Patterns of Management and Adherence to Venous Thromboembolism (VTE) Treatment Guidelines In a National Prospective Cohort Study of VTE Management In the Canadian Outpatient Setting: Recovery Study

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 565-565
Author(s):  
Susan R Kahn ◽  
Sam Schulman ◽  
Josée Martineau ◽  
John A Stewart ◽  
Anne McLeod ◽  
...  
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Median Duration ◽  
Research Funding ◽  
Treatment Guidelines ◽  
Outpatient Setting ◽  
Medical Admission ◽  
Recurrent Vte ◽  
Outpatient Settings

Abstract Abstract 565 Introduction: Little is known about patterns and quality of venous thromboembolism (VTE) management in Canadian outpatient settings, including how closely clinicians adhere to evidence based treatment guidelines. Such information could help identify gaps in patient care requiring attention. Objectives: To obtain prospective, clinical practice-based data from Canadian outpatient settings on 1) management of VTE; 2) determinants of patterns of VTE management; 3) degree of adherence with ACCP 2008 VTE treatment guidelines; and 4) frequency of bleeding and recurrent VTE during follow-up. Methods: We performed a multi-centre prospective observational study to evaluate physician practice patterns and degree of adherence to ACCP consensus guidelines for VTE treatment. From 2007–2010, we enrolled 915 consecutive patients with objectively confirmed acute symptomatic VTE who received treatment with the low molecular weight heparin (LMWH) enoxaparin alone or with warfarin in the outpatient setting (mainly thrombosis clinics) in 12 Canadian centers. Patients attended an enrolment visit, where data on demographics, site(s) of VTE, VTE risk factors, bleeding risk factors, creatinine clearance and initial treatment were recorded. A follow-up visit occurred when anticoagulant treatment was stopped or at 6 months, whichever occurred first. Indicators of adherence to VTE treatment guidelines included: (1) having received any thromboprophylaxis for VTE associated with transient risk factors (recent medical admission, major surgery or leg immobilization); (2) use of LMWH monotherapy to treat cancer-associated VTE; (3) at least 5 days median duration of LMWH in patients treated with initial LMWH overlapped with warfarin; (4) at least 1 day overlap of LMWH and warfarin once INR was therapeutic. Recurrent VTE, bleeding and adverse events were recorded throughout study follow-up. Results: At the time of abstract submission, end of study data were available for 747 of 915 enrolled patients. Average age was 56 years, 54% were male and mean body mass index was 28.3 kg/m2. Index VTE was lower or upper extremity deep venous thrombosis (DVT) in 511 (68.4%) patients, pulmonary embolism (PE) with or without DVT in 218 (29.2%) patients, and unusual site DVT in 18 (2.4%) patients. VTE was associated with cancer in 70 (9.4%) patients, transient risk factors in 289 (38.7%) patients, hormonal risk factors in 55 (7.4%) patients and was deemed unprovoked in 331 (44.3%) patients. Overall, enoxaparin was prescribed at a dose/frequency of 1.5 mg/kg QD in 85.4% of patients, 1.0 mg/kg BID in 14.6% of patients and 1.0 mg/kg QD for one patient who had creatinine clearance <30ml/min. Among patients with VTE risk factors such as recent medical admission, recent surgery or paralysis, only 37.3% had been prescribed thromboprophylaxis. Among patients with cancer-related VTE (n=70), 61.4% were prescribed LMWH monotherapy, a majority received 1.5 mg/kg once daily, and 42.9% received such treatment for >3 months. Among patients treated with initial LMWH overlapped with warfarin (n= 667; 89.3%), median duration of LMWH was 8 days (IQR 6–10 days), median duration of warfarin was 182 days (IQR 115–190) and median overlap with LMWH once INR was therapeutic was 1 day (IQR 1–2 days). However, 48 (7.2%) patients received <5 days LMWH and 99 (15%) patients had overlap <1 day. During follow-up, 16 (2.1%) patients had recurrent VTE, at a median of 71 days follow-up; rate of recurrent VTE was highest (8.6%) and occurred earliest (median, 49 days) in cancer patients. Major bleeding events (primarily GI or GU) occurred in 10 (1.3%) patients at a median of 23 days; at the time of bleed, 2 patients were receiving LMWH alone, 3 patients, LMWH and warfarin, and 5 patients, warfarin alone. Conclusions: Our study provides useful information on clinical features of patients, management of VTE and rates of recurrence and bleeding in Canadian outpatients. Our results suggest that there are important gaps in (1) use of thromboprophylaxis to prevent VTE and (2) use of LMWH monotherapy to treat VTE in cancer patients. Conversely, in patients treated with combination LMWH/warfarin therapy, adherence to recommendations regarding minimum duration of LMWH and minimum overlap of LMWH and warfarin once INR was therapeutic was quite good. Disclosures: Kahn: Sigvaris: Research Funding; sanofi-aventis: Advisory Board, Research Funding; Boehringer Ingelheim:. Schulman:Sanofi Aventis: Honoraria.

Management and adherence to VTE treatment guidelines in a national prospective cohort study in the Canadian outpatient setting

2012 ◽  
Vol 108 (09) ◽  
pp. 493-498 ◽  
Author(s):  
Vicky Springmann ◽  
Sam Schulman ◽  
Josée Martineau ◽  
John A. Stewart ◽  
Nelly Komari ◽  
...  
Keyword(s):  
Risk Factors ◽  
Treatment Guidelines ◽  
Vitamin K Antagonists ◽  
Outpatient Setting ◽  
Unusual Site ◽  
Patients With Cancer ◽  
End Of Treatment ◽  
American Society ◽  
Outpatient Settings

SummaryDocumenting patterns and outcomes of venous thromboembolism (VTE) management and degree of adherence by clinicians to treatment guidelines could help identify remediable gaps in patient care. Prospective, clinical practice-based data from Canadian outpatient settings on management of VTE, degree of adherence with treatment guidelines and frequency of recurrent VTE and bleeding during follow-up was obtained in a multicentre, prospective observational study. From 12 Canadian centres, we assessed 868 outpatients with acute symptomatic VTE who received the low-molecular-weight heparin (LMWH) enoxaparin alone or with vitamin K antagonists (VKA), at baseline and at six months (or at the end of treatment, whichever came first). Index VTE was limb deep venous thrombosis (DVT) in 583 (67.2%) patients, pulmonary embolism (PE) with or without DVT in 262 (30.2%) patients, and unusual site DVT in 23 (2.6%) patients. VTE was unprovoked in 399 (46.0%) patients, associated with cancer in 74 (8.5%) patients, transient risk factors in 327 (37.7%) patients and hormonal factors in 68 (7.8%) patients. With regard to guideline adherence, 58 (7.3%) patients received <5 days LMWH and 114 (14.5%) had overlap <1 day. Among patients with cancer-related VTE, 59.5% were prescribed LMWH monotherapy and 43.2% received such treatment for >3 months. Only 38.1% of patients with transient VTE risk factors had received thromboprophylaxis. Our study provides useful information on clinical presentation, management and related outcomes in Canadian outpatients with VTE. Our results suggest there may be important gaps in use of thromboprophylaxis to prevent VTE and use of LMWH mono-therapy to treat cancer-related VTE.Note: Part of this study was presented as an Oral Abstract Presentation at the American Society of Hematology meeting, Dec. 4–7, 2010, Orlando, FL, USA.

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

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Giustozzi ◽  
S Barco ◽  
L Valerio ◽  
F A Klok ◽  
M C Vedovati ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Venous Thromboembolism ◽  
Baseline Risk ◽  
Major Surgery ◽  
First Episode ◽  
Risk Of Recurrence ◽  
Recurrent Vte ◽  
The Impact

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.

scholarly journals Risk of Recurrent Venous Thromboembolism and Bleeding in Patients with Cancer Associated Thrombosis

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 18-18
Author(s):  
Doaa Attia ◽  
Xuefei Jia ◽  
Mailey L Wilks ◽  
Barbara Tripp ◽  
Christopher D'Andrea ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Major Bleeding ◽  
Research Funding ◽  
Cleveland Clinic ◽  
Treatment Groups ◽  
Recurrent Venous Thromboembolism ◽  
Recurrent Vte ◽  
Cancer Associated Thrombosis

Background: The treatment paradigm for cancer associated thrombosis (CAT) has evolved over recent years from using low molecular weight heparin (LMWH) to direct oral anticoagulants (DOACs). Some randomized trials suggest decreased rates of recurrent venous thromboembolism (VTE) in CAT patients treated with DOACs compared to LMWH but also reported increased rates of bleeding. The Cleveland Clinic Taussig Cancer Center has been treating cancer thrombosis in a centralized CAT clinic since 2014. Here we report our rates of bleeding and recurrent VTE in cancer patients treated with anticoagulation. Methods: We prospectively followed cancer patients referred to our clinic from 8/2014-10/2019. A total of 1548 patients were referred to the clinic, of whom 462 were diagnosed with an acute VTE. VTE events, including deep venous thrombosis, pulmonary embolism, and visceral thrombosis, were noted. The comparison of bleeding rates (defined using ISTH criteria for major and clinically relevant non major bleeding, CRNMB) among treatment groups (LMWH vs DOACs) was examined using chi-square test. Rate of recurrent VTE was analyzed using a competing model in which death was treated as a competing risk. Results: The study population comprised 462 patients with acute VTE with a mean age of 62.67±12.23 and 51.8 % males. Of these, 234 (52.9%) received LMWH, 161(36.4%) received DOACs, and 47 (10.6%) received other agents including warfarin for initial anticoagulation. Overall, the 6-month, 1 year, and 2-year VTE recurrence rate was 5.9%, 6.6%, 7.9%, respectively. Recurrent VTE rates were similar for LMWHs, DOACs and other agents (P&gt;0.05). Of 368 patients for whom follow-up data was available, 74 (16.7%) had bleeding event , of which 25 (33.8%) had major bleeding and 49 (66.4%) had CRNMB at 6 month follow-up with no difference across three treatment groups (p=0.56). Conclusion: In this real-world practice setting, rates of recurrent VTE and bleeding were similar for DOACs and LMWH suggesting that with careful patient selection the concern for higher bleeding with DOACs in cancer patients can be safely overcome. Disclosures McCrae: Momenta Pharmaceuticals: Consultancy; Novartis: Honoraria; Rigel: Consultancy; Dova: Consultancy. Khorana:Merck: Research Funding; Medscape: Honoraria; Leo Pharma: Honoraria; Seattle Genetics: Honoraria; Pharmacyte: Honoraria; Pharmacyclics: Honoraria; Array: Other: Research funding (to institution); Janssen: Honoraria; Bayer: Honoraria; Pfizer: Honoraria; Sanofi: Honoraria; BMS: Honoraria, Research Funding; Leap: Research Funding.

scholarly journals Younger Age at Diagnosis Is Associated with an Increased Risk of Venous Thromboembolism in Multiple Myeloma

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1223-1223 ◽  
Author(s):  
Aisling Barrett ◽  
John Quinn ◽  
Siobhan Glavey ◽  
Jeremy Sargent ◽  
Michelle Lavin ◽  
...  
Keyword(s):  
Risk Factors ◽  
Multiple Myeloma ◽  
Logistic Regression ◽  
Venous Thromboembolism ◽  
Research Funding ◽  
P Value ◽  
Younger Age ◽  
Increased Risk ◽  
The Mean

Abstract Introduction Multiple Myeloma (MM) patients are at an approximately 9-fold increased risk of developing venous thromboembolism (VTE), with risk being highest in the first year following diagnosis1. VTE is associated with significant morbidity and negatively influences survival in MM2. Although the Khorana score has been shown to predict rate of thrombosis in solid tumors, the validity of this score in haematological malignancies has yet to be assessed. Given the elevated rates of VTE in these conditions, in particular MM, clinically relevant risk prediction scores are essential. Additionally, data from the MRC-XI trial indicates that standard thromboprophylaxis may not prevent VTEs in MM3. Therefore identification of risk factors for MM-VTE are required to improve our understanding of the pathophysiology of thrombosis and to develop risk-adapted clinical practice guidelines. Through interrogation of an extensive clinical database we sought to identify factors predictive for VTE in our MM population. Methods We performed a retrospective cohort study of all newly diagnosed MM patients at our centre from 2001-2017. Patient medical records were reviewed for clinical and laboratory data including FBC parameters, beta-2-microglobulin, paraprotein and serum free light chain on the day of diagnosis, to minimize steroid effect. All VTE events were recorded, along with MM treatment regimen and thromboprophylaxis at time of event. History of thrombosis was defined as occurring within 6 month prior to, or following a diagnosis of MM. Patients with MGUS or smoldering MM were excluded. Statistical analysis including logistic regression and cox proportional hazard modelling was performed using SPSS (IBM Analytics, USA). A comparison of mortality was also performed between age matched cases with VTE and controls without VTE. Results Over a period of 17 years, 266 patients were diagnosed with myeloma, of which 34 (12.7%) developed VTE following MM diagnosis or within the preceding six months. The mean age of the VTE cohort at MM diagnosis was younger than the mean age of the non-VTE cohort (62.5 years vs. 68.6 years). Pulmonary embolisms and deep vein thromboses were equally represented (44% and 56% respectively) and additional risk factors for thrombosis were present in 46% of patients, not related to MM therapy. Of the patients on immunomodulatory drugs or corticosteroids at time of VTE, all were receiving thromboprophylaxis with either low molecular weight heparin (LMWH) or aspirin at time of VTE. The mortality odds ratio was 3.3 (95% CI 2.4-4.5) in patients who developed VTE in comparison to age matched controls with MM. Younger age at MM diagnosis (<64 years) predicted for VTE occurrence in logistic regression univariate (p-value=0.002) and multivariate analysis (p=0.004). Higher white cell count (WCC) at MM diagnosis showed a trend toward significance in univariate analysis (p-value=0.06) and, in combination with age, demonstrated an area under the curve of 0.72 on ROC analysis for prediction of VTE. Interestingly, the increased risk of VTE in younger patients was not related to longer duration of MM exposure or longer follow up as there was no statistically significant difference in time to VTE between all age groups (median 9 months). Other parameters incorporated in the Khorana score, such as haemoglobin and platelet count did not increase the risk of VTE (p-value=0.57, and 0.25 respectively). Conclusions Our data confirms that VTE is associated with an increased mortality in MM patients and estimates the risk of death to be 3.3 fold higher in these patients. As recently reported in a large cohort of MM patients, younger age is associated with an increased risk of VTE development4, our data support this finding and excludes longer duration of MM, and follow-up time, as confounding variables. Importantly, our data confirms, in unselected "real world" patients the signal that is now apparent from analysis of VTE in the MRC-XI trial3, that thromboprophylaxis with LMWH or aspirin is suboptimal for VTE prevention. This may point to alternative thrombotic mechanisms in MM-VTE and further data in larger MM cohorts is needed to develop risk adapted strategies for prevention strategies for these patients. References Kristinsson SY et el, Blood. 2008 Nov 1;112(9):3582-6. Schoen MW et al. J Clin Oncol 36, 2018 (suppl; abstr 8051). Bradbury CA et al, Blood 2017 130:553. Sanfilippo KM et al. Blood 2016;128:4726. Disclosures Quinn: Janssen: Honoraria. Lavin:Shire: Honoraria, Research Funding, Speakers Bureau. O'Donnell:Baxter: Research Funding, Speakers Bureau; Octapharma: Speakers Bureau; CSL Behring: Consultancy; Daiichi Sankyo: Consultancy; Pfizer: Consultancy, Research Funding; Novo Nordisk: Research Funding, Speakers Bureau; Bayer: Research Funding, Speakers Bureau; Shire: Research Funding, Speakers Bureau; Leo Pharma: Speakers Bureau.

The Incidence, Risk Factors, and Prognosis of Recurrent Venous Thromboembolism (VTE) in Patients with Advanced Solid Cancers Receiving Anticoagulation Therapy After the Diagnosis of Index Vte; A Korean Venous Thromboembolism Registry Study.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2247-2247
Author(s):  
Ho-Young Yhim ◽  
Moon Ju Jang ◽  
Won-Il Choi ◽  
Yong Cheol Lee ◽  
Jeong-Ok Lee ◽  
...  
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Anticoagulation Therapy ◽  
Tumor Site ◽  
Primary Tumor Site ◽  
Increased Risk ◽  
Recurrent Venous Thromboembolism ◽  
Independent Risk Factors ◽  
Recurrent Vte

Abstract Abstract 2247 Introduction Patients (pts) with cancer have been associated with increased risk of recurrent venous thromboembolism (VTE). However, few data are available regarding the recurrent VTE in Asian pts with advanced solid cancers. Thus, the aim of the study is to investigate the incidence and risk factors for recurrent VTE in pts with advanced solid cancers receiving anticoagulation therapy after index VTE. And, we also evaluate the prognostic impact of recurrent VTE on overall survival (OS) in this population. Methods This study was conducted using data from the web-based registry of the Korean Thrombosis Working Party (http://kdvt.chamc.co.kr), which is an ongoing, multicenter database for recruiting consecutive pts presenting with VTE. Pts were included in the study cohort if they had been diagnosed with recurrent/metastatic solid cancers between May 2004 and Dec 2011 and initiated anticoagulation therapy. Pts were excluded if they had received a diagnosis of hematologic malignancies, if solid cancers were not recurrent or metastatic disease, if index VTE was intra-abdominal venous thrombosis or vascular access-induced thrombosis, or if anticoagulation therapy was not instituted. Pts were also excluded if they were lost to follow-up within 1 week after initiating anticoagulation therapy. Maximal duration of anticoagulation therapy was 12 months and pts in whom anticoagulation therapy was stopped within 12 months were censored at the time of discontinuation. Results A total of 456 pts were included in this analysis. The median age was 65 (range, 27–91) years and 249 pts (55%) were male. Eastern Cooperative Oncology Group (ECOG) performance status (PS) was 0 or 1 in 185 pts (41%). The primary sites of tumor were breast in 22 (5%), genito-urinary tracts in 38 (8%), esophago-gastric in 76 (17%), colo-rectum in 81 (18%), hepato-biliary tracts in 37 (8%), pancreas in 66 (15%), and lung in 136 (30%). Palliative chemotherapy was administered in 328 pts (72%). The location of index VTE was isolated pulmonary embolism (PE) in 196 (43%), isolated lower-extremity deep venous thrombosis (DVT) in 169 (37%), and concomitant PE and DVT in 91 (20%). For initial anticoagulation therapy, low molecular weight heparin was administered in 362 pts (79%), and for long-term therapy, 306 pts (75%) received warfarin. The median duration of anticoagulation therapy after index VTE was 2.4 (range, 0.1–58.3) months. The 6-months and 12-month cumulative incidences of recurrent VTE were 22.4% (95% CI, 19.4–25.4) and 28.7% (95% CI, 24.0–33.4), respectively. In the multivariate analysis for identifying the risk factors associated with the development of recurrent VTE, pancreas (HR, 6.12; 95% CI, 2.00–18.73) and lung (HR, 2.98; 95% CI, 1.03–8.58) as the primary tumor site, poor ECOG PS (HR, 1.74; 95% CI, 1.14–2.67) and VTE initially presented with PE (HR, 2.29; 95% CI, 1.17–4.47) were independent risk factors for increased risk of recurrent VTE. With a median follow-up of 29.1 (range, 1.0–91.2) months, median OS was 11.9 (95% CI, 10.2–13.6) months. Pts with recurrent VTE had a significantly shorter OS than those without recurrent VTE (median, 8.4 vs. 13.0 months, P<0.001). In the multivariate model, occurrence of recurrent VTE was independently associated with the increased risk of death (HR, 1.39; 95% CI, 1.03–1.88). Conclusion Although Asian populations are thought to have lower risk for developing recurrent VTE, our study demonstrates that the incidence of recurrent VTE in pts with advanced solid cancers is comparable to that of Western populations. Lung or pancreas as a primary tumor site, poor PS, and initial presentation with PE are independent risk factors for recurrent VTE. Additionally, survival is adversely affected by recurrent VTE. Further studies are needed to validate the results of our study and to optimize the treatment strategies for improving treatment outcomes in advanced cancer pts. Disclosures: No relevant conflicts of interest to declare.

Long-term Clinical Follow-up in 265 Patients with Deep Venous Thrombosis Initially Treated with either Unfractionated Heparin or Dalteparin: A Retrospective Analysis

1999 ◽  
Vol 82 (10) ◽  
pp. 1222-1226 ◽  
Author(s):  
W. Åberg ◽  
D. Lockner ◽  
C. Paul ◽  
M. Holmström
Keyword(s):  
Risk Factor ◽  
Venous Thromboembolism ◽  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Unfractionated Heparin ◽  
Malignant Disease ◽  
Duration Of Treatment ◽  
Post Thrombotic Syndrome ◽  
Recurrent Vte

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

scholarly journals Safety and Effectiveness of Apixaban, LMWH, and Warfarin Among Venous Thromboembolism Patients with Active Cancer: A Retrospective Analysis Using Four US Claims Databases

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 326-326 ◽  
Author(s):  
Alexander T Cohen ◽  
Allison Keshishian ◽  
Theodore Lee ◽  
Gail Wygant ◽  
Lisa Rosenblatt ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Board Of Directors ◽  
Lower Risk ◽  
Select Committee ◽  
Advisory Committees ◽  
Recurrent Vte ◽  
High Risk Cancer ◽  
Similar Risk ◽  
Active Cancer

BACKGROUND: Venous thromboembolism (VTE) is the second leading cause of death in cancer patients. The treatment of cancer-associated VTE carries a significantly greater risk of major bleeding (MB) and recurrent VTE compared to that in non-cancer patients. CHEST Guidelines suggest the use of low molecular weight heparin (LMWH) over a vitamin K antagonist (VKA) in patients diagnosed with VTE and cancer. The last decade has seen an emergence of non-VKA anticoagulants (NOACs) for the treatment of VTE. Despite completed and ongoing clinical trials, there is a lack of real-world evidence comparing the effectiveness and safety of LWMH with VKAs and NOACs among VTE patients with active cancer. Therefore, this study evaluates the risk of MB, clinically relevant non-MB (CRNMB), and recurrent VTE (fatal or non-fatal) among VTE patients with active cancer prescribed apixaban, LMWH, or warfarin in routine clinical practice. METHODS: Four US commercial insurance claims databases were used to identify VTE patients with active cancer (defined as cancer diagnosis or cancer treatment [chemotherapy, radiation and cancer-related surgery] within 6 months before or 30 days after VTE diagnosis) who initiated apixaban, LMWH, or warfarin within 30-days following the first VTE event (01SEP2014-31MAR2018). Patients who used LMWH as bridging therapy for warfarin (≤14 days before or after warfarin initiation) were classified as warfarin users. Patients were followed to the earliest of: health plan disenrollment, death, index therapy discontinuation, switch to another anticoagulant, study end, or a maximum of 6 months. Additional analysis using all available follow-up was also conducted. Stabilized inverse probability treatment weighting (IPTW) was used to balance treatment cohorts. Cox proportional hazard models were used to evaluate the risk of MB, CRNMB, and recurrent VTE. RESULTS: After applying all eligibility criteria, 3,393 apixaban, 6,108 LMWH, and 4,585 warfarin patients were identified with mean ages of 65, 64, and 64 years, respectively. After IPTW, all patient characteristics were balanced. The mean follow-up was 105, 88, and 113 days for apixaban, LMWH, and warfarin, respectively. Among the weighted VTE cancer population, 51% of the patients had metastatic cancer and 77% of patients received cancer treatment. Further, 15% of patients had very high-risk cancer (brain, stomach, or pancreas), and 40% patients had high-risk cancer (lung, lymphoma, gynecologic, bladder, testicular, renal cell carcinoma). Apixaban patients had a lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH. Apixaban patients also had a lower risk of recurrent VTE and a similar risk of MB and CRNM bleeding compared to warfarin. Warfarin patients had a similar risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH (Figure). When the entire available follow-up period (mean follow-up was 137, 106, and 166 days for apixaban, LMWH, and warfarin, respectively) was used, the trends were similar to the 6-month analysis for apixaban vs. LMWH and warfarin vs. LMWH. However, apixaban patients were associated with a lower risk of both MB and recurrent VTE compared to warfarin patients. CONCLUSION: VTE patients with active cancer initiating apixaban had significantly lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH patients. Apixaban patients also had a lower risk of recurrent VTE compared to warfarin patients. These results may be helpful for clinicians in evaluating different anticoagulation treatments for VTE patients with active cancer. Further studies are needed to evaluate these outcomes between different anticoagulation treatment options. Figure Disclosures Cohen: Lifeblood: Other: advisor to Lifeblood: the thrombosis charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism; ONO: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy; TRN: Consultancy; UK Government Health Select Committee: Other: advised the UK Government Health Select Committee, the all-party working group on thrombosis, the Department of Health, and the NHS, on the prevention of VTE; Temasek Capital: Consultancy; ACI Clinical: Consultancy; Navigant: Consultancy; McKinsey: Consultancy; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Consultancy; Aspen: Consultancy, Speakers Bureau; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Boston Scientific: Consultancy; Boehringer-Ingelheim: Consultancy, Speakers Bureau; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; CSL Behring: Consultancy; GlaxoSmithKline: Consultancy, Speakers Bureau; GLG: Consultancy; Guidepoint Global: Consultancy; Johnson and Johnson: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Leo Pharma: Consultancy; Medscape: Consultancy, Speakers Bureau. Keshishian:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Lee:Pfizer Inc.: Employment, Equity Ownership. Wygant:Bristol-Myers Squibb Company: Employment. Rosenblatt:Bristol-Myers Squibb: Other: Stock Owner ; Bristol-Myers Squibb Company: Employment. Hlavacek:Pfizer Inc.: Employment. Mardekian:Pfizer Inc.: Employment. Wiederkehr:Pfizer Inc.: Employment. Sah:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Luo:Pfizer Inc.: Employment.

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.

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)

Initial Outpatient Treatment of Venous Thromboembolism with Fondaparinux (Arixtra®): The Matisse Trials.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 705-705 ◽  
Author(s):  
Harry R. Buller ◽  
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Hospital Discharge ◽  
Outpatient Treatment ◽  
Initial Treatment ◽  
Safety Data ◽  
Outpatient Basis ◽  
Efficacy And Safety ◽  
Once Daily ◽  
Recurrent Vte

Abstract Background: The MATISSE trials showed that a single dose regimen of fondaparinux, a synthetic selective factor Xa inhibitor, was at least as effective and as safe as standard therapies in the treatment of venous thromboembolism (VTE). In these trials, outpatient treatment of fondaparinux was encouraged but left at the investigator’s discretion. We analyzed the data in patients who received fondaparinux on an outpatient basis. Methods: Fondaparinux was administered at a once-daily subcutaneous dose of 7.5 mg (5.0 mg and 10.0 mg in patients <50 kg and >100 kg, respectively). In the MATISSE-DVT trial, fondaparinux was compared with twice-daily subcutaneous enoxaparin (1 mg/kg) in patients with deep-vein thrombosis (DVT). In the MATISSE-PE trial, it was compared with adjusted-dose intravenous unfractionated heparin (UFH) in patients with pulmonary embolism (PE). Outpatient treatment of DVT with enoxaparin was possible whereas outpatient treatment of PE with UFH was not feasible. All drugs were given for at least 5 days and until anticoagulation with oral anticoagulants was therapeutic. The primary efficacy and safety outcomes were recurrent VTE during 3 months’ follow-up and major bleeding (MB) and death during the initial treatment period. Results: In MATISSE-DVT, 31.4% and 33.8% of the fondaparinux- and enoxaparin-treated patients, respectively, received therapy on an outpatient basis. In MATISSE-PE, 14.3% of the patients received fondaparinux on an outpatient basis, compared with none in the UFH group. In both MATISSE-DVT and -PE, efficacy and safety data from the patients who received fondaparinux on an outpatient basis were similar to those from the total population (Tables). The rates of recurrent VTE and MB in fondaparinux outpatients were similar to those in enoxaparin outpatients or UFH inpatients. Conclusion: Outpatient initial treatment of both DVT and PE with once-daily fondaparinux is feasible, effective and safe. MATISSE DVT Enoxaparin Fondaparinux All patients Outpatients All patients Outpatients *As treated patients n 1107 374 (33.8%) 1098 345 (31.4%) Age, yr (mean±SD) 61±17 60±16 61±17 58±17 Male/female 578/529 201/173 581/517 197/148 Hospital discharge, days (mean±SD) 7.0±6.2 1.8±1.9 7.6±7.7 1.6±1.7 ≥2 VTE risk factors, n (%) 283 (25.6) 122 (32.6) 293 (26.7) 97 (28.1) VTE, n (%) 45 (4.1) 16 (4.3) 43 (3.9) 7 (2.0) MB*, n (%) 13 (1.2) 3 (0.8) 12 (1.1) 5 (1.5) MATISSE-PE UFH Fondaparinux All patients Outpatients *As treated patients n 1110 1103 158 (14.3%) Age, yr (mean±SD) 62±17 63±16 57±16 Male/female 477/633 501/601 82/76 Hospital discharge, days (mean±SD) 10.2±6.8 9.7±7.7 4.4±2.2 ≥2 VTE risk factors, n (%) 260 (23.4) 241 (21.8) 35 (22.2) VTE, n (%) 56 (5.0) 42 (3.8) 5 (3.2) MB*, n (%) 12 (1.1) 14 (1.3) 0 (0)

Sign in / Sign up

Export Citation Format

Share Document