Trial Outcomes & Findings for Treatment Patterns Among Patients With Venous Thromboembolism in the United States (NCT NCT05795062)

NCT ID: NCT05795062

Last Updated: 2024-11-22

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 13945 participants
• Primary outcome timeframe: 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)
• Results posted on: 2024-11-22

Participant Flow

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).

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	11966	1979
Overall Study COMPLETED	11966	1979
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.	Total n=13945 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=11966 Participants	0 Participants n=1979 Participants	0 Participants n=13945 Participants
Age, Categorical Between 18 and 65 years	4737 Participants n=11966 Participants	878 Participants n=1979 Participants	5615 Participants n=13945 Participants
Age, Categorical >=65 years	7229 Participants n=11966 Participants	1101 Participants n=1979 Participants	8330 Participants n=13945 Participants
Sex: Female, Male Female	6714 Participants n=11966 Participants	1130 Participants n=1979 Participants	7844 Participants n=13945 Participants
Sex: Female, Male Male	5252 Participants n=11966 Participants	849 Participants n=1979 Participants	6101 Participants n=13945 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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)

Population: Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.

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.

Outcome measures

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.
Number of Participants Who Continued Treatment With Apixaban or Warfarin Following Discharge From the Hospital	11966 Participants	1979 Participants

PRIMARY outcome

Timeframe: 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)

Population: Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.

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.

Outcome measures

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.
Mean Number of Persistent Days	233.5 Days Standard Deviation 302.9	242.6 Days Standard Deviation 304.4

PRIMARY outcome

Timeframe: At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Population: Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.

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.

Outcome measures

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.
Percentage of Participants Who Discontinued Index Treatment at 6 Months Post-Discharge Index Date	50.5 Percentage of Participants	52.2 Percentage of Participants

PRIMARY outcome

Timeframe: At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Population: Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.

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.

Outcome measures

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.
Percentage of Participants Who Discontinued Index Treatment at 12 Months Post-Discharge Index Date	72.9 Percentage of Participants	75.2 Percentage of Participants

PRIMARY outcome

Timeframe: At 6 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Population: Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.

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.

Outcome measures

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.
Percentage of Participants Who Switched From Index Treatment at 6 Months Post-Discharge Index Date	6.0 Percentage of Participants	20.9 Percentage of Participants

PRIMARY outcome

Timeframe: At 12 Months post-discharge index date (data retrieved for 5.5 years and retrospective data evaluated in approximately 7 months of this study)

Population: Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.

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.

Outcome measures

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.
Percentage of Participants Who Switched From Index Treatment at Month 12 Post-Discharge Index Date	7.1 Percentage of Participants	24.3 Percentage of Participants

PRIMARY outcome

Timeframe: 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)

Population: Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.

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.

Outcome measures

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.
Median Time to Discontinuation From the Index Treatment	5.97 Months Interval 5.83 to 6.07	5.67 Months Interval 5.17 to 6.03

PRIMARY outcome

Timeframe: 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)

Population: Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.

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.

Outcome measures

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.
Median Time to Switch From the Index Treatment	NA Months The median time to switch from the index treatment could not be estimated and calculated because more than half the participants did not experience a switch.	NA Months The median time to switch from the index treatment could not be estimated because more than half the participants did not experience a switch.

SECONDARY outcome

Timeframe: 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)

Population: Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.

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.

Outcome measures

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.
Incidence Rate of Recurrent VTE Events	1.2 Events per 100 participant-years	2.5 Events per 100 participant-years

SECONDARY outcome

Timeframe: 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)

Population: Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.

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.

Outcome measures

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.
Median Time to Recurrent VTE	NA Months The median time to event could not be estimated and calculated because more than half the participants did not experience recurrent VTE.	NA Months The median time to event could not be estimated and calculated because more than half the participants did not experience recurrent VTE.

SECONDARY outcome

Timeframe: 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)

Population: Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.

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.

Outcome measures

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.
Incidence Rate of Major Bleeding Events	1.5 Events per 100 participant-years Interval 1.2 to 1.8	2.0 Events per 100 participant-years Interval 1.3 to 2.9

SECONDARY outcome

Timeframe: 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)

Population: Eligible participants whose data was extracted and evaluated in this study and was evaluable for analysis.

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.

Outcome measures

Measure	Apixaban n=11966 Participants 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.	Warfarin n=1979 Participants 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.
Incidence Rate of Clinically Relevant Non-Major (CRNM) Bleeding Events	17.7 Events per 100 participant-years Interval 16.7 to 18.7	21.3 Events per 100 participant-years Interval 18.8 to 24.1

Adverse Events

Apixaban

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER