Anticoagulant Utilization Pattern

A Description of Warfarin and NOAC Utilization Patterns Including Initiation, Switching, and Discontinuation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01847560

Enrollment

333664

Registered

2013-05-07

Start date

2013-04-17

Completion date

2017-11-01

Last updated

2019-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

This study plans to describe utilization patterns for oral anticoagulants over time in patients with non-valvular atrial fibrillation at risk for stroke using electronic claims data from a United States commercial insurance database.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* A recorded diagnosis of atrial fibrillation * Initiation of oral anticoagulant medication * Congestive Heart Failure, Hypertension, Age \> 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) Score \>=1 * At least 18 years of age on the date of anticoagulant initiation

Exclusion criteria

* Patients with missing or ambiguous age or sex information * Patients with documented evidence of valvular disease * Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the first dispensing * Patients with prior use of any oral anticoagulant

Design outcomes

Primary

Measure	Time frame	Description
Description of the Characteristics of Anticoagulant Initiators	From January 2009 to September 2015 (The study period)	The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (\>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).
Percentage of Patients Initiating Specific Anticoagulant	From January 2009 to September 2015 (The study period)	Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users. The overall number of participants analyzed 609201 reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm. Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm. Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period.
Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran	From January 2009 to September 2015 (The study period)	Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban	From January 2009 to September 2015 (The study period)	Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban	From January 2009 to September 2015 (The study period)	Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.

Secondary

Measure	Time frame	Description
Treatment Persistence Over Time	From January 2009 to September 2015 (The study period)	Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort. Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database.

Countries

United States

Participant flow

Recruitment details

This study used a cohort design with descriptive analyses, using data from January 2009 through September 2015. The study was conducted within two US-based longitudinal healthcare claims databases (MarketScan and UnitedHealth Research Database).

Pre-assignment details

The data source for this project was a combination of claims data from UnitedHealth, a commercial health insurer, and MarketScan, a research claims database from commercial employer-sponsored health plans both of which provide comprehensive medical coverage for members with active policies.

Participants by arm

Arm	Count
Cohort UnitedHealth Dabigatran Users Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.	13,464
Cohort UnitedHealth Rivaroxaban Users Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.	19,955
Cohort UnitedHealth Apixaban Users Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.	9,731
Cohort UnitedHealth WarfarinUsers (After Dabigatran Available) Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.	56,655
Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available) Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.	27,731
Cohort MarketScan Dabigatran Users Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.	28,343
Cohort MarketScan Rivaroxaban Users Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.	40,971
Cohort MarketScan Apixaban Users Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.	19,829
Cohort MarketScan WarfarinUsers (After Dabigatran Available) Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.	77,547
Cohort MarketScan WarfarinUsers(Before Dabigatran Available) Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.	39,438
Total	333,664

Baseline characteristics

Characteristic	Cohort MarketScan WarfarinUsers(Before Dabigatran Available)	Total	Cohort UnitedHealth Dabigatran Users	Cohort UnitedHealth Rivaroxaban Users	Cohort UnitedHealth Apixaban Users	Cohort UnitedHealth WarfarinUsers (After Dabigatran Available)	Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available)	Cohort MarketScan Dabigatran Users	Cohort MarketScan Rivaroxaban Users	Cohort MarketScan Apixaban Users	Cohort MarketScan WarfarinUsers (After Dabigatran Available)
Age, Continuous	69.1 Years STANDARD_DEVIATION 12.4	70.4 Years STANDARD_DEVIATION 11.9	69.07 Years STANDARD_DEVIATION 11.4	70.04 Years STANDARD_DEVIATION 11.45	72.18 Years STANDARD_DEVIATION 11.05	73.64 Years STANDARD_DEVIATION 10.28	71.7 Years STANDARD_DEVIATION 10.8	67.17 Years STANDARD_DEVIATION 12.11	67.63 Years STANDARD_DEVIATION 12.21	69.42 Years STANDARD_DEVIATION 12.32	71.03 Years STANDARD_DEVIATION 12.11
Race and Ethnicity Not Collected	—	0 Participants	—	—	—	—	—	—	—	—	—
Sex: Female, Male Female	15539 Participants	132509 Participants	5017 Participants	7939 Participants	4225 Participants	24620 Participants	11699 Participants	10096 Participants	15305 Participants	7776 Participants	30293 Participants
Sex: Female, Male Male	23899 Participants	201155 Participants	8447 Participants	12016 Participants	5506 Participants	32035 Participants	16032 Participants	18247 Participants	25666 Participants	12053 Participants	47254 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	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Outcome results

Primary

Description of the Characteristics of Anticoagulant Initiators

The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (\>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).