{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T13:26:35Z","timestamp":1780406795368,"version":"3.54.1"},"reference-count":12,"publisher":"National Institute for Health and Care Research","issue":"Suppl 3","license":[{"start":{"date-parts":[[2009,10,1]],"date-time":"2009-10-01T00:00:00Z","timestamp":1254355200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["08-03-01"],"award-info":[{"award-number":["08-03-01"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:p>This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of rivaroxaban for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery based upon a review of the manufacturer\u2019s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission\u2019s evidence came from four randomised controlled trials (RCTs) comparing rivaroxaban with enoxaparin [RECORD (Regulation of Coagulation in Orthopedic surgery to pRevent Deep venous thrombosis and pulmonary embolism) 1\u20134] and three comparing dabigatran with enoxaparin [RE-NOVATE (the prevention of venous thromboembolism after total hip replacement trial), RE-MODEL (the prevention of venous thromboembolism after total knee replacement trial) and RE-MOBILIZE (the prevention of venous thromboembolism after total knee arthroplasty trial)]. The evidence from the four RECORD trials indicates that rivaroxaban had superior efficacy over enoxaparin after total hip replacement (THR) and total knee replacement (TKR). For the composite primary outcome of any deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE) and death from all causes the relative risk reductions were 70\u201379% in THR and 31\u201349% in TKR. Rivaroxaban also had superior efficacy over enoxaparin for the secondary outcome major VTE. Rivaroxaban was not inferior to enoxaparin on the safety outcome of major bleeding. After the correction of some errors found by the ERG, the manufacturer\u2019s economic model represented a reasonable model of patients receiving prophylaxis for THR or TKR. In the base-case analyses rivaroxaban dominated both enoxaparin and dabigatran. The incremental costs saved and quality-adjusted life-years (QALYs) gained were small (below \u00a3200 and 0.005, respectively, per person). Analyses were conducted sampling from the distributions observed from the RCTs. When all parameters were sampled rivaroxaban dominated enoxaparin in all scenarios except for two, in which enoxaparin produced more QALYs than rivaroxaban and had an incremental cost per QALY gained of \u00a35000 and \u00a38000 respectively. Rivaroxaban dominated dabigatran when RECORD 1 and RECORD 2, individually or pooled, were compared with RE-NOVATE and when all four rivaroxaban RCTs pooled were compared with all three dabigatran RCTs. Dabigatran dominated rivaroxaban comparing RECORD 4 with RE-MODEL and RE-MOBILIZE, and was more cost-effective than rivaroxaban comparing RECORD 3 (incremental cost per QALY gained of rivaroxaban compared with dabigatran of \u00a3123,000) or RECORD 3 and RECORD 4 pooled (incremental cost per QALY gained of dabigatran compared with rivaroxaban of \u00a3400) with RE-MODEL and RE-MOBILIZE. In conclusion, the evidence indicates that rivaroxaban is not inferior to enoxaparin in terms of the primary and secondary outcomes. The submission presents a reasonable estimation of the cost-effectiveness of rivaroxaban compared with enoxaparin and dabigatran, although the uncertainty in the decision has been underestimated. The results are particularly sensitive to any assumed difference in the number of fatal PEs, but the ERG does not believe there is sufficient evidence to support a difference between interventions. The NICE guidance issued as a result of the STA states that: riveroxaban, within its marketing authorisation, is recommended as an option for the prevention of venous thromboembolism in adults having elective THR or elective TKB.<\/jats:p>","DOI":"10.3310\/hta13suppl3-07","type":"journal-article","created":{"date-parts":[[2021,2,11]],"date-time":"2021-02-11T18:12:28Z","timestamp":1613067148000},"page":"43-48","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":19,"title":["Rivaroxaban for the prevention of venous thromboembolism: a single technology appraisal"],"prefix":"10.3310","volume":"13","author":[{"given":"M","family":"Stevenson","sequence":"first","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Scope","sequence":"additional","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Holmes","sequence":"additional","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Rees","sequence":"additional","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E","family":"Kaltenthaler","sequence":"additional","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2009,10]]},"reference":[{"key":"key20210211165024259_ref1-bib1","volume-title":"Guide to the single technology (STA) process","author":"National Institute for Health and Clinical Excellence","year":"2006"},{"key":"key20210211165024259_ref1-bib2","volume-title":"Rivoroxaban for the treatment of venous thromboembolism: a single technology appraisal","author":"Stevenson"},{"key":"key20210211165024259_ref1-bib3","unstructured":"Bayer Healthcare, Bayer Schering Pharma. Single technology appraisal (STA) of rivaroxaban (Xarelto) for the prevention of venous thromboemobolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Manufacturer submission to NICE; 2008."},{"key":"key20210211165024259_ref1-bib4","volume-title":"Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults: a single technology appraisal"},{"key":"key20210211165024259_ref1-bib5","doi-asserted-by":"crossref","first-page":"2765","DOI":"10.1056\/NEJMoa0800374","article-title":"Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty","volume":"358","author":"Eriksson","year":"2008","journal-title":"N Engl J Med"},{"key":"key20210211165024259_ref1-bib6","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1016\/S0140-6736(08)60880-6","article-title":"Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboemolism after total hip arthroplasty","volume":"372","author":"Kakkar","year":"2008","journal-title":"Lancet"},{"key":"key20210211165024259_ref1-bib7","doi-asserted-by":"crossref","first-page":"2776","DOI":"10.1056\/NEJMoa076016","article-title":"Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty","volume":"358","author":"Lassen","year":"2008","journal-title":"N Engl J Med"},{"key":"key20210211165024259_ref1-bib8","unstructured":"Bayer Healthcare. Pharmaceutical amendment A to RECORD 4 study: REgulation of Coagulation in ORthopedic surgery to prevent DVT and PE: a controlled, double-blind, randomised study of BAY 59\u20137939 (rivaroxaban) in the prevention of VTE in subjects undergoing elective total knee replacement. Study number 11355. Report No. MRR A41857; 2008."},{"key":"key20210211165024259_ref1-bib9","doi-asserted-by":"crossref","first-page":"949","DOI":"10.1016\/S0140-6736(07)61445-7","article-title":"Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, noninferiority trial","volume":"370","author":"Eriksson","year":"2007","journal-title":"Lancet"},{"key":"key20210211165024259_ref1-bib10","doi-asserted-by":"crossref","first-page":"2178","DOI":"10.1111\/j.1538-7836.2007.02748.x","article-title":"Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial","volume":"5","author":"Eriksson","year":"2007","journal-title":"J Thromb Haemost"},{"key":"key20210211165024259_ref1-bib11","article-title":"The oral inhibitor dabigatran etexilate vs the North American enoxaparin regimen for the prevention of venous thromboembolism after knee arthroplasty surgery","author":"Ginsberg","year":"2009","journal-title":"J Arthroplasty"},{"key":"key20210211165024259_ref1-bib12","volume-title":"Guide to the methods of technology appraisal","author":"National Institute for Health and Clinical Excellence","year":"2008"}],"container-title":["Health Technology Assessment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2035619","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/publications\/hta13suppl3-07\/hta13suppl3-07.xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2035619","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,15]],"date-time":"2023-08-15T15:37:31Z","timestamp":1692113851000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/hta\/hta13suppl3-07"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2009,10]]},"references-count":12,"aliases":["10.3310\/hta13suppl3\/07","10.3310\/hta13suppl3\/07"],"journal-issue":{"issue":"Suppl 3","published-online":{"date-parts":[[2009,10]]}},"alternative-id":["10.3310\/hta13suppl3-07"],"URL":"https:\/\/doi.org\/10.3310\/hta13suppl3-07","relation":{},"ISSN":["1366-5278","2046-4924"],"issn-type":[{"value":"1366-5278","type":"print"},{"value":"2046-4924","type":"electronic"}],"subject":[],"published":{"date-parts":[[2009,10]]},"assertion":[{"value":"This content has been made freely available to all.","name":"free","label":"Free to read"},{"value":"3-2009","name":"contractual_start_date","label":"Contractual start date","group":{"name":"article_history","label":"Article History"}},{"value":"2-2009","name":"editorial_review_begun","label":"Editorial review begun","group":{"name":"article_history","label":"Article History"}},{"value":"4-2009","name":"accepted_for_publication","label":"Accepted for publication","group":{"name":"article_history","label":"Article History"}}]}}