Clinical characteristics of italian patients with venous thromboembolism enrolled in the RIETE Registry

Introduction: The clinical characteristics, treatment strategies and outcome of patients with venous thromboembolism (VTE) may vary from country to country. Materials and methods: The RIETE (Registro Informatizado su la Enfermedad TromboEmbolica) is an ongoing, prospective registry of consecutive patients with acute, objectively confirmed, symptomatic VTE. Our aim was to assess the influence of surgery and immobility for non-surgical reasons on 3-month outcomes of all Italian patients registered in the RIETE. Results: Through July 2008, 21,397 patients with acute VTE were registered in the RIETE. Of these, 896 (4.2%) were Italian, and 360 (40%) presented with pulmonary embolism (PE). Overall, 137 (15%) developed VTE after surgery; 156 (17%) developed VTE after >4 days of immobility, and 603 (67%) developed VTE in the absence of surgery or immobility. Most patients (83%) received initial therapy with low-molecular-weight heparin; 15% received unfractionated heparin. For long-term therapy, 63% of patients received vitamin K antagonists. The incidence of fatal PE during the first 3 months of therapy was 1.5% for patients with postoperative VTE, 7.7% for who developed VTE after immobility, and 1.2% for the remaining patients. The incidence of fatal bleeding among these patients was 1.5%, 1.9% and 0.3%, respectively. Of the 137 patients with postoperative VTE, 61% had received VTE prophylaxis. Of the 156 patients with recent immobility, 24% had received VTE prophylaxis. Conclusions: VTE arising after a period of immobility was associated with the highest rates of fatal PE and fatal bleeding during the first 3 months of therapy. The use of thromboprophylaxis in this population should be improved

Clinical characteristics of italian patients with venous thromboembolism enrolled in the RIETE Registry

Introduction: The clinical characteristics, treatment strategies and outcome of patients with venous thromboembolism (VTE) may vary from country to country. Materials and methods: The RIETE (Registro Informatizado su la Enfermedad TromboEmbolica) is an ongoing, prospective registry of consecutive patients with acute, objectively confirmed, symptomatic VTE. Our aim was to assess the influence of surgery and immobility for non-surgical reasons on 3-month outcomes of all Italian patients registered in the RIETE. Results: Through July 2008, 21,397 patients with acute VTE were registered in the RIETE. Of these, 896 (4.2%) were Italian, and 360 (40%) presented with pulmonary embolism (PE). Overall, 137 (15%) developed VTE after surgery; 156 (17%) developed VTE after >4 days of immobility, and 603 (67%) developed VTE in the absence of surgery or immobility. Most patients (83%) received initial therapy with low-molecular-weight heparin; 15% received unfractionated heparin. For long-term therapy, 63% of patients received vitamin K antagonists. The incidence of fatal PE during the first 3 months of therapy was 1.5% for patients with postoperative VTE, 7.7% for who developed VTE after immobility, and 1.2% for the remaining patients. The incidence of fatal bleeding among these patients was 1.5%, 1.9% and 0.3%, respectively. Of the 137 patients with postoperative VTE, 61% had received VTE prophylaxis. Of the 156 patients with recent immobility, 24% had received VTE prophylaxis. Conclusions: VTE arising after a period of immobility was associated with the highest rates of fatal PE and fatal bleeding during the first 3 months of therapy. The use of thromboprophylaxis in this population should be improved

Low discriminating power of the modified Ottawa VTE risk score in a cohort of patients with cancer from the RIETE registry.

Treatment of patients with cancer-associated venous thromboembolism (VTE) remains a major challenge. The modified Ottawa score is a clinical prediction rule evaluating the risk of VTE recurrences during the first six months of anticoagulant treatment in patients with cancer-related VTE. We aimed to validate the Ottawa score using data from the RIETE registry. A total of 11,123 cancer patients with VTE were included in the analysis. According to modified Ottawa score, 2,343 (21 %) were categorised at low risk for VTE recurrences, 4,525 (41 %) at intermediate risk, and 4,255 (38 %) at high risk. Overall, 477 episodes of VTE recurrences were recorded during the course of anticoagulant therapy, with an incidence rate for low, intermediate, and high risk groups of 6.88 % (95 % CI 5.31-8.77), 11.8 % (95 % CI 10.1-13.6), and 21.3 % (95 % CI 18.8-24.1) patient-years, respectively. Overall mortality had an incidence rate of 21.1 % (95 % CI 18.2-24.3), 79.4 % (95 % CI: 74.9-84.1), and 134.7 % (95 % CI: 128.3-141.4) patient-years, respectively. The accuracy and discriminating power of the modified Ottawa score for VTE recurrence was modest, with low sensitivity, specificity and positive predictive value, and a C-statistics of 0.58 (95 % CI: 0.56-0.61). In our analysis, the modified Ottawa score did not accurately predict VTE recurrence among patients with cancer-associated thrombosis, thus hindering its use in clinical practice. It is time to define a new score including other clinical predictors

Venous thromboembolism in centenarians: Findings from the RIETE registry

BACKGROUND: The balance between the efficacy and safety of anticoagulant therapy in patients aged ≥100years receiving anticoagulant therapy for venous thromboembolism (VTE) is uncertain. METHODS: We used data from the RIETE (Registro Informatizado Enfermedad TromboEmbólica) database to assess the rate of VTE recurrences, bleeding events, and mortality appearing during the course of anticoagulant therapy in VTE patients aged ≥100years. RESULTS: Of 61,173 patients enrolled in RIETE as of January 2016, 47 (0.08%) were aged ≥100years. Of these, 10 (21%) were men, 21 (45%) presented with pulmonary embolism (PE), and 26 with deep vein thrombosis alone. Overall, 35 patients (74%) had severe renal insufficiency, 14 (30%) chronic heart failure, 30 (64%) anemia, 16 (34%) were taking antiplatelets, and 6 (13%) corticosteroids or non-steroidal anti-inflammatory drugs. Most patients (95%) were treated initially with low-molecular-weight heparin (LMWH) (mean daily dose, 168±42IU/kg). Then, 14 (30%) switched to vitamin K antagonists and 29 (62%) kept receiving long-term LMWH therapy (mean, 148±51IU/kg/day). During the course of anticoagulant therapy (mean duration, 139days), mortality was high (15/47; 32%). Two patients died of PE (initial PE one, recurrent PE one) and 5 (11%) had minor bleeding, but no major bleeding was reported. CONCLUSIONS: Among patients with acute VTE aged ≥100years, the risk of VTE recurrences during the course of anticoagulation outweighed the risk of bleeding. Our data suggest the use of standard anticoagulant therapy in this patient population, even if they have severe renal insufficiency.publisher: Elsevier articletitle: Venous thromboembolism in centenarians: Findings from the RIETE registry journaltitle: European Journal of Internal Medicine articlelink: http://dx.doi.org/10.1016/j.ejim.2016.07.025 content_type: article copyright: © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.status: publishe

36-month clinical outcomes of patients with venous thromboembolism: GARFIELD-VTE

Background: Venous thromboembolism (VTE), encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE), is a leading cause of morbidity and mortality worldwide.Methods: GARFIELD-VTE is a prospective, non-interventional observational study of real-world treatment practices. We aimed to capture the 36-month clinical outcomes of 10,679 patients with objectively confirmed VTE enrolled between May 2014 and January 2017 from 415 sites in 28 countries.Findings: A total of 6582 (61.6 %) patients had DVT alone, 4097 (38.4 %) had PE +/- DVT. At baseline, 98.1 % of patients received anticoagulation (AC) with or without other modalities of therapy. The proportion of patients on AC therapy decreased over time: 87.6 % at 3 months, 73.0 % at 6 months, 54.2 % at 12 months and 42.0 % at 36 months. At 12-months follow-up, the incidences (95 % confidence interval [CI]) of all-cause mortality, recurrent VTE and major bleeding were 6.5 (7.0-8.1), 5.4 (4.9-5.9) and 2.7 (2.4-3.0) per 100 person-years, respectively. At 36-months, these decreased to 4.4 (4.2-4.7), 3.5 (3.2-2.7) and 1.4 (1.3-1.6) per 100 person-years, respectively. Over 36-months, the rate of all-cause mortality and major bleeds were highest in patients treated with parenteral therapy (PAR) versus oral anti-coagulants (OAC) and no OAC, and the rate of recurrent VTE was highest in patients on no OAC versus those on PAR and OAC. The most frequent cause of death after 36-month follow-up was cancer (n = 565, 48.6 %), followed by cardiac (n = 94, 8.1 %), and VTE (n = 38, 3.2 %). Most recurrent VTE events were DVT alone (n = 564, 63.3 %), with the remainder PE, (n = 236, 27.3 %), or PE in combination with DVT (n = 63, 7.3 %).Interpretation: GARFIELD-VTE provides a global perspective of anticoagulation patterns and highlights the accumulation of events within the first 12 months after diagnosis. These findings may help identify treatment gaps for subsequent interventions to improve patient outcomes in this patient population