Trial Outcomes & Findings for Validation of Predictors of OAC Initiation Using EMR Data (NCT NCT03006341)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

140187 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2019-03-22

Participant Flow

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.

In this non-interventional study based on existing data, no patients were screened.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	26199	70071	32595	11322
Overall Study COMPLETED	1130	2566	1602	637
Overall Study NOT COMPLETED	25069	67505	30993	10685

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
Overall Study Not linked in the EMR	25069	67505	30993	10685

Baseline Characteristics

Baseline characteristics are based on all patients who successfully linked in the EMR

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.	Rivaroxaban n=1602 Participants (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.	Apixaban n=637 Participants (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.	Total n=5935 Participants Total of all reporting groups
Age, Continuous	65.1 Years STANDARD_DEVIATION 11.4 • n=1130 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR	69.3 Years STANDARD_DEVIATION 11.3 • n=2566 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR	66.2 Years STANDARD_DEVIATION 11.1 • n=1602 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR	67.3 Years STANDARD_DEVIATION 11.4 • n=637 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR	67.4 Years STANDARD_DEVIATION 11.4 • n=5935 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR
Sex: Female, Male Female	432 Participants n=1130 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR	1006 Participants n=2566 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR	600 Participants n=1602 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR	250 Participants n=637 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR	2288 Participants n=5935 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR
Sex: Female, Male Male	698 Participants n=1130 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR	1560 Participants n=2566 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR	1002 Participants n=1602 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR	387 Participants n=637 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR	3647 Participants n=5935 Participants • Baseline characteristics are based on all patients who successfully linked in the EMR
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
Percentage of Patients With Obesity Before PS matching	58.2 Percentage of patients	51.7 Percentage of patients
Percentage of Patients With Obesity After PS matching	57.4 Percentage of patients	54.2 Percentage of patients

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
Percentage of Patients Smoking Before PS matching	50.0 Percentage of patients	51.8 Percentage of patients
Percentage of Patients Smoking After PS matching	50.0 Percentage of patients	50.5 Percentage of patients

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
Percentage of Patients With Alcohol Consumption Before PS matching	47.1 Percentage of patients	50.9 Percentage of patients
Percentage of Patients With Alcohol Consumption After PS matching	50.0 Percentage of patients	38.9 Percentage of patients

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
Percentage of Patients With Abnormal Renal Function Before PS matching	5.5 Percentage of patients	11.7 Percentage of patients
Percentage of Patients With Abnormal Renal Function After PS matching	6.5 Percentage of patients	8.0 Percentage of patients

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
Percentage of Patients With Bleeding History or Predisposition Before PS matching	3.4 Percentage of patients	4.7 Percentage of patients
Percentage of Patients With Bleeding History or Predisposition After PS matching	3.7 Percentage of patients	4.6 Percentage of patients

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR) Before PS matching	86.5 Milliliter/minute/1.73 square meter Standard Deviation 21.6	78.3 Milliliter/minute/1.73 square meter Standard Deviation 25.1
EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR) After PS matching	85.4 Milliliter/minute/1.73 square meter Standard Deviation 21.9	83.4 Milliliter/minute/1.73 square meter Standard Deviation 23.5

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
EMR Characteristic: Serum Creatinine After PS matching	1.0 Milligrams per deciliter Standard Deviation 0.3	1.0 Milligrams per deciliter Standard Deviation 0.4
EMR Characteristic: Serum Creatinine Before PS matching	1.0 Milligrams per deciliter Standard Deviation 0.3	1.1 Milligrams per deciliter Standard Deviation 0.6

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
Percentage of Patients With Abnormal Liver Function Before PS matching	0.5 Percentage of patients	0.7 Percentage of patients
Percentage of Patients With Abnormal Liver Function After PS matching	0.5 Percentage of patients	0.0 Percentage of patients

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
EMR Characteristic: Duration of Atrial Fibrillation Before PS matching	22.5 Months Standard Deviation 33.8	26.4 Months Standard Deviation 32.5
EMR Characteristic: Duration of Atrial Fibrillation After PS matching	22.7 Months Standard Deviation 35.2	25.4 Months Standard Deviation 33.0

SECONDARY outcome

Timeframe: 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

EMR characteristic: History of adherence: non-adherent/adherent.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
EMR Characteristic: History/Duration of Hypertension Before PS matching	42.4 Months Standard Deviation 42.8	43.8 Months Standard Deviation 41.5
EMR Characteristic: History/Duration of Hypertension After PS matching	43.6 Months Standard Deviation 43.7	40.9 Months Standard Deviation 40.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
Percentage of Patients With Uncontrolled Hypertension Before PS matching	0.0 Percentage of patients	0.0 Percentage of patients
Percentage of Patients With Uncontrolled Hypertension After PS matching	0.0 Percentage of patients	0.0 Percentage of patients

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
EMR Characteristic: History/Duration of Congestive Heart Failure (CHF) Before PS matching	28.2 Months Standard Deviation 30.8	38.3 Months Standard Deviation 38.6
EMR Characteristic: History/Duration of Congestive Heart Failure (CHF) After PS matching	26.0 Months Standard Deviation 30.1	33.9 Months Standard Deviation 38.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
Percentage of Patients With Prior Transient Ischemic Attack Before PS matching	1.6 Percentage of patients	2.1 Percentage of patients
Percentage of Patients With Prior Transient Ischemic Attack After PS matching	1.4 Percentage of patients	2.4 Percentage of patients

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
Percentage of Patients With Diabetes Before PS matching	13.4 Percentage of patients	18.2 Percentage of patients
Percentage of Patients With Diabetes After PS matching	14.7 Percentage of patients	14.5 Percentage of patients

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
Percentage of Patients With Hyperlipidemia Before PS matching	34.8 Percentage of patients	36.8 Percentage of patients
Percentage of Patients With Hyperlipidemia After PS matching	35.6 Percentage of patients	34.0 Percentage of patients

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
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 1.0	1.6 Unit on Scale Standard Deviation 1.0
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 1.0	1.5 Unit on Scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=1130 Participants 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.	Warfarin n=2566 Participants 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.
Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs Before PS matching	18.0 Percentage of patients	18.4 Percentage of patients
Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs After PS matching	17.1 Percentage of patients	18.7 Percentage of patients

Adverse Events

Dabigatran Etexilate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Warfarin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rivaroxaban

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Apixaban

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER