scholarly journals Transition of Care for Pediatric and Adult Patients with Venous Thromboembolism in the American Thrombosis Hemostasis Network

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4711-4711
Author(s):  
Madhvi Rajpurkar ◽  
Maura Malone ◽  
Jim Munn ◽  
Julie Jaffray ◽  
Crystal Watson ◽  
...  

Abstract Background Venous thromboembolism (VTE) is the third leading cause of cardiovascular morbidity and mortality worldwide in adults and is increasingly seen in children. Optimal transition of care (TOC) from the inpatient to the outpatient setting may lead to improved outcomes for patients with VTE. Although several examples of TOC for patients with VTE exist, this project (ATHN 4: Transition of Care for Patients with VTE) is the first to create a uniform TOC model in the U.S that includes both pediatric and adult patients. The aim of this study was to improve the transition of care of adult and pediatric patients discharged on an anticoagulant after a first episode of VTE and evaluate patient/parent understanding and adherence to anticoagulation therapy-related instructions at seven and 30 days after hospital discharge. Methods Pediatric and adult hospitalized patients with a first episode of VTE requiring anticoagulation therapy were eligible to participate in ATHN 4, a multi-center quality improvement (QI) project conducted by the American Thrombosis and Hemostasis Network (ATHN). The project has two phases: a pre-intervention (PI) phase with no change in standard TOC practice, and a QI intervention phase consisting of enhanced education with standardized Comprehensive Discharge Instruction Modules (CDIM) for each anticoagulant. Demographics, disease, treatment characteristics, and outcomes were collected. Knowledge and feedback questionnaires were administered at 30 days post-discharge. Adult and pediatric data from the PI phase are presented. Results Complete data were submitted for 188 (91%) patients who were enrolled in the PI phase between May 2016 and March 2017 (Table 3). Results show that 73 (39%) were under 18 years of age, 90 (48%) were female, and 156 (83%) were non-Hispanic. A significant difference (p<0.001) in the location of the first VTE was noted among the pediatric and adult patients (Table 4). Approximately 66% (n=48) of the pediatric patients had a DVT, compared to 30% (n=34) of the adult patients. There were more adults with PE as compared to pediatric patients(43% vs. 3%). Adult and pediatric patients differ substantially (p <0.001) with respect to anticoagulant prescriptions. Pediatric patients were more likely to be prescribed Enoxaparin at discharge compared to adults (86% vs. 21%). Additionally, a significantly larger proportion of adult compared to pediatric patients was prescribed Warfarin (17% vs. 3%). Direct oral anticoagulants (DOACs) were mainly prescribed in the adult patients: Apixaban (24% vs. 0%) and Rivaroxaban (18% vs. 3%) compared to the pediatric patients. Based on the responses provided by the patients or guardians (for pediatric patients) during the Day 30 follow-up, there was almost an equal distribution among pediatric and adult patients who by clinical assessment were determined to have correctly taken the prescribed anticoagulant between the time of discharge and follow-up (98.6% of pediatrics and 97.4% of adults). Conclusions Our quality improvement study shows that the majority of pediatric and adult patients correctly took the anticoagulation medication prescribed to them at discharge for at least a month. Majority of pediatric patients presented with a DVT while PE was the most common presentation in adult patients. Enoxaparin and Apixaban were the most commonly prescribed anticoagulants to pediatric and adult patients, respectively. Factors affecting anticoagulation adherence and outcomes in these patients are currently being analyzed. Disclosures Rajpurkar: Bristol Myers Squibb: Research Funding; Shire: Honoraria; HEMA biologics: Honoraria; Pfizer: Honoraria, Research Funding; Novonordisk: Honoraria. Jaffray:Octapharma: Consultancy; CSL Behring: Consultancy, Research Funding; Bayer: Consultancy.

Vascular ◽  
2021 ◽  
pp. 170853812110209
Author(s):  
Rae S Rokosh ◽  
Jack H Grazi ◽  
David Ruohoniemi ◽  
Eugene Yuriditsky ◽  
James Horowitz ◽  
...  

Objectives Venous thromboembolism, including deep venous thrombosis and pulmonary embolism, is a major source of morbidity, mortality, and healthcare utilization. Given the prevalence of venous thromboembolism and its associated mortality, our study sought to identify factors associated with loss to follow-up in venous thromboembolism patients. Methods This is a single-center retrospective study of all consecutive admitted (inpatient) and emergency department patients diagnosed with acute venous thromboembolism via venous duplex examination and/or chest computed tomography from January 2018 to March 2019. Patients with chronic deep venous thrombosis and those diagnosed in the outpatient setting were excluded. Lost to venous thromboembolism-specific follow-up (LTFU) was defined as patients who did not follow up with vascular, cardiology, hematology, oncology, pulmonology, or primary care clinic for venous thromboembolism management at our institution within three months of initial discharge. Patients discharged to hospice or dead within 30 days of initial discharge were excluded from LTFU analysis. Statistical analysis was performed using STATA 16 (College Station, TX: StataCorp LLC) with a p-value of <0.05 set for significance. Results During the study period, 291 isolated deep venous thrombosis, 25 isolated pulmonary embolism, and 54 pulmonary embolism with associated deep venous thrombosis were identified in 370 patients. Of these patients, 129 (35%) were diagnosed in the emergency department and 241 (65%) in the inpatient setting. At discharge, 289 (78%) were on anticoagulation, 66 (18%) were not, and 15 (4%) were deceased. At the conclusion of the study, 120 patients (38%) had been LTFU, 85% of whom were discharged on anticoagulation. There was no statistically significant difference between those LTFU and those with follow-up with respect to age, gender, diagnosis time of day, venous thromboembolism anatomic location, discharge unit location, or anticoagulation choice at discharge. There was a non-significant trend toward longer inpatient length of stay among patients LTFU (16.2 days vs. 12.3 days, p = 0.07), and a significant increase in the proportion of LTFU patients discharged to a facility rather than home ( p = 0.02). On multivariate analysis, we found a 95% increase in the odds of being lost to venous thromboembolism-specific follow-up if discharged to a facility (OR 1.95, CI 1.1–3.6, p = 0.03) as opposed to home. Conclusions Our study demonstrates that over one-third of patients diagnosed with venous thromboembolism at our institution are lost to venous thromboembolism-specific follow-up, particularly those discharged to a facility. Our work suggests that significant improvement could be achieved by establishing a pathway for the targeted transition of care to a venous thromboembolism-specific follow-up clinic.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3638-3638 ◽  
Author(s):  
Xianchen Liu ◽  
John Thompson ◽  
Hemant Phatak ◽  
Jack Mardekian ◽  
Anthony R. Porcari ◽  
...  

Abstract Introduction Venous thromboembolism (VTE) is associated with a considerable risk for morbidity and recurrence and related hospitalizations. In the Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy-Extended Treatment (AMPLIFY-EXT) trial, a double-blind placebo-controlled trial with 12 months of treatment, two doses of apixaban (2.5 mg and 5 mg, twice daily) versus placebo significantly reduced symptomatic recurrent VTE or all-cause death without increasing the rate of major bleeding among 2,482 VTE patients who had completed 6-12 months of anticoagulation therapy. In this study, the effects of apixaban therapy versus placebo on medical hospitalization during AMPLIFY-EXT trial were evaluated. Methods A total of 2,477 patients who received study drugs were included in the analysis. All-cause hospitalizations during the trial were captured by dedicated case report forms. Outcomes of interest were; rate of hospitalizations and time from randomization to the first hospitalization. Patients were censored at either death, loss to follow-up, or end of study, whichever came first. Effects of treatment with apixaban versus placebo on the rates of hospitalization were assessed using Cox proportional hazards regression models. Results During a mean follow-up of 12.3 months, 138 patients were hospitalized at least once, 62 (7.5%/year) in the placebo group (n=826), 42 (4.8%/year) in the apixaban 2.5 mg group (n=840), and 34 (4.0%/year) in the apixaban 5 mg group (n=811). Compared with placebo, apixaban 2.5 mg [hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.44–0.96; p=0.030] and 5 mg (HR 0.54, 95%CI 0.36–0.83, p=0.004) were both associated with significant reduction in hospitalization. There was no significant difference in hospitalizations between the 2 doses of apixaban (5 mg vs. 2.5 mg: HR 0.84, 95%CI 0.53–1.32, p=0 .445). The mean time to first hospitalization was 153.7 days in the placebo group, 196.9 days in the apixaban 2.5 mg group, and 202.4 days in the apixaban 5 mg group (Figure). Conclusions Extended anticoagulation with apixaban at either a dose of 5 mg or 2.5 mg significantly reduced the risk of hospitalization, possibly due to the reduction in VTE recurrence. Disclosures: Liu: Pfizer: Employment, Equity Ownership. Thompson:Pfizer: Employment, Equity Ownership. Phatak:BMS: Employment, Equity Ownership. Mardekian:Pfizer: Employment, Equity Ownership. Porcari:Pfizer: Employment, Equity Ownership. Johnson:Pfizer: Employment, Equity Ownership.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2958-2958 ◽  
Author(s):  
Hisashi Ishida ◽  
Takeo Sarashina ◽  
Risa Matsumura ◽  
Katsutsugu Umeda ◽  
Tetsuo Mitsui ◽  
...  

Background: Myeloproliferative neoplasms (MPNs) are clonal hematopoietic disorders characterized by overproduction of differentiated hematopoietic cells. Among MPNs, chronic myeloid leukemia (CML) with BCR-ABL1 is the best studied subtype and is sometimes diagnosed during childhood. "Ph-negative" MPNs are typically found in older adults and are exceedingly rare during childhood. These classical Ph-negative MPNs include polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF). Because of this rarity, clinical features of pediatric MPNs are largely unknown, except for CML. Method: We administered questionnaires to institutions registered with the Japanese Society of Pediatric Hematology/Oncology (JSPHO). We collected clinical information of pediatric and young adult patients aged younger than 30 years who had been diagnosed with Ph-negative MPNs during 2000-2016. This study was conducted as a project of the Leukemia and Lymphoma Committee of the JSPHO. Results: We received responses from 145 institutions, which included all 107 board-certificated educational institutions of the JSPHO. A summary of the clinical features of included patients is shown in Table 1. From 2000 to 2016, 5 patients with PV, 42 with ET, and 2 with PMF were newly diagnosed with Ph-negative MPNs. Among them, 1 patient with PMF was excluded from subsequent analysis because of insufficient clinical information. The male-female ratio was almost balanced. The median age at diagnosis was 14 years for patients with PV, 9 years for patients with ET, and 1 patient with PMF was 10 months old. Only 1 patient with PV had a karyotype abnormality. The median follow-up period was 51 months since diagnosis. The JAK2V617F mutation was screened in almost all patients, and no patients with PV and 9 patients with ET had this mutation. With regard to treatment, 3 of 5 patients with PV received phlebotomy. Among patients with ET, aspirin was used most frequently (21 patients), followed by anagrelide (11 patients). However, 2 patients with PV and 8 patients with ET received no therapeutic approach. With regard to adverse events, hemorrhage and thrombosis were observed in 4 and 3 patients with ET, respectively, but these events were not found in patients with PV or PMF. Transformation to leukemia or myelofibrosis was found in 1 and 1 patient with PV, and 1 and 3 patients with ET, respectively. Among the patients who received no therapeutic approach, only 1 patient with PV experienced a hemorrhagic event and no other patients experienced any adverse events. Only 1 child with PV died owing to subsequent development of myelofibrosis and acute myeloid leukemia approximately 11 years after the initial diagnosis of PV. Conclusion: To the best of our knowledge, this is the first nationally-representative survey to clarify the clinical aspects of pediatric patients with Ph-negative MPNs. Although the methodology was not standardized, the frequency of the JAK2V617F mutation appears to be lower than that previously reported for adult patients. Moreover, the incidence of adverse events, such as thrombosis, hemorrhage, leukemia development, and transformation to myelofibrosis, was much lower than that of adult patients. As a result, although at relatively short durations of follow-up, the prognosis of pediatric patients with Ph-negative MPNs appears to be comparatively good. Further study with genetic analysis is warranted to determine the clinical and genetic features of pediatric patients with Ph-negative MPNs. Disclosures Mitsui: Astellas pharmaceutica: Research Funding; Daiichi Sankyo pharmaceutical: Research Funding; Chugai pharmaceutical: Research Funding; Teijin pharmaceutical: Research Funding; JCR pharmaceutical: Research Funding; Maruho pharmaceutical: Research Funding; MSD pharmaceutical: Research Funding; Shionogi pharmaceutical: Research Funding.


2002 ◽  
Vol 87 (01) ◽  
pp. 7-12 ◽  
Author(s):  
Cristina Legnani ◽  
Benilde Cosmi ◽  
Giuliana Guazzaloca ◽  
Claudia Pancani ◽  
Sergio Coccheri ◽  
...  

SummaryIn some patients with previous venous thromboembolism (VTE) D-dimer levels (D-Dimer) tend to increase after oral anticoagulant therapy (OAT) is stopped. The aim of our study was to evaluate the predictive value of D-Dimer for the risk of VTE recurrence after OAT withdrawal. After a first episode of deep vein thrombosis (DVT) of the lower limbs and/or pulmonary embolism (PE), 396 patients (median age 67 years, 198 males) were followed from the day of OAT discontinuation for 21 months. D-dimer was measured on the day of OAT withdrawal (T1), 3-4 weeks (T2) and 3 months (+/− 10 days, T3) thereafter. The main outcome events of the study were: objectively documented recurrent DVT and/or PE. D-dimer was found to be increased in 15.5%, 40.3% and 46.2% of the patients at T1, T2 and T3, respectively. In 199 (50.2%) patients, D-dimer levels were elevated in at least one measurement. During a follow-up of 628.4 years, 40 recurrences were recorded (10.1% of patients; 6.4% patient-years of follow-up). D-dimer was increased in at least one measurement in 28 of these cases, but remained normal in 11 subjects (three of whom had recurrent events triggered by circumstantial factors, three with malignancyassociated factors) (in one subject D-dimer was not measured). The negative predictive value (NPV) of D-dimer was 95.6% (95% CI 91.6-98.1) at T3 and was even higher (96.7%; 95% CI 92.9-98.8) after exclusion of the six recurrences due to circumstantial factors. Only five idiopathic recurrences occurred in the 186 patients with consistently normal D-dimer. In conclusion, D-dimer has a high NPV for VTE recurrence when performed after OAT discontinuation.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5343-5343
Author(s):  
Megan Melody ◽  
Sangeetha Gandhi ◽  
Zaid Abdel Rahman ◽  
Paula A Lengerke Diaz ◽  
Nicole Gannon ◽  
...  

BACKGROUND: Axi-cel is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy that is approved for treatment of relapsed/refractory (R/R) large B-cell lymphoma and is associated with high response rates and durable remissions. Recent data show that axi-cel is effective across various adverse prognostic features, namely cell of origin, disease bulkiness, and extranodal disease, among others. Hypoalbuminemia is a known adverse prognostic factor in lymphomas. It is unknown if axi-cel overcomes the adverse prognostic feature of hypoalbuminemia in R/R large B-cell or transformed follicular lymphoma. METHODS: We conducted a retrospective analysis of patients treated with axi-cel across three Mayo Clinic campuses (Rochester, Jacksonville, and Phoenix) from 06/01/2018 until 04/01/2019. The primary objective of this analysis was to assess the impact of hypoalbuminemia (defined at day 0, prior to infusion) on outcome after axi-cel therapy. RESULTS: A total of 50 (male=37, 74%) patients (pts), median age of 53 (26-67) years received axi-cel. The median number of prior lines of therapy was 3 (2-8) (Table 1). Two pts had no available serum albumin levels at time of axi-cel infusion. Seven (15%) of 48 pts had serum albumin levels lower than 3.5 g/dL (median= 3.3 g/dL (range 2.6-3.4)) and the median follow up of survivors was 7.6 (1.9-14.3) months. The best overall response rate (ORR) and complete remission (CR) rates in these pts were 57% and 57%, respectively. One (14%) patient had stable disease and 2 (29%) had disease progression. The median overall survival (OS) for pts with hypoalbuminemia was not reached. On the other hand, 41 (85%) pts had a normal serum albumin level (median=4.0 (range 3.5-5.1) g/dL) and the median follow up for survivors was 6.3 months. The best objective response rate (ORR) and complete remission (CR) rates in these pts were 82% and 44%, respectively. The median OS for pts with normal serum albumin was 14 (95%CI=6.3-29.6) months. There was no significant difference at 6-months and 1-year OS between pts with hypoalbuminemia vs. those with normal baseline serum albumin levels [6-month=100% vs. 79%(95%CI=64-93%); 1-year (100% vs. 54% (95%CI=26-82%), p=0.17] (Figure 1). All grades cytokine release syndrome (CRS) was diagnosed in all 7 pts with hypoalbuminemia (100%) and in 38 of 41 (92%) pts without hypoalbuminemia. There was no difference in the median duration of CRS between pts with or without hypoalbuminemia [6 (range 1-11) days vs 5 (range 1-19) days, p=0.89]. Neurotoxicity (all grades) was observed in 5 (71%) pts with hypoalbuminemia compared 26 (63%) with normal albumin levels. There was no statistically significant difference in median duration of neurotoxicity between pts with hypoalbuminemia and those with normal baseline albumin levels [9 (range 1-10) days vs. 3 (range 0-25) days, p= 0.72]. CONCLUSIONS: Hypoalbuminemia does not have a significant impact on the outcomes of axi-cel therapy, including the incidence of CRS or neurotoxicity. These results need to be validated in a large collaborative multicenter study. Further investigation is needed to assess the prognostic impact of severe hypoalbuminemia (<3g/dL) on axi-cel therapy. Disclosures Ansell: Mayo Clinic Rochester: Employment; Seattle Genetics: Research Funding; Trillium: Research Funding; Trillium: Research Funding; Mayo Clinic Rochester: Employment; Bristol-Myers Squibb: Research Funding; Bristol-Myers Squibb: Research Funding; Affimed: Research Funding; Regeneron: Research Funding; Affimed: Research Funding; Bristol-Myers Squibb: Research Funding; Mayo Clinic Rochester: Employment; LAM Therapeutics: Research Funding; Affimed: Research Funding; Bristol-Myers Squibb: Research Funding; Trillium: Research Funding; Regeneron: Research Funding; Trillium: Research Funding; Affimed: Research Funding; LAM Therapeutics: Research Funding; Mayo Clinic Rochester: Employment; LAM Therapeutics: Research Funding; LAM Therapeutics: Research Funding; Bristol-Myers Squibb: Research Funding; Mayo Clinic Rochester: Employment; Mayo Clinic Rochester: Employment; Affimed: Research Funding; Regeneron: Research Funding; LAM Therapeutics: Research Funding; Seattle Genetics: Research Funding; Trillium: Research Funding; Affimed: Research Funding; Trillium: Research Funding; Bristol-Myers Squibb: Research Funding; LAM Therapeutics: Research Funding; Mayo Clinic Rochester: Employment; Trillium: Research Funding; Regeneron: Research Funding; LAM Therapeutics: Research Funding; Bristol-Myers Squibb: Research Funding; Mayo Clinic Rochester: Employment; LAM Therapeutics: Research Funding; Seattle Genetics: Research Funding; Trillium: Research Funding; Trillium: Research Funding; Seattle Genetics: Research Funding; Regeneron: Research Funding; Bristol-Myers Squibb: Research Funding; Mayo Clinic Rochester: Employment; Bristol-Myers Squibb: Research Funding; Seattle Genetics: Research Funding; LAM Therapeutics: Research Funding; Regeneron: Research Funding; Affimed: Research Funding; Seattle Genetics: Research Funding; Regeneron: Research Funding; Seattle Genetics: Research Funding; Regeneron: Research Funding; Seattle Genetics: Research Funding; Regeneron: Research Funding; Seattle Genetics: Research Funding; Affimed: Research Funding; Affimed: Research Funding. Bennani:Seattle Genetics: Other: Advisory board; Kite Pharma: Other: Advisory board; Seattle Genetics: Other: Advisory board; Adicet Bio: Other: Advisory board; Seattle Genetics: Other: Advisory board; Purdue Pharma: Other: Advisory board; Adicet Bio: Other: Advisory board; Purdue Pharma: Other: Advisory board; Purdue Pharma: Other: Advisory board; Adicet Bio: Other: Advisory board; Bristol-Myers Squibb: Research Funding; Bristol-Myers Squibb: Research Funding; Kite Pharma: Other: Advisory board; Bristol-Myers Squibb: Research Funding; Kite Pharma: Other: Advisory board. Paludo:Verily Life Sciences: Research Funding; Celgene: Research Funding; Verily Life Sciences: Research Funding; Celgene: Research Funding. Tun:DTRM Biopharma: Research Funding; Mundi-pharma: Research Funding; BMS: Research Funding; Celgene: Research Funding; Curis: Research Funding; TG Therapeutics: Research Funding. Foran:Agios: Honoraria, Research Funding. Kharfan-Dabaja:Daiichi Sankyo: Consultancy; Pharmacyclics: Consultancy.


2020 ◽  
Vol 72 (5) ◽  
pp. e357
Author(s):  
Rae Rokosh ◽  
Jack Grazi ◽  
David Ruohoniemi ◽  
Raj Machhar ◽  
Ahkilesh Sista ◽  
...  

2020 ◽  
Vol 33 (5) ◽  
Author(s):  
Seyed Farzad Marashi Nia ◽  
Mohamad Aghaie Meybodi ◽  
Richard Sutton ◽  
Ajay Bansal ◽  
Mojtaba Olyaee ◽  
...  

Summary Esophageal foreign body impaction (EFBI) is a gastrointestinal emergency, mostly requiring endoscopic management. The aim of this study is to evaluate the epidemiology, adverse events, and outcomes of patients following the episode of EFBI. All esophagogastroduodenoscopy (EGD) reports of admitted patients for EFBI at the University of Kansas Medical Center between 2003 and 2018 were retrospectively reviewed. Of 204 patients, who met the inclusion criteria, 60% were male and the mean age was 54.7 ± 17.7 years. The encounter was the first episode of EFBI in 76% of cases. EGD in less than 24 hours of patients’ admission was required in 79% of cases. The distal esophagus was the most common site of impaction (44%). Push and pull techniques were used in 38 and 35.2% of cases, respectively, while 11% were managed by a combination of both techniques. Structural causes were the most common etiologic findings including benign strictures and stenosis in 21.5% of patients, followed by Schatzki’s ring (7.8%) and hiatal hernia (6.9%). Of all cases, 45% did follow-up in up to 1 year, and biopsy was done in 34% of cases. Out of 43 patients who had endoscopic findings suspicious for eosinophilic esophagitis (EoE), the diagnosis was confirmed by pathology in 37. The rate of recurrence EFBI was significantly higher in patients with EoE (P &lt; 0.001). EFBI-related esophageal adverse events (AEs) occurred in 4.9% of cases. Cardiovascular and pulmonary AEs occurred in 1.5 and 2.9%, respectively. Logistic regression did not find any predictor for AEs occurrence. EFBI managed very well with endoscopic treatments. Despite the emerging data about the safety of the push technique, there are still concerns regarding its adverse events especially the risk of perforations. Our study shows no significant difference in adverse events between different types of techniques.


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.


2010 ◽  
Vol 23 (4) ◽  
pp. 313-323 ◽  
Author(s):  
Susan E. Conway ◽  
Todd R. Marcy

Clinical practice guidelines currently suggest extended anticoagulation therapy for primary and secondary prevention of venous thromboembolism (VTE). The optimal duration of anticoagulation has been an active area of clinical investigation for patients undergoing orthopedic surgeries and those diagnosed with a first episode of unprovoked VTE. Practice guidelines, VTE incidence, clinical predictors/mediators, and clinical trial evidence is reviewed to help pharmacists and other health care providers make an informed, patient-specific decision on the optimal duration of anticoagulation therapy. Extended anticoagulation up to 5 weeks following orthopedic surgery for primary VTE prevention and indefinitely following a first episode of unprovoked VTE for secondary VTE prevention should be considered only if the risk of bleeding is not high and the cost and burden of anticoagulation is acceptable to the patient. The optimal duration of anticoagulation therapy for primary or secondary prevention of VTE should include the health care provider and patient making a decision based on evaluation of individual benefits, risks, and preferences.


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