Treatment Patterns Among Patients With Venous Thromboembolism in the United States

Post-Discharge Treatment Patterns and Outcomes in Patients With Venous Thromboembolism

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05795062

Enrollment

13945

Registered

2023-04-03

Start date

2023-03-10

Completion date

2023-09-30

Last updated

2024-11-22

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

Conditions

Venous Thromboembolism

Brief summary

The purpose of this study is to assess outpatient treatment patterns following hospitalization for venous thromboembolism (VTE). VTE is a condition that occurs when blood clot forms in the vein. This is a retrospective study (assessments on events that have already occurred) of healthcare claims from databases. The study sponsors will assess healthcare claim records of patients treated with either apixaban or warfarin. Assessment includes treatment persistence, switch, and stopping therapy, along with recurrent VTE and bleeding.

Interventions

DRUGapixaban

patients treated with apixaban

DRUGwarfarin

patients treated with warfarin

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* inpatient hospitalization with primary discharge diagnosis of venous thromboembolism (VTE) (this is the index hospitalization) * treatment with apixaban or warfarin during the hospitalization * at least 18 years of age

Exclusion criteria

* Hospitalization for VTE within 6 months prior to the index hospitalization * Diagnosis of atrial fibrillation/flutter or procedure for mechanical heart valve in the 6 months prior to the index hospitalization * Procedure for inferior vena cava filter or diagnosis of pregnancy during the study period * Prior use of oral anticoagulants or parenteral anticoagulants

Design outcomes

Primary

Measure	Time frame	Description
Median Time to Switch From the Index Treatment	From initiation of index treatment post-discharge till switch (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)	Time from treatment index date to treatment switch date was described in this outcome measure. Participants were considered to have switched if they filled a prescription for OAC other than apixaban or warfarin, respectively (identified through NDC codes in LRx) or for PAC within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim.
Percentage of Participants Who Discontinued Index Treatment at 12 Months Post-Discharge Index Date	At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)	Discontinuation was defined as \>= 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim.
Percentage of Participants Who Switched From Index Treatment at 6 Months Post-Discharge Index Date	At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)	Participants were considered to have switched if they filled a prescription for oral anticoagulant (OAC) other than apixaban or warfarin, respectively (identified through national drug codes \[NDC\] codes in longitudinal prescription claims \[LRx\]) or for parenteral anticoagulant (PAC) within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim.
Percentage of Participants Who Switched From Index Treatment at Month 12 Post-Discharge Index Date	At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)	Participants were considered to have switched if they filled a prescription for OAC other than apixaban or warfarin, respectively (identified through NDC codes in LRx) or for PAC within 30 days before or after the run-out date of index treatment. The date of the switch was defined as date of the prescription of such a therapy (OAC or PAC). Treatment index date: date of first outpatient apixaban or warfarin claim.
Median Time to Discontinuation From the Index Treatment	From initiation of index treatment post-discharge till its discontinuation (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)	Time from treatment index date to discontinuation date was described in this outcome measure. Discontinuation was defined as \>= 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim.
Number of Participants Who Continued Treatment With Apixaban or Warfarin Following Discharge From the Hospital	From hospital discharge date through 30 days following discharge date (from the data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)	Following discharge from inpatient hospitalization, participants who continued apixaban or warfarin, respectively, in the outpatient setting (with outpatient treatment claim occurring on or within 30-days following the hospital discharge date) were identified.
Mean Number of Persistent Days	From the index date until the first of treatment discontinuation, treatment switch, or the end of follow-up, whichever occurred first (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)	Persistent days was defined as the number of days from the index date until the first of the following: treatment discontinuation, treatment switch, or the end of follow-up. Treatment index date: date of first outpatient apixaban or warfarin claim.
Percentage of Participants Who Discontinued Index Treatment at 6 Months Post-Discharge Index Date	At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)	Discontinuation was defined as greater than or equal to (\>=) 30-day gap from the run-out of days supply of the treatment (post-discharge) index prescription (that is, apixaban or warfarin) to date of next claim for the respective therapy or with no other claims for the respective therapy. The date of discontinuation was last day of day's supply of the last filled prescription. Treatment index date: date of first outpatient apixaban or warfarin claim.

Secondary

Measure	Time frame	Description
Median Time to Recurrent VTE	From first hospitalization discharge date to subsequent inpatient hospitalization for VTE (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)	Recurrent VTE was defined as inpatient hospitalization with a primary diagnosis of VTE occurring 7 or more days after the first hospitalization discharge date. The date of the first observed event was flagged. Treatment index date: date of first outpatient apixaban or warfarin claim.
Incidence Rate of Major Bleeding Events	From first hospitalization discharge through first major bleeding event (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)	Major bleeding was defined as inpatient hospitalization with primary diagnosis of gastro-intestinal bleeding, intracranial hemorrhage (ICH) or other major bleeding. Incidence rate was defined as the number of events (major bleeding) per 100 participant years. Treatment index date: date of first outpatient apixaban or warfarin claim.
Incidence Rate of Clinically Relevant Non-Major (CRNM) Bleeding Events	From first hospitalization discharge through first CRNM bleeding event (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)	CRNM bleeding was defined as inpatient hospitalization with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM gastrointestinal (GI) bleeding or other non-critical types of bleeding. Incidence rate was defined as the number of events (CRNM bleeding) per 100 participant years.
Incidence Rate of Recurrent VTE Events	From first hospitalization discharge date to subsequent inpatient hospitalization for VTE (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)	Recurrent VTE was defined as inpatient hospitalization with a primary diagnosis of VTE occurring 7 or more days after the first hospitalization discharge date. The date of the first observed event was flagged. Incidence rate was defined as the number of events (recurrent VTE) per 100 participant years. Treatment index date: date of first outpatient apixaban or warfarin claim.

Countries

United States

Participant flow

Recruitment details

Data of eligible participants, who had hospitalization for primary diagnosis of venous thromboembolism (VTE) and received apixaban or warfarin, was extracted from databases and health claim records from 01 July 2017 to 31 December 2022 (study data identification duration of 5.5 years).

Pre-assignment details

It is a retrospective population-based register study. Available data from eligible participants was evaluated in approximately 7 months of this retrospective, observational study per its objectives.

Participants by arm

Arm	Count
Apixaban Participants who received apixaban (per clinical practice) during the hospitalization for primary diagnosis of VTE were included. Available data was evaluated in approximately 7 months of this retrospective, observational study.	11,966
Warfarin Participants who received warfarin (per clinical practice) during the hospitalization for primary diagnosis of VTE were included. Available data was evaluated in approximately 7 months of this retrospective, observational study.	1,979
Total	13,945

Baseline characteristics

Characteristic	Apixaban	Warfarin	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	7229 Participants	1101 Participants	8330 Participants
Age, Categorical Between 18 and 65 years	4737 Participants	878 Participants	5615 Participants
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	6714 Participants	1130 Participants	7844 Participants
Sex: Female, Male Male	5252 Participants	849 Participants	6101 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

Mean Number of Persistent Days

Persistent days was defined as the number of days from the index date until the first of the following: treatment discontinuation, treatment switch, or the end of follow-up. Treatment index date: date of first outpatient apixaban or warfarin claim.

Time frame: From the index date until the first of treatment discontinuation, treatment switch, or the end of follow-up, whichever occurred first (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)