Elsevier

Thrombosis Research

Volume 131, Issue 1, January 2013, Pages 24-30
Thrombosis Research

Regular Article
Three-month mortality rate and clinical predictors in patients with venous thromboembolism and cancer. Findings from the RIETE registry

https://doi.org/10.1016/j.thromres.2012.10.007Get rights and content

Abstract

Patients with venous thromboembolism (VTE), and particularly those with cancer, are at increased risk of recurrences, major bleeding, and short- / medium-term mortality.

Data from 35,539 patients (6,075 of these with cancer), presenting with symptomatic VTE in the previous three months and enrolled in the worldwide RIETE registry, were evaluated to assess overall and pulmonary embolism (PE)-related mortality, and their potential predictors, with particular focus on patients with cancer.

Overall 3-month mortality in the total RIETE population was 7.9%, and death was considered PE-related in 1.4%. Significantly more patients died among those with cancer (26.4%, vs 4.1% in no-cancer group, p < 0.001). In 3.0% of cancer patients death was considered PE-related, compared to 1.0% in no-cancer group (p < 0.001). Cancer was the strongest independent risk factor for both all-cause and PE-related mortality, and in the subgroup of cancer patients those with advanced disease, reduced mobility, chronic pulmonary disease, and those experiencing PE (vs isolated deep vein thrombosis) were at increased risk of PE-related death.

According to the findings of our very large, real-world registry, in the three months following an acute episode VTE remains a substantial cause of mortality. Cancer patients are at particular high risk of VTE-related death. Clinical factors predicting a fatal PE identified in this study (cancer, immobility, comorbidities, increasing age, PE at presentation), could be considered for risk stratification scheme for secondary prophylaxis in daily practice.

Introduction

Venous thromboembolism (VTE) is an important health-care problem, resulting in significant morbidity, resource expenditure, and mortality [1].

A number of studies have investigated the clinical course of VTE, and varying incidences of recurrent events, bleeding complications and mortality have been reported [2], [3], [4]. In cohort studies, randomized clinical trials, and general reviews on this topic, the incidence of fatal pulmonary embolism (PE) within three months from VTE varied to less than 1% to at least 7% [5], [6], [7], [8], [9], [10], [11]. This variability, mainly related to the type of patients studied, highlights that VTE is a heterogeneous disease with various presentations and prognoses.

Identifying clinical characteristics that lead patients with VTE at increased risk of death, could be important in order to improve their outcomes. However, few studies are available to examine the predictors of overall or PE-related mortality in patients with VTE, and most of them are small, or retrospective, or do not analyze this specific outcome [7], [12], [13].

Patients with cancer have at least a six-fold increased risk of VTE [14], [15], [16], and they more frequently experience recurrences and anticoagulant-related bleeding complications if compared with those without cancer [17], [18], [19], [20], [21]. Further, the development of VTE is considered to be associated with a significant reduction of survival in cancer patients [22], [23], [24], [25]. The high mortality rate in cancer patients with VTE is probably due both to VTE and its sequelae, and to the fact that malignancies associated with VTE are usually at later stages, and appear to follow a more aggressive course [22]. Even for patients with VTE and cancer, information on predictors of mortality remain largely unknown.

Aim of our analysis, based on data coming from the international registry RIETE (Registro Informatizado de la Enfermedad TromboEmbolica), was to assess overall and PE-related mortality in a large cohort of patients experiencing VTE in the previous three months, with particular focus on patients with cancer. Further, specific attention was paid to potential predictors of both all-cause and PE-related death.

Section snippets

Inclusion and Exclusion Criteria

The RIETE registry is an ongoing, international, multicenter, prospective cohort of consecutive patients presenting with symptomatic venous thromboembolism (deep vein thrombosis - DVT, PE, or both) confirmed by objective tests [26], [27]. Patients are excluded if they are currently participating in a therapeutic clinical trial with a blind medication, or if they will not be available for a 3-month follow-up. Enrolled patients are managed according to the clinical practice of each participating

Baseline Characteristics

As of September 2011, a total number of 35,539 consecutive patients presenting with symptomatic VTE were enrolled in RIETE registry. Cancer was reported in 6,075 patients (17.1% of the whole population). Baseline characteristics of the two groups of patients (cancer and no-cancer) are summarized in Table 1. Cancer group shows a higher mean age, and a higher percentage of males if compared to no-cancer group. More patients with cancer had recent surgery, whereas prior VTE and immobility ≥ 4 days

Discussion

Patients with VTE are at increased risk of recurrences, major bleeding, and short- / medium-term mortality. According to the findings of our large, real-world registry, the rate of major complications within three months from VTE is not negligible, and the rate of PE-related mortality is relevant in no-cancer but especially in cancer patients. Cancer is the strongest independent risk factor for both all-cause and PE-related mortality, and in the subgroup of cancer patients those with advanced

Conflict of Interest Statement

There are no potential conflicts of interest for each Author, concerning the submitted manuscript.

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 16,66% of the total patients included in the RIETE Registry. These supporters had no role in the study design, in the collection, analysis and interpretation of data, nor in the writing of the manuscript and the

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