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Anticoagulation in Venous Thromboembolism Prophylaxis in Medically Ill Patients: Potential Impact of NOACs.
Knotts, TL, Mousa, SA
American journal of cardiovascular drugs : drugs, devices, and other interventions. 2019;(4):365-376
Abstract
While substantial evidence supports the use of standard-duration injectable anticoagulants for venous thromboembolism (VTE) prophylaxis, consensus is mixed about which agents may be preferred in acutely ill patients with ongoing need of VTE prophylaxis past the first 10-day duration of hospital stay and post-discharge. Non-vitamin K antagonist oral anticoagulants (NOACs) provide Factor Xa inhibition to prevent the thrombin generation essential in thromboembolism development, but evidence for the efficacy and safety of most NOACs is conflicting regarding extended-duration prophylaxis. Enoxaparin, a preferred injectable anticoagulant in standard-duration VTE prophylaxis, has shown an increased risk of major bleeding events when used in extended-duration prophylaxis, which outweighs its benefit. Rivaroxaban has demonstrated efficacy in extended-duration prophylaxis, but both rivaroxaban and apixaban have shown increased risks of major bleeding. Betrixaban remains the only NOAC approved in the USA for extended-duration VTE prophylaxis, and it demonstrates efficacy, with fewer adverse effects than other NOACs. This review evaluates the appropriateness of different NOAC agents compared with current therapies for the extended-duration VTE prophylaxis setting in medically ill populations.
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[Contemporary approaches to determine the duration of anticoagulant therapy for venous thromboembolism].
Lobastov, KV
Khirurgiia. 2019;(5):94-103
Abstract
The review is devoted to the issue of optimal duration of anticoagulant therapy for venous thromboembolic complications (VTEC) using oral anticoagulants (OAC). These drugs are characterized by higher safety in comparison with vitamin K antagonists and make it possible to increase the duration of treatment for not only spontaneous thrombosis (with high risk of recurrence), but also thrombosis provoked by minor persistent and transient risk factors of VTEC. Efficacy and safety of prolonged treatment of VTEC using OAC was analyzed. Different classifications of primary thrombotic episode depending on risk of subsequent recurrence are presented. Moreover, scales for individual assessment of risk of recurrent thrombosis after anticoagulant therapy cancellation and risk of bleeding in case of continued treatment are given. Outcomes of long-term administration of rivaroxaban for VTEC are analyzed. It was concluded that OAC are safe for prolonged management of primary thrombotic episode. However, overall duration of treatment should be determined considering individual balance of benefits and risks.
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3.
Anticoagulant Medications for the Prevention and Treatment of Thromboembolism.
Brien, L
AACN advanced critical care. 2019;(2):126-138
Abstract
Venous thromboembolism is a preventable medical condition associated with significant morbidity and mortality. It can lead to deep vein thrombosis, pulmonary embolism, and stroke. Thrombi develop when intravascular conditions promote activation of the coagulation system or when there is an imbalance between endogenous anticoagulants and procoagulants. Such conditions include vascular injury, inflammation, venous stasis, and hypercoagulable states. Anticoagulant medications are indicated for the prevention and treatment of venous thromboembolism. They exert their effect on clotting factors to prevent the formation of thrombi or the propagation of an existing clot. Historically, anticoagulants were limited to heparins and vitamin K antagonists. Over the past 15 years, however, several new anticoagulant medications have been introduced. This article describes commonly prescribed and newer anticoagulants available to health care professionals, including their mechanism of action, therapeutic use, unique characteristics, and available reversal agents in the event of life-threatening bleeding.
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4.
Pathogenesis and Management of Thrombotic Disease in Myeloproliferative Neoplasms.
Arachchillage, DR, Laffan, M
Seminars in thrombosis and hemostasis. 2019;(6):604-611
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Abstract
Chronic myeloproliferative neoplasms (MPN) are characterized by clonal expansion of an abnormal hematopoietic stem/progenitor cell and include polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF). Venous thrombosis, often at unusual sites, including splanchnic vein thrombosis and arterial thrombosis, as well as a hemorrhagic tendency and a propensity to transform into myelofibrosis or acute leukemia are common complications in patients with MPNs. The pathogenesis of thrombosis in MPN patients is complex and multifactorial. Disease related factors, such as an increase in blood cell counts (i.e., leukocytosis, erythrocytosis, and thrombocytosis), and more importantly presence of JAK2 mutation can interact with non-disease patient related factors such as age, previous history of thrombotic events, obesity, hypertension, hyperlipidemia, and presence of thrombophilic defects. The overall rate of recurrent thrombosis after venous thromboembolism (VTE) is 6.0 to 6.5 per 100 patient-years in patients with MPN compared to 2.7 to 3.7 per 100 patient-years in patients without MPN, and antithrombotic therapy with vitamin K antagonists (VKAs) is associated with a clear benefit, reducing the incidence of recurrence by 48 to 69%. Life-long oral anticoagulation with VKAs is the cornerstone of the antithrombotic treatment for splanchnic vein thrombosis (SVT). Patients with MPN-related cerebral venous thrombosis (CVT) should also be treated with long-term anticoagulation with VKAs. The role of direct acting oral anticoagulants in patients with thrombosis and MPN is not established and the use of these anticoagulants should be considered on an individual basis according to the risk of recurrent of VTE and bleeding.
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[Modern treatment of deep vein thrombosis and pulmonary embolism].
Renczes, J, Lindhoff-Last, E
Der Internist. 2019;(6):644-655
Abstract
Virchow's triad has been known for a 100 years. The development of therapeutic possibilities during this time was enormous. Today anticoagulant therapy is much more differentiated. Four new oral substances have replaced the traditional treatment with vitamin K antagonists in angiology. A standardized dosage is available. The monitoring of the coagulation parameters is no longer necessary, but it is important to monitor renal function. Direct oral anticoagulants are approved for the treatment of venous thrombosis and pulmonary embolism, but not during pregnancy or in children. Severe bleeding complications, especially intracerebral bleeding, are less common. The incidence of venous thromboembolism is still high. Obesity and cancer are of particular importance. The "therapeutic pact" with the patient requires that physicians master the art of "talking medicine".
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Betrixaban: Safely Reducing Venous Thromboembolic Events with Extended Prophylaxis.
Dobesh, PP, Trevarrow, BJ
The American journal of medicine. 2019;(3):307-311
Abstract
Although venous thromboembolism prophylaxis of acute medically ill patients is commonly employed, a percentage of high-risk patients still have venous thromboembolic events within 30 days of discharge. Research over the last several years has attempted to identify characteristics of these high-risk patients to facilitate provision of extended prophylaxis and venous thromboembolic event reduction; however, extended prophylaxis has been associated with a significant increase in the risk for major bleeding until recently. Betrixaban, a new oral direct Xa inhibitor with once-daily dosing and limited renal elimination, significantly reduces the risk of venous thromboembolism without increasing the risk for major bleeding. Consequently, betrixaban is the only anticoagulant approved by the Food and Drug Administration for preventing venous thromboembolism with extended prophylaxis in acute medically ill patients.
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Direct-Acting Oral Anticoagulants in Critically Ill Patients.
Rali, P, Gangemi, A, Moores, A, Mohrien, K, Moores, L
Chest. 2019;(3):604-618
Abstract
The direct-acting oral anticoagulants (DOACs) have been increasingly used over vitamin K antagonists in recent years because they do not require monitoring and have an immediate anticoagulation effect. In general, DOACs have exhibited a better safety profile and noninferiority for prophylaxis and treatment of venous thromboembolism (VTE) and stroke prevention in patients with atrial fibrillation compared with vitamin K antagonists in the non-ICU population; whether this finding holds true in patients who are critically ill remains unknown. The current review addresses the role of DOACs in special ICU populations, use of these agents for VTE prophylaxis, perioperative management of DOACs, drug monitoring, and potential drug interactions of DOACs in critically ill patients. Adverse events and available reversal agents for DOACs are also discussed.
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It's time for head-to-head trials with direct oral anticoagulants.
Tritschler, T, Castellucci, LA
Thrombosis research. 2019;:64-69
Abstract
Direct oral anticoagulants (DOACs) have become the recommended first choice anticoagulant agent for treatment of acute venous thromboembolism (VTE) in non-cancer patients and are increasingly prescribed worldwide. They have not only intrinsic advantages, such as rapid onset of action and wide therapeutic windows, but also a lower risk of major, intracranial and fatal bleeding in VTE patients compared to vitamin K antagonists. Even though DOACs are often referred to as uniform drug class, there is growing evidence that each DOAC has a specific risk profile. Indirect comparisons and retrospective cohort studies suggest that apixaban may be associated with a lower risk of major bleeding than other DOACs, but there are no head-to-head trials with DOACs. Therefore, current guidelines do not recommend one DOAC over another and the choice of a specific DOAC is mainly based on physician and patient preferences, reimbursement and availability. Retrospective cohort studies and VTE registries are important to identify potential differences in efficacy and safety between DOACs; but they are methodologically too limited to inform the optimal choice of oral anticoagulant agent. Randomized controlled trials are crucial to inform sound treatment recommendations, because proper randomization is the key to unprejudiced treatment allocation and minimization of unmeasured and unknown confounding. Given increasing evidence of differences in safety profiles of DOACs from indirect comparisons and observational studies, it's time for head-to-head trials with DOACs.
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9.
What have we learned from real-world NOAC studies in venous thromboembolism treatment?
Beyer-Westendorf, J
Thrombosis research. 2018;:83-91
Abstract
Venous thromboembolism (VTE) remains a substantial clinical and health-economic burden worldwide and effective anticoagulant treatment is necessary immediately after VTE is suspected to reduce short- and long-term VTE related morbidity and mortality. For decades, low molecular weight heparin (LMWH), fondaparinux and Vitamin K antagonists (VKAs) have been the standard of anticoagulant therapy for VTE patients but these treatment options had clinically relevant drawbacks and limitations. The introduction of non-VKA oral anticoagulants (NOACs) that specifically inhibit either thrombin or factor Xa have resolved many of these drawbacks because these new compounds exhibit a rapid onset and offset of action, fewer food and drug interactions and a predictable anticoagulant effect. All NOACs have successfully completed their respective phase-III trial programs consisting of many large randomized controlled trials, leading to approval for acute VTE treatment around the world. Nevertheless, their introduction into daily care practice is challenging and a careful evaluation of the effectiveness and safety of NOACs in less selected cohorts outside carefully monitored clinical trials is essential. This review introduces the different types of real-world evidence (RWE) and explores the available data for VTE treatment with NOACs, based on a literature search using the key words "venous thromboembolism" or "VTE" in combination with "NOAC", "DOAC", "apixaban", "dabigatran", "edoxaban" and "rivaroxaban" on June 30; 2017, followed by data extraction from studies that reported real-world outcome data for VTE treatment with NOACs, although available evidence is almost exclusively limited to rivaroxaban.
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10.
Novel oral anticoagulants in chronic kidney disease: ready for prime time?
Ashley, J, Sood, MM
Current opinion in nephrology and hypertension. 2018;(3):201-208
Abstract
PURPOSE OF REVIEW Patients with chronic kidney disease (CKD) are at increased risk of atrial fibrillation, stroke, and bleeding posing unique clinical challenges. Novel oral anticoagulants (NOACs) including dabigatran, rivaroxaban, and apixaban have become recognized as alternative therapy to Vitamin K Antagonists (VKA) regarding the prevention of venous thromboembolism (VTE) and reduce the risk of stroke in atrial fibrillation. However, the understanding of NOACs in CKD is still underdeveloped. This review summarizes recent literature on the efficacy and safety of NOACs in patients with CKD. RECENT FINDINGS Studies focusing on patients with moderate kidney disease were drawn from post hoc analyses from three major NOAC trials, meta-analyses, and postmarketing surveillance studies. Cumulatively, these studies continue to demonstrate NOACs as equivalent if not superior therapies to VKAs in regards to both efficacy and safety. These studies are limited by small sample sizes as well as a lack of direct comparison between NOACs. SUMMARY The role of NOACs in managing VTE and atrial fibrillation is increasing. Current research suggests that NOACs are at least as efficacious and well tolerated as VKAs. More research is required to elucidate which NOAC is preferable in the clinical setting.