scholarly journals Risk of Recurrent Venous Thromboembolism and Major Bleeding in Cancer-Associated Incidental Pulmonary Embolism Amongst Treated and Untreated Patients: A Pooled Analysis of 926 Patients

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 590-590 ◽  
Author(s):  
T van der Hulle ◽  
P L den Exter ◽  
G Meyer ◽  
B Planquette ◽  
S Soler ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Individual Patient Data ◽  
Incidence Rates ◽  
Patient Data ◽  
Anticoagulant Treatment ◽  
Incidental Pulmonary Embolism ◽  
Recurrent Venous Thromboembolism ◽  
Recurrent Vte

Abstract Introduction Incidental pulmonary embolism (IPE) is defined as a pulmonary embolism diagnosed on a CT-scan performed for reasons other than a clinical suspicion of PE. Generally identified on staging scans, IPE has been estimated to occur in 3.1% of all cancer patients and is a growing challenge for clinicians and patients. Nevertheless, knowledge about the treatment and prognosis of cancer-associated IPE is scarce. In order to determine the outcome more accurately, and to identify clinical characteristics related to the prognosis, we pooled individual patient data from eleven observational studies and ongoing registries. Methods A systematic literature search aiming to identify studies reporting on patients diagnosed with cancer-associated IPE was performed. Authors of selected studies were invited to participate. Incidence rates of objectively diagnosed symptomatic recurrent venous thromboembolism (VTE), major bleeding and mortality during 6-month follow-up were pooled. Individual patient data was collected to perform subgroup analyses, for which all patients were considered as one cohort. Hazard ratios (HR) were adjusted for age, sex and cancer stage. Results Individual patient data of 926 cancer patients with IPE from 11 observational studies and ongoing registries were included (Table 1). The overall pooled 6-month risk of symptomatic recurrent VTE was 5.8% (95%CI 3.7-8.3), of major bleeding 4.7% (95%CI 3.0-6.8) and of mortality 37% (95%CI 28-47). The VTE recurrence risk was comparable in patients treated with VKA and LMWH with incidence rates of 6.4% (95%CI 2.2-12) and 6.2% (95%CI 3.5-9.6), HR 0.89 (95%CI 0.27-2.9). In contrast, this incidence rate was 12% (95%CI 4.7-23) in patients who were left untreated, HR 2.9 (95%CI 0.65-13; Figure 1). The risk of major bleeding was significantly higher in patients treated with VKA compared to those treated with LMWH, 13% (95%CI 6.4-20) versus 3.9% (95%CI 2.3-5.9), HR of 3.2 (95%CI 1.4-7.4) (Figure 2). The 6-month mortality was 37% (95%CI 29-44) in patients treated with LMWH, 28% (95%CI 18-40) in those treated with VKA and 47% (95%CI 28-66) amongst untreated patients. The all-cause mortality at 6 months was significantly higher for patients with a central thrombus (either central or lobar) compared to those with a more peripheral IPE (either segmental or subsegmental); 42% (95%CI 33-52) versus 30% (95%CI 25-36, HR 1.8 (95%CI 1.4-2.3). Conclusions The most important finding of this study is the 12% 6-month risk of symptomatic recurrent VTE in patients with cancer-associated IPE who did not receive anticoagulant treatment, which is more than double the risk of patients who were anticoagulated. These numbers recall the effect size of anticoagulants used in symptomatic PE and support the judicious initiation of anticoagulant treatment in cancer-associated IPE. The association between more centrally-located thrombi and mortality following IPE is a new finding that parallels outcomes for symptomatic PE, and one which may further support similar management. Regarding the choice of anticoagulant, VKA were associated with a significantly higher risk of major bleeding than LMWH, with a comparable risk of recurrent VTE. The findings of this observational study should be preferably confirmed in a randomized trial. Figure 1: Figure 1:. The 6-month risk of recurrent venous thromboembolism related to anticoagulant treatment. Figure 2: The 6-month risk of major bleeding related to anticoagulant treatment. Figure 2:. The 6-month risk of major bleeding related to anticoagulant treatment. Abstract 590. Table 1: Baseline characteristics Treatment All patients n=926 (100%) LMWH n=732 (79%) VKA n=100 (11%) No treatment n=53 (6%) Other treatment n=41 (4%) Mean age (SD) 65 (12) 64 (12) 68 (12) 65 (14) 68 (13) Male sex, n (%) 491 (53) 378 (52) 60 (60) 31 (58) 22 (54) Cancer stage, n (%) Metastatic 501 (54) 400 (55) 56 (56) 33 (62) 12 (29) Non-metastatic 192 (21) 143 (20) 34 (34) 12 (23) 3 (7.3) Unspecified 233 (25) 189 (26) 10 (10) 8 (15) 26 (63) Cancer type, n (%) Lung 176 (19) 135 (18) 16 (16) 18 (34) 7 (17) Colorectal 185 (20) 150 (20) 20 (20) 9 (17) 6 (15) Other gastrointestinal 187 (20) 147 (20) 15 (15) 13 (25) 12 (29) Breast 65 (7.0) 52 (7.1) 10 (10) 1 (1.9) 2 (4.9) Gynaecological 64 (6.9) 56 (7.7) 5 (5.0) 0 (0) 3 (7.3) Other 206 (22) 155 (21) 31 (31) 10 (19) 10 (24) Haematological 43 (4.6) 37 (5.1) 3 (3.0) 2 (3.8) 1 (2.4) Largest artery involved, n (%) Central 292 (32) 230 (31) 30 (30) 11 (21) 21 (51) Peripheral 495 (53) 395 (54) 62 (62) 29 (55) 9 (22) Unspecified 139 (15) 107 (15) 8 (8.0) 13 (25) 11 (27) Disclosures No relevant conflicts of interest to declare.

scholarly journals Incidental Pulmonary Embolism. Analysis of Mayo Clinic Venous Thromboembolism Database

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1147-1147
Author(s):  
Ewa Wysokinska ◽  
Damon E. Houghton ◽  
Danielle Vlazny ◽  
Aneel A. Ashrani ◽  
David A Froehling ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Venous Thromboembolism ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Cancer Information ◽  
Mortality Data ◽  
Patients With Cancer ◽  
Incidental Pulmonary Embolism ◽  
Underlying Malignancy ◽  
Recurrent Vte

Background: Incidental pulmonary embolism (PE) is not infrequently found on CT scans with highest incidence reported in patients with cancer. It is unclear whether patients with symptomatic pulmonary embolism (iPE) have different clinical profile or outcomes compared to patients with symptomatic PE (sPE) and whether this is affected by the presence or type of malignancy. Objective: Compare baseline characteristics of patients diagnosed with iPE to patients with sPE with attention to cancer-specific risk factors as well as evaluate clinical outcomes. Methods: Consecutive patients enrolled in the Mayo Thrombophilia Clinic VTE Registry between March 1, 2013 and December 31st, 2018 with PE were followed prospectively. Outcomes of recurrent venous thromboembolism (VTE), major bleeding, clinically relevant non-major bleeding (CRNMB) and mortality data were collected every 3 months. Clinical outcomes were analyzed with specific focus on patients with cancer. Information was collected and managed using REDCap (Research Electronic Data Capture) and data analysis was performed using SAS software (SAS Institute Inc., Cary, North Carolina). Results: Out of a total of 1033 patients with PE in VTE registry, there were 655 patients with PE (284 with incidental and 363 symptomatic) who completed at least 3 months of anticoagulation and were started on treatment within 14 days of diagnosis. Apixaban was used in 220 (34 %), Rivaroxaban 175 (27 %), Enoxaparin 179 (27%), and Warfarin in 81 (12 %) patients. Overall cancer was present in 61% of patients and was more common in patients with iPE compared to sPE (80.2% vs 45.2%, p<0.001). Patients with iPE were less likely to have previous VTE (8.2% vs 25.5%, p< 0.0001) and tended to have lower BMI (mean 28.8 vs 31.4, p<0.0001) Characteristics of the subgroup of only cancer patients with PE are summarized in the Table. Of note, pancreatic and GI cancers were more common in patients with iPE. There were no differences in recurrent VTE, major bleeding and CRNMB in patients with iPE compared to sPE. This also held true for patients with underlying malignancies. Mortality rates were significantly higher in all patients with iPE even when adjusting for presence of malignancy (p=0.03). When adjusting for presence of metastatic malignancy though the difference was no longer present (p=0.33). Conclusion: Patients with iPE were more likely to have an underlying malignancy, potentially due to higher likelihood of undergoing staging imaging studies. Additionally, patients with iPE more often had metastatic disease which was associated with higher mortality. Recurrent VTE and bleeding outcomes were similar in patients with iPE and sPE, this was independent of the presence of underlying malignancy. Disclosures McBane: BMS: Research Funding.

Treatment and Long-Term Clinical Outcomes of Incidental Pulmonary Embolism in Patients With Cancer: An International Prospective Cohort Study

2019 ◽  
Vol 37 (20) ◽  
pp. 1713-1720 ◽  
Author(s):  
Noémie Kraaijpoel ◽  
Suzanne M. Bleker ◽  
Guy Meyer ◽  
Isabelle Mahé ◽  
Andrés Muñoz ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Cohort Study ◽  
Venous Thromboembolism ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Cumulative Incidence ◽  
Patients With Cancer ◽  
Incidental Pulmonary Embolism ◽  
Recurrent Venous Thromboembolism

PURPOSE Pulmonary embolism is incidentally diagnosed in up to 5% of patients with cancer on routine imaging scans. The clinical relevance and optimal therapy for incidental pulmonary embolism, particularly distal clots, is unclear. The aim of the current study was to assess current treatment strategies and the long-term clinical outcomes of incidentally detected pulmonary embolism in patients with cancer. PATIENTS AND METHODS We conducted an international, prospective, observational cohort study between October 22, 2012, and December 31, 2017. Unselected adults with active cancer and a recent diagnosis of incidental pulmonary embolism were eligible. Outcomes were recurrent venous thromboembolism, major bleeding, and all-cause mortality during 12 months of follow-up. Outcome events were centrally adjudicated. RESULTS A total of 695 patients were included. Mean age was 66 years and 58% of patients were male. Most frequent cancer types were colorectal (21%) and lung cancer (15%). Anticoagulant therapy was initiated in 675 patients (97%), of whom 600 (89%) were treated with low-molecular-weight heparin. Recurrent venous thromboembolism occurred in 41 patients (12-month cumulative incidence, 6.0%; 95% CI, 4.4% to 8.1%), major bleeding in 39 patients (12-month cumulative incidence, 5.7%; 95% CI, 4.1% to 7.7%), and 283 patients died (12-month cumulative incidence, 43%; 95% CI, 39% to 46%). The 12-month incidence of recurrent venous thromboembolism was 6.4% in those with subsegmental pulmonary embolism compared with 6.0% in those with more proximal pulmonary embolism (subdistribution hazard ratio, 1.1; 95% CI, 0.37 to 2.9; P = .93). CONCLUSION In patients with cancer with incidental pulmonary embolism, risk of recurrent venous thromboembolism is significant despite anticoagulant treatment. Patients with subsegmental pulmonary embolism seemed to have a risk of recurrent venous thromboembolism comparable to that of patients with more proximal clots.

Venous Thromboembolism in Lymphoma: How Effectively Are We Treating Patients?.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1878-1878
Author(s):  
Alaa A. Muslimani ◽  
Timothy P. Spiro ◽  
Asif A. Chaudhry ◽  
Hamed A. Daw
Keyword(s):  
Pulmonary Embolism ◽  
Retrospective Study ◽  
Therapeutic Range ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Minor Bleeding ◽  
Anticoagulant Treatment ◽  
Recurrent Thrombosis ◽  
Oral Anticoagulant Treatment ◽  
Recurrent Vte

Abstract Introduction: Patients (pts) with solid tumors and venous thromboembolic episodes (VTE) have a high risk of complications (recurrent VTE/bleeding) during oral anticoagulant treatment. However, few data are available in pts with lymphoma. We conducted a retrospective study to determine the frequency of complications during oral anticoagulant treatment in lymphoma pts. Methods: Charts of histologically proven non-Hodgkin’s (NHL) and Hodgkin lymphoma (HL) pts at our institution from January 1998 through April 2007 were retrospectively reviewed. After excluding pts with thrombocytosis, solid tumors, hypercoagulability or previous treatment with anticoagulants, pts with their first acute symptomatic VTE were identified (49 NHL, 8 HL). 31 were males and 26 females, with an age range of 40–89 years. The first symptomatic VTE was defined as lymphoma associated if the VTE occurred within 3 months before or after the biopsy diagnosis of the lymphoma but before chemotherapy. These VTE were confirmed by contrast venography or doppler ultrasound for venous thrombosis (neck and upper-lower extremities) and chest computed tomography, ventilation/perfusion scan, or pulmonary angiography for pulmonary embolism. Major bleeding was defined as bleeding that required transfusion, caused a drop of hemoglobin &gt; 2 g/dL, or occurred in critical sites. Minor bleeding was defined as any overt bleeding that required stopping the anticoagulant treatment but not fulfilling the definition of major bleeding. Results: All 57 pts were initially treated with high dose adjusted intravenous heparin or body weight adjusted low molecular weight heparin (LMWH). 46 pts were started on oral warfarin during the first 10 days of the initial treatment witch was continued for at least 3 months after discontinuing heparin. 11 pts received continuing LMWH and no warfarin. Recurrent VTE occurred in 14/46 pts on warfarin therapy. The international normalized ratio (INR) was within the therapeutic range (2.0–3.0) in 10/14 pts, and below the therapeutic INR (&lt; 2.0) in 4/14 pts. Death was directly correlated to recurrent VTE (massive pulmonary embolism) in 2 pts in the warfarin treated group; a third death was caused by massive intracranial bleeding. Major bleeding was documented in 6/46 pts (4 pts had an INR within the therapeutic range, 2 had INR &gt; 3), and minor bleeding in 9/46 pts. Recurrent VTE occurred in 1/11 pts treated with LMWH, major bleeding in 0/11 and minor bleeding in 3/11 pts with no deaths. Conclusions: Previous studies showed an overall incidence of 27.1% recurrent thrombosis and 5.4% major bleeding in pts with malignancy treated with oral anticoagulant for VTE. Our study showed 30.4% recurrent thrombosis and 13% major bleeding in pts with lymphoma. Most bleeding and thrombotic complications occurred with an INR within the therapeutic range (65%). The percentage of serious complications was very high during the use of warfarin (43.5%), and the death rate 6.5%, compared to 9% and 0% during the use of LMWH. A high failure rate of oral anticoagulant treatment in pts with lymphoma suggests the need for alternative treatment. Since the number of pts in this retrospective study is small, a prospective randomized, controlled study comparing warfarin with LMWH is indicated.

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.

Subgroup Analysis of Patients with Cancer in Xalia - a Non-Interventional Study of Rivaroxaban in Routine Treatment of Deep Vein Thrombosis

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1438-1438 ◽  
Author(s):  
Alexander G G Turpie ◽  
Lorenzo G Mantovani ◽  
Sylvia Haas ◽  
Reinhold Kreutz ◽  
Danja Monje ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Research Funding ◽  
Incidence Rates ◽  
Vein Thrombosis ◽  
All Cause Mortality ◽  
Recurrent Vte ◽  
Deep Vein ◽  
Active Cancer

Abstract Background: XALIA is a prospective, non-interventional study of rivaroxaban in the treatment of acute deep vein thrombosis. The overall XALIA results showed that rivaroxaban was associated with similarly low rates of major bleeding and symptomatic recurrent venous thromboembolism (VTE) as standard anticoagulation. A subset of patients in XALIA had active cancer at the time of enrolment into the study. Purpose: To describe the demographics, clinical characteristics, treatment strategies and outcomes of patients in XALIA with cancer and VTE. The primary outcomes were major bleeding, recurrent VTE and all-cause mortality. Methods: Patients with deep vein thrombosis with or without concomitant pulmonary embolism aged ≥18 years who had active cancer and were scheduled to receive ≥3 months of anticoagulation with rivaroxaban or standard therapy were eligible. Therapy type, dose and duration were at the physician's discretion. For the purpose of this substudy, we defined the following treatment cohorts: rivaroxaban cohort (patients treated with rivaroxaban alone or who received heparin/fondaparinux for ≤48 hours before switching to rivaroxaban); early switchers cohort (patients treated with rivaroxaban who received heparin/fondaparinux for >48 hours-14 days and/or a vitamin K antagonist [VKA] for 1-14 days before changing to rivaroxaban); standard anticoagulation cohort (patients treated with heparin/fondaparinux and a VKA or a VKA only); and heparin/fondaparinux cohort (patients treated with heparin/fondaparinux alone). Results: Of 5136 patients in XALIA who received study medication, 587 (11.4%) had active cancer at baseline. Of these, 146 (24.9%) received rivaroxaban, 30 (5.1%) were early switchers, 167 (28.4%) received standard anticoagulation (of which 26 [4.4%] received a VKA only) and 244 (41.6%) received heparin/fondaparinux only, of whom 223 (38.0%) received low molecular weight heparin and the remainder other heparins or fondaparinux. Demographics are shown in Table 1. The most common type of active cancer at baseline in all cohorts was genitourinary, with the exception of the heparin/fondaparinux cohort where gastrointestinal cancer was the most common type (Table 2). The incidence rates for the primary outcomes for each cohort are shown in Figure 1. The rates of major bleeding were highest in the standard anticoagulation cohort (n=8 [4.8%]) and lowest in the early switchers (no major bleeding events occurred). The rates of recurrent VTE were similar in the in the rivaroxaban, early switcher and standard anticoagulation cohorts (n=5 [3.4%], n=1 [3.3%] and n=6 [3.6%], respectively) and were highest in the heparin/fondaparinux cohort (n=12 [4.9%]). All-cause mortality was highest in the heparin/fondaparinux cohort (n=61 [25.0%]) and lowest in the early switchers (no deaths occurred). Conclusions: In the real-world XALIA study, 38.0% of patients with cancer received treatment with low molecular weight heparin, which was in line with guidelines. The remaining patients received rivaroxaban, standard anticoagulation or were early switchers. For the three primary outcomes, the lowest incidence rates were observed in the early switcher cohort. The highest rates were in the standard anticoagulation cohort for major bleeding and the heparin/fondaparinux cohort for recurrent VTE and all-cause mortality; rates for all three primary outcomes were low in the rivaroxaban cohort, suggesting that rivaroxaban may be a safe and effective treatment option for patients with VTE and active cancer. Figure 1 Primary outcomes in patients with active cancer at baseline by treatment group. VTE, venous thromboembolism. Figure 1. Primary outcomes in patients with active cancer at baseline by treatment group. / VTE, venous thromboembolism. Disclosures Turpie: Janssen Research & Development, LLC: Consultancy, Honoraria; Bayer Pharma AG: Consultancy, Honoraria. Mantovani:Janssen-Cilag Ltd: Research Funding; Boehringer Ingelheim: Research Funding; Daiichi Sankyo: Consultancy; Bayer Pharma AG: Consultancy; Pfizer Inc: Research Funding. Haas:Sanofi SA: Consultancy; Pfizer Inc: Consultancy; Daiichi Sankyo: Consultancy; Bristol-Myers Squibb: Consultancy; Bayer Pharma AG: Consultancy; Aspen Pharmacare: Consultancy. Kreutz:Bayer Pharma AG: Honoraria; Servier Laboratories Ltd: Consultancy; Lundbeck Ltd: Consultancy; Daiichi Sankyo: Consultancy; Berlin-Chemie Menarini: Consultancy; Bayer Pharma AG: Consultancy; Bristol-Myers Squibb: Honoraria; Daiichi Sankyo: Honoraria. Monje:Bayer Pharma AG: Employment. Schneider:Bayer Pharma AG: Employment. van Eickels:Bayer Pharma AG: Employment. Gebel:Bayer Pharma AG: Employment. Ageno:Boehringer Ingelheim: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Bayer Pharmaceuticals: Research Funding; Daiichi Sankyo: Consultancy, Honoraria; Bayer Pharma AG: Consultancy, Honoraria.

Risk of recurrent venous thromboembolism after a first oestrogen-associated episode

2010 ◽  
Vol 104 (09) ◽  
pp. 498-503 ◽  
Author(s):  
Grégoire Le Gal ◽  
Michael Kovacs ◽  
Marc Carrier ◽  
Kimberley Do ◽  
Susan Kahn ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Oral Contraceptives ◽  
Hormone Replacement ◽  
Anticoagulant Treatment ◽  
Exogenous Oestrogen ◽  
Recurrent Venous Thromboembolism ◽  
Recurrent Vte ◽  
Post Menopausal ◽  
Age Range

SummaryThe use of exogenous oestrogen in women with otherwise unprovoked venous thromboembolism (VTE) could be considered sufficient explanation to classify VTE as provoked if the risk of recurrent VTE after 3–6 months of anticoagulant treatment is similar to the risk of recurrent VTE observed after a surgery or prolonged immobilisation. Our objective was to assess the risk of recurrent VTE in women after a first unprovoked episode on oestrogen. The REVERSE study is a cohort study of patients with a first unprovoked VTE treated with anticoagulant treatment for 5–7 months. The risk of recurrent VTE during follow-up was compared between women users and non users of oestrogen at the time of index VTE. Among the 646 patients included, 314 were women, of them 67 were current users of oestrogen at the time of their VTE: 49 were on oral contraceptives and 18 on post-menopausal hormone replacement therapy (HRT). No significant association was found between oestrogen exposure, either oral contraceptives or HRT, and a lower risk of recurrent VTE after adjustment for age, or analysis restricted to women in the same age range as oestrogen contraceptives and HRT users, respectively. The risk of recurrent VTE is low in women after a first otherwise unprovoked oestrogen-associated VTE. However, this risk is not significantly lower than in women whose VTE was not related to oestrogen use.

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.

Cost Effectiveness of Rivaroxaban Versus Warfarin for the Prevention of Recurrent Venous Thromboembolism.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3177-3177 ◽  
Author(s):  
Craig D. Seaman ◽  
Margaret V. Ragni ◽  
Kenneth J. Smith
Keyword(s):  
Venous Thromboembolism ◽  
Cost Effectiveness ◽  
Major Bleeding ◽  
Cost Effective ◽  
Base Case ◽  
Minor Bleeding ◽  
Old Patients ◽  
Life Years ◽  
Recurrent Venous Thromboembolism ◽  
Recurrent Vte

Abstract Abstract 3177 Background: Rivaroxaban is an oral anticoagulant administered once daily that works by direct inhibition of factor Xa. It has been found to be noninferior to warfarin in the prevention of recurrent venous thromboembolism (VTE). Whether rivaroxaban is cost effective in the prevention of recurrent VTE, however, is not known. Methods: To assess the cost effectiveness of rivaroxaban compared with warfarin in the prevention of recurrent VTE, we built a Markov state transition model over a 10-year time horizon. The base case analysis consisted of a hypothetical cohort of 60-year-old patients who were diagnosed with their first VTE and received secondary prophylaxis with either rivaroxaban or warfarin for 6 months. Cost estimates were derived from the Healthcare and Utilization Project (HCUP) and other sources. Probabilities for VTE recurrence and mortality and for major and minor bleeding were based on the EINSTEIN PE trial (NEJM 2012; 366: 1287–97). Outcomes included costs in 2011 United States dollars, quality adjusted life years (QALYs), and incremental cost effectiveness ratios (ICERs) over 10 years from a societal perspective. Results: Base case results are shown in the Table, showing total medication and other medical costs associated with each strategy. Compared with warfarin, the rivaroxaban strategy cost less ($4057 vs $7004) and was more effective (9.30 QALYs vs 9.16 QALYs). Thus, warfarin was dominated by rivaroxaban. In sensitivity analyses, results were most sensitive to changes in the probability of major bleeding with rivaroxaban. As shown in the Figure, when major bleeding with rivaroxaban (base case 1.1%) was less than 4.5%, the ICRE was within the $100,000 per QALY gained acceptability threshold range. Results favoring rivaroxaban were robust to individual variation of other parameter values. Conclusion: Prophylactic anticoagulation with rivaroxaban appears to be a cost effective, and perhaps cost saving, alternative to warfarin for the prevention of recurrent VTE. Disclosures: Off Label Use: Rivaroxaban - Prevention of recurrent venous thromboembolism.

Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis

Blood ◽  
2002 ◽  
Vol 100 (10) ◽  
pp. 3484-3488 ◽  
Author(s):  
Paolo Prandoni ◽  
Anthonie W. A. Lensing ◽  
Andrea Piccioli ◽  
Enrico Bernardi ◽  
Paolo Simioni ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Venous Thrombosis ◽  
Cancer Patients ◽  
Major Bleeding ◽  
Cumulative Incidence ◽  
Hazard Ratio ◽  
Anticoagulant Treatment ◽  
Thromboembolic Complications ◽  
Patients With Cancer ◽  
Recurrent Venous Thromboembolism

A small proportion of patients with deep vein thrombosis develop recurrent venous thromboembolic complications or bleeding during anticoagulant treatment. These complications may occur more frequently if these patients have concomitant cancer. This prospective follow-up study sought to determine whether in thrombosis patients those with cancer have a higher risk for recurrent venous thromboembolism or bleeding during anticoagulant treatment than those without cancer. Of the 842 included patients, 181 had known cancer at entry. The 12-month cumulative incidence of recurrent thromboembolism in cancer patients was 20.7% (95% CI, 15.6%-25.8%) versus 6.8% (95% CI, 3.9%- 9.7%) in patients without cancer, for a hazard ratio of 3.2 (95% CI, 1.9-5.4) The 12-month cumulative incidence of major bleeding was 12.4% (95% CI, 6.5%-18.2%) in patients with cancer and 4.9% (95% CI, 2.5%-7.4%) in patients without cancer, for a hazard ratio of 2.2 (95% CI, 1.2-4.1). Recurrence and bleeding were both related to cancer severity and occurred predominantly during the first month of anticoagulant therapy but could not be explained by sub- or overanticoagulation. Cancer patients with venous thrombosis are more likely to develop recurrent thromboembolic complications and major bleeding during anticoagulant treatment than those without malignancy. These risks correlate with the extent of cancer. Possibilities for improvement using the current paradigms of anticoagulation seem limited and new treatment strategies should be developed.

Clinical outcome of patients with major bleeding after venous thromboembolism

2008 ◽  
Vol 100 (05) ◽  
pp. 789-796 ◽  
Author(s):  
José Nieto ◽  
Timoteo Camara ◽  
Elena Gonzalez-Higueras ◽  
Nuria Ruiz-Gimenez ◽  
Ricardo Guijarro ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Venous Thromboembolism ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Vena Cava ◽  
Vena Cava Filter ◽  
Fatal Bleeding ◽  
History Of ◽  
Recurrent Vte ◽  
Overall Mortality

SummaryThe natural history of patients with venous thromboembolism (VTE) who develop a major bleeding complication while on anticoagulant therapy is not well known. RIETE is a prospective registry of consecutive patients with symptomatic, objectively confirmed, acute VTE. The clinical characteristics, treatment decisions and outcome of all VTE patients who had major bleeding during the first three months of anticoagulant therapy were retrospectively studied. As of January 2007, 17,368 patients were included in RIETE. Of these, 407 (2.3%) had major bleeding during the study period: 144 gastrointestinal, 119 haematoma, 51 intracranial, 43 genitourinary, 50 other. In 286 (69%) patients anticoagulant therapy was discontinued, in 74 (18%) not modified, in 38 (9.1%) a vena cava filter was inserted. During the first 30 days after bleeding, 24 (5.9%) patients re-bled, 20 (4.9%) had recurrent VTE, 133 (33%) died. Of these, 75 died of bleeding, 12 of recurrent pulmonary embolism. Most deaths occurred shortly after the bleeding episode (median:1 day).On multivariate analysis, insertion of a vena cava filter was the only variable independently associated with a lower incidence of fatal bleeding (odds ratio [OR]: 0.10; 95% confidence interval [CI]: 0.01–0.79) and all-cause mortality (OR: 0.21; 95%CI: 0.07–0.63). In conclusion, the occurrence of major bleeding in patients with VTE is outstanding in terms of overall mortality (33% within 30 days), fatal bleeding (18%) or re-bleeding (5.9%). However, these patients also have an increased incidence of recurrent VTE (4.9%) and fatal pulmonary embolism (1.2%).

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