scholarly journals Clinical Outcomes of Multiple Myeloma Patients Treated with Direct Oral Anticoagulants for Immunomodulatory Drug Associated Venous Thromboembolism

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4964-4964 ◽  
Author(s):  
Zachary Crowther ◽  
Jamie Doyle ◽  
Stanford Taylor ◽  
Nadia Ali
Keyword(s):  
Multiple Myeloma ◽  
Venous Thromboembolism ◽  
Clinical Outcomes ◽  
Chart Review ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Direct Result ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Growing Body

Introduction: Venous thromboembolism (VTE) is a common complication in multiple myeloma (MM) patients for several reasons; hematologic malignancy itself is a VTE risk factor and standard of care immunomodulatory drugs (IMiDs) in combination with dexamethasone (Dex) increase the risk further. This combination therapy has a mean VTE incidence of 21.5% in studies that did not use thromboprophylaxis and is recommended for all patients on IMiDs, although the optimal thromboprophylactic regimen remains uncertain. In clinical practice, aspirin (ASA) is commonly prescribed for VTE prophylaxis due to the ease of use. Despite this, the incidence of VTE remains between 7-14%. There is a growing body of literature supporting the efficacy and safety of direct oral anticoagulants (DOACs) for the treatment of VTE in cancer populations. We wanted to assess the incidence of VTE despite ASA prophylaxis at our institution and to further characterize the role of DOACs in the MM population. To do this, we performed a chart review of all MM patients who had been treated with lenalidomide and a DOAC, assessing for VTE development and patient outcomes. Methods: We conducted a retrospective chart review of patients with the diagnosis of MM treated with lenalidomide therapy at Fox Chase Cancer Center at Temple University Hospital or Cottman Avenue after Jan 1st, 2015 to July 2019. Eligible patients were identified through electronic medical record data mining for patients that had been diagnosed with MM, had been prescribed lenalidomide, had been taking ASA while on lenalidomide, and switched to rivaroxaban, edoxaban or apixaban. For comparison, the number of patients treated with lenalidomide and ASA who did not switch to a DOAC were also identified. Patient charts were reviewed for VTE development and bleeding complications after DOAC administration. Results: 132 patients were identified who had a diagnosis of MM and had been prescribed lenalidomide between Jan 1, 2015 and July 31, 2019. These patients were also prescribed aspirin except for three who were already on a DOAC prior to starting lenalidomide. Of the total 132 patients, only 17 were prescribed a DOAC. Six of the patients were on DOACs for reasons other than VTE (atrial fibrillation N=4, atrial flutter N=1, marantic endocarditis N=1). Eleven patients were started on DOACs for VTE; incidence of 8.3% in our myeloma population. However three of these VTEs occurred within one month of high dose melphalan chemotherapy and autologous stem cell rescue. These three patients had been off lenalidomide for over one month prior to VTE. Eight of the 17 patients with VTE developed clots in the setting of active MM and concurrent therapy with IMiD/Dex, independent of hospitalizations or other provoking factors. This is an incidence of 6.0% for VTE directly attributed to therapy. Six patients were on lenalidomide and Dex, while two patients developed VTE while on pomalidomide and Dex. No patients on lenalidomide experienced recurrent VTEs after being switched to therapeutic dose DOAC. One patient on pomalidomide/Dex did experience recurrent VTE. We examined all 17 patients who were on DOACs, 16 of which had been on IMiD and DOACs concurrently. Three had minor bleeding events which all resolved spontaneously. One patient had a major bleeding event, which was a fatal ruptured cerebral aneurysm while on a DOAC and ASA concurrently. Conclusion: The incidence of VTE in our patient population receiving IMiD/Dex while on ASA prophylaxis therapy was similar to what has been previously reported in the literature. We examined the clinical outcomes of 16 patients treated with IMiDs and DOACs concurrently and found few bleeding events. The one major bleed was likely precipitated by malignant hypertension and not a direct result of being on a DOAC. Taken together these results further support the growing body of evidence that DOACs are effective and safe treatments for VTE in cancer patients, including MM. Moving forward, our clinical experience with treatment dose DOACs supports the use of prophylactic dose DOACs to potentially further reduce the incidence of VTE in this high-risk population. Disclosures No relevant conflicts of interest to declare.

scholarly journals Treatment Patterns and Clinical Outcomes in Korean Cancer Patients With Venous Thromboembolism: A Retrospective Cohort Study

2021 ◽  
Vol 27 ◽  
pp. 107602962097957
Author(s):  
Soo-Mee Bang ◽  
Jin-Hyoung Kang ◽  
Min Hee Hong ◽  
Jin-Seok Ahn ◽  
So Yeon Oh ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Events ◽  
Factors Associated ◽  
Vein Thrombosis ◽  
Medical Chart Review ◽  
Deep Vein

This study assessed epidemiologic data and clinical outcomes, including venous thromboembolism (VTE) recurrence and bleeding events, in patients with cancer-associated VTE, and assessed factors associated with clinical outcomes. Data were extracted from retrospective medical-chart review of adult patients diagnosed with cancer-associated deep vein thrombosis or pulmonary embolism who received anticoagulation treatment for ≥3 months. Patients were classified by: low-molecular-weight heparin (LMWH), direct oral anticoagulants (DOACs), and other anticoagulants. First VTE recurrence and bleeding events, and factors associated with their occurrence, were assessed during the initial 6 months of treatment. Overall, 623 patients (age: 63.7 ± 11.3 years, 49.3% male) were included (119, 132, and 372 patients in LMWH, DOACs and other anticoagulants groups, respectively). The cumulative 6-month incidence of VTE recurrence was 16.6% (total), 8.3% (LMWH), 16.7% (DOACs), and 20.7% (other); respective bleeding events were 22.5%, 11.0%, 12.3%, and 30.7%). VTE recurrence and bleeding rates differed only between LMWH and other anticoagulants (HR 2.4, 95% CI: 1.2-5.0 and 3.6, 1.9-6.8, respectively). These results highlight the importance of initial VTE treatment choice for preventing VTE recurrence and bleeding events. LMWH or DOACs for ≥3 months can be considered for effective VTE management in cancer patients.

Safety and efficacy of direct oral anticoagulants for venous thromboembolism and stroke prophylaxis in patients with hematologic malignancies

2019 ◽  
Vol 26 (2) ◽  
pp. 351-360 ◽  
Author(s):  
Stephanie Kim ◽  
Jennifer Namba ◽  
Aaron M Goodman ◽  
Thi Nguyen ◽  
Ila M Saunders
Keyword(s):  
Molecular Weight ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Hematologic Malignancies ◽  
Low Molecular Weight ◽  
Direct Oral Anticoagulant ◽  
Low Molecular Weight Heparins ◽  
Bleeding Events

Purpose Low-molecular-weight heparins are currently the recommended antithrombotic therapy for treatment and prevention of malignancy-related venous thromboembolism. Currently, the evidence evaluating direct oral anticoagulants versus low-molecular-weight heparins or a vitamin K antagonist in cancer patients with hematologic malignancies is limited. We evaluated the safety and efficacy of direct oral anticoagulants for venous thromboembolism treatment or stroke prevention for non-valvular atrial fibrillation in patients with hematologic malignancies. Methods This was a retrospective evaluation of adult patients with hematologic malignancies who received at least one dose of the Food and Drug Administration-approved direct oral anticoagulant for venous thromboembolism treatment or stroke prevention. We determined the frequency of major bleeding events, non-major bleeding events, stroke, systemic embolism, appropriateness of initial direct oral anticoagulant doses, holding practices prior to procedures, and the rate of all-cause mortality. An analysis was also performed to compare the incidence of bleeding between patients with a history of hematopoietic stem cell transplant to non-transplant patients. Results A total of 103 patients were identified, with the majority of patients receiving rivaroxaban for venous thromboembolism treatment. Major bleeding events occurred in four patients and no fatal bleeding events occurred. Non-major bleeding occurred in 29 patients, most commonly epistaxis and bruising. Two patients experienced a systemic embolism while on direct oral anticoagulant therapy. Conclusion Direct oral anticoagulants may be a safe and effective alternative for anticoagulation therapy in patients with hematologic malignancies. However, larger prospective studies comparing direct oral anticoagulants to low-molecular-weight heparins or vitamin K antagonists are warranted to compare efficacy and safety outcomes in this patient population.

scholarly journals Safety of Rivaroxaban for Postoperative Venous Thromboembolism Prophylaxis Following Abdominal Body Contouring Surgery: 600 Patients

2020 ◽  
Author(s):  
Vasileios Vasilakis ◽  
Bill G Kortesis ◽  
Gaurav Bharti ◽  
Matthew H Isakson ◽  
Joseph P Hunstad
Keyword(s):  
Venous Thromboembolism ◽  
Oral Anticoagulants ◽  
Body Contouring ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Level Of Evidence ◽  
Once Daily ◽  
Postoperative Course ◽  
Body Contouring Surgery ◽  
Vte Prophylaxis

Abstract Background Reducing the incidence of venous thromboembolism (VTE) following abdominal body contouring surgery remains a top priority for patient safety. There is a lack of consensus regarding the optimal chemoprophylactic agent for postoperative VTE prophylaxis, and the role of oral anticoagulants warrants further investigation. Objectives The aim of this multisurgeon, single-institution study was to determine the safety and efficacy of a 7-day postoperative rivaroxaban regimen for VTE prophylaxis in abdominal body contouring surgery. Methods A retrospective chart review was performed of all patients who underwent abdominoplasty, circumferential body lift, fleur-de-lis panniculectomy, or circumferential fleur-de-lis panniculectomy at our surgical center from August 2014 to November 2019. A 7-day postoperative course of once-daily 10 mg rivaroxaban, starting on postoperative day 1, was administered to every patient unless there was a contraindication. The 2 primary endpoints were the incidence of VTE and bleeding events. Results A total of 600 patients were included in the study. There were no deaths. There were 4 (0.7%) incidents of VTE events: 2 (0.3%) patients suffered pulmonary embolus and 2 (0.3%) patients suffered a lower-extremity deep venous thrombosis. A total of 13 (2.2%) patients suffered complications related to bleeding. Of these, operative intervention for control and evacuation was required in 7 (1.2%) patients. Conclusions A 7-day postoperative course of once-daily rivaroxaban for VTE risk reduction in abdominal body contouring surgery is associated with a low incidence of VTE events and a low risk of bleeding complications. Level of Evidence: 4

The Effectiveness and Safety of Direct Oral Anticoagulants (DOACs) Vs. Traditional Anticoagulants in Patients with Cirrhosis

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5015-5015
Author(s):  
Justin Hum ◽  
Janice Jou ◽  
Thomas G. Deloughery ◽  
Joseph Shatzel
Keyword(s):  
Major Bleeding ◽  
Conflicts Of Interest ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Complications ◽  
Efficacy And Safety ◽  
Recurrent Thrombosis ◽  
Bleeding Events ◽  
Cirrhotic Patients

Abstract Introduction: The coagulopathy associated with cirrhosis is complex and places patients at risk for both bleeding and thrombosis. Direct oral anticoagulants (DOACs) have been shown to have superior efficacy and safety compared to vitamin K antagonists; however their efficacy and safety in cirrhotic patients is not clear. The aim of this study is to retrospectively compare the effectiveness and bleeding complications of DOACs as compared to traditional anticoagulants in cirrhotic patients. Methods: This study was a retrospective review of patients treated at a single academic center between 2012-2015 who were prescribed a DOAC (apixaban or rivaroxaban), or a traditional anticoagulant (warfarin or low molecular weight heparin), with an ICD-9 code for the diagnosis of cirrhosis. The primary outcomes of interest are recurrent thrombosis or stroke (efficacy failure), or bleeding events (safety failure). Major bleeds were characterized as fatal bleeding, symptomatic bleeding in critical organ area, or bleeding causing a fall in hemoglobin level >2 or leading to transfusion of 2+ units of packed red blood cells. Results: During the study period, 27 cirrhotic patients were prescribed a DOAC and 18 were prescribed a traditional anticoagulant (either LMWH or warfarin). Both groups had similar total bleeding events (8 DOAC vs. 10 traditional anticoagulation, p = 0.12). There were significantly less major bleeding episodes in the DOAC group, (1 (4%) vs. 5 (28%), p = 0.03) and less intracranial bleeding (3 (17% ) vs. 0 (0%) p=0.06). Recurrent thrombosis or stroke occurred in 1 (4%) patient in the DOAC group and 1 (6%) patient in the traditional group (p = 1.0). Conclusions: Anticoagulation with DOACs in cirrhotic patients may be as safe as traditional anticoagulants with respect to bleeding events. Patients with cirrhosis at our center prescribed DOACs had less major bleeding events, while maintaining efficacy at preventing stroke or recurrent thrombosis. Table Table. Disclosures No relevant conflicts of interest to declare.

scholarly journals Use of Direct Oral Anticoagulants in Patients on Immunomodulatory Agents

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1449-1449 ◽  
Author(s):  
Louise Man ◽  
Amy L Morris ◽  
Jacqueline Brown ◽  
Surabhi Palkimas ◽  
Kelly Mercer Davidson
Keyword(s):  
Multiple Myeloma ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Thrombotic Event ◽  
Antiplatelet Agent ◽  
Bleeding Events ◽  
Thrombotic Risk ◽  
Vte Prophylaxis ◽  
Warfarin Group ◽  
Risk Patients

Abstract The risk of venous thromboembolism (VTE) is increased in individuals with cancer, particularly in those with multiple myeloma. The immunomodulatory agents (IMiDs) thalidomide, lenalidomide and pomalidomide are commonly used to treat multiple myeloma and other hematologic malignancies and are associated with increased risk of VTE. Current National Comprehensive Cancer Network (NCCN) guidelines (v.1.2016) on cancer-associated VTE utilize a risk assessment model based on a few small studies to guide VTE prophylaxis for multiple myeloma patients being treated with an IMiD (Palumbo, et al. Leukemia, 2008). Aspirin is recommended for lower risk patients while prophylactic-dose low molecular weight heparin or therapeutic warfarin are recommended for higher risk patients. The use of direct oral anticoagulants (DOACs) for cancer-associated VTE is currently under investigation (Raskob, et al. Lancet Haematol, 2016). Little is known about their role in VTE prophylaxis in patients on IMiDs. The purpose of this study was to explore the use of DOACs in patients receiving IMiDs. We performed a retrospective chart review of all patients at the University of Virginia Health System who received an IMiD and who were taking either a DOAC or warfarin between January 1, 2010 and December 31, 2015. DOACs included dabigatran, rivaroxaban, and apixaban. IMiDs included lenalidomide, thalidomide, and pomalidomide. The primary endpoint was to assess the safety of DOACs as compared to warfarin, and the secondary endpoint was to assess their efficacy. We collected baseline patient information, as well as diagnosis, IMiD, anticoagulant, antiplatelet agent and dose, duration of treatment, concurrent antineoplastic therapies, and thrombotic risk factors. We utilized the NCCN definitions of individual and myeloma-related thrombotic risk factors. Many patients had changes in their IMiD or anticoagulation. Thus, separate encounters were collected, where an encounter was the combination of an IMiD agent and dose, the anticoagulant, the antiplatelet agent (if any), and the thrombotic risk profile for that time period. Descriptive analyses were performed on all encounters in both groups. Rates of bleeding and thrombotic events were calculated. There were 21 discrete patients in the DOAC group and 16 in the warfarin group. Characteristics and outcomes are described in Table 1. There were four non-major bleeding events in the DOAC group; two of the four bleeding events occurred while on concomitant aspirin therapy. The patient with hematuria stopped anticoagulation and cystoscopy revealed bladder cancer. The other patients did not change or stop therapy. There were six bleeding events in the warfarin group: two were major and four were non-major. The two major events were gastrointestinal bleeding (GIB) and a subarachnoid hemorrhage (SAH). Neither event occurred while on concomitant antiplatelet therapy. The GIB required cessation of therapy, hospitalization, and transfusions. The INR at the time is unknown. The SAH was preceded by a fall while INR was in therapeutic range. Both major and two of the non-major bleeding events occurred in the same patient at different time points and accounted for most of the warfarin-related bleeding events. There was one thrombotic event in the DOAC group. The patient had a non-ST segment elevation myocardial infarction (NSTEMI) while on prophylactic-dose rivaroxaban. She was not on concomitant antiplatelet therapy. Arterial thrombotic events are not typically seen with IMiDs, and the NSTEMI was thought to be related to the recent initiation of carfilzomib. There were no thrombotic events in the warfarin group. This was a retrospective, single-institution study assessing the safety and efficacy of DOACs as compared to warfarin in patients on IMiDs. In our study, all bleeding events in the DOAC group were non-major, while patients on warfarin experienced both major and non-major bleeds. Only one thrombotic event was recorded in the DOAC group. DOACs may represent an attractive alternative to warfarin for VTE prophylaxis in these patients, given no need for routine monitoring and fewer dietary restrictions. Prospective studies in this population are warranted. Disclosures No relevant conflicts of interest to declare.

455Prediction of major bleeding in patients receiving DOACs for venous thromboembolism: a prospective cohort study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M C Vedovati ◽  
A Mancuso ◽  
L Pierpaoli ◽  
U Paliani ◽  
S Conti ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Prospective Cohort ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Risk Scores ◽  
Bleeding Complications ◽  
Risk Category ◽  
Vein Thrombosis ◽  
C Statistic

Abstract Background The accuracy of currently available bleeding scores in patients on treatment with direct oral anticoagulants (DOACs) for venous thromboembolism (VTE) is undefined. Purpose In a prospective cohort of patients with VTE treated with DOACs, we evaluated the accuracy of the ATRIA, HAS-BLED, Kuijer, ORBIT, RIETE and VTE-BLEED risk scores in predicting major bleeding (according to ISTH definition). Methods The accuracy of different scores to correctly classify subjects into a defined risk category was assessed by the c-statistic. Results Overall, 1141 patients were evaluated and 1034 included in the study. The index event was pulmonary embolism in 509 patients (49.2%) and proximal deep vein thrombosis in the remaining patients (50.8%). During the 12-month study period, 26 major bleedings occurred in 25 patients (2.8% patient-year): 14 major bleedings occurred in the first 6 months of treatment and 12 from 6 to 12 months in the 654 patients remained on treatment. In the 12-month study period, the VTE-BLEED score showed the best predictive value for bleeding complications (c-statistics 0.674, 95% CI 0.593–0.755). The lowest incidence of major bleeding (0.3%) was observed in the low risk category of VTE-BLEED which includes 38% of patients. The highest incidence of major bleeding (7.1%) was observed in the high-risk category of ORBIT which includes 10.9% of patients. Conclusions The VTE-BLEED score had the best accuracy in predicting major bleeding during treatment with DOACs for VTE. Whether the VTE-BLEED score can be used for decision making on anticoagulation should be tested in a management study.

Reversal strategies in patients treated with direct oral anticoagulants

VASA ◽  
2019 ◽  
Vol 48 (5) ◽  
pp. 389-392 ◽  
Author(s):  
Paul Gressenberger
Keyword(s):  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Invasive Procedure ◽  
Bleeding Risk ◽  
Study Data ◽  
Current Evidence ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Reversal Agent

Summary. Administration of direct oral anticoagulants (DOACs) for the treatment of venous thrombotic events (VTE) or non-valvular atrial fibrillation (AF) is now standard of care and has demonstrated clinical efficacy and safety in numerous clinical studies. Usually these substances have lower overall mortality and less risk of cerebral hemorrhage, but depending on the substance and study, they are more likely to cause gastrointestinal bleeding than vitamin K antagonists (VKA), the medication that used to be standard for VTE and AF. Since DOACs have very short plasma elimination half-lives compared to VKA, for most bleeding events, expert opinions suggest that withdrawal of DOACs and supportive care will likely suffice to stop a bleeding episode. Because there is a bleeding risk associated with DOACs, reversal strategies may be needed if a patient receiving DOAC therapy bleeds during surgery or an invasive procedure. So far, idarucizumab has been the only available antidote that binds specifically to dabigatran and safely and quickly reverses its anticoagulant effects. Idarucizumab has no effects on anti Xa inhibitors or other anticoagulants. To date, treatment of serious, life-threatening bleeds in patients with anti-Xa-inhibitor has involved 4 factor prothrombin complex concentrates (PCC). PCC restores normal hemostasis laboratory values in most patients with major bleeding events after anti Xa inhibitor intake. Recently, the US Food and Drug Administration (FDA) approved andexanet alfa as the first specific antidote for the anti-Xa inhibitors apixaban and rivaroxaban. So far clinical experience with this substance and data comparing it with PCC are lacking. Currently ciraparantag is under investigation as a universal reversal agent for all DOACs and low molecular weight heparin as well. Because it is so broadly applicable, ciraparantag might be a good future option for the management of most bleeding complications under anticoagulant treatment. The aim of this review is to summarize recent study data and recommendations on nonspecific and specific DOAC reversal strategies and to present the current evidence.

scholarly journals Contrasts in Glioblastoma—Venous Thromboembolism versus Bleeding Risk

Cells ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. 1414
Author(s):  
Viktoria Muster ◽  
Thomas Gary
Keyword(s):  
Venous Thromboembolism ◽  
Patient Group ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Bleeding Events ◽  
Therapeutic Anticoagulation ◽  
Vulnerable Patient ◽  
Risk Treatment ◽  
Thrombogenic Potential

Glioblastoma is among the tumor entities with an extreme thrombogenic potential and patients are at very high risk of developing a venous thromboembolism (VTE) over the course of the disease, with an incidence of up to 30% per year. Major efforts are currently being made to understand and gain novel insights into the underlying pathomechanisms of the development of VTE in patients with glioblastoma and to find appropriate biomarkers. Yet, patients with glioblastoma not only face a high thromboembolic risk but are also at risk of bleeding events. In the case of VTE, a therapeutic anticoagulation with low molecular weight heparin or, in the case of low bleeding risk, treatment with a direct oral anticoagulant, is recommended, according to recently published guidelines. With respect to an elevated bleeding risk in glioblastoma patients, therapeutic anticoagulation remains challenging in this patient group and prospective data for this vulnerable patient group are scarce, particularly with regard to direct oral anticoagulants.

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