Final appraisal determination rivaroxaban for treating pulmonary embolism and preventing recurrent venous thromboembolism issue date. Rivaroxaban is an oral, direct factor xa inhibitor, approved for the treatment of pulmonary embolism pe and deep vein thrombosis dvt and the secondary prevention of recurrent pe and dvt as a fixeddose, monotherapy regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism. Jun 06, 2019 about 73% and 92% of xareltotreated patients in the einstein dvt and einstein pe studies, respectively, received initial parenteral anticoagulant treatment for a median duration of 2 days. The fixed dose regimen of rivaroxaban is at least as effective for the initial and longterm treatment of pe as the standard therapy with enoxaparin followed by a vka safety. Rivaroxaban xarelto is an oral factor xa inhibitor. By binding reversibly to the active site of factor.
Approval of rivaroxaban for this indication was based on the results of the einstein dvt, einstein pe, and einstein ext phase iii clinical studies. The einstein pe study was a randomized, openlabel trial of the efficacy and safety of rivaroxaban as compared with standard therapy consisting of enoxaparin and a vitamin k antagonist in. Enoxaparinvkatreated patients in the einstein dvt and einstein pe studies received initial parenteral anticoagulant treatment for a median duration of 8 days. Can i use rivaroxaban to treat a pulmonary embolism pe in a patient with active cancer. Pdf treatment of pulmonary embolism with rivaroxaban. Rivaroxaban for the treatment of pulmonary embolism. Einstein pe study results, with south african expert comment rivaroxaban revolutionises treatment of pulmonary embolism rivaroxaban has been shown to be as effective as initial and longterm treatment with enoxaparin and warfarin for pulmonary embolism pe, with a potentially improved risk profile benefit.
Funded by bayer healthcare and janssen pharmaceuticals. Therefore, clinical trials of anticoagulation in children require novel approaches to deal with numerous challenges. A prespecified pooled analysis of the einsteindvt and einstein pe studies compared the efficacy and safety of rivaroxaban 15. The bleeding rates were similar in the two study groups, with fewer major bleeding events in the rivaroxaban group. Rivaroxaban for the treatment of deep vein thrombosis or pulmonary embolism. Einsteinpe investigators, buller hr, prins mh, lensin aw.
Reduceddosed rivaroxaban in the longterm prevention of. Randomized, openlabel phase iii noninferiority study active treatment. Oral, fixed dose, no blood levels to monitor, and recently approved by the fda for venous thromboembolism vte treatment. Prespecified pooled analysis of the einstein dvt and einstein pe randomized phase iii studies active treatment. Pdf on jun 28, 2012, dearbhaile m odonnell and others published oral rivaroxaban for pulmonary embolism find, read and cite all the research you need on researchgate. Although effective, treatment with warfarin requires frequent blood tests and is thus burdensome for patients. Rivaroxaban or aspirin for extended treatment of venous. Patients were randomized to receive openlabel rivaroxaban 15mg twice daily for the first 3 weeks, then 20mg daily or enoxaparin at a dose of. Oral direct factor xa inhibitor rivaroxaban in patients with. Anticoagulation using a fixeddose regimen of rivaroxaban has been shown to be as effective as standard anticoagulant therapy and is an attractive alternative due to its efficacy and lack of requirement of monitoring.
In the einstein jr phase 1 and 2 studies, bodyweightadjusted rivaroxaban dose regimens with tablets or a newly developed oral suspension have been established for children aged between birth and 18 years matching the exposure range of young adults treated with rivaroxaban 20 mg once daily. Rivaroxaban xarelta is a xa inhibitor that seems to blow coumadin out of the water. Other adverse reactions reported by greater than or equal to 1% of xareltotreated patients in einstein dvt and einstein pe studies. Einsteinpe investigators, buller hr, prins mh, lensin aw, decousus h, jacobson. Weighing the options for anticoagulation in obesity caitlin s. Published in 2012, einstein pe randomized 4,832 patients with acute pe to rivaroxaban or standard therapy with enoxaparin and a vka.
Jun 30, 2019 oral rivaroxaban for the treatment of symptomatic pulmonary embolism. The einstein dvt and einstein pe studies were each designed to test the hypothesis that rivaroxaban would be noninferior to standardtherapy. Rivaroxaban for the treatment of deep vein thrombosis or. The continued treatment study einstein extension was a doubleblind study in which patients with confirmed symptomatic dvt or pulmonary embolism who had been treated for 6 or 12 months with a. Oral, direct factor xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis or pulmonary embolism. Summary of the results of the clinical trials of rivaroxaban for the treatment of acute vte and secondary prevention of vte. Rivaroxaban will reduce symptomatic recurrent venous thromboembolism. Oral direct factor xa inhibitor rivaroxaban in patients with acute symptomatic pulmonary embolism the einstein pe study the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Weighing the options for anticoagulation in obesity. Rivaroxaban versus standard anticoagulation for acute. Clinical and applied practical management of rivaroxaban.
This study was presented at the 25th congress of the international society on thrombosis and haemostasis, june 2025, 2015, toronto, on, canada. A fixeddose regimen of rivaroxaban, an oral factor xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deepvein thrombosis, without the need for laboratory monitoring. Patientreported treatment satisfaction with oral rivaroxaban. Oral rivaroxaban versus enoxaparin with vitamin k antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer einstein dvt and einstein pe. Rivaroxaban for the treatment of venous thromboembolism in r. Einsteinpulmonary embolism pe study american college. Longterm anticoagulation with rivaroxaban for preventing. A prespecified pooled analysis of the einstein dvt and einstein pe studies compared the efficacy and safety of rivaroxaban 15 mg twicedaily for 21 days, followed by 20 mg oncedaily with standardtherapy enoxaparin 1.
Oral rivaroxaban for symptomatic venous thromboembolism. Jeff tabas giving a lecture on the perennially hot topic of pulmonary embolism pe at the upcoming ucsf high risk em conference main link, pdf brochure in san francisco may 2224, 20, i thought i would get a sneak peek into his discussion points. Rivaroxaban is a new oral anticoagulant indicated for the treatment of venous thromboembolic events vte including deep vein thrombosis dvt and pulmonary embolism pe. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.
Oral direct factor xa inhibitor rivaroxaban in patients. Rivaroxaban for treating pulmonary embolism and preventing. Rivaroxaban inhibits factorxa in the coagulation cascade. A prespecified pooled analysis of the einsteindvt and einsteinpe studies compared the efficacy and safety of rivaroxaban 15 mg. Published in, einsteinpe randomized 4, patients with acute pe to rivaroxaban or standard therapy with enoxaparin and a vka. Einstein jr phase iii is a randomized, openlabel, study comparing the efficacy and safety of rivaroxaban 20 mgequivalent dose regimens with those of standard anticoagulation for the treatment of any types of acute. Rivaroxaban is a potent, oral, highly selective, direct. Einstein dvt and einstein pe were randomized, openlabel studies that compared the efficacy and safety of rivaroxaban with standard therapy, consisting of enoxaparin and adjusteddose vka, in patients with acute, symptomatic dvt andor pe. A fixeddose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and longterm treatment of pulmonary embolism and had a potentially improved benefitrisk profile. Rivaroxaban for the treatment of symptomatic deepvein. Rivaroxaban xarelto for treatment of deep vein thrombosis. Extent of deepvein thrombosis and pulmonary embolism at study entry. Original article from the new england journal of medicine oral rivaroxaban for the treatment of symptomatic pulmonary embolism. Oral rivaroxaban versus standard therapy for the treatment of.
The einstein clinical development programme has established the efficacy and safety of rivaroxaban for the treatment of pulmonary embolism pe and deep. Einstein pe was an extension of the einstein program and was the first large, randomized study of rivaroxaban in the treatment of acute pe. Pdf rivaroxaban for the treatment of pulmonary embolism. This study will systematically assess its efficacy and safety for pe. Oral rivaroxaban for symptomatic venous thromboembolism nejm. Dec 16, 20 the worldwide einstein dvt and einstein pe studies randomized 8282 patients with acute symptomatic deepvein thrombosis dvt andor pulmonary embolism pe and, for the first time in trials in this setting, included patients in china. Einsteinpulmonary embolism pe study american college of. Methods study design and patients the j einstein dvt and pe program had an openlabel, randomized design and compared 3, 6, or 12 months of rivaroxaban with ufh and warfarin in patients older than 20 years who had acute, objectively confirmed. Outcomes by simplified pulmonary embolism severity index score from a post hoc analysis of the einstein pe study acad emerg med, 2015.
Rivaroxaban xarelto for treatment of deep vein thrombosis and pulmonary embolism, and for prevention of venous thromboembolism recurrence. Bodyweightadjusted rivaroxaban for children with venous. Einstein pe trial, detailed results are available in table 4 11. Treatment with bodyweightadjusted rivaroxaban appears to be safe in children. Due to the small number of obese patients in each of these studies, it may not be easy to extrapolate the results of this study to an obese population. Oct 12, 2017 safety of pe treatment with rivaroxaban treatment of pulmonary embolism with rivaroxaban. Rivaroxaban is a oncedaily direct factor xa inhibitor indicated for the management of vte. Patients were eligible if they were of legal age and had objectively confirmed acute, symptomatic dvt andor pe. Original article lengthofstayandeconomicconsequenceswith. We will carry out this study by searching the following electronic databases from inception to march. Among patients in the einstein choice trial who had completed a 6 to 12month course of anticoagulation for vte, extending anticoagulation with either prophylaxis 10 mg or treatment 20 mg doses of rivaroxaban for 1 year is superior to aspirin in reducing recurrent vte events. Published in, einstein pe randomized 4, patients with acute pe to rivaroxaban or standard therapy with enoxaparin and a vka. Comparison of rivaroxaban and enoxaparin plus vka in the based on weight and bmi in the einstein pe trial einstein pe9. The einsteinpe study was a randomized, openlabel trial of the efficacy and safety of rivaroxaban as compared with standard therapy consisting of enoxaparin and a vitamin k antagonist in.
Rivaroxaban is noninferior b to subcutaneous enoxaparin plus warfarin for preventing vte recurrence in people with dvt without pe and in people with pe with or without dvt in trials investigating the initial treatment of dvt acute dvt study and pe einstein pe study, incidence of major or clinically relevant nonmajor bleeding was similar between. The einstein dvt1 and einstein pe2 studies compared rivaroxaban an oral direct inhibitor of factor xa with enoxaparin given with and followed by a vitamin k antagonist for the treatment of deepvein thrombosis einstein dvt or pulmonary embolism einstein. Sep 20, 20 all other results for thrombosis and pe were classified as intermediate. Rivaroxaban is a direct factor xa inhibitor used for treatment and prevention of venous thromboembolism vte. Mar 24, 2019 einsteinpe investigators, buller hr, prins mh, lensin aw.
The treatment regimens that we confirmed in children with bodyweights of at least 20 kg and the revised treatment regimens that we predicted in those with bodyweights less than 20 kg will be evaluated in the einstein jr phase 3 trial in children with acute venous thromboembolism. Rivaroxaban revolutionises treatment of pulmonary embolism. The objective was to assess adverse outcomes in relation to the simplified pulmonary embolism severity index pesi score in patients treated with rivaroxaban or standard therapy in the phase iii einstein pe study and to evaluate the utility of the simplified pesi score to identify lowrisk pulmonary embolism pe patients. Einsteinextension trial, which compared continued rivaroxaban with placebo in. This analysis evaluates the results of these studies in this subgroup of patients.
Eligible patients with deepvein thrombosis einstein dvt or pulmonary embolism einstein pe were randomly assigned in a 1. Rivaroxaban is noninferior to standard therapy of enoxaparin and vitamin k antagonist in treating acute, symptomatic deepvein thrombosis. Longterm anticoagulation with rivaroxaban for preventing recurrent vte a benefitrisk analysis of einstein extension. In the einstein dvt study, rivaroxaban was as effective and safe as standard therapy for acute treatment of symptomatic dvt. Oct 11, 2019 nonhemorrhagic adverse reactions reported in greater than or equal to 1% of xareltotreated patients in the einstein dvt and einstein pe studies are shown in table 5. Rivaroxaban for preventing venous thromboembolism in highrisk ambulatory patients with cancer. Rivaroxaban and the einstein clinical trial programme. A prespecified pooled analysis of the einsteindvt and einsteinpe studies compared the efficacy and safety of rivaroxaban 15. Previous clinical trials have addressed that rivaroxaban is effective for the treatment of patients with pulmonary embolism pe. Sep 05, 2019 oral rivaroxaban for the treatment of symptomatic pulmonary embolism. We conducted a randomized, doubleblind, phase 3 study comparing the efficacy and safety of two doses of rivaroxaban with those of aspirin for the extended treatment of. Dec 21, 2018 use of this approach resulted in drug exposure similar to that observed in young adults treated with rivaroxaban 20 mg oncedaily. The einstein cyp cohort study was a multicenter, open label, phase 2 study designed to evaluate the population pk pd of an adapted rivaroxaban dosing regimen in patients with acute, proximal dvt or acute pe and concomitant use of a strong cyp3a4 inducer i.
Outcomes by simplified pulmonary embolism severity index score from a post hoc analysis of the einstein pe study. Einstein dvt rivaroxaban 15mg bid 20mg daily enoxaparin 1. Randomized, phase 3, multicenter, openlabel, parallelgroup, activecontrolled, eventdriven, noninferiority studies einstein dvt and einstein pe with patients receiving xarelto at an initial dose of 15 mg twice daily with food for the first 3 weeks, followed by xarelto 20 mg once daily with food or enoxaparin 1 mgkg twice daily for at least 5 days. Recurrence of pulmonary embolism while on rivaroxaban. Rivaroxaban for preventing venous thromboembolism in. Methods treatment and study design full details of the einstein dvt and pe studies have been published14,15. Pdf rivaroxaban and the einstein clinical trial programme. Avoid the use of xarelto in patients with crcl less than 30 mlmin due to an expected increase in rivaroxaban exposure and pharmacodynamic effects in this patient population. Rivaroxaban, a direct oral anticoagulant, is widely used for the treatment of venous thromboembolism vte in adult patients. A potentially fatal condition caused by a blood clot blocking a vessel in the lung.
In summary, the einstein pe study demonstrated that rivaroxaban, an oral factor xa inhibitor, can be administered without laboratory monitoring in the prevention of recurrent thromboembolism following an acute pe. Oral rivaroxaban for the treatment of symptomatic pulmonary. Saddle pulmonary embolism in a morbidly obese patient on. Rivaroxaban for cancerassociated venous thromboembolism. Venous thromboembolism vte is a relatively rare condition in childhood with treatment mainly based on extrapolation from studies in adults. In the einstein dvt and einstein pe trials, rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily thereafter was shown. The approval of rivaroxaban for the treatment of deep vein thrombosis and pulmonary embolism and the extended secondary prevention of recurrent vte is based on the results of the einstein dvt and einstein pe trials, and the einstein ext and einstein choice trials. Oral rivaroxaban for japanese patients with symptomatic. The risk of major and clinically relevant nonmajor bleeding was not significantly different when comparing rivaroxaban with standard therapy. Rivaroxaban compared with standard anticoagulants for the. By prathap sooriyakumaran, md and jeffrey tabas, md ucsfsfgh emergency medicine. Idarucizumab for dabigatran reversal, rivaroxaban for pe. Consider discontinuation of xarelto in patients who develop acute renal failure while on xarelto.