RECORD 1 (REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism 1)
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Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin

Auteurs Bayer
Registry of Trials clinicaltrials.gov
Year 2006
Liens Registry of Trials

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.

Primary study

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Oral rivaroxaban versus subcutaneous enoxaparin for extended thromboprophylaxis after total hip replacement: RECORD1

Conférence 48th Annual Scientific Meeting of the British Society for Haematology (Published in: British Journal of Haematology2008;141(Suppl 1):82)
Year 2008

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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Primary study

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Le rivaroxaban par rapport à l'énoxaparine pour une thromboprophylaxie après une arthroplastie de la hanche.

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Journal The New England journal of medicine
Year 2008
Liens Pubmed DOI

Cet article est inclus dans 41 Systematic reviews Systematic reviews (41 references) 1 Structured summary of primary studies Structured summaries of primary studies (1 reference)

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CONTEXTE: Cette étude de phase 3 a comparé l'efficacité et la tolérance du rivaroxaban, un inhibiteur oral du facteur Xa directe, avec ceux de l'énoxaparine pour une thromboprophylaxie prolongée chez les patients subissant une arthroplastie totale de hanche. MÉTHODES: Dans cette étude randomisée, en double aveugle, nous avons attribué 4541 patients pour recevoir soit 10 mg de rivaroxaban par voie orale une fois par jour, commençant après la chirurgie, ou 40 mg d'énoxaparine sous-cutanée une fois par jour, en commençant le soir avant la chirurgie, plus d'un comprimé placebo ou d'injection. Le critère principal d'efficacité était un critère composite de la thrombose veineuse profonde (soit symptomatique ou détectées par phlébographie bilatérale si le patient était asymptomatique), l'embolie pulmonaire non mortelle, ou décès de toute cause de 36 jours (extrêmes, 30 à 42). Le résultat principal d'efficacité secondaire était la maladie thromboembolique veineuse majeure (proximale thrombose veineuse profonde, embolie pulmonaire non mortelle, ou la mort de la maladie thromboembolique veineuse). Le critère principal de tolérance était saignement majeur. Résultats: Un total de 3153 patients ont été inclus dans l'analyse de supériorité (après 1388 exclusions), et 4433 ont été inclus dans l'analyse de sûreté (après 108 exclusions). Le critère principal d'efficacité a eu lieu dans 18 de 1595 patients (1,1%) dans le groupe rivaroxaban et 58 de 1558 patients (3,7%) dans le groupe énoxaparine (réduction du risque absolu de 2,6%, intervalle de confiance 95% [IC], 1,5 à 3,7; P <0,001). Thrombo-embolie veineuse majeurs se sont produits dans 4 de 1686 patients (0,2%) dans le groupe rivaroxaban et 33 de 1678 patients (2,0%) dans le groupe énoxaparine (réduction du risque absolu de 1,7%, IC 95%, 1,0 à 2,5, p <0,001 ). Saignements majeurs se sont produits dans 6 des patients 2209 (0,3%) dans le groupe rivaroxaban et 2 de 2224 patients (0,1%) dans le groupe énoxaparine (p = 0,18). CONCLUSIONS: Une fois par jour, 10 mg dose orale de rivaroxaban a été significativement plus efficace pour une thromboprophylaxie prolongée d'un unique quotidienne, de 40 mg en dose sous-cutanée de l'énoxaparine chez les patients devant subir une arthroplastie totale de hanche. Les deux médicaments avaient des profils de sécurité similaires. (Nombre ClinicalTrials.gov, NCT00329628.)

Primary study

Unclassified

Rivaroxaban, an oral, direct factor Xa inhibitor in extended prophylaxis of thromboembolism after total hip replacement: RECORD1

Journal Pathophysiology of Haemostasis and Thrombosis
Year 2008

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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Primary study

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Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement.

Journal The Journal of bone and joint surgery. British volume
Year 2009
Liens Pubmed DOI

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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A once-daily dose of rivaroxaban 10 mg, an oral, direct Factor Xa inhibitor, was compared with enoxaparin 40 mg subcutaneously once daily for prevention of venous thromboembolism in three studies of patients undergoing elective hip and knee replacement (RECORD programme). A pooled analysis of data from these studies (n = 9581) showed that rivaroxaban was more effective than enoxaparin in reducing the incidence of the composite of symptomatic venous thromboembolism and all-cause mortality at two weeks (0.4% vs 0.8%, respectively, odds ratio 0.44; 95% confidence interval 0.23 to 0.79; p = 0.005), and at the end of the planned medication period (0.5% vs 1.3%, respectively; odds ratio 0.38; 95% confidence interval 0.22 to 0.62; p &lt; 0.001). The rate of major bleeding was similar at two weeks (0.2% for both) and at the end of the planned medication period (0.3% vs 0.2%). Rivaroxaban started six to eight hours after surgery was more effective than enoxaparin started the previous evening in preventing symptomatic venous thromboembolism and all-cause mortality, without increasing major bleeding.

Primary study

Unclassified

Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty. Pooled analysis of four studies.

Journal Thrombosis and haemostasis
Year 2011
Liens Pubmed DOI

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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Four phase III studies compared oral rivaroxaban with subcutaneous enoxaparin for the prevention of venous thromboembolism (VTE) after total hip or knee arthroplasty (THA or TKA). A pooled analysis of these studies compared the effect of rivaroxaban with enoxaparin on symptomatic VTE plus all-cause mortality and bleeding events, and determined whether these effects were consistent in patient subgroups. Patients (N=12,729) aged ≥18 years and scheduled for elective THA or TKA received rivaroxaban 10 mg once daily or enoxaparin 40 mg once daily or 30 mg every 12 hours. The composite of symptomatic VTE and all-cause mortality, the prespecified primary efficacy endpoint and adjudicated bleeding events were analysed in the day 12± 2 active treatment pool. Subgroup analyses of these outcomes were performed over the total treatment period. In the day 12± 2 pool, the primary efficacy endpoint occurred in 29/6,183 patients receiving rivaroxaban (0.5%) versus 60/6,200 patients receiving enoxaparin (1.0%; p=0.001). Major bleeding occurred in 21 (0.3%) versus 13(0.2%) patients, p=0.23; major plus non-major clinically relevant bleeding in 176(2.8%) versus 152 (2.5%) patients, p=0.19; and any bleeding in 409 (6.6%) versus 384 (6.2%) patients, p=0.38, respectively. The reduction of symptomatic VTE plus all-cause mortality was consistent across prespecified subgroups (age, gender, body weight, creatinine clearance) in the total treatment period. Compared with enoxaparin regimens, rivaroxaban reduces the composite of symptomatic VTE and all-cause mortality after elective THA or TKA, with a small increase in bleeding, no signs of compromised liver safety and fewer serious adverse events.

Primary study

Unclassified

Stress-induced hyperglycaemia and venous thromboembolism following total hip or total knee arthroplasty: analysis from the RECORD trials.

Journal Thrombosis and haemostasis
Year 2012
Liens Pubmed DOI

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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Stress-induced hyperglycaemia is common during orthopaedic surgery. In addition, hyperglycaemia activates coagulation. The aim of the study was to assess whether stress-induced hyperglycaemia is associated with symptomatic or asymptomatic venous thromboembolism (VTE) following orthopaedic surgery. We performed post-hoc analyses in the four RECORD studies (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of Deep venous thrombosis and pulmonary embolism). Separate analyses were performed for patients undergoing elective total hip or knee replacement. Outcome measures were symptomatic VTE and "total VTE" (defined as the composite of symptomatic VTE, asymptomatic DVT assessed by per protocol venography and all cause mortality). Glucose levels were measured pre-op and 6 hours post-op, categorised into quartiles, based on the distribution in the respective cohorts. The influence of glucose, adjusted for body mass index, age, gender and diabetes mellitus on VTE was assessed by logistic regression analyses. A total of 12,383 patients were eligible for assessment of symptomatic VTE, and 8,512 patients were eligible for assessment of total VTE. Increased glucose levels after total hip replacement were associated with total VTE; adjusted odds ratio (OR) highest versus lowest quartile 1.9 (95% confidence interval [CI] 1.3 to 3.0). Furthermore, increase in glucose levels during total hip replacement was associated with total VTE (OR highest versus lowest quartile 1.8 (95%CI 1.2 to 2.8). This was not observed in patients undergoing total knee replacement, probably due to differences in the applied surgical procedures.

Primary study

Unclassified

Concomitant use of medication with antiplatelet effects in patients receiving either rivaroxaban or enoxaparin after total hip or knee arthroplasty.

Journal Thrombosis research
Year 2012
Liens Pubmed DOI

Cet article est inclus dans 3 Systematic reviews Systematic reviews (3 references)

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INTRODUCTION: The RECORD programme compared oral rivaroxaban with enoxaparin for prevention of venous thromboembolism after elective total hip or knee replacement. This analysis compared the safety of concomitant use of specified medications with rivaroxaban and enoxaparin by evaluating postoperative bleeding rates from the pooled RECORD1-4 data. MATERIALS AND METHODS: The co-medications were non-steroidal anti-inflammatory drugs and platelet function inhibitors, including acetylsalicylic acid (no dose restriction). The endpoints evaluated were the composite of major and non-major clinically relevant bleeding and any bleeding occurring after first oral study drug intake. The time relative to surgery was stratified into three time periods: day 1-3, day 4-7 and after day 7. Relative bleeding rate ratios for co-medication use versus non-use were derived using stratified Mantel-Haenszel methods and compared between rivaroxaban and enoxaparin groups. RESULTS: Co-medication use with rivaroxaban or enoxaparin resulted in non-significant increases in bleeding events. Respective rate ratios were not significantly different between rivaroxaban and enoxaparin for all bleeding endpoints with concomitant use of non-steroidal anti-inflammatory drugs (any bleeding, 1.22 vs 1.22; major and non-major clinically relevant bleeding, 1.28 vs 0.90) and with concomitant use of platelet function inhibitors/acetylsalicylic acid (any bleeding, 1.32 vs 1.40; major and non-major clinically relevant bleeding, 1.11 vs 1.13). CONCLUSIONS: This explorative analysis indicates that there is no significant increase in bleeding risk for rivaroxaban compared with enoxaparin when co-administered with non-steroidal anti-inflammatory drugs or acetylsalicylic acid, although, because of low usage, the experience with platelet function inhibitors (except acetylsalicylic acid) was limited.

Primary study

Unclassified

The effects of rivaroxaban on the complications of surgery after total hip or knee replacement: results from the RECORD programme.

Journal The Journal of bone and joint surgery. British volume
Year 2012
Liens Pubmed DOI

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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Post-operative complications after total hip or knee replacement can delay recovery, prolong hospitalisation, increase rates of re-admission and, in the most severe cases, lead to long-term disability or even death. In this analysis of pooled data from four large, randomised, phase III clinical trials that compared the oral, direct Factor Xa inhibitor rivaroxaban with subcutaneous enoxaparin for the prevention of venous thromboembolism after total hip or knee replacement (n = 12,729), the incidence of complications, including bleeding and adverse events related to surgery (such as wound infection, wound dehiscence and haemarthrosis) are reported. Interventions and procedures relating to surgery are also compared between the groups. Bleeding events, including excessive wound haematoma and surgical-site bleeding, occurred at similar rates in the rivaroxaban and enoxaparin groups. Over the total study duration, adverse surgical events occurred at a similar rate in the rivaroxaban group compared with the enoxaparin group after total knee replacement (2.26% vs. 2.69%, respectively) and total hip replacement (1.48% vs. 1.65%, respectively). Blood loss, wound drainage and transfusion requirements were also similar between the two groups. This analysis shows that the incidence of adverse surgical events with rivaroxaban was similar to enoxaparin.

Primary study

Unclassified

Incidence of neuraxial haematoma after total hip or knee surgery: RECORD programme (rivaroxaban vs. enoxaparin).

Journal Acta anaesthesiologica Scandinavica
Year 2013
Liens Pubmed DOI

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Patients receiving anticoagulants could be at higher risk of compressive haematoma with neuraxial anaesthesia use. The phase III RECORD programme compared rivaroxaban with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement surgery in more than 12,500 patients. This observational analysis evaluated the risk of neuraxial haematoma after neuraxial anaesthesia in patients receiving rivaroxaban or enoxaparin using pooled RECORD1-4 data. METHODS: The incidences of intraspinal bleeding or haemorrhagic puncture were recorded as part of the criteria for major bleeding (the primary safety outcome in the RECORD studies). Incidences of allogeneic transfusion and venous thromboembolism by type of anaesthesia were also recorded. RESULTS: No compressive haematomas occurred in rivaroxaban-treated patients (10 mg once daily started 6-8 h after surgery) who underwent neuraxial anaesthesia (n = 4086). Among enoxaparin-treated patients (n = 4090), one compressive spinal haematoma requiring laminectomy occurred after epidural catheter removal in an elderly female patient with renal insufficiency undergoing total knee replacement. Total venous thromboembolism rates did not differ according to type of anaesthesia. CONCLUSION: Although no issues were observed with the use of neuraxial anaesthesia in this population of 4086 patients receiving rivaroxaban after total hip or knee replacement, it is important to remain aware of the risk of compressive haematoma. This may be of particular concern in elderly patients with renal insufficiency receiving an anticoagulant predominantly eliminated via the kidneys.

Primary study

Unclassified

Oral Rivaroxaban Compared with Subcutaneous Enoxaparin for Extended Thromboprophylaxis after Total Hip Arthroplasty: The RECORD1 Trial.

Journal Blood
Year 2015
Liens bloodjournal.org
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BACKGROUND: Thromboprophylaxis for at least 10 days and for up to 4–5 weeks is recommended after total hip arthroplasty (THA). Rivaroxaban is an oral, direct Factor Xa inhibitor in advanced clinical development for the prevention and treatment of thromboembolic disorders. RECORD1 was a phase III, multinational, randomized, double-blind, double-dummy trial, conducted to determine the efficacy and safety of oral rivaroxaban, compared with subcutaneous enoxaparin, for 5 weeks of thromboprophylaxis in patients undergoing THA. METHODS: Patients received rivaroxaban 10 mg beginning 6–8 hours after surgery and once daily (od) thereafter, or enoxaparin 40 mg od, beginning the evening before surgery (restarting 6–8 hours after surgery). Therapy continued for 35±4 days and mandatory, bilateral venography was conducted the next day. The primary efficacy endpoint was the composite of any deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE), and all-cause mortality. The primary efficacy analysis was a test for non-inferiority in the per-protocol (PP) population, followed by a test for superiority in the modified intention-to-treat (mITT) population. The main secondary efficacy endpoint was major venous thromboembolism (VTE): the composite of proximal DVT, non-fatal PE and VTE-related death. Major and non-major bleeding during the active treatment period were the primary and secondary safety endpoints, respectively. RESULTS: A total of 4541 patients were randomized; 4433 were eligible for the safety population, 3153 for the mITT population, and 3029 for the PP population. The criteria for non-inferiority were met and testing for superiority was performed. Rivaroxaban significantly reduced the incidence of the primary efficacy endpoint (p<0.001) and major VTE (p<0.001), compared with enoxaparin, in the mITT population (Table). The incidence of major and non-major bleeding events was similar in both groups (Table). CONCLUSIONS: Rivaroxaban was significantly more effective than enoxaparin for extended prophylaxis after THA, with a similar safety profile. This is the first pivotal trial to demonstrate the efficacy and safety of a fixed, unmonitored dose of an oral, direct Factor Xa inhibitor - rivaroxaban - for extended thromboprophylaxis after THA.