Elsevier

Thrombosis Research

Volume 135, Issue 4, April 2015, Pages 666-672
Thrombosis Research

Regular Article
Duration of anticoagulation after venous thromboembolism in real world clinical practice

https://doi.org/10.1016/j.thromres.2015.02.001Get rights and content

Highlights

  • A substantial proportion of VTE patients receives anticoagulants for > 1 year.

  • Fatal bleeding events outweigh fatal pulmonary embolism.

  • The majority of fatal bleeds occur after the first 3 months of treatment.

Abstract

Introduction

Venous thromboembolism (VTE) carries a considerable risk of recurrence and anticoagulants should be administered for a minimum of three months. Since little is known about real life management of VTE, we aimed to describe current practice in the secondary prevention of VTE.

Materials and Methods

Using the database of an international, prospective registry on patients treated for VTE, RIETE, information was collected on risk factors for VTE and bleeding, anticoagulant treatment, and clinical outcomes during follow up. Multivariate analysis using logistic regression was performed to identify predictors of treatment duration.

Results

Of 6944 patients with a first episode of VTE 41.1% had unprovoked VTE, 31.8% had transient risk factors, 27.1% had cancer. After the exclusion of patients who died during the first year of observation, the rate of patients treated for > 12 months was 55.1%, 41.9%, and 43.2%, respectively (p < 0.001). Pulmonary embolism at presentation, recurrence while on treatment, chronic heart failure and age > 65 years were independently associated with treatment for > 12 months. Body weight < 75 kg, anemia, cancer, and the presence of transient risk factors were associated with treatment for 12 months or less. Major bleeding occurred more frequently than recurrent VTE in patients with VTE secondary to transient risk factors and cancer; fatal bleeding was more frequent than fatal recurrent PE in all subgroups.

Conclusions

We observed heterogeneous duration of anticoagulant treatment for the secondary prevention of VTE. A substantial proportion of patients, in particular those with VTE secondary to transient risk factors, may be exposed to a possibly unnecessary risk of bleeding.

Introduction

Deep vein thrombosis (DVT) and pulmonary embolism (PE) have a considerable long-term risk of recurrence [1], [2]. The major determinant of this risk is the presence of identifiable major provoking factors at the time of the index event [3], [4].

Based on evidence from clinical trials, the American College of Chest Physicians (ACCP) guidelines recommend 3 months of anticoagulant therapy in patients with venous thromboembolism (VTE) secondary to recent surgery or to a nonsurgical transient risk factor, and extended treatment duration in those with active cancer or unprovoked VTE [5]. However, little is known about patterns of management of VTE in real life, particularly after hospital discharge. Such information could identify amendable gaps in patient care.

The RIETE (Registro Informatizado de Enfermedad TromboEmbólica) Registry is an ongoing, multicenter, international (Spain, Italy, France, Israel, Greece, Switzerland, Czech Republic and Macedonia), observational registry of consecutive patients with symptomatic, objectively confirmed, acute VTE. It started in Spain in 2001, and 6 years later the database was translated into English with the aim to expand the Registry to other countries, ultimately allowing physicians worldwide to use the database to select the most appropriate therapy for their patients. Data from this registry have been used to evaluate outcomes after acute VTE, such as the frequency of recurrent VTE, bleeding and mortality, and risk factors for these outcomes. In the current analysis, we evaluated demographic and clinical characteristics of patients with VTE, trying to describe current practice in the secondary prevention of VTE and to identify determinants of duration of anticoagulant therapy.

Section snippets

Study Design

At each participating site, investigators of the RIETE registry enrolled consecutive patients with acute symptomatic VTE confirmed by objective testing including high probability ventilation-perfusion scan or positive spiral computerized tomography for PE, and positive compression ultrasonography for DVT. Treatment decisions were entirely left at the discretion of attending clinicians, and no therapeutic algorithms were provided. Patients enrolled in blinded randomized controlled trials on VTE

Results

A total of 6,944 patients with objectively diagnosed VTE were enrolled in this study. Mean duration of follow-up was 722 days, median 564 days. Baseline characteristics of the study population are reported in Table 1.

Therapeutic strategies are described in Table 2. Median duration of treatment was significantly longer in patients with unprovoked VTE, and the rate of patients who were still on anticoagulant treatment after 12 months was 55.1% in patients with unprovoked VTE, 41.9% in patients with

Discussion

The objective of this study was to obtain clinical practice-based data from the RIETE registry on the management of symptomatic VTE. The results of this large prospective cohort study on nearly 7,000 patients with a first episode of VTE show that in real-world clinical practice, 55% of patients with unprovoked events, 42% of patients with a transient risk factor, and 43% of patients with cancer receive anticoagulant treatment for more than 12 months. The ACCP guidelines recommend a 3-month

Authors’ Contributions

Study concept and design: Ageno, Dentali, Di Micco, Monreal; Acquisition of data: Samperiz, Caballero, Di Micco, Uresandi, Monreal; Analysis and interpretation of data: Ageno, Dentali, Di Micco, Prandoni, Becattini, Verhamme, Monreal; Drafting of the manuscript: Ageno, Dentali, Di Micco, Monreal; Critical revision of the manuscript for important intellectual content: Samperiz, Caballero, Prandoni, Becattini, Uresandi, Verhamme; Final approval of the article: Ageno, Samperiz, Caballero, Dentali,

Conflict of Interest Statement

None to disclose

Financial Disclosure

This Registry is supported by unrestricted educational grants from Sanofi Spain and Bayer Pharma AG.

Acknowledgements

We express our gratitude to Sanofi Spain for supporting this Registry with an unrestricted educational grant. We also express our gratitude to Bayer Pharma AG for supporting this Registry. Bayer Pharma AG’s support was limited to the part of RIETE outside Spain, which accounts for a 20,07 % of the total patients included in the RIETE Registry. We also thank the RIETE Registry Coordinating Center, S & H Medical Science Service, for their quality control data, logistic and administrative support

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1

A full list of the RIETE investigators is given in the appendix. Written permission has been obtained from all persons named in the acknowledgment.

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