scholarly journals Direct oral anticoagulants in the treatment of venous thromboembolism, with a focus on patients with pulmonary embolism: an evidence-based review

2014 ◽  
pp. 627 ◽  
Author(s):  
Antonio Gomez-Outes ◽  
M. Luisa Suarez-Gea ◽  
Ramon Lecumberri ◽  
Ana-Isabel Terleira-Fernandez ◽  
Emilio Vargas-Castrillon
Keyword(s):  
Pulmonary Embolism ◽  
Venous Thromboembolism ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Evidence Based

scholarly journals Dabigatran after Short Heparin Anticoagulation for Acute Intermediate-Risk Pulmonary Embolism: Rationale and Design of the Single-Arm PEITHO-2 Study

2017 ◽  
Vol 117 (12) ◽  
pp. 2425-2434 ◽  
Author(s):  
Frederikus Klok ◽  
Walter Ageno ◽  
Stefano Barco ◽  
Harald Binder ◽  
Benjamin Brenner ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Venous Thromboembolism ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Phase Iii ◽  
Thrombin Inhibitor ◽  
Intermediate Risk ◽  
Safety Outcome ◽  
Efficacy Outcome ◽  
Heparin Anticoagulation

AbstractPatients with intermediate-risk pulmonary embolism (PE) may, depending on the method and cut-off values used for definition, account for up to 60% of all patients with PE and have an 8% or higher risk of short-term adverse outcome. Although four non-vitamin K-dependent direct oral anticoagulants (NOACs) have been approved for the treatment of venous thromboembolism, their safety and efficacy as well as the optimal anticoagulation regimen using these drugs have not been systematically investigated in intermediate-risk PE. Moreover, it remains unknown how many patients with intermediate-high-risk and intermediate-low-risk PE were included in most of the phase III NOAC trials. The ongoing Pulmonary Embolism International Thrombolysis 2 (PEITHO-2) study is a prospective, multicentre, multinational, single-arm trial investigating whether treatment of acute intermediate-risk PE with parenteral heparin anticoagulation over the first 72 hours, followed by the direct oral thrombin inhibitor dabigatran over 6 months, is effective and safe. The primary efficacy outcome is recurrent symptomatic venous thromboembolism or death related to PE within the first 6 months. The primary safety outcome is major bleeding as defined by the International Society on Thrombosis and Haemostasis. Secondary outcomes include all-cause mortality, the overall duration of hospital stay (index event and repeated hospitalizations) and the temporal pattern of recovery of right ventricular function over the 6-month follow-up period. By applying and evaluating a contemporary risk-tailored treatment strategy for acute PE, PEITHO-2 will implement the recommendations of current guidelines and contribute to their further evolution.

Evaluation of Efficacy and Safety of Direct Oral Anticoagulants (DOACS) in the Treatment of Venous Thromboembolism in Cancer Patients

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5016-5016
Author(s):  
Ali McBride ◽  
Reem Diri ◽  
Chris Campen ◽  
Ivo Abraham
Keyword(s):  
Pancreatic Cancer ◽  
Pulmonary Embolism ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Secondary Prophylaxis ◽  
Efficacy And Safety ◽  
Bleeding Episodes ◽  
Current Guidelines

Abstract Background: Nearly twenty percent of all patients with deep venous thrombosis (DVT) or pulmonary embolism (PE) have an underlying malignancy. Current guidelines recommend low molecular weight heparin (LMWH)-based therapy for venous thromboembolism (VTE) treatment in cancer patients; however, patient considerations including access for treatment and monitoring, co-pay costs and self-administration can be a limitation for its use. Alternative treatments such as direct oral anticoagulants (DOACs) are an attractive alternative to patients and clinicians because of limited monitoring, fixed dosing and limited drug and food interaction. Current guidelines, including those of the American Society of Clinical Oncology and National Comprehensive Cancer Network, do not recommend the use of DOACs for VTE treatment at this time in cancer patients as there is limited data for VTE treatment and secondary prophylaxis with DOAC's. Methods :We performed a retrospective evaluation of cancer patients at our institution with an active VTE diagnosis who were administered DOACs (rivaroxaban, apixaban and dabigatran) between November 2013 and April 2016. Data collected included patient demographics, diagnosis, and chemotherapy regimen, previous history of VTE, and efficacy and safety during anticoagulation with DOAC's. Results : One hundred and thirty-seven patients were included in the study (Table 1), with 112 patients on rivaroxaban, 20 patients on apixaban, and 5 patients on dabigatran. DOACs were administered to treat deep venous thrombosis (DVT) in 86 patients, pulmonary embolism (PE) in 31 patients, and both DVT and PE diagnosis in 20 patients. Only four patients had a secondary clot on therapy during treatment: one patient with pancreatic cancer on apixaban developed recurrent portal vein thrombosis, and three patients with pancreatic cancer, adenocarcinoma of the lung, and Factor V Leiden deficiency on rivaroxaban; 2 patients developed recurrent DVT, and 1 patient developed recurrent PE. Overall, 34/137 (25%) patients experienced a total of 37 bleeding episodes, of which 33/37 were classified as clinically relevant non-major bleeding and 4/37 as minor bleeding. Thirty eight patients had their doses held ,discontinued, discontinued or switched to different anticoagulation therapy; in 11 patients secondary to bleeding, four failed therapy, three experienced intolerance to DOAC, two patients were changed secondary to drug interactions and two patients could not continue therapy secondary to co-pay costs, and two were held prior to surgery. Ten patients had recurrent (>2) bleeding episodes including epistaxis, hematochezia, hematuria, and hematemesis. Conclusion :In our analysis, DOACs did yield efficacy in cancer patients treated for secondary prophylaxis of VTE with few noted side effects. In our study, DOAC's did not cause fatal or major bleeding. Future prospective studies are warranted for secondary prophylaxis in this setting. Table 1. Baseline characteristics and outcomes of patients on DOAC's for Secondary DVT prophylaxis Evaluation of Efficacy and Safety of DOACsin the Treatment of Venous Thromboembolism in Cancer Patients Evaluation of Efficacy and Safety of DOACsin the Treatment of Venous Thromboembolism in Cancer Patients Disclosures McBride: Sanofi: Research Funding.

scholarly journals Safety and efficacy of direct oral anticoagulants (DOACs) vs low molecular weight heparin (LMWH) in malignancy induced venous thromboembolism-a systematic review and meta analysis

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
A Abdul Razzack ◽  
N Hussain ◽  
S Adeel Hassan ◽  
S Mandava ◽  
F Yasmin ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Low Molecular Weight Heparin ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Low Molecular Weight ◽  
Efficacy And Safety ◽  
Dichotomous Data ◽  
Significant Difference

Abstract Funding Acknowledgements Type of funding sources: None. Background- Low molecular weight heparin (LMWH) and direct oral anticoagulants (DOACs) have been proven to be more effective in the management of venous thromboembolism (MVTE). The efficacy and safety of LMWH or DOACs in treatment of recurrent or malignancy induced VTE is not studied in literature. Objective To compare the efficacy and safety of LMWH and  DOACs in the management of malignancy induced  VTE Methods- Electronic databases ( PubMed, Embase, Scopus, Cochrane) were searched from inception to November  28th, 2020. Dichotomous data was extracted for prevention of VTE and risk of major bleeding in patients taking either LMWH or DOACs. Unadjusted odds ratios (OR) were calculated from dichotomous data using Mantel Haenszel (M-H) random-effects with statistical significance to be considered if the confidence interval excludes 1 and p < 0.05.  Results- Three studies with 2607 patients (DOACs n = 1301 ; LMWH n = 1306) were included in analysis. All the study population had active cancer of any kind diagnosed within the past 6 months. Average follow-up period for each trial was 6 months. Patients receiving DOACs have a lower odds of recurrence of MVTE as compared to LMWH( OR 1.56; 95% CI 1.17-2.09; P = 0.003, I2 = 0). There was no significant difference in major bleeding among patients receiving LMWH or DOACs  (OR-0.71, 95%CI 0.46-1.10, P = 0.13, I2 = 22%) (Figure 1). We had no publication bias in our results (Egger’s regression p > 0.05). Conclusion- DOACs are superior to LMWH in prevention of MVTE and have similar major bleeding risk as that of LMWH. Abstract Figure. A)VTE Recurrence B)Major Bleeding events

scholarly journals Anticoagulant treatment satisfaction with warfarin and direct oral anticoagulants for venous thromboembolism

2021 ◽  
Author(s):  
Margaret C. Fang ◽  
Alan S. Go ◽  
Priya A. Prasad ◽  
Jin-Wen Hsu ◽  
Dongjie Fan ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Treatment Satisfaction ◽  
Clinical Characteristics ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Treatment Options ◽  
Laboratory Monitoring ◽  
Routine Laboratory ◽  
Anticoagulant Treatment ◽  
The Difference

AbstractTreatment options for patients with venous thromboembolism (VTE) include warfarin and direct oral anticoagulants (DOACs). Although DOACs are easier to administer than warfarin and do not require routine laboratory monitoring, few studies have directly assessed whether patients are more satisfied with DOACs. We surveyed adults from two large integrated health systems taking DOACs or warfarin for incident VTE occurring between January 1, 2015 and June 30, 2018. Treatment satisfaction was assessed using the validated Anti-Clot Treatment Scale (ACTS), divided into the ACTS Burdens and ACTS Benefits scores; higher scores indicate greater satisfaction. Mean treatment satisfaction was compared using multivariable linear regression, adjusting for patient demographic and clinical characteristics. The effect size of the difference in means was calculated using a Cohen’s d (0.20 is considered a small effect and ≥ 0.80 is considered large). We surveyed 2217 patients, 969 taking DOACs and 1248 taking warfarin at the time of survey. Thirty-one point five percent of the cohort was aged ≥ 75 years and 43.1% were women. DOAC users were on average more satisfied with anticoagulant treatment, with higher adjusted mean ACTS Burdens (50.18 v. 48.01, p < 0.0001) and ACTS Benefits scores (10.21 v. 9.84, p = 0.046) for DOACs vs. warfarin, respectively. The magnitude of the difference was small (Cohen’s d of 0.29 for ACTS Burdens and 0.12 for ACTS Benefits). Patients taking DOACs for venous thromboembolism were on average more satisfied with anticoagulant treatment than were warfarin users, although the magnitude of the difference was small.

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.

P5239Cost-effectiveness of direct oral anticoagulants for cancer-associated venous thromboembolism

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J King ◽  
S Bhat ◽  
L J Heath ◽  
C G Derington ◽  
Z Yu ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cost Effectiveness ◽  
Relative Risk ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Cost Effective ◽  
Low Molecular Weight ◽  
Cost Effectiveness Ratio ◽  
Major Bleed ◽  
Recurrent Vte

Abstract Background Direct oral anticoagulants (DOACs) are at least as effective as low-molecular weight heparins (LMWH) at preventing recurrence after cancer-associated venous thromboembolism (CA-VTE). DOACs are also oral and far less costly, but they may confer a higher bleeding risk than LMWH. Purpose To estimate the cost-effectiveness of DOACs and LMWHs for CA-VTE. Methods We developed a health state transition model to estimate recurrent VTE, bleeding events, quality-adjusted life years (QALY), and direct healthcare costs (2018 United States dollars) associated with DOACs vs. LMWH use. The model had four states: (1) long-term anticoagulation (first 3 months after VTE), (2) extended anticoagulation (more than 3 months after VTE), (3) off anticoagulants, and (4) death. We used a United States healthcare sector perspective, 3-month cycle length, and 1-year time horizon. Event probabilities were derived from the Hokusai Cancer VTE trial and other literature. Event and medication costs were obtained from national sources. We used a threshold of less than $50,000 per QALY gained to define cost-effectiveness. Results Compared to LMWH, DOACs were less costly (mean costs: $8,477 vs. $33,917 per year) and similarly effective (mean QALY: 0.616 vs. 0.622). The incremental cost-effectiveness ratio was $4,479,374 per QALY gained with LMWH, indicating that DOACs are cost-effective (Table 1). In threshold analyses, LMWH therapy only became cost-effective when DOAC recurrent VTE risk increased to at least 72% (relative risk vs. LMWH, 6.19) or DOAC clinically relevant bleeding increased to at least 39% (relative risk vs. LMWH, 10.09). Scenarios Recurrent VTE, % Major bleed, % Mean difference DOAC − LMW ICER DOAC LMWH Relative Risk DOAC LMWH Relative Risk Cost QALY Base case 8.1 11.6 0.71 6.8 4.0 1.75 −$25,440 (−26,496, −24,274) −0.006 (−0.019, 0.008) $4,479,374 DOAC outcome rate threshold at which LMWH becomes cost-effective*   Recurrent VTE 71.5 11.7 6.19 – – – −$6,064 (−7,534, −4,627) −0.121 (−0.136, −0.108) $49,886   Major Bleed – – – 38.9 4.0 10.09 −$2,192 (−3,400, −704) −0.044 (−0.056, −0.030) $49,878 DOAC = direct oral anticoagulant, ICER = incremental cost-effectiveness ratio, LMWH = low-molecular-weight heparin, VTE = venous thromboembolism. Values are mean (95% Uncertainty Interval). Uncertainty was derived from 1,000 stochastic model iterations. *Represents the minimum increased risk with DOAC that would result in LMWH achieving an ICER <$50K per QALY gained. Conclusion In this simulation study, DOACs were a cost-effective oral alternative to LMWH for the treatment of CA-VTE. For LMWH to be cost-effective, DOAC event rates needed to be far higher than what is likely to be observed in clinical practice. Acknowledgement/Funding Agency for Health Research and Quality R18HS026156

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