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Despite the availability of updated guidelines for the diagnosis and treatment of venous thromboembolism (VTE), the management of this disorder in clinical practice is often not standardized, given the different degree of compliance with official recommendations by the various involved specialists. The aim of this consensus paper, as a result of a board of experts in thromboembolism, is to define strategies to improve the quality of patients' care and the efficiency of healthcare resources utilization, by means of: (a) analysis of the guidelines for diagnosis and treatment of VTE; (b) analysis of diagnostic and therapeutic algorithms currently used in clinical practice by different specialists; (c) agreement on a common algorithm for diagnosis and treatment of VTE in different clinical settings; (d) definition of the possible role of the new oral anticoagulant agents (NOAC), such as rivaroxaban, based on their potential benefits for both acute and chronic therapy. The so-called "single drug approach" (as opposed to the traditional heparin/VKA combination), which can be adopted with these drugs, makes anticoagulation more convenient for both patients and healthcare providers, without the need for a close monitoring of the hemocoagulative status, and with a concomitant reduction of length of hospitalization and treatment costs. Among NOACs, in this paper we focused on rivaroxaban only because it was the unique available NOAC in Italy for the treatment of VTE at the time the manuscript was written. Concerning rivaroxaban, the results of two phase III, randomized and controlled trials confirm the non-inferiority of this drug compared to standard therapy (enoxaparin/warfarin) for the treatment of patients with pulmonary embolism (EINSTEIN PE Study) or deep vein thrombosis (EINSTEIN DVT Study) in terms of both efficacy and safety, supporting its use as an effective therapeutic option for these disorders.

Objective: In this multicentre study, we aimed to evaluate the capacity of a computer-assisted automated QCT method to identify patients with SSc-associated interstitial lung disease (SSc-ILD) with high mortality risk according to validated composite clinical indexes (ILD-Gender, Age, Physiology index and du Bois index)., Methods: Chest CT, anamnestic data and pulmonary function tests of 146 patients with SSc were retrospectively collected, and the ILD-Gender, Age, Physiology score and DuBois index were calculated. Each chest CT underwent an operator-independent quantitative assessment performed with a free medical image viewer (Horos). The correlation between clinical prediction models and QCT parameters was tested. A value of P < 0.05 was considered statistically significant., Results: Most QCT parameters had a statistically different distribution in patients with diverging mortality risk according to both clinical prediction models (P < 0.01). The cut-offs of QCT parameters were calculated by receiver operating characteristic curve analysis, and most of them could discriminate patients with different mortality risk according to clinical prediction models., Conclusion: QCT assessment of SSc-ILD can discriminate between well-defined different mortality risk categories, supporting its prognostic value. These findings, together with the operator independence, strengthen the validity and clinical usefulness of QCT for assessment of SSc-ILD., (© The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com)

Venous thromboembolism (VTE) has a significant impact on healthcare costs but is largely preventable with anticoagulant prophylaxis using low-molecular-weight heparins (LMWHs), such as enoxaparin or dalteparin. Rivaroxaban and dabigatran etexilate are two new oral anticoagulants (NOACs) both compared with enoxaparin in separate trials. A decision analytic model with a healthcare and national payer perspective over a five-year time horizon was used to evaluate the cost-effectiveness of the NOACs for VTE prophylaxis after total hip replacement (THR) or total knee replacement (TKR) in France, Italy and Spain. Efficacy and safety data were obtained from randomised controlled trials of rivaroxaban vs enoxaparin and an indirect statistical comparison for rivaroxaban vs dabigatran. Rivaroxaban demonstrated dominance across all comparisons, indications and countries. In THR, total per-patient costs were reduced by up to €160 in the enoxaparin comparison and €115 in the dabigatran comparison, respectively. In addition, quality-adjusted life-years (QALYs) were increased by up to 0.0011 and 0.0012 in each comparison, respectively. Similarly, total costs were reduced in TKR by up to €137 and €28 in the enoxaparin and dabigatran comparisons, respectively. The total number of QALYs was increased by up to 0.0014 in the enoxaparin comparison and 0.0005 in the dabigatran comparison. The results were driven by costs since the incremental benefits were minimal. Rivaroxaban use could result in substantial healthcare cost savings and improved quality of life. The results are applicable across three European countries with differing healthcare systems so, potentially, could be generalised to a much wider population.

The prevalence of major risk factors for VTE may differ according to age, gender and clinical presentation. We tested this hypothesis in a large Italian VTE population. MASTER is a multicenter registry aimed to prospectively collect information on a large cohort of patients with acute VTE. The presence of major risk factors was captured by an electronic data network in consecutive patients with objectively confirmed acute VTE. We enrolled 2,119 patients (49.8% men) of whom 424 (20%) <40 years, 529 (25%) between 41 and 60 years, 943 (44.5%) between 61 and 80 years, and 223 (10.5%) >80 years. The prevalence of known risk factors in the four age groups is 63.9, 52.6, 54.6, and 58.3%, respectively (p = 0.002). Immobilization and severe medical disorders are more commonly associated with VTE in patients >80 years, trauma is significantly more common in patients <40 years than in older patient groups. The prevalence of unprovoked events is the highest in patients 41-60 years, and lowest in patients less than 40 years. After logistic regression analysis, patients with pulmonary embolism are more likely to have known risk factors for VTE than patients with deep vein thrombosis at presentation (p = 0.0021), and women are less likely than men to have an unprovoked VTE (p < 0.0001). In conclusion, a substantial proportion of VTE events remain classified as unprovoked. Unprovoked events are more common in middle aged patients, in men, and in patients presenting with deep vein thrombosis.

Pharmacological prophylaxis for preventing venous thromboembolism (VTE) is a worldwide established procedure in hip and knee replacement surgery, as well as in the treatment of femoral neck fractures, but few data exist to its regard in other fields of orthopedics and traumatology. Indeed, no guidelines or recommendations are available in the literature, except for a limited number of weak statements about knee arthroscopy and lower limb fractures. The present paper represents the first multidisciplinary effort to provide suggestions on the prophylaxis of VTE in the remaining fields of orthopedic surgery (minor orthopedic surgery and orthopedic trauma). The Italian Society for Studies on Hemostasis and Thrombosis (SISET), the Italian Society of Orthopedics and Traumatology (SIOT) and the association of Orthopedic Traumatology of Italian Hospitals (OTODI) together with the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI) and the Italian Society of General Medicine (SIMG) have set down quick and easy suggestions for VTE prophylaxis in a number of surgical conditions for which only scarce evidence is available. This inter-society consensus statement aims at simplifying the approach to VTE prophylaxis in the single patient with the goal of improving its clinical application.

Pharmacological prophylaxis for preventing venous thromboembolism (VTE) is a worldwide established procedure in hip and knee replacement surgery, as well as in the treatment of femoral neck fractures, but few data exist in other fields of orthopaedics and traumatology. Thus, no guidelines or recommendations are available in the literature except for a limited number of weak statements about knee arthroscopy and lower limb fractures. In any case, none of them are a multidisciplinary effort as the one here presented. The Italian Society for Studies on Haemostasis and Thrombosis (SISET), the Italian Society of Orthopaedics and Traumatology (SIOT), the Association of Orthopaedic Traumatology of Italian Hospitals (OTODI), together with the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI) and the Italian Society of General Medicine (SIMG) have set down easy and quick suggestions for VTE prophylaxis in a number of surgical conditions for which only scarce evidence is available. This inter-society consensus statement aims at simplifying the approach to VTE prophylaxis in the single patient with the goal to improve its clinical application.

Venous thromboembolism (VTE) is a frequent complication in the acute setting after spinal cord injury (SCI). Less is known about the long-term risk of VTE in these patients. It was the aim of this study to prospectively evaluate the short- and long-term risk of VTE in a cohort of patients after acute SCI and during rehabilitation and post-rehabilitation follow-up period. From January 2003 to November 2007 all consecutive adult patients admitted to a Spinal Rehabilitation Unit (RU) after surgical treatment in three Neurosurgical Units for SCI, were enrolled. After an accurate evaluation of their neurosurgical medical records the patients were prospectively evaluated for VTE occurrence. Ninety-four patients (80 males; mean age 40.3 years, SD 15.9) were recruited. All the patients received thromboprophylaxis with low-molecular-weight heparin combined with compressive stockings during hospitalization (median duration 7 months, IQR 4.5-8.8). Over a median follow-up period of 36.3 months (IQR 4.4-48) after SCI, VTE was diagnosed in 22 patients (23.4%) The majority of VTE events were recorded during the first three months of follow-up (34.4 VTE events/100 patient-years in the first 3 months and 0.3 VTE events/100 patient-years thereafter); age over 45 years (HR 8.4, 95% CI 3-23.5), previous VTE (HR 6.0, 95% CI 1.6-23.3) and paraplegia (HR 4.7, 95% CI 1.6-13.7) were independently associated with the occurrence of VTE. In conclusion, the risk of VTE in patients suffering from SCI is high despite the use of thromboprophylaxis, in particular in some patients categories. However, this risk appears to be limited to the first 3 months after the index event.

Background: 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 24 months 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., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Venous thromboembolism (VTE) is an important cause of morbidity and mortality following major orthopaedic surgery. However, the incidence of VTE and the role of additional risk factors have not yet been well explored in Italian clinical practice. The objective of the study is to estimate the incidence of VTE in the 3 months following elective hip and knee replacement (HR, KR) in a large cohort of patients, and the association between some selected risk factors and the occurrence of VTE. A large cohort study based on the record linkage between automated archives of the National Health System was analysed. In particular, all the residents in the Lombardy Region (Italy) who underwent HR and KR between 2005 and 2008 were followed for 3 months after surgery. The odds ratio (OR) of VTE associated with selected known risk factors was estimated by multivariate logistic regression. Amongst the 69,770 patients included in the study, 2,393 experienced at least one VTE event during the follow-up; the overall risk of VTE after HR or KR was 3.4%. The adjusted odds of experiencing a VTE event was higher in male patients (OR 1.11; 95% confidence interval 1.01-1.21), aged 60 years or older (1.30; 1.00-1.68), undergoing KR (1.47; 1.35-1.61), with previous deep vein thrombosis (1.96; 1.20-3.19), pulmonary embolism (3.25; 1.84-5.75) or cancer (1.21; 1.00-1.46). In conclusion, the incidence of VTE after elective HR and KR in the Italian clinical practice is high. Our results suggest the need of optimising the management of thromboprophylaxis to further reduce postoperative VTE.

Background: Prevention of venous thromboembolism (VTE) in cancer patients remains controversial in most clinical settings., Purpose: The Italian Society for Haemostasis and Thrombosis (SISET) commissioned a project to develop clinical practice guidelines for the prevention of VTE in patients with malignancy., Methods: Key questions concerning the prevention of VTE in patients with malignancy were formulated by a multidisciplinary working group consisting of experts in clinical medicine and research. After a systematic review and discussion of the literature, recommendations were formulated and graded according to the supporting evidence. For those questions for which the literature search did not find any definitive answers (due to absence of evidence, low quality evidence and/or contradictory evidence), a formal consensus method was used instead to issue clinical recommendations., Results: The search for "VTE prevention" resulted in 1021 citations; 69 articles were selected and 24 were used for drafting clinical recommendations. Four areas were graded A to C: 1) Need of prevention (pharmacological and/or mechanical) in cancer patients undergoing major abdominal or pelvic surgery and in 2) those with an acute medical disease requiring hospitalization and who are bedridden. Avoid prevention in 3) cancer patients with a central venous catheter and 4) those on chemotherapy, radiotherapy or hormonal therapy, except patients with multiple myeloma treated with thalidomide/lenalidomide plus high-dose dexamethasone, and those with gastrointestinal or lung cancer. Six areas were considered to be clinically important, but lacked evidence from the literature and thus required a formal consensus (grade D): 1) need of prevention during chemo- radiotherapy or hormonal therapy in patients with previous VTE; 2) optimal duration of pharmacological prevention in patients who are hospitalized/bedridden for acute medical illness; 3) optimal duration of pharmacological prevention in patients undergoing major surgery other than abdominal and pelvic; 4) optimal duration of pharmacological prevention in myeloma patients receiving thalidomide plus dexamethasone; 5) presence of cerebral metastasis as a contraindication to pharmacological prevention; 6) prevention in cancer patients undergoing surgery by laparoscopic procedures lasting>30min., Conclusion: Results of the systematic literature review and an explicit approach to consensus techniques have led to recommendations for the most clinically important issues in the prevention of VTE in cancer patients., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Background: The management of acute aortic aneurysm rupture or dissection (AARD) requires specific medical expertise, diagnostic techniques, and therapeutic options, not always available in all hospitals through the entire week. The aim of our study was to evaluate whether an association exists between weekday (WD) or weekend (WE) admission and mortality for patients with ARRD., Methods: Based on the database of routinely collected hospital admissions of the region of Emilia Romagna (RER) of Italy, we examined the discharge sheets of all patients with AARD (January 1999 to December 2009). The risk of in-hospital death was calculated for admissions on the WE compared with the admissions during a WD., Results: The analysis considered 4559 events in 4461 patients. AARD admissions were most frequent on Monday (14.7%) and Friday (14.8%) and less frequent on Saturday (12.6%). The percentage of events admitted on Sunday/holiday was 15.0%, whereas the distribution of death rate with respect to day of admission was significantly different (χ(2) = 23.472; P < .001) with the highest frequency peak on Sunday/holiday (17.4%) and the lowest on Tuesday (12.9%). WE admissions were associated with significantly higher in-hospital mortality (43.4%) than WD admissions (36.9%, P < .001). Multivariate regression analysis showed that WE admission was an independent risk factor for increased in-hospital mortality odds ratio 1.318; 95% confidence interval, 1.144-1.517; P < .001)., Conclusions: Our findings show that hospitalization for AARD on WE is associated with a significantly higher mortality rate than hospitalization on WD. Further studies are needed to investigate whether ensuring optimal diagnostic and therapeutic approaches during the entire week might improve the overall survival of patients with ARRD., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Cardiovascular (CV) disease is the leading cause of death in women. It is known that acute CV events exhibit temporal patterns of onset, that is, seasonal and weekly. We aimed to verify whether such patterns show differences by gender., Methods: We analyzed cumulative data from our previous studies dealing with hospital admissions for CV events, such as acute myocardial infarction (AMI), stroke, transient ischemic attack (TIA), aortic diseases (AD), and pulmonary embolism (PE), in the region Emilia-Romagna (RER) of Italy (ICDM9-CM codes, years 1998?2006). Total population and subgroups by gender (percentage of monthly and daily events) were tested for uniformity with the chi-square test, and a chronobiologic method was applied to monthly percentage of data for seasonal rhythmic analysis., Results: Season: We considered 130,693 patients (45.1% women): 64,191 AMI, 43,642 TIA, 4,615 AD, 19,425 PE. The monthly and seasonal distribution showed respective peaks in January and in winter, with no differences by gender. Day-of-week: We considered 168,921 patients (45.6% women): 64,191 AMI, 56,453 stroke, 43,642 TIA, 4,615 AD. The weekly distribution showed a peak on Monday, with no differences by gender. A multivariate regression logistic analysis, including in the model either major CV risk factors (hypertension, dyslipidemia, diabetes mellitus) and subgroups by age, did not find any difference in the temporal distribution of events in women and men., Conclusions: The seasonal and day-of-week distribution of occurrence of CV events seems to be independent of gender.

The management of acute pulmonary embolism (PE) is often challenging and requires specific medical expertise, diagnostic techniques and therapeutic options that may not be available in all hospitals throughout the entire week. The aim of our study was to evaluate whether or not an association exists between weekday or weekend admission and mortality for patients hospitalised with acute PE. Using routinely collected hospital administrative data, we examined patients discharged with a diagnosis of PE from the hospitals of the Emilia- Romagna Region in Italy (January 1999-December 2009). The risk of in-hospital death was calculated for admissions at the weekend and compared to weekday admissions. Of a total of 26,560 PEs, 6,788 (25.6%) had been admitted during weekends. PE admissions were most frequent on Mondays (15.8%) and less frequent on Saturdays and Sundays/holidays (12.8%) (p<0.001). Weekend admissions were associated with significantly higher rates of in-hospital mortality than weekday admissions (28% vs. 24.8%) (p<0.001). The risk of weekend admission and in-hospital mortality was higher after adjusting for sender, hospital characteristics, and the Charlson co-morbidity index. In conclusion, hospitalisation for PE on weekends seems to be associated with a significantly higher mortality rate than on weekdays. Further research is needed to investigate the reasons for this observed difference in mortality in order to try and implement future strategies that ensure an adequate level of care throughout the entire week.

Anticoagulant prophylaxis for preventing venous thromboembolism (VTE) is a worldwide established procedure in hip and knee replacement surgery, as well as in the treatment of femoral neck fractures (FNF). Different guidelines are available in the literature, with quite different recommendations. None of them is a multidisciplinary effort as the one presented. The Italian Society for Studies on Haemostasis and Thrombosis (SISET), the Italian Society of Orthopaedics and Traumatology (SIOT), the association of Orthopaedists and Traumatologists of Italian Hospitals (OTODI), together with the Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care (SIAARTI) have set down easy and quick suggestions for VTE prophylaxis in hip and knee surgery as well as in FNF treatment. This inter-society consensus statement aims at simplifying the grading system reported in the literature, and its goal is to benefit its clinical application. Special focus is given to fragile patients, those with high bleeding risk, and those receiving chronic antiplatelet (APT) and vitamin K antagonists treatment. A special chapter is dedicated to regional anaesthesia and VTE prophylaxis.

A current goal of the Italian Society for Thrombosis and Haemostasis (SISET) is the production of guidelines for clinical conditions related to haemostasis and thrombosis. In 2006, the Executive Committee of SISET adopted a new program for the production of methodologically and scientifically sound guidelines aimed at both addressing clinical practice and stimulating new research. The first major step for this program was to train methodologists to manage working groups that compose the guidelines, and to create a reference document that describes the development of the program. The aim of the present paper is to report a short version of this methodological document, for those who wish to follow SISET guidelines. We start by giving a brief outline of the SISET mission, then present the SISET guideline development process, which includes: project funding, selection of guidelines topics, multidisciplinary group composition, definition of clinical questions, literature search, evidence appraisal, grading recommendations, guideline implementation, external peer review, and guideline updating.

Background: The treatment of venous thromboembolism (VTE) in cancer patients remains controversial., Purpose: The Italian Society for Thrombosis and Haemostasis (SISET) commissioned a project to develop clinical practice guidelines for the therapy of VTE in patients with malignancies., Methods: Key questions about the treatment of VTE in patients with malignancies were formulated by a multidisciplinary working group consisting of experts in clinical medicine and research. After a systematic review and discussion of the literature, recommendations were formulated and graded according to the supporting evidence. For those questions for which the literature search did not yield any definitive answer (absence of evidence evidence of low quality, and contradictory evidence), a formal consensus method was used to issue clinical recommendations., Results: The results of the available literature on VTE treatment in cancer patients were reviewed and clinical recommendations were drafted., Conclusion: We describe the results of a systematic literature review and an explicit approach to consensus techniques which resulted in recommendations for the key therapeutic issues in cancer patients with VTE.

Many studies showed that the occurrence of cardiovascular and cerebrovascular events exhibits a seasonal variation. As for venous thromboembolism (VTE), not univocal results are available, and studies are mainly retrospective. We aimed to confirm the existence of a seasonal pattern in the occurrence of VTE on a large prospective population. The analysis considered consecutive cases of VTE enrolled into the MASTER Registry in 25 Italian hospitals, between January 2002 and November 2004. The total population consisted of 2119 subjects (1056 men, mean age 59 +/- 18 years). The total sample was divided into subgroups by gender, age (<40, 41-60, 61-80, > or = 80 years), type of event (first episode; proximal or distal; upper or lower limb; idiopathic or secondary deep vein thrombosis or pulmonary embolism, or both), and underlying risk factors, eg, cancer, previous VTE, estroprogestinic therapy, lack of prophylaxis, immobilization, surgery, pregnancy or puerperium, and medical diseases. Cases were grouped according to season and month of occurrence, and the data were analyzed by either the chi(2) test for goodness of fit and chronobiological analysis. VTE was most frequent in Autumn and less frequent in Spring (32.9% vs 19%, respectively, chi(2) = 90.62; P < .001). This pattern was shown for most subgroups. Chronobiological analysis identified a significant rhythmic annual pattern, with a main September-October peak for several subgroups (men, age 41-60 and 61-80 years, secondary event, previous VTE, immobilization), and a trend for most of the others. It is possible that subjects at increased risk could perhaps deserve appropriate or potentiated VTE prophylaxis in certain periods of the year.

Approximately 50-75% of patients with venous thromboembolism have a readily identifiable risk factor, either transient or permanent, whereas the remaining episodes are classified as unprovoked. The incidence of first-time venous thromboembolism rises exponentially with age. Whether the prevalence and the relative weight of major risk factors differ between elderly and younger patients is unclear. We performed a multicenter, prospective, observational study on consecutive patients with objectively confirmed acute venous thromboembolism admitted to 25 Italian hospitals. Baseline characteristics and information on temporary and permanent risk factors at the time of the index event were secured by an electronic data network. We enrolled 2119 patients (49.8% men), of whom 440 (20%) were more than 75 years of age and 1679 (79.2%) 75 years of age or less. Elderly patients were more likely to have pulmonary embolism at presentation (33.6 and 25.6%, respectively, P < 0.001). After binary logistic regression analysis, we found that the risk of venous thromboembolism in the elderly, compared with the younger age group, was significantly associated with immobilization (odds ratio: 2.46, 95% confidence interval: 1.85-3.27) and with severe medical disorders (odds ratio: 1.99, 95% confidence interval: 1.41-2.80), whereas male sex (odds ratio: 0.53, 95% confidence interval: 0.42-0.66), surgery (odds ratio: 0.61, 95% confidence interval: 0.43-0.85), and trauma (odds ratio: 0.49, 95% confidence interval: 0.31-0.77) were less common risk factors in the elderly than in younger patients. Use of thromboprophylaxis prior to the index event was not different between the two age groups. Severe medical disorders and immobilization are strongly associated with the occurrence of venous thromboembolism in the elderly. Our findings stress the need for adequate thromboprophylaxis in this setting.

Introduction: Information on the epidemiology and long-term clinical outcome of venous thromboembolism (VTE) is mainly based on data from clinical trials and thus may be not representative of the full spectrum of VTE patients. The aim of this multicenter registry (MASTER) was to prospectively collect data on the epidemiology and long-term clinical outcome of VTE in an unselected cohort of patients., Materials and Methods: In symptomatic patients with objectively confirmed acute VTE, information about clinical presentation, diagnostic methods, temporary and permanent risk factors, pre-event prophylaxis and treatment were captured by an electronic data network at the time of the index event. A 24-month follow-up is currently ongoing., Results: From January 2002 to October 2004, 2119 patients were included in the MASTER registry in 25 Italian centers. At entry, the mean patient age was 59.3+/-18.1 years (range 18-99 years). 1541 patients (72.7%) were affected by deep vein thrombosis, 206 patients (9.7%) by pulmonary embolism and 372 patients (17.5%) by both deep vein thrombosis and pulmonary embolism. 676 patients (31.9%) received home-treatment. 899 patients (42.4%) had one or more temporary risk factors. 381 patients (18.0%) had a known cancer at the time of the index event and in 50 patients (2.4%) a new cancer was discovered at the time of the index event. 311 patients (14.7%) had a previous VTE., Conclusions: Following a real world approach, our registry describes the clinical presentation, risk factors, diagnosis and treatment procedures in a large cohort of unselected patients with VTE.