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Rivaroxaban is an orally administered direct inhibitor of factor Xa. As compared with enoxaparin, rivaroxaban was more effective in preventing venous thromboembolism after hip replacement, without a significant increase in major bleeding. Rivaroxaban is an orally administered direct inhibitor of factor Xa. As compared with enoxaparin, rivaroxaban was more effective in preventing venous thromboembolism after hip replacement, without a significant increase in major bleeding. Prophylactic anticoagulant therapy is standard practice after total hip or knee arthroplasty, with a minimum recommended duration of 10 days. 1 After total hip arthroplasty, extended prophylaxis for 5 weeks after surgery reduces the incidence of symptomatic and asymptomatic venous thromboembolism more effectively than does short-term prophylaxis. 2 New deep-vein thromboses have been shown to form after the discontinuation of short-term prophylaxis. 3 Several meta-analyses suggest that extended thromboprophylaxis after total hip arthroplasty leads to a reduction in symptomatic venous thromboembolic events, without increasing the risk of major bleeding. 4 – 6 These findings led to a grade 1A recommendation for extended thromboprophylaxis after total . . .

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.

In a randomized trial, oral apixaban was noninferior to a low-molecular-weight heparin, dalteparin, in preventing recurrent venous thromboembolism at 6 months in patients with cancer. The use of apixaban was not associated with a higher risk of major bleeding than dalteparin, even in patients with gastrointestinal cancer.

In a trial in patients with pelvic or acetabular fractures or extremity fractures that were treated operatively, aspirin thromboprophylaxis was noninferior to low-molecular-weight heparin in preventing death at 90 days.

Pregnancy-related venous thromboembolism is a leading cause of maternal morbidity and mortality, and thromboprophylaxis is indicated in pregnant and post-partum women with a history of venous thromboembolism. The optimal dose of low-molecular-weight heparin to prevent recurrent venous thromboembolism in pregnancy and the post-partum period is uncertain. In this open-label, randomised, controlled trial (Highlow), pregnant women with a history of venous thromboembolism were recruited from 70 hospitals in nine countries (the Netherlands, France, Ireland, Belgium, Norway, Denmark, Canada, the USA, and Russia). Women were eligible if they were aged 18 years or older with a history of objectively confirmed venous thromboembolism, and with a gestational age of 14 weeks or less. Eligible women were randomly assigned (1:1), before 14 weeks of gestational age, using a web-based system and permuted block randomisation (block size of six), stratified by centre, to either weight-adjusted intermediate-dose or fixed low-dose low-molecular-weight heparin subcutaneously once daily until 6 weeks post partum. The primary efficacy outcome was objectively confirmed venous thromboembolism (ie, deep-vein thrombosis, pulmonary embolism, or unusual site venous thrombosis), as determined by an independent central adjudication committee, in the intention-to-treat (ITT) population (ie, all women randomly assigned to treatment). The primary safety outcome was major bleeding which included antepartum, early post-partum (within 24 h after delivery), and late post-partum major bleeding (24 h or longer after delivery until 6 weeks post partum), assessed in all women who received at least one dose of assigned treatment and had a known end of treatment date. This study is registered with ClinicalTrials.gov, NCT01828697, and is now complete. Between April 24, 2013, and Oct 31, 2020, 1339 pregnant women were screened for eligibility, of whom 1110 were randomly assigned to weight-adjusted intermediate-dose (n=555) or fixed low-dose (n=555) low-molecular-weight heparin (ITT population). Venous thromboembolism occurred in 11 (2%) of 555 women in the weight-adjusted intermediate-dose group and in 16 (3%) of 555 in the fixed low-dose group (relative risk [RR] 0·69 [95% CI 0·32–1·47]; p=0·33). Venous thromboembolism occurred antepartum in five (1%) women in the intermediate-dose group and in five (1%) women in the low-dose group, and post partum in six (1%) women and 11 (2%) women. On-treatment major bleeding in the safety population (N=1045) occurred in 23 (4%) of 520 women in the intermediate-dose group and in 20 (4%) of 525 in the low-dose group (RR 1·16 [95% CI 0·65–2·09]). In women with a history of venous thromboembolism, weight-adjusted intermediate-dose low-molecular-weight heparin during the combined antepartum and post-partum periods was not associated with a lower risk of recurrence than fixed low-dose low-molecular-weight heparin. These results indicate that low-dose low-molecular-weight heparin for thromboprophylaxis during pregnancy is the appropriate dose for the prevention of pregnancy-related recurrent venous thromboembolism. French Ministry of Health, Health Research Board Ireland, GSK/Aspen, and Pfizer.

Patients discharged from the hospital carry an increased risk of venous thromboembolism after discharge. A randomized trial of rivaroxaban for 6 weeks after hospital discharge had no significant effect on the risk of venous thromboembolism as compared with placebo.

Patients receiving cancer treatment who had an intermediate-to-high risk of venous thromboembolism were randomly assigned to apixaban or placebo for 6 months. VTE was noted in 4.2% of patients receiving apixaban and 10.2% of those receiving placebo, a significant difference. Major bleeding occurred in 3.5% of patients with apixaban and in 1.8% with placebo.

A placebo-controlled trial assessed the efficacy of rivaroxaban to prevent venous thrombosis in patients with cancer at high risk for thrombosis. The thrombosis rate was lower with rivaroxaban, but for the 180-day assessment period, the difference was not significant. Bleeding was approximately twice as common in the rivaroxaban group.

In patients with provoked venous thromboembolism and ongoing risk factors, extended treatment with low-dose apixaban for 12 months resulted in a lower risk of recurrent VTE than placebo, with a low risk of major bleeding.