Patients With the Reason for Definitive Treatment Discontinuation | Visit 5 (Month 12) | Serious adverse event | 0 Participants |
Secondary
Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.
Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and \> 2, respectively).
Time frame: 6 month (visit 3)
Population: Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran (Dabigatran vs VKA) | Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | High | 5.88 Percentage of participants |
| Dabigatran (Dabigatran vs VKA) | Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | Low | 19.12 Percentage of participants |
| Dabigatran (Dabigatran vs VKA) | Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | Medium | 45.8 Percentage of participants |
| Dabigatran (Dabigatran vs VKA) | Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | Missing | 29.2 Percentage of participants |
| VKA (Dabigatran vs VKA) | Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | Missing | 25.42 Percentage of participants |
| VKA (Dabigatran vs VKA) | Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | High | 3.99 Percentage of participants |
| VKA (Dabigatran vs VKA) | Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | Medium | 46.85 Percentage of participants |
| VKA (Dabigatran vs VKA) | Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | Low | 23.74 Percentage of participants |