Defining the Risk: Benefit Ratio of Venous Thromboembolism (VTE) Prophylaxis in Hospitalized Cancer Patients

Abstract Introduction: VTE affects 1.6-1.8/1000 hospitalized patients per year; active cancer increases the rate of VTE 6-fold. Despite the high risk of VTE, studies show cancer patients receive inpatient VTE prophylaxis at a lower rate than general medical patients. In addition, VTE prophylaxis is often held for a platelet value of <50x109/L, despite a lack of evidence. Current recommendations for all inpatients with cancer (and no contraindication to blood thinners) are to receive prophylactic anticoagulation, regardless of an increased bleeding tendency in this population. A formal risk:benefit ratio of inpatient VTE prophylaxis for cancer patients has not been evaluated to date. Methods: The Michigan Hospital Medicine Safety Consortium, a 49 hospital quality collaborative, has prospectively collected data on VTE risk factors and outcomes in medical patients > 18 years of age. Exclusion criteria include surgical patients, pregnancy, admission to the ICU or for palliative care, therapeutic anticoagulation, diagnosis of acute thrombus, history of VTE within 6 months, and length of stay < 2 days. We compared rates of VTE prophylaxis, bleeding and new VTE between cancer and general medicine patients who were eligible for prophylaxis (i.e. no contraindications including active bleed within 3 months, coagulopathy, or high risk brain metastasis). Student's t-test was used for continuous variables and chi-square for categorical data. Logistic regression was used to calculate odds ratio (OR). The number needed to treat and number needed to harm were used to derive a risk:benefit ratio. Results: Between 7/2012-7/2015, 86,634 admissions were captured in the cohort; 70,086 were eligible for VTE prophylaxis and included in this analysis. 22% of cases had a diagnosis of cancer. Table 1. Demographics on Admission Cancer (n= 15,166), % General Medicine (n=54,920), % p Race (Caucasian) 82.3 74.3 <0.001 Age mean yrs (SD) 72.5 (14.4) 63.7 (18.8) <0.001 Gender (female) 53.6 56.5 <0.001 Central Line 17.8 4.1 <0.001 History of VTE 7.6 5.3 <0.001 Caprini risk score ≥ 5 88.1 35.8 <0.001 Charleston Index mean (SD) 5.1 (2.5) 2.1 (2.0) <0.001 Ever Smoked 59.6 56.3 <0.001 Obese 29.3 37.1 <0.001 Surgery w/in 30 days 3.6 2.1 <0.001 Trauma w/in 30 days 0.3 0.4 0.01 Of cancer admissions, 89.5% had solid tumors, 13.5% hematologic malignancies, 3.4% both and 20% metastatic disease. Active treatment for cancer was delivered <6 months from index admission in 32.1%, within 6-12 mo in 3.2%, >12 mo in 44.4% and no treatment or unknown in 20.3%. When compared to general medical admissions, cancer admissions were more likely to receive VTE prophylaxis (72.16% vs 69.21%, p<0.001), and have a new VTE out to 90 days post discharge despite prophylaxis (0.91% vs 0.45%, p<0.001, unadjusted OR 2.07 (95% CI 1.6-2.7)). There was no difference in VTE rate with regard to platelet count in cancer cases (0.43% for plt < 50 vs 1.08% for plt ≥ 50, p=0.10). Among all patients receiving VTE prophylaxis, bleeding was more common in cancer cases (major bleeding 0.84% vs 0.58%, p=0.005; minor bleeding 1.80% vs 1.36%, p=0.002). Among cancer cases, bleeding rates were higher in patients with platelet <50 vs ≥ 50 (major bleed 4.86% vs 1.88%, p<0.001; minor bleed 2.88% vs 1.7%, p=0.04). Table 2. The Number Needed to Treat (NNT) to Prevent One VTE During Admission or 90 Days Post Discharge and Number Needed to Harm (NNH) to Cause One Major Bleed During Admission with Risk:Benefit Ratio (NNH:NNT) General Medicine Cancer NNT 1428 NNT 1000 NNH 2500 NNH 277.9 NNH:NNT 1.75 NNH:NNT 0.28 Conclusions: In this prospective inpatient cohort, we compared general medicine to cancer cases and found cancer admissions received VTE prophylaxis at a higher rate. This is different than previously reported data, likely due to the exclusion of patients with contraindications to prophylaxis. However, despite prophylaxis, cancer patients had a higher rate of VTE during admission and 90 days post discharge as well as more bleeding complications. The risk:benefit ratio of VTE prophylaxis is 6 times worse in cancer patients due to bleeding. While bleeding occurs more frequently in cancer patients with platelet count <50x109/L, VTE occurs at a similar rate regardless of platelet count, meaning that cancer patients are at high risk of both clotting and bleeding. Recommendations for inpatient VTE prophylaxis for cancer patients require a targeted approach to identify a subset who would most benefit from VTE prophylaxis. Disclosures Flanders: Institute for Healthcare Improvement and the Society of Hospital Medicine: Consultancy; Wiley Publishing: Patents & Royalties; CDC Foundation: Research Funding; Blue Cross Blue Shield of Michigan: Research Funding; Michigan Hospital Association: Research Funding. Sood:Bayer: Research Funding.

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Rates of venous thromboembolism occurrence in medical patients among the insured population

Thrombosis and Haemostasis ◽

10.1160/th09-02-0073 ◽

2009 ◽

Vol 102 (11) ◽

pp. 951-957 ◽

Cited By ~ 27

Author(s):

Mohamed Hussein ◽

Jay Lin ◽

David Battleman ◽

Alex Spyropoulos

Keyword(s):

Venous Thromboembolism ◽

High Risk ◽

Multivariate Logistic Regression Analysis ◽

The United States ◽

Primary Diagnosis ◽

Severe Form ◽

World Population ◽

Medical Patients ◽

Post Discharge ◽

Vte Prophylaxis

SummaryThe burden of venous thromboembolism (VTE) remains high in the United States (US). This study assesses the rate of VTE prophylaxis in a large real-world population of medically ill patients and identifies factors which confer VTE risk to this population. Discharges from the PharMetrics database were included if they were aged ≥40 years and had a hospitalisation claim (Jan 2001-Dec 2005) for cancer, congestive heart failure (CHF), severe infectious disease (SID), or lung disease. Discharges with incomplete records in the prior year to the index hospitalisation claim date were excluded. VTE rate, type (deep venous thrombosis [DVT] or pulmonary embolism [PE]), and time to VTE were compared between groups. Multivariate logistic regression analysis was used to identify independent predictors of VTE occurrence. A total of 158,325 patients were included in the study. Cancer patients had the highest incidence of VTE (7.6%), with the average for all patients being 5.6% (1.5% PE).VTE occurred most frequently post discharge, with the median time being 74 days. Post-discharge prophylaxis was provided to 13.1% of CHF patients and < 5% of all other patients. Independent predictors of VTE included a pre-index VTE (odds ratio [OR] 9.06, 95% confidence interval [CI] 8.28–9.91) and a primary diagnosis of cancer compared with a diagnosis of SID (OR 1.34, 95% CI 1.24–1.46). In conclusion, commercially insured medical patients in the US are at high risk of VTE following hospital discharge. One-quarter of medical patients who developed a VTE are at high risk of developing the more severe form of the disease, namely PE, with independent predictors of VTE in the postdischarge period including previous VTE and cancer.

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VTE Prophylaxis Across the Continuum of Care in US Medical Patients at Risk of Venous Thromboembolism.

Blood ◽

10.1182/blood.v114.22.1386.1386 ◽

2009 ◽

Vol 114 (22) ◽

pp. 1386-1386

Author(s):

Alpesh Amin ◽

Jay Lin ◽

Amy Ryan

Keyword(s):

At Risk ◽

Research Funding ◽

Medical Patients ◽

Post Discharge ◽

Vte Prophylaxis ◽

Individual Patient Level ◽

Patients At Risk ◽

The Individual ◽

Severe Lung Disease ◽

The Continuum

Abstract Abstract 1386 Poster Board I-408 Background: Medical patients with chronic medical illnesses are often at risk of VTE both in-hospital and post-discharge. However, although injectable prophylaxis options are available and suitable for providing in-hospital and post-discharge prophylaxis, there is often a lack of continuity in VTE post-discharge prophylaxis. This analysis evaluated in-hospital and post-discharge VTE prophylaxis patterns for US medical patients. Methods: Premier's Perspective™ inpatient data were cross-matched at the individual patient level with Ingenix LabRx® outpatient data from the I3 database (January 2005-December 2007) to assess VTE prophylaxis patterns in medical patients (cancer without surgery, heart failure, severe lung disease, infectious disease) at risk of VTE (according to the American College of Chest Physicians 2004 guidelines) and with no contraindications for anticoagulation. Inpatients were assessed for any anticoagulation received in-hospital and were followed post-discharge to assess their outpatient prophylaxis use. Drug utilization and clinical practice patterns during and within 30 days after hospitalization were collected and compared descriptively between groups. Results: Of the 9,675 medical discharges at risk of VTE and included in this analysis, 6,185 (63.9%) did not receive any anticoagulation at all. Of the remaining 3,490 (36.1%) discharges that did receive anticoagulation, 2,045 (58.6%) received enoxaparin and 1,044 (29.9%) received unfractionated heparin (UFH) (Table). After discharge, 98.2% of all patients did not receive any prophylaxis within the following 30 days. Only 174 (1.8%) discharges received outpatient prophylaxis, with 67.8% receiving warfarin alone and 18.4% receiving enoxaparin and warfarin (Table). Conclusion: This analysis presents both inpatient and outpatient VTE prophylaxis patterns in real-world medical patients that are at risk of VTE. Nearly 64% of patients received no inpatient VTE prophylaxis, and less than 2% received outpatient prophylaxis. Further efforts to improve VTE prevention in hospitalized patients are required, with particular emphasis needed on the transition to outpatient prophylaxis. Disclosures: Amin: sanofi-aventis: Research Funding, Speakers Bureau, The authors received editorial/writing support in the preparation of this abstract funded by sanofi-aventis U.S., Inc.. Lin: sanofi-aventis: Employment. Ryan: sanofi-aventis: Research Funding.

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Quality management in the prophylaxis of venous thrombembolism - Results of a survey including 464 medical and surgical patients

VASA ◽

10.1024/0301-1526/a000082 ◽

2011 ◽

Vol 40 (2) ◽

pp. 123-130

Author(s):

Klein-Weigel ◽

Richter ◽

Arendt ◽

Gerdsen ◽

Härtwig ◽

...

Keyword(s):

Renal Function ◽

High Risk ◽

Quality Management ◽

High Risk Group ◽

Surgical Patients ◽

Medical Patients ◽

Risk Status ◽

Vte Prophylaxis ◽

Safety Concerns

Background: We surveyed the quality of risk stratification politics and monitored the rate of entries to our company-wide protocol for venous thrombembolism (VTE) prophylaxis in order to identify safety concerns. Patients and methods: Audit in 464 medical and surgical patients to evaluate quality of VTE prophylaxis. Results: Patients were classified as low 146 (31 %), medium 101 (22 %), and high risk cases 217 (47 %). Of these 262 (56.5 %) were treated according to their risk status and in accordance with our protocol, while 9 more patients were treated according to their risk status but off-protocol. Overtreatment was identified in 73 (15.7 %), undertreatment in 120 (25,9 %) of all patients. The rate of incorrect prophylaxis was significantly different between the risk categories, with more patients of the high-risk group receiving inadequate medical prophylaxis (data not shown; p = 0.038). Renal function was analyzed in 392 (84.5 %) patients. In those patients with known renal function 26 (6.6 %) received improper medical prophylaxis. If cases were added in whom prophylaxis was started without previous creatinine control, renal function was not correctly taken into account in 49 (10.6 %) of all patients. Moreover, deterioration of renal function was not excluded within one week in 78 patients (16.8 %) and blood count was not re-checked in 45 (9.7 %) of all patients after one week. There were more overtreatments in surgical (n = 53/278) and more undertreatments in medical patients (n = 54/186) (p = 0.04). Surgeons neglected renal function and blood controls significantly more often than medical doctors (p-values for both < 0.05). Conclusions: We found a low adherence with our protocol and substantial over- and undertreatment in VTE prophylaxis. Besides, we identified disregarding of renal function and safety laboratory examinations as additional safety concerns. To identify safety problems associated with medical VTE prophylaxis and hot spots quality management-audits proved to be valuable instruments.

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Primary Thromboprophylaxis in Ambulatory Cancer Patients: Where Do We Stand?

Cancers ◽

10.3390/cancers12020367 ◽

2020 ◽

Vol 12 (2) ◽

pp. 367 ◽

Cited By ~ 1

Author(s):

Frits I. Mulder ◽

Floris T. M. Bosch ◽

Nick van Es

Keyword(s):

Risk Assessment ◽

Clinical Practice ◽

High Risk ◽

Cancer Patients ◽

Number Needed To Treat ◽

Vascular Medicine ◽

Assessment Scores ◽

Vein Thrombosis ◽

Risk Of Bleeding ◽

Deep Vein

Venous thromboembolism (VTE), comprising deep-vein thrombosis and pulmonary embolism, is a frequent complication in ambulatory cancer patients. Despite the high risk, routine thromboprophylaxis is not recommended because of the high number needed to treat and the risk of bleeding. Two recent trials demonstrated that the number needed to treat can be reduced by selecting cancer patients at high risk for VTE with prediction scores, leading the latest guidelines to suggest such an approach in clinical practice. Yet, the interpretation of these trial results and the translation of the guideline recommendations to clinical practice may be less straightforward. In this clinically-oriented review, some of the controversies are addressed by focusing on the burden of VTE in cancer patients, discussing the performance of available risk assessment scores, and summarizing the findings of recent trials. This overview can help oncologists, hematologists, and vascular medicine specialists decide about thromboprophylaxis in ambulatory cancer patients.

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Time-to-Treatment in Chronic Myelomonocytic Leukemia - a Novel Prediction Model

Blood ◽

10.1182/blood.v128.22.5547.5547 ◽

2016 ◽

Vol 128 (22) ◽

pp. 5547-5547

Author(s):

Florian Huemer ◽

Lukas Weiss ◽

Viktoria Faber ◽

Daniel Neureiter ◽

Alexander Egle ◽

...

Keyword(s):

Bone Marrow ◽

Platelet Count ◽

Lactate Dehydrogenase ◽

High Risk ◽

Prediction Model ◽

Scoring System ◽

Research Funding ◽

Treatment Initiation ◽

Bone Marrow Blast ◽

Time To Treatment

Abstract Introduction For chronic myelomonocytic leukemia (CMML) several scores exist which prognosticate overall survival (OS) based on different clinical and genetic parameters. The time-to-treatment (TTT) among CMML patients is highly variable, and a predictive model to specifically estimate TTT in CMML has not been described so far. The aims of this single-center retrospective study were (a) to test and validate established myelodysplastic syndrome (MDS)-specific and CMML-specific prognostic scores in our patient cohort, (b) to evaluate which baseline factors were relevant to the time point of treatment initiation with either hydroxyurea or azacitidine, and (c) to propose a prediction model for TTT in CMML. Methods This retrospective analysis was based on the data of 55 unselected, consecutive CMML patients diagnosed and/or treated at our tertiary center between 2004 and 2015. We applied the following published prognostic models to our CMML cohort, using both OS and TTT as endpoints: the MD Anderson Prognostic Score (MDAPS), the modified MDAPS (MDAPS M1), the CMML-specific Prognostic Scoring System (CPSS), the Mayo Prognostic Model, the Düsseldorf Score, the International Prognostic Scoring System (IPSS), and the Revised International Prognostic Scoring System (IPSS-R). Results According to the CMML-specific MDAPS, 27% of our patients were classified as "higher-risk" (23% intermediate-2, 4% high-risk) (Figure 1). At the time of data analysis, 38% and 24% of patients had received azacitidine and hydroxyurea as first-line treatment. A total of 40 (73%) patients had died at the time point of data analysis. The median time of follow-up was 24.8 months (range 1.7-74.8 months). All applied MDS-specific (Düsseldorf Score, IPSS, IPSS-R) and CMML-specific (MDAPS, MDAPS M1, CPSS, Mayo Prognostic Model) prediction scores were able to significantly discriminate patient cohorts with different OS probabilities. The following variables were associated with a shorter TTT in the univariate analysis: the presence of immature myeloid cells in the peripheral blood, white blood cell count ≥14.5 G/L, platelet count <55 G/L, absolute neutrophil count ≥6 G/L, absolute lymphocyte count ≥2.3 G/L, absolute monocyte count ≥2.8 G/L, serum lactate dehydrogenase ≥223 G/L, peripheral blood blasts >0%, bone marrow blast percentage ≥7.5%, red blood cell transfusion-dependence, palpable spleen and/or symptomatic splenomegaly, and the presence of B-symptoms at the time of initial diagnosis. In multivariate analysis, the following factors remained independently associated with TTT: lactate dehydrogenase (HR 5.428; p = 0.008), bone marrow blast count (HR 4.570; p = 0.001), and platelet count (HR 2.660; p = 0.027). These three clinical parameters were included in the TTT prediction model and CMML patients were stratified into three subgroups: low-risk, intermediate-risk and high-risk. Median TTT was not reached for low-risk patients, 16.5 months for intermediate-risk patients, and almost immediate treatment initiation (0.6 months) was observed in the high-risk group (Figure 2). Conclusions We validated seven existing MDS-specific and CMML-specific prognostic scores in 55 CMML patients treated at the center in Salzburg. We were able to demonstrate that lactate dehydrogenase, bone marrow blast percentage and platelet count at initial diagnosis were the most relevant parameters for predicting time to treatment initiation in our CMML cohort. Based on these three parameters, we propose the first TTT prediction score for treatment-naïve CMML patients. Clinical implications of this score include the identification of CMML patients for early investigational trials, as well as the tailoring of individual follow-up intervals. Disclosures Huemer: Roche: Other: Travel funding; Merck: Other: Travel funding. Egle:Gilead: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Other: travel support; Celgene: Consultancy, Honoraria; Roche: Consultancy, Honoraria, Other: travel support. Greil:Pfizer: Honoraria, Research Funding; Boehringer-Ingelheim: Honoraria; Eisai: Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Mundipharma: Honoraria, Research Funding; Merck: Honoraria; Janssen-Cilag: Honoraria; Genentech: Honoraria, Research Funding; Novartis: Honoraria; AstraZeneca: Honoraria; Roche: Honoraria, Research Funding; Sanofi Aventis: Honoraria; GSK: Research Funding; Ratiopharm: Research Funding; Cephalon: Consultancy, Honoraria, Research Funding; Bristol-Myers-Squibb: Consultancy, Honoraria. Pleyer:Celgene: Consultancy, Honoraria; Bristol-Myers-Squibb: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; AOP Orphan Pharmaceuticals: Honoraria.

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Post-discharge venous thromboembolism prophylaxis for surgical oncology patients.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.8_suppl.79 ◽

2017 ◽

Vol 35 (8_suppl) ◽

pp. 79-79

Author(s):

Ashlie Nadler ◽

Mary Ellen Morba ◽

Jesse Pezzella ◽

Jeffrey M. Farma

Keyword(s):

Venous Thromboembolism ◽

High Risk ◽

Compliance Rate ◽

Surgical Oncology ◽

Pelvic Surgery ◽

Cancer Center ◽

Thromboembolism Prophylaxis ◽

Post Discharge ◽

Oncology Patients ◽

Vte Prophylaxis

79 Background: A number of guidelines have been proposed for prolonged venous thromboembolism (VTE) prophylaxis following hospital discharge for cancer patients undergoing major abdominal or pelvic surgery. However, there is disparity in how closely these guidelines are followed. The purpose of this study was to examine the administration and complications of post-discharge chemical VTE prophylaxis (pdVTE) at an institutional level among surgical oncology patients to help inform policy creation. Methods: A retrospective study at a tertiary referral cancer center was performed. Data was analyzed for patients undergoing surgery in 2015. Chi-square tests were performed. Results: Of 566 colorectal, urologic, and gynecologic surgical oncology procedures performed in 2015, 24% (137) were discharged with a prescription for enoxaparin for pdVTE. An additional 24 patients were already on another form of anticoagulation at the time of discharge. Of the patients discharged on pdVTE, 77% (105) had the prescriptions filled. The compliance rate of those patients was 96% (101). The rate of VTE was 3.5% for all patients. There was a significantly greater rate of VTE amongst patients that received pdVTE (10.4%) compared to those who did not (1.6%) (OR 7.20, CI 2.80-18.46, p < 0.001). For each subspecialty, there was also a significantly greater rate of VTE amongst patients that received pdVTE (p < 0.001). Conclusions: There is a very low rate of pdVTE administration despite current guidelines. Identifying patients who received pdVTE appears to identify patients at high risk for VTE rather than the benefits of pdVTE. Institutional policies regarding prolonged VTE prophylaxis should be implemented to target high-risk patients and to ensure appropriate prescribing practices. [Table: see text]

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Cost-Utility Analysis of Apixaban Compared to Usual Care for the Primary Thromboprophylaxis of Ambulatory Cancer Patients Initiating Chemotherapy

Blood ◽

10.1182/blood-2019-127286 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 329-329

Author(s):

Miriam Kimpton ◽

Srishti Kumar ◽

Philip S. Wells ◽

Marc Carrier ◽

Kednapa Thavorn

Keyword(s):

Relative Risk ◽

High Risk ◽

Usual Care ◽

Cancer Patients ◽

Major Bleeding ◽

Research Funding ◽

Cost Utility ◽

Cost Utility Analysis ◽

Utility Analysis ◽

Tumour Type

Introduction: Apixaban 2.5mg twice daily has been shown to significantly reduce the risk of venous thromboembolism (VTE) compared to placebo for the primary thromboprophylaxis of VTE in ambulatory cancer patients initiating chemotherapy, who are at intermediate-high risk of VTE, with a Khorana score of ≥2 (hazard ratio, 0.41; 95% confidence interval, 0.26 to 0.65; P<0.001). In this study, we estimated whether the health benefit gained from apixaban justified its costs. Method: We conducted a cost-utility analysis of apixaban (2.5mg twice daily) compared to usual care, whereby no apixaban is prescribed, from the perspective of Canada's healthcare system. Our target population was ambulatory cancer patients starting chemotherapy with an intermediate-high risk of VTE. We developed a Markov model with a cycle length of 1-week to simulate costs and quality-adjusted life years (QALYs) for patients receiving either apixaban or usual care over 6 months (Figure 1). To estimate the baseline time varying risk of VTE among ambulatory cancer patients undergoing chemotherapy, we created pseudo patient-level data from survival curves reported for patients in the placebo arm of the AVERT trial using 'WebPlotDigitizer'. We fitted parametric survival models to the patient-level data points to extrapolate VTE risk beyond the trial follow-up period (median follow-up 183 days). The best model was selected based on a visual inspection and the Akaike Information Criterion. The relative risk of VTE, clinically relevant non-major bleeding, and major bleeding (using the International Society of Thrombosis and Haemostasis criteria) as a result of apixaban was obtained from the AVERT trial using the on-treatment analysis. We conducted a targeted literature search to obtain the risk of complications among cancer patients receiving low-molecular-weight heparin for the initial treatment and secondary prevention of VTE using a meta-analysis technique. Hazard ratio for increased risk of death due to cancer was estimated as a weighted average of the age-standardized mortality rate by tumor type, based on the proportion of patients with each tumor type in the AVERT trial. Costs were obtained from published Canadian sources. Baseline health utility values for patients on chemotherapy and in remission were calculated as a weighted average of utility values by tumour type, also based on the proportion of patients with each tumour type in the AVERT trial. Utility values for chemotherapy and remission for each tumour type, as well as event specific disutility values, were obtained from the published literature. Both costs and QALYs were discounted using an annual rate of 1.5%, as recommended by the Canadian Agency for Drugs and Technologies in Health. We conducted deterministic and probabilistic sensitivity analyses to assess robustness of study findings. Results: Over a 6-month period, apixaban was associated with a lower health system cost (C$25,987 vs C$26,268) and a slight increase in QALYs (0.3339 vs 0.3337) compared to usual care (Table 1). The probability that apixaban was cost-saving compared to usual care was 90%; however, this probability decreased with the greater willingness to pay (WTP) values partly due to the high uncertainty in the difference in QALYs. At a WTP threshold of C$50,000/QALY, the probability of apixaban being cost effective was 57% (Figure 2). Over 1 year, apixaban reduced health care system costs by C$1,113 and improved QALYs by 0.0005 units compared to usual care. At a WTP threshold of C$50,000/QALY, the probability of apixaban being cost effective increased to 70%. Our results were robust to the change in time horizon; however, they were more sensitive to the relative risk of VTE, the relative risk of major bleeding, the costs amassed in the post-VTE period, and the treatment cost of acute VTE. Probabilistic sensitivity analysis indicated a high-level uncertainty around cost effectiveness estimates, which may be driven by the wide confidence intervals around estimates for relative risk of complications in patients receiving thromboprophylaxis with apixaban. Conclusion: From a publicly funded health system's perspective apixaban is a cost saving option for thromboprophylaxis among ambulatory cancer patients initiating chemotherapy. Disclosures Wells: BMS/Pfizer: Honoraria, Research Funding; Bayer: Honoraria; Sanofi: Honoraria; Daiichi Sankyo: Honoraria. Carrier:Servier: Honoraria; Bayer: Honoraria; Pfizer: Honoraria, Research Funding; BMS: Honoraria, Research Funding; Leo Pharma: Honoraria, Research Funding. OffLabel Disclosure: Apixaban can be used as postoperative prophylaxis of DVT/PE and for treatment of DVT/PE. We performed a cost-utility analysis of apixaban 2.5mg BID for the primary thromboprophylaxis of ambulatory cancer patients initiating chemotherapy, at intermediate-high risk of venous thromboembolism.

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Venous Thromboembolism Prophylaxis in Acute Medically Ill Patients: A Retrospective Cohort Study

Blood ◽

10.1182/blood-2019-124495 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 3678-3678

Author(s):

Anat Gafter-Gvili ◽

Genady Drozdinsky ◽

Oren Zusman ◽

Shiri Kushnir ◽

Leonard Leibovici

Keyword(s):

Internal Medicine ◽

Cohort Study ◽

Venous Thromboembolism ◽

High Risk ◽

Retrospective Cohort ◽

Medical Patients ◽

Vte Prophylaxis ◽

Medically Ill ◽

Pharmacologic Prophylaxis ◽

Medically Ill Patients

Background and Aims Venous thromboembolism (VTE) is considered as a preventable cause of death for hospitalized patients. Current guidelines recommend pharmacologic prophylaxis for medical patients considered high risk for VTE, despite failure of studies to show reduction in mortality. We aimed to assess the benefit and safety of VTE prophylaxis in acutely ill medical patients hospitalized in internal medicine wards. Methods Retrospective cohort study of all patients admitted to the internal medicine and acute geriatric departments, with an admission lasting more than 48 hours, during 2012-2018. Patients who received pharmacologic prophylaxis were compared to those who did not. The primary outcome was 30-day mortality. Secondary outcomes were the 90 day incidence of pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), and major bleeding. Propensity-weighted logistic multivariable analysis was performed. Results A total of 18890 patient-unique episodes were included in the analysis. Of them 3206 (17%) received prophylaxis. A total of 1309 (6.9%) died. 540/1309 (41.3%) of those who received VTE prophylaxis died and 769/1309 (58.7%) of those who did not receive prophylaxis died. VTE Prophylaxis was not associated with a reduction in mortality, multivariate-adjusted OR 0.99 (95% CI 0.84-1.14). One hundred and forty two patients (0.7%) developed VTE. The frequency of VTE among patients who received VTE prophylaxis was 31% (44/142) compared with 69% (98/142) in patients who did not receive prophylaxis. The frequency of VTE in patients who had a Padua score ≥4 and received VTE prophylaxis, was 1.9% (30/1573) compared with 1.6% (44/2797) in those with a Padua score ≥4 who did not receive prophylaxis. 74/142 (52.1%) of patients with VTE had a Padua score ≥4, 44/1309 (1.4%) of those who received VTE prophylaxis and 98/15864 (0.6%) of those who did not. VTE Prophylaxis was not associated with reduction in VTE in the whole cohort, multivariable-adjusted OR 1.09 (95% CI 0.52-2.29). VTE prophylaxis was associated with an increase in major bleeding (multivariable-adjusted OR 1.24, 95% CI 1.04-1.48) Conclusion The current practice of routinely administering VTE prophylaxis to medically ill patients considered at high risk for VTE, resulted in a high risk for bleeding a without clear clinical benefit, and should be reassessed. Disclosures No relevant conflicts of interest to declare.

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Abstract P36: Venous Thromboembolism Prophylaxis in Hospitalized Medically Ill Patients

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.4.suppl_2.ap36 ◽

2011 ◽

Vol 4 (suppl_2) ◽

Author(s):

Trudy Pendergraft ◽

Montserrat Vera-Llonch ◽

Alex Kartashov ◽

Xianchen C Liu ◽

Hemant Phatak ◽

...

Keyword(s):

High Risk ◽

Venous Catheter ◽

Intermittent Pneumatic Compression ◽

Nursing Home Admission ◽

Thromboembolism Prophylaxis ◽

Post Discharge ◽

Vte Prophylaxis ◽

Medically Ill ◽

C Statistic ◽

Medically Ill Patients

Background: Many hospitalized medically ill patients are at risk of VTE, during admission and after discharge. Risk factors include prior VTE, older age, immobility, obesity, heart or respiratory failure, and cancer. ACCP guidelines recommend use of low-molecular weight heparin (LMWH) or unfractionated heparin (UFH), and mechanical prophylaxis otherwise, in high-risk patients. VTE prophylaxis may be underutilized, however. Methods: Using a database linking admission records from >150 US hospitals to health insurance claims, we identified all persons, aged >=40 years, hospitalized from 2003 to 2008 and at high risk of VTE (based on ACCP guidelines). We excluded patients who: (1) underwent surgery; (2) were hospitalized in prior 30 days; (3) were treated for VTE in prior 30 days; (4) had hypercoagulability at admission; and (5) received LMWH, UFH, or fondaparinux (FOND) at therapeutic dosages on hospital day 1 or 2. We examined use of VTE prophylaxis during hospital admission and post-discharge. Results: We identified 35,606 patients who met all study entry criteria. Mean age was 67 years. Only 17.9% of study subjects received in-hospital VTE prophylaxis, most frequently LMWH (10.1%), intermittent pneumatic compression (4.5%), warfarin (2.9%), and/or stockings (2.0%). Prophylaxis use exceeded 25% only in patients with history (>30 days) of VTE and those admitted from nursing homes. Very few patients (1.7%) received post-discharge VTE prophylaxis; use was limited to LMWH. While there were several significant predictors of VTE prophylaxis (nursing home admission [odds ratio, 2.15; 95% confidence interval 1.91-2.42], central venous catheter placement [1.76; 1.60-1.94], ischemic stroke [1.68; 1.54-1.84] obesity [1.58; 1.47-1.70], and prior VTE [1.57; 1.24-1.99]), model discrimination was relatively poor (c statistic = 0.61). Conclusion: VTE prophylaxis is under-utilized in high-risk hospitalized medically ill patients, during initial admission and following hospital discharge.

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Final Analysis of MELISSE, a Large Multicentric Observational Study to Determine Risk Factors of Venous Thromboembolism in Patients with Multiple Myeloma Treated with Immunomodulator Drugs

Blood ◽

10.1182/blood.v118.21.1235.1235 ◽

2011 ◽

Vol 118 (21) ◽

pp. 1235-1235 ◽

Cited By ~ 1

Author(s):

Xavier Leleu ◽

Laurent Daley ◽

Philippe Rodon ◽

Cyrille Hulin ◽

Charles Dauriac ◽

...

Keyword(s):

Risk Factors ◽

Multiple Myeloma ◽

High Risk ◽

Incidence Rate ◽

Research Funding ◽

Final Analysis ◽

Vte Prophylaxis ◽

High Risk Patients ◽

Increased Risk ◽

Risk Patients

Abstract Abstract 1235 Background. Immunomodulator drugs (IMiDs) are associated with an increased risk of thromboembolic events (TE). Multiple Myeloma patients (MM) that can not benefit from novel agents, including IMiDs, only have 9 months survival. IMiDs must be stopped when TE occurs with the consequence of potential shortened life expectancy. MELISSE was designed to prospectively evaluate the incidence and risk factors of venous TE (VTE) associated with IMiDs in MM. We have presented the interim analysis of MELISSE at ASH 2010. A reduced incidence rate of early VTE was observed when a prophylaxis for VTE was started as compared to patients that had no prophylaxis. Interestingly, we also reported that most of the patients had received aspirin, while aspirin is not considered to exert any venous prophylactic effect. LMWH was primarily proposed to patients with high risk of TE according to physician's evaluation. We present the final analysis of MELISSE with updated results at 1 year. Method. A total of 524 MM treated with IMiDs-based therapy were included in 52 IFM centers. VTE prophylaxis was recommended prior to start IMiDs, the choice of which was left at the discretion of the investigator. Patients gave written informed consent according to the declaration of Helsinki. The physicians were to record the risk of VTE occurrence, categorized as low, moderate and high, based on guidelines and their own appreciation of the risk. Occurrence of any VTE was to be recorded along with the management of the event and the patient's outcome. The data were collected at entry in the study, and then after 4 and 12 months. Results. The median age was 70 years old, with 64.67% of patients >65 years old. Overall 36.0% had thalidomide-based and 64.0% had lenalidomide-based therapy, with 180 patients in first line and the remaining patients in 2nd and 3rd lines of therapy. The observed repartition of TE risk factors was as expected in a European population with myeloma. The risk of VTE was assessed as high in 14.2% patient and small or intermediate otherwise. Interestingly, approximately 70% of patients rated as low and intermediate risk received aspirin as a routine prophylaxis for VTE as compared to 20% in high risk patients. LMWH was primarily given to high risk patients, 45.8%. Surprisingly, 16.0% of patients had no VTE prophylaxis. Investigators recorded 29 (5.5% annual incidence rate) TE at 12 months, including 12 associated with PE. The incidence rate of TE was similar within the first 4 months (early occurrence, 3.5%) versus after 4 months (late, 2.5%). We have not identified any risk factor that would explain early versus late occurrence of VTE. Interestingly, the incidence of VTE was higher in patients that had no prophylaxis treatment, 8.5%, as compared to 4.4% and 5.9% in the LMWH and aspirin groups, respectively. There was no PE recorded in patients that were on LMWH prophylaxis. The VTE was equally breakdown across the 3 groups of risk factors. The bleeding adverse events were reported for 27 patients, mainly patients with aspirin. We isolated a model with 3 variables that independently predicted a higher risk to develop VTE in the multivariate model, and that comprised the male gender [OR 4.31 (95% CI 1.60 – 13.90)], the smoking habit [6.76 (1.73–22.42)] and the association to EPO [2.66 (1.04–6.58)]. Aspirin showed no significance, but with a p value at 0.55. The multivariate analysis is limited as certain subgroups with high risk factors might have received the optimal VTE prophylaxis, such as patients with bed rest and patients with prior history of VTE. These 2 groups rarely had aspirin. Survival data will be updated and presented at ASH 2011. Conclusion. This study further demonstrates that TE prophylaxis is required for MM treated with IMiDs-based therapy. There is a slight increase risk of VTE/PE with the use of aspirin as compared to LMWH, but a significant increase in bleeding events. Although we have identified risk factors of VTE in MM treated with IMiDs, for the first time, we could not identified VTE risk factors to guide investigators between LMWH and aspirin-based prophylaxis. The optimal dose and duration of LMWH remains to be determined. Disclosures: Leleu: LeoPharma: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Janssen Cilag: Honoraria, Research Funding; Roche: Research Funding; Amgen: Honoraria; Novartis: Research Funding. Daley:LeoPharma: Employment. Hulin:Janssen: Honoraria; Celgene: Honoraria. Lamblin:LeoPharma: Employment. Natta:LeoPharma: Employment.

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