An observational study in Atrial Fibrillation, sponsored by Boehringer Ingelheim. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-02.
Sponsored by Boehringer Ingelheim · Observational
The study is an analysis using the French national health insurance database, six months after the beginning of NOAC launch in the NVAF indication.
The aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding, arterial thrombotic events, myocardial infarction (MI), death) between patients starting a NOAC and patients starting a VKA for NVAF in 2013
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 103,101 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
New users of NOAC or VKA for NVAF
Patients with NVAF with a first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA in 2013, with no other identified indication for anticoagulation; Without any VKA or NOAC (Pradaxa®, Xarelto®, or Eliquis®) reimbursed dispensation for the last 3 years before the first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA
Exclusion criteria:
None
New oral anticoagulant groups
VKA group
Clinically Relevant Bleeding
First hospitalization with primary diagnosis (Tenth Revision codes of the International Classification of Diseases (ICD-10 codes)) of: 1. Hemorrhagic stroke, 2. Other critical organ or site bleeding, 3. Other bleeding (gastro-intestinal bleeding, urogenital bleeding and other bleeding subtype).
Time frame: One year
Major Bleeding
First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Hemorrhagic stroke, 2. Other critical organ or site bleeding, 3. Other bleeding with transfusion, or acute post-hemorrhagic anemia or death during hospital stay.
Time frame: 1 year
Arterial Thrombotic Event
First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Ischemic or undefined stroke, 2. Systemic arterial embolism.
Time frame: 1 year
Acute Coronary Syndrome
First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Myocardial infarction (ST-segment elevation Myocardial infarction (STEMI) and non-ST-segment elevation Myocardial infarction(NSTEMI)), 2. Unstable angina.
Time frame: One year
Death (All-cause)
All-cause death (cause of death not available in the database).
Time frame: 1 year
Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death)
First event among clinically relevant bleeding, arterial thrombotic event, acute coronary syndrome, or death defined above.
Time frame: One year
The study ENGEL 2 is a real-world historical cohort study in the French nationwide healthcare claims and hospitalization database (SNIIRAM) including new users of DOAC or VKA for nonvalvular atrial fibrillation (NVAF) in 2013 with a follow-up for one year (main objective).
| Milestone | Dabigatran | Rivaroxaban | Vitamin K Antagonists |
|---|---|---|---|
| Started | 27060 | 31388 | 44653 |
| Completed | 27060 | 31388 | 44653 |
| Not completed | 0 | 0 | 0 |
First hospitalization with primary diagnosis (Tenth Revision codes of the International Classification of Diseases (ICD-10 codes)) of: 1. Hemorrhagic stroke, 2. Other critical organ or site bleeding, 3. Other bleeding (gastro-intestinal bleeding, urogenital bleeding and other bleeding subtype).
| participants with event | Dabigatran (Dabigatran vs VKA) | VKA (Dabigatran vs VKA) | Rivaroxaban (Rivaroxaban vs VKA) | VKA (Rivaroxaban vs VKA) |
|---|---|---|---|---|
| Clinically Relevant Bleeding | 367 (2.2 to 2.7) | 668 (4.1 to 4.8) | 635 (3.5 to 4.1) | 767 (4.2 to 4.8) |
First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Hemorrhagic stroke, 2. Other critical organ or site bleeding, 3. Other bleeding with transfusion, or acute post-hemorrhagic anemia or death during hospital stay.
| participants with events | Dabigatran (Dabigatran vs VKA) | VKA (Dabigatran vs VKA) | Rivaroxaban (Rivaroxaban vs VKA) | VKA (Rivaroxaban vs VKA) |
|---|---|---|---|---|
| Major Bleeding | 178 (1.0 to 1.4) | 341 (2.0 to 2.5) | 280 (1.5 to 1.9) | 417 (2.2 to 2.7) |
First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Ischemic or undefined stroke, 2. Systemic arterial embolism.
| participants with events | Dabigatran (Dabigatran vs VKA) | VKA (Dabigatran vs VKA) | Rivaroxaban (Rivaroxaban vs VKA) | VKA (Rivaroxaban vs VKA) |
|---|---|---|---|---|
| Arterial Thrombotic Event | 226 (1.4 to 1.8) | 321 (1.9 to 2.4) | 343 (1.8 to 2.2) | 351 (1.9 to 2.3) |
First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Myocardial infarction (ST-segment elevation Myocardial infarction (STEMI) and non-ST-segment elevation Myocardial infarction(NSTEMI)), 2. Unstable angina.
| participants with events | Dabigatran (Dabigatran vs VKA) | VKA (Dabigatran vs VKA) | Rivaroxaban (Rivaroxaban vs VKA) | VKA (Rivaroxaban vs VKA) |
|---|---|---|---|---|
| Acute Coronary Syndrome | 176 (1.1 to 1.4) | 238 (1.4 to 1.8) | 230 (1.2 to 1.5) | 277 (1.4 to 1.8) |
All-cause death (cause of death not available in the database).
| participants with events | Dabigatran (Dabigatran vs VKA) | VKA (Dabigatran vs VKA) | Rivaroxaban (Rivaroxaban vs VKA) | VKA (Rivaroxaban vs VKA) |
|---|---|---|---|---|
| Death (All-cause) | 686 (4.6 to 5.3) | 983 (6.4 to 7.3) | 908 (5.2 to 6.0) | 1186 (6.9 to 7.8) |
First event among clinically relevant bleeding, arterial thrombotic event, acute coronary syndrome, or death defined above.
| participants with events | Dabigatran (Dabigatran vs VKA) | VKA (Dabigatran vs VKA) | Rivaroxaban (Rivaroxaban vs VKA) | VKA (Rivaroxaban vs VKA) |
|---|---|---|---|---|
| Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death) | 1340 (8.8 to 9.8) | 1970 (12.5 to 13.7) | 1967 (11.1 to 12.1) | 2328 (13.2 to 14.3) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dabigatran | — | — | — |
| Rivaroxaban | — | — | — |
| Vitamin K Antagonists | — | — | — |
The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
| Age, Customized(Years) | Dabigatran | Rivaroxaban | Vitamin K Antagonists | Total |
|---|---|---|---|---|
| Overall | 73.2 ± 11.8 | 73.2 ± 11.8 | 77.9 ± 11.1 | 75.2 ± 11.7 |
| Dabigatran vs VKA (matched pop) | 75.3 ± 10.7 | — | 75.4 ± 10.7 | 75.4 ± 10.7 |
| Rivaroxaban vs VKA (matched pop) | — | 75.3 ± 10.7 | 75.4 ± 10.7 | 75.4 ± 10.7 |
| Sex/Gender, Customized(Participants) | Dabigatran | Rivaroxaban | Vitamin K Antagonists | Total |
|---|---|---|---|---|
| Overall — Male | 15253 | 17653 | 22868 | 55774 |
| Overall — Female | 11807 | 13735 | 21785 | 47327 |
| Dabigatran vs VKA (matched pop) — Male | 11164 | — | 11164 | 22328 |
| Dabigatran vs VKA (matched pop) — Female | 9325 | — | 9325 | 18650 |
| Rivaroxaban vs VKA (matched pop) — Male | — | 12557 | 12557 | 25114 |
| Rivaroxaban vs VKA (matched pop) — Female | — | 10496 | 10496 | 20992 |
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim