Treatment Patterns and Bleeding Risk of Anticoagulants in Patients With Venous Thromboembolism in Korea

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55759 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-31

Study Completion Date

2021-09-30

Brief Summary

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This study is a retrospective, observational, nationwide population-based cohort study utilizing the South Korea's Health Insurance and Review Assessment Service (HIRA) database. The aims of this study are to describe the sociodemographic and clinical characteristics of patients with venous thromboembolism according to their anticoagulant treatment (parenteral anticoagulants, warfarin, or non-vitamin K antagonist oral anticoagulants), to describe the treatment patterns related to anticoagulants, and to examine the risk of major bleeding according to the specific type of oral anticoagulants. The study will be conducted in two phases: Phase I for descriptive study and Phase II for comparative study.

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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Parenteral anticoagulant only

LMWH, UFH

Parenteral anticoagulant

Intervention Type DRUG

Parenteral anticoagulant only

Warfarin-based

Warfarin only + parenteral anticoagulant bridged warfarin

Warfarin

Intervention Type DRUG

Warfarin-based

NOAC-based

NOAC only + parenteral anticoagulant bridged NOAC

NOAC: apixaban, rivaroxaban, dabigatran, edoxaban

Apixaban

Intervention Type DRUG

Apixaban

Rivaroxaban

Intervention Type DRUG

Rivaroxaban

Dabigatran

Intervention Type DRUG

Dabigatran

Edoxaban

Intervention Type DRUG

Edoxaban

Interventions

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Parenteral anticoagulant

Parenteral anticoagulant only

Intervention Type DRUG

Warfarin

Warfarin-based

Intervention Type DRUG

Apixaban

Intervention Type DRUG

Rivaroxaban

Intervention Type DRUG

Dabigatran

Intervention Type DRUG

Edoxaban

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Incident VTE diagnosis in an inpatient or outpatient setting between 1 Mar 2013 and 30 Jun 2019
2. Received anticoagulation therapy (all medication codes for anticoagulants approved for VTE in Korea; UFH, LMWH, warfarin, and NOACs) within 30 days of their VTE diagnosis (the index date will be defined as the date of treatment initiation with anticoagulants)
3. Aged ≥18 years at index date

Exclusion Criteria

1. Had a record of VTE diagnosis within the 12-month period prior to the index VTE encounter.
2. Diagnosed with atrial fibrillation/flutter, mechanical heart valve replacement or mitral stenosis anytime prior to index date
3. Had a record of Inferior Vena Cava filter anytime prior to index date
4. Received anticoagulatory therapy within the 12-month period prior to index VTE encounter
5. Prescribed two different anticoagulants on the same index date
6. Had a record of pregnancy within the 9-month period prior to index date
7. Had a record of active cancer within the past 6 months of period prior to index date

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No