scholarly journals Rate of Venous Thromboembolism in Obese Patients Undergoing General Surgery: A Retrospective Cohort Study

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4261-4261
Author(s):  
Andrea Meade ◽  
Sudeep Shivakumar ◽  
Susan Bowles ◽  
Mark Walsh ◽  
Michael MacNeil
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Epidural Catheter ◽  
Major Bleeding ◽  
General Surgery ◽  
Fixed Dose ◽  
Specific Recommendation ◽  
Obese Patients ◽  
Pharmacological Prophylaxis ◽  
Vte Prophylaxis

Abstract Background: Implementation of prophylactic drug therapy for venous thromboembolism (VTE) can greatly reduce VTE-associated morbidity and mortality in patients undergoing surgery. Obesity has been demonstrated to be an independent risk factor for fatal pulmonary embolism following surgery; however, there is currently a lack of guidance with regard to the optimal drug regimen for VTE prophylaxis in obese patients. At the QEII Health Sciences Center (QEII HSC), a district-wide pre-printed order form is used to guide risk classification and corresponding VTE prophylactic regimens for a variety of nonorthopedic surgical populations. In the absence of a contraindication, such as heparin-induced thrombocytopenia, dalteparin is the drug of choice for the majority of patients. A standard fixed dose of dalteparin 5000 units given subcutaneously is employed for most patients except for those patients weighing less than 40 kg or over the age of 80, in which a lower fixed dose of 2500 units is recommended. There is no specific recommendation for obese patients with regard to dosing. Objectives: To determine the rate of objectively confirmed VTE during admission or up to six weeks post-discharge in obese patients (Body Mass Index (BMI) ≥ 35 kg/m2), compared to non-obese patients, that undergo general surgery at the QEII HSC. Risk factors associated with the development of VTE and practice patterns with regard to implementation of pharmacologic VTE prophylaxis were also evaluated. Methods:A retrospective chart review of 378 patients,18 years or older, who underwent general surgery (colorectal, surgical oncology, or hepatobiliary) from January 1, 2010 to December 31, 2013 was performed. Patient and procedure-related data was collected and analyzed using summary statistics and multivariate logistic regression. Results: The rate of VTE was not significantly different when comparing obese and non-obese patients (3.3% vs. 2.5%; p = NS). There were no risk factors identified to be significantly associated with VTE in patients undergoing general surgery. Although not included as an endpoint in our research objectives, data collected with regard to bleeding revealed a significant difference between obese and non-obese patients in the rate of major bleeding events (2.8% vs 7.6%; p=0.03). Being non-obese (OR 2.87, 95% CI 1.021 - 8.06; p=0.0456), having a higher dose per total body weight (OR 1.02, 95% CI 1.01 - 1.04; p=0.0346) and per BMI (OR 1.07, 95% CI 1.01 - 1.14; p=0.0330), having cancer (OR 2.65, 95% CI 1.07 - 6.58; p=0.0355), failure to ambulate early after surgery (OR 21.25, 95% CI 2.81 - 160.40; p=0.0030), and having a central venous catheter (OR 4.97, 95% CI 1.65 - 14.96); p=0.0043) and/or epidural catheter in place (OR 4.21, 95% CI 1.29 - 13.78; p=0.0174) increased the risk of a major bleeding event. Ninety-nine percent (374/378) of patients received some form of pharmacological prophylaxis. Of the 374 who received prophylactic therapy, 6 patients received pre-operative prophylaxis only and 368 patients received post-operative prophylaxis. Of the patients that received post-operative prophylaxis, 217 (59%) patients received dalteparin and 145 (39%) patients received unfractionated heparin (UFH), while the remaining 6 (2%) patients had a switch from one agent to the other. Of the 145 patients that received UFH, 24 patients (17%) had a recommended indication for its use as they required an epidural catheter while the remaining 121 (83%) did not. Conclusions: The rate of VTE in patients undergoing general surgery is low and obese patients (BMI ≥ 35 kg/m2) appear to be adequately protected against VTE. There is no need to alter our current VTE prophylaxis dosing strategy; however, in order to maintain a low rate of VTE, continued compliance with the implementation of pharmacological prophylaxis as well as assessment of VTE risk on a case by case basis is recommended. We likely failed to see an association of risk factors with the outcome of VTE as we had a low event rate and would have required a larger sample size to find significance. The rate of bleeding, although significantly different between groups, appears to be consistent with the rate reported in the literature. The percentage of patients receiving UFH outside of the recommended indications was fairly high and therefore further education is needed to ensure selection of the most appropriate pharmacologic agent. Disclosures No relevant conflicts of interest to declare.

scholarly journals Risk assessment and prevention of venous thromboembolism among hospitalized patients: Results of the regional multicenter study

2021 ◽  
pp. 26-40
Author(s):  
A. B. Sugraliyev ◽  
Sh. S. Aktayeva ◽  
Sh. B. Zhangelova ◽  
S. A. Shiller ◽  
Zh. M. Kussymzhanova ◽  
...  
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Multicenter Study ◽  
Bed Rest ◽  
Primary Objective ◽  
Hospitalized Patients ◽  
Public Health Issue ◽  
Medical Patients ◽  
Pharmacological Prophylaxis ◽  
Vte Prophylaxis

Introduction. Venous thromboembolism (VTE) is a major public health issue that is frequently underestimated. The primary objective of this multicenter study was to identify patients at risk for VTE, and to define the rate of patients receiving appropriate prophylaxis in the regions of Kazakhstan.Materials and methods. Standardized case report forms were filled by trained medical doctors on one predefined day in selected hospitals. Data were analyzed by independent biostatistician. Risk of VTE was categorized according to Caprini score which was recommended by 2004 American College of Chest Physicians (ACCP) guidelines.Results. 432 patients from 4 regions of Kazakhstan; 169 (39.10%) medical patients and 263 (60.9%) surgical patients were eligible for the study. Patients were at low (10%), moderate (19.2%), high (33.6%) and very high risk (37.3%) for VTE. The main risk factors (RF) of VTE among hospitalized patients were heart failure (HF), obesity, prolonged bed rest, and the presence of acute non-infective inflammation. From total number of hospitalized patients with RF with indications to VTE prophylaxis, 58.1% of patients received pharmacological prophylaxis and only 24.6% of them received VTE prophylaxis according ACCP. On the other hand, 23.5% patients with the risk of VTE but who were not eligible for it received pharmacological prophylaxis.Conclusion. These results indicate the existence of inconsistency between eligibility for VTE prophylaxis on one hand and its application in practice (p < 0.001). Risk factors for VTE and eligibility for VTE prophylaxis are common, but VTE prophylaxis and guidelines application are low.

Impact of a Venous Thromboembolism Prophylaxis “Smart Orderset”: Improved Compliance, Fewer Events

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 172-172
Author(s):  
Amer M. Zeidan ◽  
Michael B. Streiff ◽  
Syed-Rafay Ahmed ◽  
Peggy S Kraus ◽  
Deborah Hobson ◽  
...  
Keyword(s):  
Risk Factors ◽  
Decision Support ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Vte Prophylaxis ◽  
Patient Demographics ◽  
Medicine Service ◽  
Before And After ◽  
Pharmacologic Prophylaxis ◽  
The Impact

Abstract Abstract 172FN2 Introduction: Venous Thromboembolism affects 900,000 Americans annually. Prophylaxis reduces the risk of VTE by 60% but many patients do not receive risk-appropriate VTE prophylaxis. We developed mandatory computer decision support “smart ordersets” (i.e. electronic menus with DVT prophylaxis recommendations) to improve our institution's VTE prophylaxis performance. The ordersets require providers to respond to 2 questions that assess VTE risk factors and contraindications to pharmacologic prophylaxis. Using these answers along with known patient demographics, the orderset gives providers an evidence-based risk-appropriate VTE prophylaxis recommendation. Methods: To study the impact of Medicine service-specific orderset on compliance with the 2008 American College of Chest Physicians (ACCP) VTE prophylaxis guideline and clinical outcomes, we conducted a retrospective cohort chart review of consecutive patients admitted to the Medicine service during one month immediately prior to (November 2007) and a single month subsequent to (April 2010) orderset launch. Data collection included patient demographics, VTE risk factors, and use and type of VTE prophylaxis. Patient characteristics before and after implementation of the protocol were compared. The primary outcome measures were compliance with thromboprophylaxis guidelines in patients at risk for VTE and the 90-day VTE rate. Secondary outcomes were bleeding events and 30-day mortality. Outcomes were compared by Student's t-test and Fisher's exact test. Results: The before and after cohorts contained 1,025 and 1,057 patients, respectively. Demographic characteristics and contraindications to pharmacologic prophylaxis were similar between groups. (Table 1) Some VTE risk factors were more prevalent in the before group. (Table 1) ACCP compliant prophylaxis increased significantly from 68.3% to 85.9% (p <.0001). Provider choices for prophylaxis changed with an increase in mechanical prophylaxis and twice daily heparin in the post-orderset implementation cohort. (Table 2) Radiographically-documented symptomatic VTE by day 90 post-hospital discharge declined from 2.8% to 0.7% after orderset implementation (p=0.001). There was also a trend toward fewer in-hospital VTE (0.8% versus 0.2%, p=0.06). (Figure 1) Major bleeding remained unchanged (0.3% to 0.1%, p=0.47). Conclusion: A VTE prophylaxis computerized decision support “smart orderset” improves ACCP-compliant VTE prophylaxis and results in lower risk of symptomatic VTE without an increase in major bleeding. Disclosures: Streiff: BristolMyers Squibb: Research Funding; sanofi-aventis: Consultancy; Daiichi-Sankyo: Consultancy; Eisai: Member of study outcome adjudication committee; sanofi-aventis: Honoraria.

scholarly journals Incidence, Management and Outcomes of Arterial and Venous Thromboembolism after Chimeric Antigen Receptor Modified T Cells for B-Cell Lymphoma and Multiple Myeloma

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 7-7
Author(s):  
Anna L. Parks ◽  
Swetha Kambhampati ◽  
Bita Fakhri ◽  
Charalambos Andreadis ◽  
Lissa Gray ◽  
...  
Keyword(s):  
Risk Factors ◽  
Multiple Myeloma ◽  
T Cells ◽  
Venous Thromboembolism ◽  
B Cell ◽  
Research Funding ◽  
Vte Prophylaxis ◽  
Therapeutic Anticoagulation ◽  
Car T ◽  
History Of

Introduction: Chimeric antigen receptor modified T Cell (CAR-T) therapy is a rapidly developing treatment for patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). Although this population is at high risk for thrombosis, there are few data about rates of venous thromboembolism (VTE) and arterial thromboembolism (ATE) with CAR-T. Additionally, treatment with anticoagulation is complicated because of the prevalence of thrombocytopenia following CAR-T. Our goal was to determine the incidence, associated risk factors, management and outcomes of VTE and ATE in the 60 days following CAR-T therapy. Methods: We performed a single-center, retrospective cohort study of all patients who received inpatient CAR-T cells at UCSF Medical Center between January 2018 and May 2020 for R/R NHL or MM as standard-of-care or on a clinical trial. The outcomes of incident VTE and ATE were identified by ICD-10 codes and medical record review. Patient characteristics, pre-existing thrombosis risk factors, laboratory results, medications, and major or clinically relevant non-major bleeding or recurrent thrombotic complications were obtained through chart review. We used descriptive statistics to delineate risk factors, incidence, management and outcomes of thrombotic events. Results: Ninety-one patients who underwent CAR-T therapy were included in the analysis, 37 with NHL and 54 with MM. For NHL, mean age was 63 (range 38-82), and 41% were women. For MM, mean age was 62 (range 33-77), and 50% were women. Patients with NHL were treated with either investigational or Federal Drug Administration-approved CD19-directed therapies, and patients with MM were treated with a variety of investigational B-cell maturation antigen-directed (BCMA) therapies. For thrombotic risk factors, 13% of patients with NHL had a history of VTE, 3% had a history of ATE, 27% had a BMI ≥30, 59% had a recent procedure including central venous catheter (CVC) placement, 14% had an intensive care unit (ICU) stay, and 22% had an infectious complication in the 30 days pre- or post-CAR-T. Forty-one percent of patients with NHL had neurotoxicity of any grade, and 59% had CRS of any grade. At 30 days, 57% had a complete response, 41% had a partial response, 3% had stable disease. For MM, 6% of patients had a pre-existing history of VTE, 2% had a history of ATE, 19% had a BMI ≥30, 96% had a recent procedure, 11% had an ICU stay and 19% had an infection. Seventeen percent had neurotoxicity, and 85% had CRS. Thirty-two percent of patients with NHL and 48% with MM received pharmacologic VTE prophylaxis while undergoing CAR-T. For those who did not receive VTE prophylaxis, thrombocytopenia was the reason for holding prophylaxis, which occurred in 51% and 50% of NHL and MM patients, respectively. In the 60 days post-CAR-T, 4 (11%) patients with NHL were diagnosed with VTE-3 pulmonary embolism (PE) and 1 lower extremity deep vein thrombosis (DVT) associated with a previously placed inferior vena cava filter. Four (7%) patients with MM were diagnosed with VTE-1 PE and 3 upper extremity DVTs associated with CVCs. Five out of these 8 (63%) patients had symptomatic VTE, while the remainder were incidental on PETCT. Mean time from CAR-T infusion to VTE diagnosis was 20 days (range 6-39 days). There were no documented ATEs. Six out of 8 (75%) were treated with therapeutic anticoagulation. Of those who were anticoagulated, 4 patients received direct oral anticoagulants and 2 received low-molecular-weight-heparin. Duration was 3 months in 3 patients, 11 days in 1, 150 days in 1, and indefinitely in 1 with atrial fibrillation. Among all 8 patients with VTE, there were no bleeding events or recurrent thromboses regardless of whether or not they received anticoagulation. Discussion: In this cohort of patients with R/R NHL or MM who received either CD19- or BCMA-directed therapies, almost 1 in 10 developed VTE in the 60 days post-CAR-T. This occurred in the context of a high prevalence of risk factors for thrombosis and low rates of pharmacologic prophylaxis. Among those who developed VTE, the majority were treated with therapeutic anticoagulation for at least 3 months, without documented bleeding or recurrent VTE. Our findings provide crucial information on a common complication that can inform patients, clinicians and researchers and should be expanded upon in larger, prospective studies to identify optimal preventive and therapeutic strategies. Disclosures Fakhri: University of California San Francisco: Current Employment. Andreadis:Jazz Pharmaceuticals: Honoraria; Karyopharm: Honoraria; Incyte: Consultancy; Merck: Research Funding; Gilead/Kite: Consultancy; Novartis: Research Funding; BMS/Celgene/Juno: Honoraria, Research Funding; Genentech: Consultancy, Current equity holder in publicly-traded company. Wong:Janssen: Research Funding; Amgen: Consultancy; Roche: Research Funding; Fortis: Research Funding; Sanofi: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Research Funding; GSK: Research Funding. Shah:BMS, Janssen, Bluebird Bio, Sutro Biopharma, Teneobio, Poseida, Nektar: Research Funding; GSK, Amgen, Indapta Therapeutics, Sanofi, BMS, CareDx, Kite, Karyopharm: Consultancy.

Impact of Postoperative Venous Thromboembolism on Postoperative Morbidity, Mortality, and Resource Utilization after Hepatectomy

2015 ◽  
Vol 81 (12) ◽  
pp. 1216-1223 ◽  
Author(s):  
Timothy E. Newhook ◽  
Damien J. Lapar ◽  
Dustin M. Walters ◽  
Shruti Gupta ◽  
Joshua S. Jolissaint ◽  
...  
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Fold Increase ◽  
The United States ◽  
Albumin Level ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Resource Usage ◽  
Vte Prophylaxis ◽  
The Impact

The impact of venous thromboembolism (VTE) after hepatectomy on patient morbidity, mortality, and resource usage remains poorly defined. Better understanding of thromboembolic complications is needed to improve perioperative management and overall outcomes. About 3973 patients underwent hepatectomy within NSQIP between 2005 and 2008. Patient characteristics, operative features, and postoperative correlates of VTE were compared with identify risk factors for VTE and to assess its overall impact on postoperative outcomes. Overall incidence of postoperative VTE was 2.4 per cent. Risk factors for postoperative VTE included older age, male gender, compromised functional status, degree of intraoperative blood transfusion, preoperative albumin level (all P < 0.05), and extent of hepatectomy ( P = 0.004). Importantly, major postoperative complications, including acute renal failure, pneumonia, sepsis, septic shock, reintubation, prolonged ventilation, cardiac arrest, and reoperation were all associated with higher rates of VTE (all P < 0.05). Operative mortality was increased among patients with VTE (6.5% vs 2.4%, P = 0.03), and patients with VTE had a 2-fold increase in hospital length of stay (12.0 vs 6.0 days, P < 0.001). Postoperative VTE remains a significant source of morbidity, mortality, and increased resource usage after hepatectomy in the United States. Routine aggressive VTE prophylaxis measures are imperative to avoid development of VTE among patients requiring hepatectomy.

Postoperative Venous Thromboembolism after Extracranial Otologic Surgery

2019 ◽  
Vol 161 (1) ◽  
pp. 144-149
Author(s):  
Yohan Song ◽  
Jennifer C. Alyono ◽  
Noor-E-Seher Ali ◽  
Nikolas H. Blevins
Keyword(s):  
Venous Thromboembolism ◽  
General Surgery ◽  
Average Length ◽  
Assessment Model ◽  
Risk Scores ◽  
Cross Sectional ◽  
Vte Prophylaxis ◽  
Otologic Surgery ◽  
Academic Center ◽  
Postoperative Diagnosis

Objective To determine the incidence of postoperative venous thromboembolism (VTE) in adults undergoing otologic surgery. Study Design Cross-sectional retrospective study. Setting Single tertiary academic center. Subjects and Methods Adults undergoing nononcologic, extracranial otologic surgery from August 2009 to December 2016. Patients with postoperative diagnosis VTE codes were identified. Imaging and clinical documents were searched for VTE evidence within the first 30 postoperative days. Methods of thromboprophylaxis were documented, and Caprini risk scores were calculated. Results In total, 1213 otologic surgeries were evaluated. No postoperative VTE events were identified (0/1268). Mean age was 51.0 ± 17.3 years (range, 18.1-93.4 years). Average length of surgery was 136.0 ± 79.0 minutes (range, 5-768 minutes). The average Caprini score in all patients was 4.0 ± 1.7 (range, 1-15). Eighty-five percent of patients had a Caprini score ≥3, the threshold at which chemoprophylaxis has been recommended in general surgery patients by the American College of Chest Physicians 2012 guidelines. Six patients had documented preoperative chemoprophylaxis and a Caprini score of 4.8 ± 1.7. This was not significantly different from that of patients who did not receive preoperative chemoprophylaxis ( t test, P = .3). The literature would estimate a rate of 3.7% VTE in adults with similar Caprini scores undergoing general surgery procedures with no VTE prophylaxis. Conclusion The Caprini risk assessment model may overestimate VTE risk in patients undergoing extracranial otologic surgery. Postoperative VTE following otologic surgery is rare, even in patients traditionally considered moderate or high risk. Chemoprophylaxis guidelines in this group should be balanced against the potential risk of increased intraoperative bleeding and its associated effects on surgical visualization and morbidity.

Weight-Based Enoxaparin for Venous Thromboembolism in Obesity Gives Similar Anti-Xa Levels to Patients <100 kg, with No Increase in Major Bleeding

2019 ◽  
Vol 45 (01) ◽  
pp. 094-099 ◽  
Author(s):  
Hannah Stevens ◽  
Huyen Tran ◽  
Sanjeev Chunilal ◽  
Kylee Maclachlan
Keyword(s):  
Venous Thromboembolism ◽  
Renal Impairment ◽  
Major Bleeding ◽  
Factor Xa ◽  
Therapeutic Drug ◽  
Obese Patients ◽  
Post Dose ◽  
Retrospective Audit ◽  
Level 2 ◽  
Similar Peak

AbstractIn trials assessing venous thromboembolism (VTE) treatment, obese patients are under-represented or excluded. The main objective of this article is to examine the safety of weight-based enoxaparin dosing in obesity, as assessed by anti-factor Xa (anti-Xa) activity, bleeding, and recurrence. A 5-year retrospective audit of patients with acute VTE, weighing > 100 kg, prescribed enoxaparin 1 mg/kg twice daily, with an anti-Xa level 2 to 6 hours post-dose. The primary outcome was anti-Xa levels, and the secondary outcomes were bleeding and recurrence. Results were compared with patients weighing < 100 kg (n = 64), and obese patients prescribed doses < 1 mg/kg (n = 28). One-hundred sixty-six patients weighing > 100 kg with VTE were identified, with 64 excluded for not fulfilling criteria. The remaining 102 patients had a median weight of 130 kg (range: 105–222 kg). The median peak anti-Xa level was 0.93 U/mL, with 56% of levels being in the proposed therapeutic range (0.5–1.0 U/mL), 40% > 1.0 U/mL, and 4% < 0.5 U/mL. The median anti-Xa levels and distribution were not significantly different between patients > 100 kg and patients < 100 kg, while obese patients prescribed < 1 mg/kg were more frequently subtherapeutic (21%). Regardless of weight, the majority of patients with moderate renal impairment (eGFR 30–59 mL/min) had an anti-Xa level > 1.0 U/mL (61%). In the obese patients, there was no major bleeding or recurrence within 30 days. In comparison, patients weighing < 100 kg, despite similar peak anti-Xa levels, had higher rates of bleeding and recurrence. This was likely due to their older age and comorbidities, particularly renal impairment and cancer. These data support weight-based dosing of enoxaparin in obesity with no maximum dose, ensuring therapeutic drug levels, with anti-Xa levels suggested in obese patients with clinical risk factors for bleeding.

scholarly journals American Society of Hematology 2019 guidelines for management of venous thromboembolism: prevention of venous thromboembolism in surgical hospitalized patients

2019 ◽  
Vol 3 (23) ◽  
pp. 3898-3944 ◽  
Author(s):  
David R. Anderson ◽  
Gian Paolo Morgano ◽  
Carole Bennett ◽  
Francesco Dentali ◽  
Charles W. Francis ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
General Surgery ◽  
Major Trauma ◽  
Major Surgery ◽  
Common Source ◽  
Neurosurgical Procedures ◽  
Gynecological Surgery ◽  
Pharmacological Prophylaxis ◽  
American Society ◽  
Major General

AbstractBackground:Venous thromboembolism (VTE) is a common source of perioperative morbidity and mortality.Objective:These evidence-based guidelines from the American Society of Hematology (ASH) intend to support decision making about preventing VTE in patients undergoing surgery.Methods:ASH formed a multidisciplinary guideline panel balanced to minimize bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline-development process, including performing systematic reviews. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment.Results:The panel agreed on 30 recommendations, including for major surgery in general (n = 8), orthopedic surgery (n = 7), major general surgery (n = 3), major neurosurgical procedures (n = 2), urological surgery (n = 4), cardiac surgery and major vascular surgery (n = 2), major trauma (n = 2), and major gynecological surgery (n = 2).Conclusions:For patients undergoing major surgery in general, the panel made conditional recommendations for mechanical prophylaxis over no prophylaxis, for pneumatic compression prophylaxis over graduated compression stockings, and against inferior vena cava filters. In patients undergoing total hip or total knee arthroplasty, conditional recommendations included using either aspirin or anticoagulants, as well as for a direct oral anticoagulant over low-molecular-weight heparin (LMWH). For major general surgery, the panel suggested pharmacological prophylaxis over no prophylaxis, using LMWH or unfractionated heparin. For major neurosurgery, transurethral resection of the prostate, or radical prostatectomy, the panel suggested against pharmacological prophylaxis. For major trauma surgery or major gynecological surgery, the panel suggested pharmacological prophylaxis over no prophylaxis.

The International Medical Prevention Registry on Venous Thromboembolism (IMPROVE): Venous Thromboembolism Prophylaxis Practices in Acutely Ill Medical Patients.

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 ◽  
...  
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Major Surgery ◽  
Medical Illness ◽  
Medical Patients ◽  
Median Length ◽  
Thromboembolism Prophylaxis ◽  
Vte Prophylaxis ◽  
Elastic Stockings

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)

Once-Daily Oral Rivaroxaban Versus Placebo in the Long-Term Prevention of Recurrent Symptomatic Venous Thromboembolism. the Einstein-Extension Study

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. LBA-2-LBA-2 ◽  
Author(s):  
Harry Roger Buller
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Recurrent Events ◽  
Oral Anticoagulants ◽  
Acute Episode ◽  
Extension Study ◽  
Fixed Dose ◽  
Anticoagulant Treatment ◽  
Once Daily ◽  
Recurrent Vte

Abstract Abstract LBA-2 Background: In a large proportion of patients that have completed 6 to 12 months of treatment with a vitamin K antagonist (VKA) for their acute episode of venous thromboembolism (VTE) the question arises whether to stop or continue this treatment. Continuation implies the need for regular laboratory control and subsequent dose adjustments. Furthermore, the risk of bleeding persists. New oral anticoagulants hold the promise of simple fixed-dose regimens without the need for monitoring and could make continuation of therapy more attractive. The Einstein-Extension study was therefore designed to assess the relative efficacy and safety of rivaroxaban, a direct oral factor Xa inhibitor, versus placebo in patients who had completed 6 to 12 months of anticoagulant treatment for their acute episode of VTE. Patients in whom there was a clear indication for continued anticoagulant treatment were not eligible. Study Design: This randomized, double-blind, placebo-controlled, superiority study evaluated therapy with rivaroxaban 20 mg once-daily for an additional 6 or 12 months. The primary efficacy outcome was symptomatic recurrent VTE (i.e., the composite of recurrent DVT, non-fatal PE, and fatal PE). The principal safety outcome was major bleeding. Also the occurrence of clinically relevant non-major bleeding (e.g. nose bleeds, large skin hematomas, and macroscopic hematuria) was recorded. The study was event-driven requiring a minimum of 30 confirmed recurrent events. All outcomes were adjudicated by an independent blinded committee. Results: A total of 1197 patients were randomized between February 2007 and May 2009 by 280 study sites in 28 countries. The intention-to-treat population consisted of 602 rivaroxaban and 594 placebo patients. Baseline characteristics and risk factors for VTE were comparable between the two groups. The mean duration of study treatment was 190 days in both groups. During the treatment period, symptomatic recurrent VTE events occurred in 42 (7.1%) of the placebo treated patients and in 8 (1.3%) of the rivaroxaban recipients (hazard ratio, 0.18; 95 % CI, 0.09 – 0.39; p< 0.0001). After the stop of study medication, 6 symptomatic recurrent VTE events occurred in each group during the one month observational period. Major bleeding did not occur in placebo patients and was observed in 4 (0.7%) rivaroxaban recipients (p=0.106). None of these bleeding events were fatal or in a critical site. Clinically relevant non-major bleeding was noted in 7 (1.2%) and 32 (5.4%) of the placebo and rivaroxaban recipients, respectively. Two (0.3%) patients in the placebo group died versus 1 (0.2%) in the rivaroxaban group. No patients were observed to have an alanine aminotransferase (ALT) rise above 3 times the upper limit of normal (xULN) combined with a total bilirubin above 2 xULN. Conclusion: A fixed dose of 20 mg of rivaroxaban once-daily is associated with an 82% relative risk reduction in the recurrence of VTE in patients who had completed a 6 to 12 month course of anticoagulant therapy for their index event. Based on the estimated cumulative incidence rates, approximately, 15 patients need to be treated to prevent one recurrent VTE event. This clinically relevant reduction in recurrence was associated with a low incidence of major bleeding (0.7%). This oral once-daily regimen provides the clinician with a simple option for patients in whom continued anticoagulant treatment is indicated. Disclosures: Buller: Bayer Healthcare: Research Funding.

Primary Venous Thromboembolism Prophylaxis in Patients with Solid Tumors Receiving Chemotherapy: A Meta-Analysis

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1157-1157
Author(s):  
Minh Phan ◽  
Sonia John ◽  
Ana Isabel Casanegra ◽  
Alfonso Tafur
Keyword(s):  
Venous Thromboembolism ◽  
Solid Tumors ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Mortality Data ◽  
Significant Heterogeneity ◽  
Bleeding Events ◽  
Vte Prophylaxis ◽  
Major Bleeding Events ◽  
Pharmacological Thromboprophylaxis

Abstract Abstract 1157 Background: Venous thromboembolism [VTE] is the second highest cause of mortality among patients with cancer. However, pharmacological thromboprophylaxis for patients with solid tumor is only recommended during hospitalization. Primary outpatient thromboprophylaxis is not a widely accepted practice. Objective: Determine safety and efficacy of outpatient primary VTE prophylaxis in patients with solid tumors. Data sources: A systematic review was conducted using MEDLINE and EMBASE up to June 2012. Key search words included venous thromboembolism, malignancy, anticoagulants, and chemotherapy. Studies were considered for our meta-analysis if they included outpatient primary pharmacological thromboprophylaxis in adult patients with active solid cancer. All the information was independently reviewed by 2 of the authors [MP, SJ] and a third reviewer resolved discrepancies. The measure of association was calculated with R (R: A Language and Environment for Statistical, R Development Core Team, www.R-project.org), R META package (Version 0.8–2, Author: Guido Schwarzer). The Q statistic was calculated and a formal test of homogeneity was conducted. Random-effects model was preferred in case of heterogeneity. Results: A total of 1371 abstracts were reviewed and 29 manuscripts were fully abstracted. Eight randomized controlled trials including 6706 patients were analyzed. There were less VTE events with outpatient prophylaxis: odds ratio [OR] of 0.53 (95% CI, 0.40–0.70). Six studies used low or ultra-low molecular weight heparin and two studies used warfarin. In the subgroup analysis of heparin based primary prophylaxis, there was a significant reduction in VTE events [OR 0.47, 95% CI, 0.34–0.64], no significant heterogeneity [FIG 1]. In addition, there was no difference in major bleeding events between groups [OR 1.48, 95% CI, 0.89–2.46]. Five studies reported mortality data; there was significant heterogeneity between studies. Conclusions: Heparin based outpatient VTE prophylaxis in patients with solid tumors reduced by half the risk of VTE with no significant differences in major bleeding events. The current publications do not allow a meaningful grouped analysis of survival data, improved patient selection is necessary in order to adequately target VTE prevention strategies. Disclosures: No relevant conflicts of interest to declare.

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