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In the treatment of patients with acute pulmonary embolism, the efficacy of rivaroxaban, a factor Xa inhibitor, was similar to that of traditional anticoagulation therapy. There was less bleeding in the group receiving rivaroxaban, which supports its use in the treatment of this condition. Pulmonary embolism is a common disease, with an estimated annual incidence of 70 cases per 100,000 population. 1 , 2 The condition usually leads to hospitalization and may recur; it can be fatal. 3 For half a century, the standard therapy for most patients with pulmonary embolism has been the administration of heparin, overlapped and followed by a vitamin K antagonist. 4 , 5 This regimen is effective but complex. 5 – 9 Recently developed oral anticoagulants that are directed against factor Xa or thrombin overcome some limitations of standard therapy, including the need for injection and for regular dose adjustments on the basis of laboratory monitoring. . . .

In this clinical trial, rivaroxaban, an oral factor Xa inhibitor, was effective in the initial and continued treatment of symptomatic venous thromboembolism; it may become part of the treatment armamentarium for this common clinical problem. Acute venous thromboembolism (i.e., deep-vein thrombosis [DVT] or pulmonary embolism) is a common disorder with an annual incidence of approximately 1 or 2 cases per 1000 persons in the general population. 1 , 2 Short-term treatment is effective, with the risk of recurrent disease — the major complication — reduced from an estimated 25% to about 3% during the first 6 to 12 months of therapy. 3 The risk of recurrence remains after treatment ends and can reach 5 to 10% during the first year. 4 , 5 Standard treatment for acute venous thromboembolism is limited by the need for parenteral heparin initially, with overlapping . . .

The risk of venous thromboembolism is high after total hip arthroplasty and could persist after hospital discharge. Our aim was to compare the use of rivaroxaban for extended thromboprophylaxis with short-term thromboprophylaxis with enoxaparin. 2509 patients scheduled to undergo elective total hip arthroplasty were randomly assigned, stratified according to centre, with a computer-generated randomisation code, to receive oral rivaroxaban 10 mg once daily for 31–39 days (with placebo injection for 10–14 days; n=1252), or enoxaparin 40 mg once daily subcutaneously for 10–14 days (with placebo tablet for 31–39 days; n=1257). The primary efficacy outcome was the composite of deep-vein thrombosis (symptomatic or asymptomatic detected by mandatory, bilateral venography), non-fatal pulmonary embolism, and all-cause mortality up to day 30–42. Analyses were done in the modified intention-to-treat population, which consisted of all patients who had received at least one dose of study medication, had undergone planned surgery, and had adequate assessment of thromboembolism. This study is registered at ClinicalTrials.gov, number NCT00332020. The modified intention-to-treat population for the analysis of the primary efficacy outcome consisted of 864 patients in the rivaroxaban group and 869 in the enoxaparin group. The primary outcome occurred in 17 (2·0%) patients in the rivaroxaban group, compared with 81 (9·3%) in the enoxaparin group (absolute risk reduction 7·3%, 95% CI 5·2–9·4; p<0·0001). The incidence of any on-treatment bleeding was much the same in both groups (81 [6·6%] events in 1228 patients in the rivaroxaban safety population vs 68 [5·5%] of 1229 patients in the enoxaparin safety population; p=0·25). Extended thromboprophylaxis with rivaroxaban was significantly more effective than short-term enoxaparin plus placebo for the prevention of venous thromboembolism, including symptomatic events, in patients undergoing total hip arthroplasty. Bayer HealthCare AG, Johnson & Johnson Pharmaceutical Research and Development LLC.

A phase 2 trial compared various doses of milvexian with standard enoxaparin for thromboprophylaxis after total knee replacement. Venous thromboembolism occurred in 7 to 8% of patients who received 200 mg of milvexian once or twice daily and in 21% of those who received enoxaparin. The risk of bleeding was similar with milvexian and enoxaparin.

In patients undergoing total knee replacement, a single injection of abelacimab (an antibody to factor XI) administered postoperatively was superior to standard care with enoxaparin for the prevention of venous thromboembolism. Bleeding events were rare.

In this multicenter trial, the oral factor Xa inhibitor apixaban was compared with enoxaparin and warfarin for the treatment of acute venous thromboembolism. Apixaban was noninferior to enoxaparin and warfarin with respect to efficacy and superior with respect to safety. Venous thromboembolism, with an annual incidence of 1 to 2 cases per 1000 persons in the general population, is the third most common cause of vascular death after myocardial infarction and stroke. 1 Conventional treatment consists of a parenteral anticoagulant, such as enoxaparin, for at least 5 days, and warfarin begun during this time and continued for at least 3 months. 2 Although effective, this regimen presents a challenge because enoxaparin requires daily subcutaneous injections, and warfarin therapy requires coagulation monitoring and dose adjustment. Apixaban is an oral factor Xa inhibitor with a rapid onset of action and predictable pharmacokinetics that allow . . .

The anticoagulant edoxaban, an oral inhibitor of activated factor X, does not require monitoring. As initial treatment for acute venous thromboembolism, heparin–edoxaban was noninferior to heparin–warfarin and caused less bleeding. Venous thromboembolism is the third most common cardiovascular disease after myocardial infarction and stroke, affecting at least 700,000 persons annually in North America. 1 – 3 The standard treatment consists of low-molecular-weight heparin followed by vitamin K antagonists. 4 A number of studies have established that new oral anticoagulants with or without initial heparin therapy are effective alternatives. 5 – 8 Edoxaban is a direct inhibitor of activated factor X with a rapid onset of action. It is administered orally once daily and has proven antithrombotic efficacy. 9 – 11 The Hokusai-VTE study was a randomized, double-blind clinical trial that was conducted to evaluate edoxaban for the . . .

Enoxaparin is used to prevent deep-vein thrombosis in patients undergoing total knee arthroplasty. In this study, an antisense oligonucleotide against factor XI was more effective than enoxaparin in preventing deep-vein thrombosis and caused less bleeding. Patients undergoing total knee arthroplasty are at risk for postoperative venous thromboembolism. Conventional therapies for the prevention of this complication involve inhibitors of factor Xa or thrombin, such as enoxaparin. These drugs are effective but are associated with a risk of bleeding. 1 The pathogenesis of venous thromboembolism after surgery is incompletely understood, but tissue factor exposed at the surgical site is thought to be the major driver through the extrinsic pathway of coagulation (Figure 1). 2 The role of the intrinsic pathway in this process is uncertain. Experimental data suggest that targeting factor XI, a key component of the intrinsic pathway, . . .

Edoxaban, an oral factor Xa inhibitor, is non-inferior for prevention of stroke and systemic embolism in patients with atrial fibrillation and is associated with less bleeding than well controlled warfarin therapy. Few safety data about edoxaban in patients undergoing electrical cardioversion are available. We did a multicentre, prospective, randomised, open-label, blinded-endpoint evaluation trial in 19 countries with 239 sites comparing edoxaban 60 mg per day with enoxaparin–warfarin in patients undergoing electrical cardioversion of non-valvular atrial fibrillation. The dose of edoxaban was reduced to 30 mg per day if one or more factors (creatinine clearance 15–50 mL/min, low bodyweight [≤60 kg], or concomitant use of P-glycoprotein inhibitors) were present. Block randomisation (block size four)—stratified by cardioversion approach (transoesophageal echocardiography [TEE] or not), anticoagulant experience, selected edoxaban dose, and region—was done through a voice-web system. The primary efficacy endpoint was a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular mortality, analysed by intention to treat. The primary safety endpoint was major and clinically relevant non-major (CRNM) bleeding in patients who received at least one dose of study drug. Follow-up was 28 days on study drug after cardioversion plus 30 days to assess safety. This trial is registered with ClinicalTrials.gov, number NCT02072434. Between March 25, 2014, and Oct 28, 2015, 2199 patients were enrolled and randomly assigned to receive edoxaban (n=1095) or enoxaparin–warfarin (n=1104). The mean age was 64 years (SD 10·54) and mean CHA2DS2-VASc score was 2·6 (SD 1·4). Mean time in therapeutic range on warfarin was 70·8% (SD 27·4). The primary efficacy endpoint occurred in five (<1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin–warfarin group (odds ratio [OR] 0·46, 95% CI 0·12–1·43). The primary safety endpoint occurred in 16 (1%) of 1067 patients given edoxaban versus 11 (1%) of 1082 patients given enoxaparin–warfarin (OR 1·48, 95% CI 0·64–3·55). The results were independent of the TEE-guided strategy and anticoagulation status. ENSURE-AF is the largest prospective randomised clinical trial of anticoagulation for cardioversion of patients with non-valvular atrial fibrillation. Rates of major and CRNM bleeding and thromboembolism were low in the two treatment groups. Daiichi Sankyo provided financial support for the study.

In acutely ill patients, 10 days of rivaroxaban was noninferior to 10 days of enoxaparin for thromboprophylaxis. Extended-duration rivaroxaban treatment (35 days) reduced the risk of venous thromboembolism. Rivaroxaban was associated with an increased risk of bleeding. Patients with active cancer, stroke, myocardial infarction, or acute exacerbations of a variety of medical conditions are at increased risk for venous thromboembolism. 1 Prolonged immobilization and risk factors such as an age older than 75 years, chronic heart failure, a history of venous thromboembolism, and obesity can increase this risk further. 2 , 3 Randomized, controlled trials involving hospitalized patients at increased risk for venous thromboembolism have shown the benefits of administering anticoagulant agents for up to 14 days, 4 – 8 and guidelines recommend the use of unfractionated heparin, low-molecular-weight heparins, or fondaparinux in such patients. 9 There is some evidence that the risk . . .