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Prevention and Treatment of Venous Thromboembolism and Pulmonary Embolism: The Role of Novel Oral Anticoagulants.

Venous thromboembolism, encompassing deep vein thrombosis and pulmonary embolism, is the third most common cause of vascular death after myocardial infarction and stroke. Clinicians are often summoned to make challenging decisions for the prevention and treatment of high risk patients with an unpredicted outcome, often relying on data that are less than definitive.

During the last decades, heparins (unfractionated and low molecular weight heparins) as well as vitamin K antagonists, such as warfarin, and indirect Xa inhibitors, such as fontaparinux, are the cornerstone for the prevention and treatment of patients with venous thromboembolism. However, the traditionally used anticoagulants have several drawbacks that may limit their efficacy and use in every day clinical practise. The newly developed oral anticoagulants, belonging to the categories of direct thrombin inhibitors (DTIs) and direct Xa inhibitors, have emerged as promising agents with remarkable efficacy, concentrating many parameters of an ideal anticoagulant. Rivaroxaban, dabigatran and apixaban are the most studied agents, while a plethora of others are investigated in clinical trials of different phases and are expected to reach the market in the following years.

The purpose of this review is to summarize the so far acquired knowledge on these agents, to report briefly some of their pharmacodynamic and pharmacokinetic properties and to focus on their role in the treatment and prevention of venous thromboembolism.

Long-term death and recurrence in patients with acute venous thromboembolism: The MASTER registry.

The long-term clinical outcome of VTE has been essentially assessed in cohorts of selected patients. The aim of this multicenter registry was to prospectively assess the long-term clinical outcome in a cohort of unselected patients with objectively confirmed acute VTE.

MATERIALS AND METHODS: Death and VTE recurrence at 24months were the main study outcomes. Univariate and multivariate survival analyses were performed according to the Kaplan-Meyer and Cox proportional hazard model, respectively.

RESULTS: 2119 patients with acute VTE were included in the registry: 1541 (72.7%) with deep vein thrombosis, 206 (9.7%) with pulmonary embolism and 372 (17.6%) with both. Information about death was available in 2021 patients (95.4%) and about recurrence in 1988 patients (93.8%). 167 patients (4.55% patient-year) died during follow-up. After adjusting for age, cancer (Hazard ratio [HR]: 7.2; 95%CI 4.8-10.8), long-term heparin treatment (HR: 2.5; 95%CI 1.8-3.5), in-hospital management of VTE (HR: 2.0; 95%CI 1.3-3.0), and ileo-caval thrombosis (HR: 1.7; 95%CI 1.2-2.4) were found to be independent predictors of death. 124 (3.63% patient-year) patients had a VTE recurrence during follow-up. In-hospital management of VTE (HR: 1.8; 95%CI 1.2-2.9), male gender (HR: 1.7; 95%CI 1.2-2.4) were independent risk factors for recurrent VTE. Cancer (HR: 1.6; 95%CI 1.0-2.8) showed a trend for increased risk of VTE recurrence (p=0.056). The reported rate of major bleeding was 2.5%.

CONCLUSIONS: In a large cohort of unselected VTE patients, cancer, ileo-caval thrombosis, long-term heparin treatment and in-hospital management were associated with increased mortality during long-term follow-up. In-hospital management, male gender were associated with an increased risk of VTE recurrence.

Ordering CT pulmonary angiography to exclude pulmonary embolism: defense versus evidence in the emergency room.

PURPOSE: To identify reasons for ordering computed tomography pulmonary angiography (CTPA), to identify the frequency of reasons for CTPA reflecting defensive behavior and evidence-based behavior, and to identify the impact of defensive medicine and of training about diagnosing pulmonary embolism (PE) on positive results of CTPA.

METHODS: Physicians in the emergency department of a tertiary care hospital completed a questionnaire before CTPA after being trained about diagnosing PE and completing questionnaires.

RESULTS: Nine hundred patients received a CTPA during 3 years. For 328 CTPAs performed during the 1-year study period, 140 (43 %) questionnaires were completed. The most frequent reasons for ordering a CTPA were to confirm/rule out PE (93 %), elevated D-dimers (66 %), fear of missing PE (55 %), and Wells/simplified revised Geneva score (53 %). A positive answer for "fear of missing PE" was inversely associated with positive CTPA (OR 0.36, 95 % CI 0.14-0.92, p = 0.033), and "Wells/simplified revised Geneva score" was associated with positive CTPA (OR 3.28, 95 % CI 1.24-8.68, p = 0.017). The proportion of positive CTPA was higher if a questionnaire was completed, compared to the 2-year comparison period (26.4 vs. 14.5 %, OR 2.12, 95 % CI 1.36-3.29, p < 0.001). The proportion of positive CTPA was non-significantly higher during the study period than during the comparison period (19.2 vs. 14.5 %, OR 1.40, 95 % CI 0.98-2.0, p = 0.067).

CONCLUSION: Reasons for CTPA reflecting defensive behavior-such as "fear of missing PE"-were frequent, and were associated with a decreased odds of positive CTPA. Defensive behavior might be modifiable by training in using guidelines.

Risk stratification and treatment strategy of pulmonary embolism.

Pulmonary embolism remains one of the leading causes of cardiovascular mortality. The wide range of reported mortality rates reflects heterogeneity in comorbidity and severity of pulmonary embolism. Optimizing risk stratification to prognose pulmonary embolism patients appears to be important to improve management, treatment and clinical outcome.

RECENT FINDINGS: Hemodynamic status is the most important short-term prognostic factor. High-risk pulmonary embolism or massive pulmonary embolism is defined by the patient response more than the clot size: patients with circulatory shock including sustained hypotension should receive thrombolytic therapy in absence of contraindications. Nonmassive or normotensive pulmonary embolism can be further stratified using clinical features, imaging (echocardiography, computed tomography) and biomarkers (troponins, natriuretic peptides): low-risk pulmonary embolism, evaluated by clinical model (Pulmonary Embolism Severity Index; PESI) can potentially be treated as outpatients; and intermediate-risk pulmonary embolism, which can be further stratified into less-severe and more-severe intermediate risk. The last may benefit from intensive clinical surveillance but the risk-benefit ratio for thrombolysis has been inadequately quantified to make any strong recommendation. New anticoagulants may transform traditional pulmonary embolism treatment.

SUMMARY: Optimizing risk stratification of patients with normotensive pulmonary embolism before they develop overt hemodynamic instability is the challenge of current pulmonary embolism management. Treatment strategy has to integrate this risk stratification and new anticoagulants arrival.

Advances in the diagnosis and treatment of acute pulmonary embolism.

Over the past two decades, considerable progress in technology and clinical research methods have led to advances in the diagnosis, treatment and prevention of acute venous thromboembolism. Despite this, however, the diagnosis is still often missed and preventive methods are often ignored.

Published guidelines are useful, but are limited by the existing evidence base so that controversies remain with regard to topics such as duration of anticoagulation, indications for placement and removal of inferior vena caval filters, and when and how to administer thrombolytic therapy. The morbidity and mortality of this disease remain high, particularly when undiagnosed.

While preventive approaches remain crucial, the focus of this review is on the diagnostic and therapeutic approach to acute venous thromboembolism, with an emphasis on acute pulmonary embolism.

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