Role Of New Oral Anticoagulants Research Articles

Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis with Rivaroxaban (Prais Study): A Prospective, Randomized, Open Label, Multicenter Trial

Introduction: Recently new oral anticoagulants (NOAC) has replaced vitamin K antagonist (VKA) for the treatment of deep vein thrombosis (DVT). But the role of NOAC after thrombolysis of acute iliofemoral DVT is not yet defined. The aim of this randomized clinical trial is to compare the safety and efficacy of rivaroxaban versus VKA after thrombolysis of acute iliofemoral DVT. Methods: Patients were recruited from 7 hospitals in Korea. After successful thrombolysis or mechanical thrombectomy of acute iliofemoral DVT, 72 patients were randomized to standard anticoagulation (enoxaparin and warfarin) or rivaroxaban. Primary efficacy outcome was recurrence of any venous thromboembolism within 6 months. Secondary safety outcome were major bleeding and clinically relevant non-major bleeding (CRNMB). Other safety variables including any adverse events, vascular events, and all-cause mortality were also analyzed. Results: Intention-to-treat analysis was done for 67 patients (35 in rivaroxaban group, and 32 in VKA group). The primary outcome of recurrent VTE occurred in 4 patients in each group (11.4% vs 12.5%; hazard ratio[HR], 0.90; 95% confidence interval [CI], 0.21 to 3.96; P=1). Major bleeding or CRNMB developed in 1 patient in the rivaroxaban group and 3 patients in the VKA group (2.9% vs 9.4%, HR, 0.28; 95% CI, 0.03 to 2.88; P=0.34). Recurrence-free survival and significant bleeding-free survival at 6 month were not different in both groups. (P=0.28 and P=0.98, respectively) Conclusion: After thrombolysis of acute iliofemoral DVT, rivaroxaban was as effective as warfarin for the prevention of DVT recurrence. Rivaroxaban group showed a tendency of lower incidence of major bleeding/CRNMB. Rivaroxaban can safely replace warfarin in patients after successful thrombolysis for acute iliofemoral DVT. (Funded by Bayer Schering Pharma; ClinicalTrials.gov number, NCT01986192.)

The role of new oral anticoagulants in orthopaedics: an update of recent evidence.

Rivaroxaban, dabigatran, apixaban and edoxaban are the four available new oral anticoagulants (NOAC) which are currently approved for venous thromboembolism prophylaxis after total hip and knee replacement. Large phase 3 and phase 4 studies comparing NOAC with low molecular weight heparins have shown similar results regarding the efficacy and safety of these two categories of anticoagulants. Management of bleeding complications is a matter of great significance. Three reversal agents have been developed: idarucizumab, andexanet alfa and ciraparantag. Idarucizumab is now commercially available. Regarding the perioperative management of NOAC, two main scientific groups have published their own recommendations. The European Heart Rhythm Association recommends 48-h period of stoppage preoperatively for factor Xa inhibitors and at least 3 or 4days for dabigatran, while the French Study Group on Thrombosis and Haemostasis recommends 5-day discontinuation for all NOAC. Conventional clot tests can only be used as rough indicators for laboratory assessment of the activity of NOAC. Specific laboratory tests have been developed for more accurate measurements of NOAC blood levels, including a dilute thrombin time test (Hemoclot test) and the ecarin clot test for dabigatran and chromogenic anti-factor Xa assays for direct factor Xa inhibitors. Due to the beneficial properties of NOAC, these drugs are gaining ground in daily orthopaedic practice, and many studies are being conducted in order to extend the indications of these anticoagulants agents.

The Role of New Oral Anticoagulants in the Early Discharge of Acute Pulmonary Embolism Patients at Low and Intermediate Risk of Mortality

The Role of New Oral Anticoagulants in the Early Discharge of Acute Pulmonary Embolism Patients at Low and Intermediate Risk of Mortality

The Role of New Oral Anticoagulants (NOACs) in Cancer Patients.

New oral anticoagulants (NOACs) are likely to have a major impact in the next few years, changing clinical practice of anticoagulation therapy. Evidence on its efficacy and superiority to vitamin K antagonists (VKAs) in treating non-cancer patients have been reported in a few clinical trials. However, patients with cancer are complicated by the prothrombotic nature of the disease, need for potentially invasive surgery and interventions, and altered drug handling. This chapter examines the available evidence and guidelines on the use of NOAC in patients with cancer.

Venous thrombosis in patients with high-grade glioma.

High-grade glioma (HGG) patients are at particularly high risk of venous thromboembolism (VTE) occurrence and recurrence. VTE is associated with worsened survival in these patients. At present, the main challenge when prescribing anticoagulants in HGG patients is to address the risk of intracranial hemorrhage and provide the optimal treatment. Here, we discuss the latest biological findings and their potential implications for better classification in daily practice and stratification of patients in future trials according to their risk of developing a VTE. To help clinicians, international guidelines have been provided for cancer patients, but their implementation remains suboptimal. We report here the specificities of VTE management in HGG patients relative to other cancer patients. Particular aspects such as anticoagulation under targeted therapies, primary and secondary prophylaxis, and the role of new oral anticoagulants are discussed as well.

Low incidence of post-thrombotic syndrome in patients treated with new oral anticoagulants and percutaneous endovenous intervention for lower extremity deep venous thrombosis.

Post-thrombotic syndrome (PTS) is a common complication of deep venous thrombosis (DVT) of the iliofemoral venous system leading to significant morbidity and high health care costs. It has been recently shown that percutaneous endovenous intervention (PEVI) can effectively reduce the incidence of PTS. The role of new oral anticoagulants (NOACs) in combination with PEVI in the reduction of PTS has not been previously studied. This report sought to evaluate the role of PEVI plus NOACs in the reduction of PTS in acute symptomatic femoropopliteal and iliac DVT. We studied 127 patients with acute lower extremity DVT who had undergone PEVI plus administration of NOACs. All had received a minimum of 3 months of anticoagulation with a NOAC following PEVI. The mean follow-up was 22±5 months. The patients were evaluated for development of PTS, bleeding, recurrent venous thromboembolism (VTE), duration of hospitalization and mortality. There was no in-hospital bleeding. The mean duration of hospitalization was 46±9 hours. DVT occurred in two patients who had been later switched to warfarin. There were four non-VTE-related deaths. PTS developed in five patients (3%), two of whom were those who had been switched to warfarin. Their mean Villalta score was 6.2±0.9. We conclude that the combination of PEVI plus NOAC and low dose aspirin is associated with a very low rate of PTS with the severity being only mild. This approach leads to very low rates of bleeding and recurrent VTE and promotes early discharge.

Prevention of venous thromboembolism: consensus, controversies, and challenges

The last 50 years have witnessed a multitude of publications evaluating the efficacy, safety and cost effectiveness of many different thromboprophylaxis interventions. There is widespread consensus that thromboprophylaxis safely reduces morbidity and mortality. More than 25 evidence-based guidelines, published since 1986, also recommend routine thromboprophylaxis in the majority of hospitalized patients. As a result, thromboprophylaxis is recognized as a key safety priority for hospitals. Some of the remaining areas of controversy that will be discussed in this paper include the role of individual risk assessments to determine thrombosis risk and prophylaxis, replacement of low-dose heparin by low-molecular-weight heparin (LMWH), the optimal duration of prophylaxis, the role of combined thromboprophylaxis modalities, the safety of anticoagulant prophylaxis with regional analgesia, the use of LMWHs in chronic renal insufficiency, and the emerging role of new oral anticoagulants as thromboprophylactic agents. Despite the overwhelming evidence supporting thromboprophylaxis, rates of thromboprophylaxis use remain far from optimal. Successful implementation strategies to bridge this knowledge:care gap are the most important current challenges in this area. These strategies must be multifaceted, utilizing local, systems-based approaches as well as legislation and incentives that reinforce best practices.