Recurrence of malignancy-associated venous thromboembolism among patients treated with rivaroxaban compared to enoxaparin

2017 ◽  
Vol 24 (3) ◽  
pp. 185-189 ◽  
Author(s):  
Megan D Nicklaus ◽  
Shannon L Ludwig ◽  
Jacob K Kettle
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Group Versus ◽  
Factor Xa ◽  
Standard Of Care ◽  
Duration Of Treatment ◽  
Time To Recurrence ◽  
Enoxaparin Group ◽  
Secondary Outcomes ◽  
Recurrent Vte

Purpose Although low-molecular-weight heparin (LMWH) remains the standard of care, factor Xa inhibitors such as rivaroxaban may serve as an alternative treatment for venous thromboembolism (VTE) in patients with active malignancy. The purpose of the analysis was to evaluate outcomes of VTE management in cancer patients treated with rivaroxaban compared to enoxaparin. Methods This single-center retrospective analysis was conducted on patients with malignancy-associated VTE initiated on treatment with either rivaroxaban or enoxaparin. The primary endpoint was the incidence of recurrent VTE. Secondary outcomes included a comparison in rates of bleeding, mean duration of treatment, and mean time to recurrence of VTE. Results A total of 45 patients were included in each group. The incidence of recurrent VTE was 8.9% in the rivaroxaban group versus 13.3% in the enoxaparin group ( p = 0.53). There were no statistically significant differences in the secondary outcomes with the exception of longer mean duration of treatment in the rivaroxaban group compared to the enoxaparin group (169 vs. 110 days, respectively; p = 0.04). Conclusions This study provides important preliminary information regarding the efficacy and safety of rivaroxaban for treatment of VTE in cancer patients. Although LMWH should remain the standard of care, these results provide initial reassurance that rivaroxaban serves as a viable alternative in the event that injectable anticoagulation is not an acceptable approach to VTE management.

Spotlight on real-world evidence for the treatment of DVT: XALIA

2016 ◽  
Vol 116 (S 02) ◽  
pp. S41-S49 ◽  
Author(s):  
Alexander Turpie ◽  
Walter Ageno
Keyword(s):  
Venous Thromboembolism ◽  
Real World ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
Standard Of Care ◽  
Thrombin Inhibitors ◽  
Direct Thrombin Inhibitors ◽  
Vein Thrombosis ◽  
Real World Evidence ◽  
Recurrent Vte

SummaryVenous thromboembolism (VTE), comprising both deep-vein thrombosis (DVT) and pulmonary embolism (PE), is a serious and common cardiovascular disease associated with the risk of chronic complications, recurrent VTE events and even death. The treatment landscape has, in recent years, seen a paradigm shift from the use of traditional anticoagulants (low-molecular-weight heparin [LMWH] overlapping with and followed by a vitamin K antagonist [VKA]) to non-VKA oral anticoagulants (NOACs). This class of agents, encompassing direct factor Xa inhibitors and direct thrombin inhibitors have shown non-inferior efficacy and better safety to standard of care in randomised controlled trials (RCTs). The direct, oral factor Xa inhibitor rivaroxaban was the first to be approved for treatment of acute DVT and PE and secondary prevention of recurrent VTE events based on data from EINSTEIN DVT and EINSTEIN PE, respectively. Real-world evidence now helps to further support data from RCTs, and also bridges the gap for physicians regarding any areas of clinical uncertainty that may not be addressed by RCTs. XA inhibition with rivaroxaban for Long-term and Initial Anticoagulation in venous thromboembolism (XALIA) was the first large, prospective, observational, real-world study that has investigated the safety and effectiveness profile of rivaroxaban in patients with DVT and PE associated with DVT in routine clinical practice. This article will present the key clinical outcomes from this important global non-interventional study, and will discuss remaining questions to be addressed in Phase IV studies.

The use of rivaroxaban for short- and long-term treatment of venous thromboembolism

2012 ◽  
Vol 107 (06) ◽  
pp. 1035-1043 ◽  
Author(s):  
Alexander Cohen ◽  
Mark Dobromirski
Keyword(s):  
Venous Thromboembolism ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Factor Xa ◽  
Standard Of Care ◽  
Term Treatment ◽  
Current Standard ◽  
Long Term Treatment ◽  
Extended Duration ◽  
Recurrent Vte

SummaryVenous thromboembolism (VTE) is a major healthcare concern and affects more than 1.6 million individuals each year worldwide. Long-term complications include recurrent VTE, chronic thromboembolic pulmonary hypertension and post-thrombotic syndrome. Rivaroxaban is an oral, direct factor Xa inhibitor that has advantages over traditional VTE therapies, including minimal drug and food interactions and no requirement for routine coagulation monitoring. It is currently approved for VTE prevention in adult patients undergoing elective hip or knee replacement surgery. This review evaluates the potential clinical implications of the multicentre, randomised EINSTEIN studies (EINSTEIN DVT and EINSTEIN EXT), which investigated rivaroxaban for the treatment and prevention of recurrent VTE. In EINSTEIN DVT, rivaroxaban was non-inferior to the standard of care (enoxaparin plus a vitamin K antagonist) for recurrent VTE in patients with acute deep-vein thrombosis (DVT) without pulmonary embolism (PE). In EINSTEIN EXT, extended-duration rivaroxaban had superior efficacy to placebo in patients with confirmed DVT or PE who had received 6–12 months of prior VTE treatment. Rivaroxaban was associated with an acceptable safety profile in both studies. The net clinical benefit (efficacy and safety end-points combined) of rivaroxaban was significantly greater than its comparators. The EINSTEIN studies are the first demonstration that a single drug - rivaroxaban - can be effective for both the initial treatment of DVT and prevention of recurrent VTE. Moreover, the simple, once-daily oral administration of rivaroxaban could potentially improve adherence to extended-duration VTE treatment compared with the current standard of care in individuals with confirmed DVT or PE.

Treatment and secondary prevention of venous thromboembolism in cancer patients

2012 ◽  
Vol 03 (03) ◽  
pp. 121-125
Author(s):  
I. Pabinger ◽  
C. Ay
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Patients With Cancer ◽  
Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

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.

Predictors of the Indefinite-Duration Anticoagulation Treatment Strategy In Patients with Cancer-Associated Thrombosis.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 1097-1097
Author(s):  
David Spirk ◽  
Wolfgang Korte ◽  
Marc Husmann ◽  
Beat Frauchiger ◽  
Martin Banyai ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Metastatic Disease ◽  
Metastatic Cancer ◽  
Anticoagulation Therapy ◽  
Medical Attention ◽  
Patients With Cancer ◽  
Anticoagulation Treatment ◽  
Recurrent Vte ◽  
Cancer Associated Thrombosis

Abstract Abstract 1097 Background: In patients with cancer and acute venous thromboembolism (VTE), current consensus guidelines recommend anticoagulation therapy for an indefinite duration or until the cancer is resolved. Methods and results: Among 1’247 patients with acute VTE enrolled in the Swiss Venous Thromboembolism Registry (SWIVTER) from 18 hospitals, 315 (25%) had cancer of whom 179 (57%) had metastatic disease, 159 (50%) ongoing or recent chemotherapy, and 83 (26%) tumor surgery within 6 months. Patients with cancer were older (66±14 vs. 60±19 years, p<0.001), more often hospitalized at the time of VTE diagnosis (46% vs. 36%, p=0.001), immobile for >3 days (25% vs. 16%, p<0.001), and more often had thrombocytopenia (6% vs. 1%, p<0.001) than patients without cancer. The 30-day rate of VTE-related death or recurrent VTE was 9% in cancer patients vs. 4% in patients without cancer (p<0.001), and the rates of bleeding requiring medical attention were 5% in both groups (p=0.57). Cancer patients received indefinite-duration anticoagulation treatment more often than patients without cancer (47% vs. 19%, p<0.001), and LMWH mono-therapy during the initial 3 months was prescribed to 45% vs. 8%, p<0.001, respectively. Among patients with cancer, prior VTE (OR 4.0, 95%CI 2.0–8.0), metastatic disease (OR 3.0, 95%CI 1.7–5.2), outpatient status at the time of VTE diagnosis (OR 3.8, 95%CI 1.9–7.6), and inpatient treatment (OR 4.4, 95%CI 2.1–9.2) were independently associated with the prescription of indefinite-duration anticoagulation treatment. Conclusions: Less than half of the cancer patients with acute VTE received a prescription for indefinite-duration anticoagulation treatment. Recurrent VTE, metastatic cancer, outpatient VTE diagnosis, and VTE requiring hospitalization were associated with an increased use of this strategy. Disclosures: Spirk: sanofi-aventis (suisse) sa: Employment.

scholarly journals Canadian consensus recommendations on the management of venous thromboembolism in patients with cancer. Part 2: treatment

2015 ◽  
Vol 22 (2) ◽  
pp. 144 ◽  
Author(s):  
J.C. Easaw ◽  
M.A. Shea-Budgell ◽  
C.M.J. Wu ◽  
P.M. Czaykowski ◽  
J. Kassis ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Renal Insufficiency ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Factor Xa ◽  
Patients With Cancer ◽  
Clinical Scenarios ◽  
Increased Risk

Patients with cancer are at increased risk of venous thromboembolism (vte). Anticoagulation therapy is used to treat vte; however, patients with cancer have unique clinical circumstances that can often make decisions surrounding the administration of therapeutic anticoagulation complicated. No national Canadian guidelines on the management of established cancer-associated thrombosis have been published. We therefore aimed to develop a consensus-based, evidence-informed guideline on the topic.PubMed was searched for clinical trials and meta-analyses published between 2002 and 2013. Reference lists of key articles were hand-searched for additional publications. Content experts from across Canada were assembled to review the evidence and make recommendations.Low molecular weight heparin is the treatment of choice for cancer patients with established vte. Direct oral anticoagulants are not recommended for the treatment of vte at this time. Specific clinical scenarios, including the presence of an indwelling venous catheter, renal insufficiency, and thrombocytopenia, warrant modifications in the therapeutic administration of anticoagulation therapy. Patients with recurrent vte should receive extended (>3 months) anticoagulant therapy. Incidental vte should generally be treated in the same manner as symptomatic vte. There is no evidence to support the monitoring of anti–factor Xa levels in clinically stable cancer patients receiving prophylactic anticoagulation; however, levels of anti–factor Xa could be checked at baseline and periodically thereafter in patients with renal insufficiency. Follow-up and education about the signs and symptoms of vte are important components of ongoing patient care.

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.

Direct oral anticoagulants for the treatment of cancer-associated venous thromboembolism

Phlebologie ◽  
2017 ◽  
Vol 46 (06) ◽  
pp. 340-351
Author(s):  
M. Voigtlaender ◽  
F. Langer
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Treatment Phase ◽  
Standard Of Care ◽  
Longterm Treatment ◽  
Increased Risk ◽  
Direct Head

SummaryCancer patients with venous thromboembolism (VTE) are at increased risk for both bleeding and VTE recurrence. Anticoagulation with low-molecular-weight heparin (LMWH) is the standard of care during the initial and longterm treatment phase (i.e. during the first 3–6 months of therapy) based on its overall beneficial safety and efficacy profile compared to vitamin K antagonists (VKAs). The direct oral anticoagulants (DOACs) rivaroxaban, apixaban, edoxaban, and dabigatran are approved for the treatment of acute VTE, and the combined six phase-3 trials have included > 1 500 patients with active cancer, as defined by variable selection criteria. Subgroup analyses of these patients, either pooled or separately reported, suggest that DOACs could be a safe and efficacious alternative to VKA therapy for the treatment of cancer-associated VTE. However, the populations of cancer patients included in the DOAC and LMWH trials are not comparable with regard to mortality and VTE risk, and no specific data from direct head-to-head comparisons of DOACs with LMWHs are currently available. The use of DOACs for the management of VTE in cancer is thus not recommended by clinical practice guidelines.

Real-world treatment patterns, survival, and cost among elderly cervical cancer patients.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18226-e18226
Author(s):  
Changxia Shao ◽  
Jinghua He ◽  
Chizoba Nwankwo ◽  
Karen Stein ◽  
Stephen Michael Keefe
Keyword(s):  
Cervical Cancer ◽  
Cancer Patients ◽  
Real World ◽  
Median Overall Survival ◽  
Stage Iv ◽  
Standard Of Care ◽  
Emergency Room Visits ◽  
Duration Of Treatment ◽  
Medicare Data ◽  
Systemic Therapies

e18226 Background: Limited chemotherapy data is available for elderly cervical cancer patients (pts). This study aimed to investigate real-world use of systemic therapies, survival, and costs among elderly pts in U.S. Methods: Pts who aged 65+ years and initially diagnosed with cervical cancer between 2007 and 2013 were identified using the SEER-Medicare data. Regimens were classified into 3 mutually-exclusive categories, i.e. cisplatin (Cis), carboplatin (Car), and Other based therapies. Chemotherapy within 90 days of surgery or radiation therapy were not considered as first line (1L) systemic therapy. All costs were converted to 2016 US dollars. Results: A total of 1 651 eligible pts were identified with 430 (26%) being stage IV at diagnosis. Among pts received systemic therapies, the median overall survival (OS) was 14 m from 1L initiation and 10 m from 2L initiation. Among 225 pts who received 1L, 58% pts received Cis-based therapy, and 17% pts received Car-based therapy. Car + paclitaxel was the most commonly used regimen (44%). Among 73 pts who received 2L, 34% and 15% pts received Cis- and Car-based therapy, respectively. Pts with 2L therapy received a variety of regimens with the top 3 being Car + paclitaxel (19%), gemcitabine (11%), and topotecan (9.6%). Median duration of treatment (DOT) was 4-6 m across line of therapies (LOTs), yet median time to next treatment (TTNT) ranged 10-32 m for 1L, and 9-11 m for 2L. The average per person per month (PPPM) costs were 7.1k for 1L and 8.8k for 2L with primary drivers of spending being outpatient and emergency room visits. Conclusions: Elderly pts with advanced cervical cancer requiring chemotherapy had poor prognosis and had no standard of care for 2L therapy. Per-patient economic burden is substantial for both 1L and 2L therapy, exceeding 7k dollars per month. [Table: see text]

Edoxaban for treatment of venous thromboembolism in patients with cancer

2015 ◽  
Vol 114 (12) ◽  
pp. 1268-1276 ◽  
Author(s):  
Marcello Di Nisio ◽  
Suzanne M. Bleker ◽  
Annelise Segers ◽  
Michele F. Mercuri ◽  
Lee Schwocho ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Anticoagulant Treatment ◽  
Design Features ◽  
Symptomatic Disease ◽  
Cancer Study ◽  
Patients With Cancer ◽  
Long Term Treatment ◽  
Recurrent Vte

SummaryDirect oral anticoagulants may be effective and safe for treatment of venous thromboembolism (VTE) in cancer patients, but they have not been compared with low-molecular-weight heparin (LMWH), the current recommended treatment for these patients. The Hokusai VTE-cancer study is a randomised, open-label, clinical trial to evaluate whether edoxaban, an oral factor Xa inhibitor, is non-inferior to LMWH for treatment of VTE in patients with cancer. We present the rationale and some design features of the study. One such feature is the composite primary outcome of recurrent VTE and major bleeding during a 12-month study period. These two complications occur frequently in cancer patients receiving anticoagulant treatment and have a significant impact. The evaluation beyond six months will fill the current gap in the evidence base for the long-term treatment of these patients. Based on the observation that the risk of recurrent VTE in patients with active cancer is similar to that in those with a history of cancer, the Hokusai VTE-cancer study will enrol patients if whose cancer was diagnosed within the past two years. In addition, patients with incidental VTE are eligible because their risk of recurrent VTE is similar to that in patients with symptomatic disease. The unique design features of the Hokusai VTE-cancer study should lead to enrolment of a broad spectrum of cancer patients with VTE who could benefit from oral anticoagulant treatment.

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