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Anticoagulants Comparative Benefit-risk Ratio in Real Life

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ClinicalTrials.gov Identifier: NCT02785354
Recruitment Status : Completed
First Posted : May 27, 2016
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Atrial Fibrillation
Enrollment 103101
Recruitment Details 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).
Pre-assignment Details The main objective was to compare the risk & effectiveness for dabigatran vs VKA, & for rivaroxaban vs VKA. The main analysis was done for hdPS matched patients (pts.) with atrial fibrillation (AF) diagnosis information in the database.
Arm/Group Title Dabigatran Rivaroxaban Vitamin K Antagonists
Hide Arm/Group Description Patients with a first dispensing of dabigatran in 2013 for NVAF. Patients with a first dispensing of rivaroxaban in 2013 for NVAF. Patients with a first dispensing of VKA in 2013 for NVAF.
Period Title: Overall Study
Started 27060 31388 44653
Completed 27060 31388 44653
Not Completed 0 0 0
Arm/Group Title Dabigatran Rivaroxaban Vitamin K Antagonists Total
Hide Arm/Group Description Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS. Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS. Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS. Total of all reporting groups
Overall Number of Baseline Participants 27060 31388 44653 103101
Hide Baseline Analysis Population Description
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   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Overall Number Analyzed 27060 participants 31388 participants 44653 participants 103101 participants
73.2  (11.8) 73.2  (11.8) 77.9  (11.1) 75.2  (11.7)
Dabigatran vs VKA (matched pop) Number Analyzed 20489 participants 0 participants 20489 participants 40978 participants
75.3  (10.7) 75.4  (10.7) 75.4  (10.7)
Rivaroxaban vs VKA (matched pop) Number Analyzed 0 participants 23053 participants 23053 participants 46106 participants
75.3  (10.7) 75.4  (10.7) 75.4  (10.7)
[1]
Measure Analysis Population Description: 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.
Sex/Gender, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Overall Number Analyzed 27060 participants 31388 participants 44653 participants 103101 participants
Male
15253
  56.4%
17653
  56.2%
22868
  51.2%
55774
  54.1%
Female
11807
  43.6%
13735
  43.8%
21785
  48.8%
47327
  45.9%
Dabigatran vs VKA (matched pop) Number Analyzed 20489 participants 0 participants 20489 participants 40978 participants
Male
11164
  54.5%
11164
  54.5%
22328
  54.5%
Female
9325
  45.5%
9325
  45.5%
18650
  45.5%
Rivaroxaban vs VKA (matched pop) Number Analyzed 0 participants 23053 participants 23053 participants 46106 participants
Male
12557
  54.5%
12557
  54.5%
25114
  54.5%
Female
10496
  45.5%
10496
  45.5%
20992
  45.5%
[1]
Measure Analysis Population Description: 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.
1.Primary Outcome
Title Clinically Relevant Bleeding
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients (pts) with a first dispensing (dispen.) of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks (wks.)), gender, age at index date (± 1 year (yr)) and high-dimensional propensity score (hdPS, ± 0.05).
Arm/Group Title Dabigatran (Dabigatran vs VKA) VKA (Dabigatran vs VKA) Rivaroxaban (Rivaroxaban vs VKA) VKA (Rivaroxaban vs VKA)
Hide Arm/Group Description:
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Overall Number of Participants Analyzed 20489 20489 23053 23053
Measure Type: Number
Unit of Measure: participants with event
367 668 635 767
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs VKA), VKA (Dabigatran vs VKA)
Comments Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95% Confidence Interval (CI ) (and death as a competing risk).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fine and Gray model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.51 to 0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Rivaroxaban vs VKA), VKA (Rivaroxaban vs VKA)
Comments Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Fine and Gray model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.75 to 0.92
Estimation Comments [Not Specified]
2.Primary Outcome
Title Major Bleeding
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).
Arm/Group Title Dabigatran (Dabigatran vs VKA) VKA (Dabigatran vs VKA) Rivaroxaban (Rivaroxaban vs VKA) VKA (Rivaroxaban vs VKA)
Hide Arm/Group Description:
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Overall Number of Participants Analyzed 20489 20489 23053 23053
Measure Type: Number
Unit of Measure: participants with events
178 341 280 417
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs VKA), VKA (Dabigatran vs VKA)
Comments Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fine and Gray model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.46 to 0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Rivaroxaban vs VKA), VKA (Rivaroxaban vs VKA)
Comments Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fine and Gray model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.58 to 0.79
Estimation Comments [Not Specified]
3.Primary Outcome
Title Arterial Thrombotic Event
Hide Description

First hospitalization with primary diagnosis (ICD-10 codes) of:

  1. Ischemic or undefined stroke,
  2. Systemic arterial embolism.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).
Arm/Group Title Dabigatran (Dabigatran vs VKA) VKA (Dabigatran vs VKA) Rivaroxaban (Rivaroxaban vs VKA) VKA (Rivaroxaban vs VKA)
Hide Arm/Group Description:
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Overall Number of Participants Analyzed 20489 20489 23053 23053
Measure Type: Number
Unit of Measure: participants with events
226 321 343 351
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs VKA), VKA (Dabigatran vs VKA)
Comments Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Fine and Gray model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.63 to 0.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Rivaroxaban vs VKA), VKA (Rivaroxaban vs VKA)
Comments Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8341
Comments [Not Specified]
Method Fine and Gray model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.85 to 1.14
Estimation Comments [Not Specified]
4.Primary Outcome
Title Acute Coronary Syndrome
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).
Arm/Group Title Dabigatran (Dabigatran vs VKA) VKA (Dabigatran vs VKA) Rivaroxaban (Rivaroxaban vs VKA) VKA (Rivaroxaban vs VKA)
Hide Arm/Group Description:
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Overall Number of Participants Analyzed 20489 20489 23053 23053
Measure Type: Number
Unit of Measure: participants with events
176 238 230 277
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs VKA), VKA (Dabigatran vs VKA)
Comments Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0147
Comments [Not Specified]
Method Fine and Gray model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.65 to 0.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Rivaroxaban vs VKA), VKA (Rivaroxaban vs VKA)
Comments Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0501
Comments [Not Specified]
Method Fine and Gray model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.71 to 1.00
Estimation Comments [Not Specified]
5.Primary Outcome
Title Death (All-cause)
Hide Description All-cause death (cause of death not available in the database).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).
Arm/Group Title Dabigatran (Dabigatran vs VKA) VKA (Dabigatran vs VKA) Rivaroxaban (Rivaroxaban vs VKA) VKA (Rivaroxaban vs VKA)
Hide Arm/Group Description:
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Overall Number of Participants Analyzed 20489 20489 23053 23053
Measure Type: Number
Unit of Measure: participants with events
686 983 908 1186
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs VKA), VKA (Dabigatran vs VKA)
Comments Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cox proportional hazard risk model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.67 to 0.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Rivaroxaban vs VKA), VKA (Rivaroxaban vs VKA)
Comments Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cox proportional hazard risk model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.71 to 0.84
Estimation Comments [Not Specified]
6.Primary Outcome
Title Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death)
Hide Description First event among clinically relevant bleeding, arterial thrombotic event, acute coronary syndrome, or death defined above.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).
Arm/Group Title Dabigatran (Dabigatran vs VKA) VKA (Dabigatran vs VKA) Rivaroxaban (Rivaroxaban vs VKA) VKA (Rivaroxaban vs VKA)
Hide Arm/Group Description:
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
Overall Number of Participants Analyzed 20489 20489 23053 23053
Measure Type: Number
Unit of Measure: participants with events
1340 1970 1967 2328
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs VKA), VKA (Dabigatran vs VKA)
Comments Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cox proportional hazard risk model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.66 to 0.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rivaroxaban (Rivaroxaban vs VKA), VKA (Rivaroxaban vs VKA)
Comments Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cox proportional hazard risk model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.79 to 0.89
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Claims and hospitalization database without any adverse event declaration, and using secondary individual anonymous information. Thus all outcomes studied were reported in aggregate in the final study report.
 
Arm/Group Title Dabigatran Rivaroxaban Vitamin K Antagonists
Hide Arm/Group Description Patients with a first dispensing of dabigatran in 2013 for NVAF. Patients with a first dispensing of rivaroxaban in 2013 for NVAF. Patients with a first dispensing of VKA in 2013 for NVAF.
All-Cause Mortality
Dabigatran Rivaroxaban Vitamin K Antagonists
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Dabigatran Rivaroxaban Vitamin K Antagonists
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Rivaroxaban Vitamin K Antagonists
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
DOAC & VKA were prescribed by physicians in their daily practice,with differences for pts & disease characteristics,including stroke & bleeding risk factors.To control this pts were 1:1 matched on date of 1st dispensing, gender,age & hdPS.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02785354    
Other Study ID Numbers: 1160.263
First Submitted: May 25, 2016
First Posted: May 27, 2016
Results First Submitted: April 4, 2017
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018