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