P3850Impact of sex and risk factors for venous thromboembolism on the clinical course of first acute venous thromboembolism. Insights from the PREFER in VTE

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Giustozzi ◽  
S Barco ◽  
L Valerio ◽  
F A Klok ◽  
M C Vedovati ◽  
...  

Abstract Introduction The interaction between sex and specific provoking risk factors for venous thromboembolism (VTE) may influence initial presentation and prognosis. Purpose We investigated the impact of sex on the risk of recurrence across subgroups of patients with first VTE classified according to baseline risk factors. Methods PREFER in VTE was an international, non-interventional registry (2013–2015) including patients with a first episode of acute symptomatic objectively diagnosed VTE. We studied the risk of recurrence in patients classified according to baseline provoking risk factors for VTE consisted of i) major transient (major surgery/trauma, >5 days in bed), ii) minor transient (pregnancy or puerperium, estroprogestinic therapy, prolonged immobilization, current infection or bone fracture/soft tissue trauma); iii) unprovoked events, iv) active cancer-associated VTE. Results A total of 3,455 patients diagnosed with first acute VTE were identified, of whom 1,623 (47%) were women. The percentage of patients with a major transient risk factor was 22.2% among women and 19.7% among men. Minor transient risk factors were present in 21.3% and 12.4%, unprovoked VTE in 51.6% and 61.6%, cancer-associated VTE in 4.9% of women and 6.3% of men, respectively. The proportions of cases treated with Vitamin-K antagonists (VKAs) and direct oral anticoagulants (DOACs) were similar between sexes. Median length of treatment of VKAs was 181.5 and 182.0 days and of DOACs was 113.0 and 155.0 days in women and men, respectively. At 12-months of follow-up, VTE recurrence was reported in 74 (4.8%) women and 80 (4.5%) men. Table 1 shows the sex-specific proportion of recurrences by VTE risk factor categories. Table 1 Major Transient (n=722) Minor transient (n=573) Cancer-associated (n=195) Unprovoked (1965) Women (361) Men (361) OR (95% CI) Women (346) Men (227) OR (95% CI) Women (79) Men (116) OR (95% CI) Women (837) Men (1128) OR (95% CI) One-year follow-up, n (N%)   Recurrent VTE, 21 (6.2) 10 (2.9) 0.46 (0.2; 0.9) 9 (2.7) 12 (5.4) 2.09 (0.9; 5.0) 6 (8.0) 5 (4.5) 0.54 (0.2; 1.9) 38 (4.7) 53 (4.7) 1.03 (0.7; 1.6)   Major bleeding, 6 (1.8) 5 (1.5) 0.83 (0.3; 2.7) 5 (1.5) 1 (0.5) 0.30 (0.1; 2.6) 1 (1.3) 3 (2.7) 2.07 (0.2; 20) 10 (1.2) 15 (1.4) 1.11 (0.6; 2.4)   All-cause death, 37 (10.2) 31 (8.5) 0.82 (0.5; 1.4) 10 (2.9) 14 (6.2) 2.21 (0.9; 5.1) 26 (32.9) 49 (42.2) 1.49 (0.8; 2.7) 33 (3.9) 30 (2.7) 0.66 (0.4; 1.1) Conclusions The proportion of patients with recurrent VTE events after first acute symptomatic VTE provoked by transient risk factors was not negligible during the first year of follow-up during in both women and men. These results may have implications on the decision whether to consider extended anticoagulant therapy in selected patients with provoked events. Acknowledgement/Funding This study was funded by Daiichi Sankyo.

TH Open ◽  
2019 ◽  
Vol 03 (01) ◽  
pp. e58-e63 ◽  
Author(s):  
Luca Valerio ◽  
Chiara Ambaglio ◽  
Marisa Barone ◽  
Mariella Ciola ◽  
Stavros Konstantinides ◽  
...  

Background It remains unclear whether the distal location of deep vein thrombosis (DVT) is independently associated with a lower risk of recurrence in all patients, or represents a marker of the presence and severity of provoking factors for venous thromboembolism (VTE). Methods We investigated the impact of distal (vs. proximal) DVT location on the risk of developing symptomatic, objectively confirmed recurrent VTE in 831 patients with a first acute symptomatic DVT not associated with pulmonary embolism (PE), who were stratified by the presence of transient or persistent risk factors at baseline. The primary outcome was symptomatic, objectively diagnosed recurrent VTE, including proximal DVT and PE. Results A total of 205 (24.7%) patients presented with a transient risk factor, 189 (22.7%) with a minor persistent risk factor, 202 (24.3%) with unprovoked DVT, and 235 (28.3%) with cancer-associated DVT. One-hundred twenty-five patients (15.0%) experienced recurrent DVT or PE. The largest relative difference between patients with distal (vs. proximal) DVT was observed in the absence of identifiable risk factors (adjusted hazard ratio [aHR]: 0.11; 95% CI [confidence interval]: 0.03–0.45). In patients with cancer, distal and proximal DVT had a comparable risk of recurrence (aHR: 0.70; 95% CI: 0.28–1.78]). Conclusions The distal (vs. proximal) location of first acute symptomatic DVT represented, in the absence of any identifiable transient or persistent risk factors, a favorable prognostic factor for recurrence. In contrast, the prognostic impact of DVT location was weaker if persistent provoking risk factors for VTE were present, notably cancer.


2018 ◽  
Vol 35 (02) ◽  
pp. 99-104 ◽  
Author(s):  
Marissa Rybstein ◽  
Maria DeSancho

AbstractInherited and acquired thrombophilias and hypercoagulable states, such as active cancer, estrogen-induced, autoimmune disorders, major surgery, hospitalization, and trauma, are well-known risk factors for venous thromboembolism (VTE). The effect of these on recurrent VTE is different for each specific risk factor. The major risk factors affecting VTE recurrence include the presence of active cancer and an unprovoked first VTE. In addition, the use of combined female hormones in a woman with a previous history of estrogen-related VTE is a major risk factor for VTE recurrence. The extent of influence of inherited thrombophilia on the risk of recurrence is controversial. Conversely, the presence of antiphospholipid antibodies, specifically triple positive carriers, appears to increase the risk of VTE recurrence. Understanding the rates of recurrent VTE in a patient and the individual risk of bleeding is important in determining the duration of anticoagulation therapy.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2250-2250
Author(s):  
Maria Ljungqvist ◽  
Kristina Sonnevi ◽  
Annica Bergendal ◽  
Margareta Holmstrom ◽  
Helle Kieler ◽  
...  

Abstract Abstract 2250 Introduction: Venous thromboembolism (VTE) is a multifactorial disease with a high risk of recurrence. The risk of recurrence is highest during the first year with an incidence of 10–15%, thereafter recurrence occurs in 3 to 5 % per year. The risk of recurrence is associated with age, gender and whether the first VTE was provoked by a transient risk factor or not. Obesity increases the risk of a first event of VTE but its role for a recurrent event is unclear. Methods: We performed a nested cohort study and included 1394 women 18 to 64 years of age with a previous first episode of deep vein thrombosis (DVT) located in the leg or pelvis or with a pulmonary embolism (PE). All women had taken part in TEHS, a population based case-control study on risk factors for VTE. Information on risk factors was obtained by interviews and DNA-analyses immediately after the VTE and information of recurrent VTE was obtained from a follow-up questionnaire or from data recorded in the Swedish Patient Register. Only women who were not on continues anticoagulant treatment were included for assessment of recurrent VTE. Women with a BMI ≥ 30 were considered obese. Risks of recurrence were calculated in Cox regression models and are presented as hazard ratios (HRs) with 95% confidence intervals. Results: A total of 964 women (mean age 46 ± 13 years) with a median follow-up of 76 months accepted participation in the nested cohort study. The recurrence rate was 10.3% and 221 women (23%) were obese when diagnosed with their first VTE. At follow up 240 women (25%) were obese. The recurrence rate was higher in obese than in non-obese women (15.8% vs. 8.6%, p=0.002). The HR for recurrence was 1.9 (p=0.02, 95% CI 1.3–2.9) for obese women compared to non-obese. The HR was unchanged in a multivariate analysis, adjusting for age, index VTE (provoked or unprovoked by cast/surgery or hormonal treatment) and presence of factor V Leiden or prothrombin gene mutation. Conclusion: Obesity is a strong independent risk factor for recurrent VTE in women. Obese women with a first VTE might benefit from long time treatment with anticoagulants and consultation on weight reduction. Disclosures: No relevant conflicts of interest to declare.


2018 ◽  
Vol 2 (7) ◽  
pp. 788-796 ◽  
Author(s):  
Martin H. Prins ◽  
Anthonie W. A. Lensing ◽  
Paolo Prandoni ◽  
Philip S. Wells ◽  
Peter Verhamme ◽  
...  

Key Points The risk of recurrence in patients with VTE provoked by minor transient or persistent risk factors is uncertain. The risk of recurrence with VTE provoked by minor transient or persistent risk factors is similar to that with unprovoked VTE.


1999 ◽  
Vol 82 (10) ◽  
pp. 1222-1226 ◽  
Author(s):  
W. Åberg ◽  
D. Lockner ◽  
C. Paul ◽  
M. Holmström

SummaryThe primary objective of this retrospective study was to describe the frequency of a post-thrombotic syndrome in 265 patients previously treated for deep venous thrombosis (DVT). The secondary objectives were to document the frequency of recurrent venous thromboembolism (VTE) and mortality, especially from malignant disease. The patients were evaluated 5-14 years after inclusion in three randomized trials comparing continuous intravenous (i. v.) infusion of unfractionated heparin (UFH) (n = 85) with a low molecular weight heparin (LMWH), dalteparin (n = 180). The median post-thrombotic score at follow-up was 2 (range 0-8). In a multiple step-wise regression analysis the post-thrombotic score was significantly higher among patients with initial proximal DVT (p = 0,0001) as compared with those who had distal DVT. A recurrent venous thromboembolic event was diagnosed in 29,4% of the patients treated with dalteparin and in 23,5% of the patients treated with UFH (ns). A secondary risk factor for venous thromboembolism and a longer duration of treatment with oral anticoagulants (OAC) were significantly associated with a lower risk for recurrent VTE, whereas malignant disease diagnosed during follow-up was associated with a higher risk. During follow-up a total of 40,7% of patients had died. No difference in total mortality or mortality from malignant disease was demonstrated between the two drugs. In conclusion, a severe post-thrombotic syndrome occured relatively infrequent. considering the long observation period. Proximal DVT was significantly associated with a more severe post-thrombotic syndrome. After 14 years follow-up, no significant differences were observed in overall mortality, mortality from malignant disease or recurrent VTE between UFH- and dalteparin-treated patients. Malignant disease was a risk factor for recurrent VTE, the presence of a secondary risk factor and a longer duration of treatment with OAC decreased the risk for recurrent VTE.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Tanya N Turan ◽  
Azhar Nizam ◽  
Michael J Lynn ◽  
Colin P Derdeyn ◽  
David Fiorella ◽  
...  

Purpose: SAMMPRIS is the first stroke prevention trial to include protocol-driven aggressive management of multiple vascular risk factors. We sought to determine the impact of this protocol on early risk factor control in the trial. Materials and Methods: SAMMPRIS randomized 451 patients with symptomatic 70%-99% intracranial stenosis to aggressive medical management or stenting plus aggressive medical management at 50 USA sites. For the primary risk factor targets (SBP < 140 mm/Hg (<130 if diabetic) and LDL < 70 mg/dL), the study neurologists follow medication titration algorithms and risk factor medications are provided to the patients. Secondary risk factors (diabetes, non-HDL, weight, exercise, and smoking cessation) are managed with assistance from the patient’s primary care physician and a lifestyle modification program (provided). Sites receive patient-specific recommendations and feedback to improve performance. Follow-up continues, but the 30-day data are final. We compared baseline to 30-day risk factor measures using paired t-tests for means and McNemar tests for percentages. Results: The differences in risk factor measures between baseline and 30 days are shown in Table 1. Conclusions: The SAMMPRIS protocol resulted in major improvements in controlling most risk factors within 30 days of enrollment, which may have contributed to the lower than expected 30 day stroke rate in the medical group (5.8%). However, the durability of this approach over time will be determined by additional follow-up.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Audrey L Austin ◽  
Michael G Crowe ◽  
Martha R Crowther ◽  
Virginia J Howard ◽  
Abraham J Letter ◽  
...  

Background and Purpose: Research suggests that depression may contribute to stroke risk independent of other known risk factors. Most studies examining the impact of depression on stroke have been conducted with predominantly white cohorts, though blacks are known to have higher stroke incidence than whites. The purpose of this study was to examine depressive symptoms as a risk factor for incident stroke in blacks and whites, and determine whether depressive symptomatology was differentially predictive of stroke among blacks and whites. Methods: The REasons for Geographic and Racial Differences in Stroke (REGARDS), is a national, population-based longitudinal study designed to examine risk factors associated with black-white and regional disparities in stroke incidence. Among 30,239 participants (42% black) accrued from 2003-2007, excluding those lacking follow-up or data on depressive symptoms, 27,557 were stroke-free at baseline. As of the January 2011 data closure, over an average follow-up of 4.6 years, 548 incident stroke cases were verified by study physicians based on medical records review. The association between baseline depressive symptoms (assessed via the Center for Epidemiological Studies Depression scale, 4-item version) and incident stroke was analyzed with Cox proportional hazards models adjusted for demographic factors (age, race, and sex), stroke risk factors (hypertension, diabetes, smoking, atrial fibrillation, and history of heart disease), and social factors (education, income, and social network). Results: For the total sample, depressive symptoms were predictive of incident stroke. The association between depressive symptoms and stroke did not differ significantly based on race (Wald X 2 = 2.38, p = .1229). However, race-stratified analyses indicated that the association between depressive symptoms and stroke was stronger among whites and non-significant among blacks. Conclusions: Depressive symptoms were an independent risk factor for incident stroke among a national sample of blacks and whites. These findings suggest that assessment of depressive symptoms may warrant inclusion in stroke risk scales. The potential for a stronger association in whites than blacks requires further study.


Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1762-1762 ◽  
Author(s):  
Victor F. Tapson ◽  
Herve Decousus ◽  
Jean-Fran[ccedi]ois Bergmann ◽  
Beng H. Chong ◽  
James B. Froehlich ◽  
...  

Abstract Background Despite consensus group recommendations indicating that medical patients should receive appropriate venous thromboembolism (VTE) prophylaxis, prophylaxis practices remain poorly characterized. This analysis of IMPROVE, a prospective study of acutely ill medical patients, describes in-hospital prophylaxis practices prior to the publication of updated VTE prevention guidelines by the American College of Chest Physicians. Methods Patient recruitment began in July 2002. Patients ≥18 years old, and hospitalized for ≥3 days with an acute medical illness are enrolled consecutively. Exclusion criteria are: therapeutic antithrombotics/thrombolytics at admission; major surgery or trauma during 3 months prior to admission; and VTE treatment begun within 24 hours of admission. Results Data were from 4315 patients (32% from USA) enrolled up to 30 June 2004 in 37 hospitals in 11 countries (76% with 3-month follow-up data). Patients are 50% female, median (IQR) age 69 (50–80) years, median length of hospital stay 8 (5–14) days, median weight 68 (58–80) kg, and 40% were immobile for ≥3 days (median length of immobility 7 [4–14] days, including immobility immediately prior to admission). In-hospital VTE prophylaxis was received by 41% of patients (Table 1). Of patients with no risk factors (44%), one risk factor (40%), or ≥2 risk factors (16%), 25%, 49%, and 67% received prophylaxis, respectively. 12% of IMPROVE patients would have been eligible for inclusion in the MEDENOX study. Of these, only 52% received prophylaxis in hospital. Prophylaxis was provided to 6% of patients during the 3-month follow-up period, and continued in 11% of patients after discharge. Conclusions Only 41% of IMPROVE patients received VTE prophylaxis, with considerable variation in types and regimens of prophylaxis used. While MEDENOX showed the benefits of VTE prophylaxis (enoxaparin 40 mg) in acutely ill medical patients, only half of MEDENOX-eligible patients received prophylaxis. Table 1. Use of in-hospital VTE prophylaxis (N=4315) VTE prophylaxis Patients receiving VTE prophylaxis, % ROW, rest of world; *Excluding elastic stockings and aspirin ≥1 type of VTE prophylaxis* 41 LMWH - USA (Q12h, Qd) 7 (5, 1) LMWH- ROW (Q12h, Qd) 31 (29, 2) UFH - USA (Q12h, Q8h) 28 (15, 11) UFH - ROW (Q12h, Q8h) 6 (5, 0) Intermittent pneumatic compression (USA, ROW) 6 (19, 0) Aspirin (USA, ROW) 4 (7, 3) Elastic stockings (USA, ROW) 6 (3, 8)


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3348-3348
Author(s):  
Luis Fernando Bittar ◽  
Bruna Mazetto Fonseca ◽  
Silmara Lima Montalvão ◽  
Fernanda Loureiro de Andrade Orsi ◽  
Erich V de Paula ◽  
...  

Abstract Abstract 3348 Introduction: Venous thromboembolism (VTE) is a multifactorial disease, and increased levels of coagulation factor VIII (FVIII) has been demonstrated as risk factor for first and recurrent episodes of VTE. Some authors reported that these high levels of FVIII were still persistent after 4 years of the episode, but median follow-up in these studies are relatively short. The aim of the study was investigate if after a long-term follow-up of 4–15 years (median of 10 years), patients with high levels of FVIII after anticoagulant treatment still showed this alteration. Design and Methods: Previously, we selected 174 adult patients with a first episode of acute VTE between January 1990 and September 2004. One hundred seventy four healthy adult individuals selected from blood donors were chosen as controls, from the same geographic area of origin. Of this group of VTE patients, 68 patients with plasma FVIII: C levels above the 90th percentile were selected. FVIII levels (FVIII:C) were measured by a one-stage clotting assay with FVIII-deficient plasma in duplicate in an automated coagulometer. Levels were measured twice, in 2004 and then in 2011. C-reactive protein (CRP) levels were determined in the same samples by a nephelometric method to evaluate the influence of inflammation on FVIII levels. For individuals with CRP values higher than 1mg/dL, an additional blood sample was analyzed. High FVIII levels were only considered for further analysis when in the presence of normal CRP levels. The presence of post-thrombotic syndrome (PTS) was evaluated and classified clinically by the Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification System. Results: 68 patients with VTE and high levels of FVIII (19M:49F) with a median age of 47 years (range 20–70) were included in the study. The control group consisted of 59 subjects (42M:17F) with a median age of 35 years (range 21–56 years). VTE was spontaneous in 26 (38.2%) patients and secondary to an acquired risk factor in 61.8%. In the 1st evaluation, in 2004, patients with VTE had higher plasma levels of FVIII:C (median 235.8 IU/dL vs. 127.0 IU/dL; p<0.001) compared to controls. In 2011, seven years after the first evaluation and after a median follow-up of 10 years after the first VTE episode, this difference was still present (median 144.6 IU/dL vs. 96.4 IU/dL; p<0.001). Patients with severe PTS (167 IU/dL) showed higher plasma levels of FVIII when compared with patients without PTS (median 141.4 IU/dL), mild PTS patients (median 142.8 IU/dL), and moderate PTS patients (median 143.2); p=0.04. Conclusions: Our results show that even after a median of 10 years of VTE, patients still have increased levels of FVIII. Moreover, there seems to be a relationship between severe post-thrombotic syndrome and increased plasma levels of FVIII. Disclosures: No relevant conflicts of interest to declare.


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