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Rivaroxaban compared with standard thromboprophylaxis after major orthopaedic surgery: co-medication interactions.

ABSTRACT: AIM:The aim of the present study was to analyse concomitant drug use and its association with outcome in patients (N = 17 701) receiving rivaroxaban or standard of care (SOC) for the prevention of venous thromboembolism after major orthopaedic surgery in the non-interventional, phase IV XAMOS (Xarelto® in the prophylaxis of post-surgical venous thromboembolism after elective major orthopaedic surgery of hip or knee) study. METHODS:Concomitant drug use was at the discretion of the treating physician. Prespecified co-medications of interest were cytochrome P450 (CYP) 3A4/P-glycoprotein inhibitors/inducers, platelet aggregation inhibitors (PAIs) and nonsteroidal anti-inflammatory drugs (NSAIDs). Crude event incidences were compared between rivaroxaban and SOC groups. RESULTS:CYP3A4/P-glycoprotein inhibitor/inducer use was infrequent, in contrast to PAI (~7%) and NSAID (~52%) use. Rivaroxaban was associated with a lower incidence of overall symptomatic thromboembolic events compared with SOC, regardless of co-medication use. In both treatment groups, PAI users, with higher age and prevalence of cardiovascular co-morbidities, had similar higher (>7-fold) incidences of symptomatic arterial but not venous thromboembolic events compared with non-users. NSAID use had no influence on thromboembolic events. However, odds ratios (ORs) for major bleeding events (European Medicines Agency definition) were higher in NSAID users compared with non-users in rivaroxaban [OR = 1.50; 95% confidence interval (CI) 1.06, 2.13] and SOC (OR = 1.70; CI 1.16, 2.49) groups. In PAI users, ORs for major bleeding events were no different from those of non-users in both the rivaroxaban (OR = 1.49; CI 0.84, 2.65) and SOC (OR = 1.46; CI 0.82, 2.62) groups. CONCLUSIONS:Use of NSAIDs in XAMOS was frequent and associated with a higher frequency of bleeding events in patients receiving rivaroxaban or SOC, although the benefit-risk profile of rivaroxaban compared with SOC was maintained.

SUBMITTER: Kreutz R

PROVIDER: S-EPMC4799939 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Rivaroxaban compared with standard thromboprophylaxis after major orthopaedic surgery: co-medication interactions.

Kreutz Reinhold R Haas Sylvia S Holberg Gerlind G Lassen Michael R MR Mantovani Lorenzo G LG Schmidt André A Turpie Alexander G G AG

British journal of clinical pharmacology 20160212 4

<h4>Aim</h4>The aim of the present study was to analyse concomitant drug use and its association with outcome in patients (N = 17 701) receiving rivaroxaban or standard of care (SOC) for the prevention of venous thromboembolism after major orthopaedic surgery in the non-interventional, phase IV XAMOS (Xarelto® in the prophylaxis of post-surgical venous thromboembolism after elective major orthopaedic surgery of hip or knee) study.<h4>Methods</h4>Concomitant drug use was at the discretion of the ...[more]

PMID: 26580706

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Project description:ImportanceVenous thromboembolism (VTE) is a leading cause of morbidity and mortality after bariatric surgery. Clinical end point studies on thromboprophylaxis with direct oral anticoagulants in patients undergoing bariatric surgery are lacking.ObjectiveTo assess the efficacy and safety of a prophylactic dose of 10 mg/d of rivaroxaban for both 7 and 28 days after bariatric surgery.Design, setting, and participantsThis assessor-blinded, phase 2, multicenter randomized clinical trial was conducted from July 1, 2018, through June 30, 2021, with participants from 3 academic and nonacademic hospitals in Switzerland.InterventionPatients were randomized 1 day after bariatric surgery to 10 mg of oral rivaroxaban for either 7 days (short prophylaxis) or 28 days (long prophylaxis).Main outcomes and measuresThe primary efficacy outcome was the composite of deep vein thrombosis (symptomatic or asymptomatic) and pulmonary embolism within 28 days after bariatric surgery. Main safety outcomes included major bleeding, clinically relevant nonmajor bleeding, and mortality.ResultsOf 300 patients, 272 (mean [SD] age, 40.0 [12.1] years; 216 women [80.3%]; mean body mass index, 42.2) were randomized; 134 received a 7-day and 135 a 28-day VTE prophylaxis course with rivaroxaban. Only 1 thromboembolic event (0.4%) occurred (asymptomatic thrombosis in a patient undergoing sleeve gastrectomy with extended prophylaxis). Major or clinically relevant nonmajor bleeding events were observed in 5 patients (1.9%): 2 in the short prophylaxis group and 3 in the long prophylaxis group. Clinically nonsignificant bleeding events were observed in 10 patients (3.7%): 3 in the short prophylaxis arm and 7 in the long prophylaxis arm.Conclusions and relevanceIn this randomized clinical trial, once-daily VTE prophylaxis with 10 mg of rivaroxaban was effective and safe in the early postoperative phase after bariatric surgery in both the short and long prophylaxis groups.Trial registrationClinicalTrials.gov Identifier: NCT03522259.

Project description:BackgroundThere has been a shift towards greater use of neuraxial over general anaesthesia for patients undergoing total hip or knee arthroplasty. Furthermore, suggestions that peripheral nerve block may reduce adverse effects have recently been put forward. Although older studies showed a reduction in venous thromboembolism (VTE) with neuraxial compared with general anaesthesia, this difference has not been confirmed in studies using effective current thromboprophylaxis. We used a large data set to investigate the pattern of anaesthesia usage, and whether anaesthesia type affects efficacy and bleeding outcomes of thromboprophylaxis overall, within each treatment group, or for the novel oral anticoagulant dabigatran etexilate versus enoxaparin.MethodsThree previously reported trials compared 220 mg and 150 mg dabigatran etexilate once daily with enoxaparin after knee or hip arthroplasty. A pooled analysis was performed in patients receiving general or neuraxial anaesthesia, or the combination of either with peripheral nerve block (n = 8062). Outcome measures were major VTE plus VTE-related mortality, major bleeding and major plus clinically relevant bleeding events.ResultsGeneral, neuraxial and combination anaesthesia were used in 29%, 52% and 19% of patients, respectively. Differences in efficacy and safety between anaesthesia subgroups were small and not significant, except for a slightly higher rate of major VTE and VTE-related mortality with general versus neuraxial anaesthesia (odds ratio: 1.40; 95% confidence interval: 1.03-1.90; p = 0.035) in the overall population. There were no significant effects of anaesthesia type on efficacy or safety of dabigatran etexilate versus enoxaparin.ConclusionsAnaesthesia type did not greatly affect efficacy and safety outcomes in the pooled population of all three treatment groups. The efficacy and safety of dabigatran etexilate was comparable with enoxaparin, regardless of type of anaesthesia.Trial registrationClinicalTrials.gov identifiers: NCT00168805, NCT00168818, NCT00152971.

Project description:ObjectivesFor the non-vitamin-K oral anticoagulants, data on bleeding when used for 42 days as thromboprophylaxis after total knee arthroplasty (TKA) are scarce. This pilot study assessed feasibility of a multicentre randomised clinical trial to evaluate major and clinically relevant non-major bleeding during 42-day use of dabigatran, nadroparin and rivaroxaban after TKA.Patients and methodsIn 70 weeks, between July 2012 and November 2013, 198 TKA patients were screened for eligibility in the Martini Hospital (Groningen, the Netherlands). Patients were randomly assigned to dabigatran (n=45), nadroparin (n=45) or rivaroxaban (n=48). The primary outcome was the combined endpoint of major bleeding and clinically relevant non-major bleeding. Secondary endpoints of this study were the occurrence of clinical venous thromboembolism (VTE) (pulmonary embolism or deep venous thrombosis), compliance, duration of hospital stay, rehospitalisation, adverse events and Knee Injury and Osteoarthritis Outcome Score (KOOS).ResultsThe primary outcome was observed in 33.3% (95% CI 20.0% to 49.0%), 24.4% (95% CI 12.9% to 39.5%) and 27.1% (95% CI 15.3% to 41.8%) of patients who received dabigatran, nadroparin or rivaroxaban, respectively (p=0.67). Major bleeding was found in two patients who received nadroparin (p=0.21). Clinically relevant non-major bleeding was observed in 33.3% (95% CI 20.0% to 49.0%), 22.2% (95% CI 11.2% to 37.1%) and 27.1% (95% CI 15.3% to 41.8%) for dabigatran, nadroparin and rivaroxaban, respectively (p=0.51). Wound haematoma was the most observed bleeding event. VTE was found in one patient who received dabigatran (p=0.65). The presurgery and postsurgery KOOS qQuestionnaires were available for 32 (71%), 35 (77%) and 35 (73%) patients for dabigatran, nadroparin and rivaroxaban, respectively. KOOS was highly variable, and no significant difference between treatment groups in mean improvement was observed.ConclusionsA multicentre clinical trial may be feasible. However, investments will be substantial. No differences in major and clinically relevant non-major bleeding events were found between dabigatran, nadroparin and rivaroxaban during 42 days after TKA. KOOS may not be suitable to detect functional loss due to bleeding.Trial registration numberNCT01431456.

Project description:BackgroundPhysiotherapist-led orthopaedic triage, where physiotherapists diagnose and determine management plans, aims to enhance effectiveness and provide the best care. However, scientific evidence for the effectiveness of this model of care remains limited, and there are few studies reporting on patients' perceptions of the care provided. The purpose of this study was to evaluate patients' perceived quality of care in a physiotherapist-led orthopaedic triage in primary care, compared with standard practice.MethodsIn a randomised controlled trial, patients of working age referred for orthopaedic consultation at a primary healthcare clinic in Sweden received either physiotherapist-led triage (n = 102) or standard practice (orthopaedic surgeon assessment) (n = 101). Neither subjects nor clinicians were blinded. The questionnaire Quality from the Patient's Perspective (QPP) was used to evaluate perceived quality of care focusing on the caregivers' medical-technical competence and identity-orientated approach. Also, to what extent patients' expectations were met, and their intention to follow advice was evaluated.ResultsFor this study, 163 patients (80 %) were analysed (physiotherapist-led triage (n = 83), standard practice (n = 80)). Participants perceived significantly higher quality of care with the triage than with the standard practice in regards to receiving best possible examination and treatment (medical-technical competence) (p < 0.001). This was also found in regards to receiving information about examination and treatment (p < 0.001), results (p < 0.001), and self-care (p < 0.001), the caregiver's understanding (p < 0.001), respect (p < 0.001) and commitment (p < 0.001) as well as the opportunity to participate in decision-making (p = 0.01) (identity-orientated approach). Participants in the physiotherapist-led triage group reported to a significantly higher extent that their expectations of the treatment were met (p < 0.001), as well as the intent to follow the advice and instructions received (p = 0.019).ConclusionsThis paper reports on patients' perceptions of quality of care in a physiotherapist-led orthopaedic triage compared with standard practice. Patients in both groups reported that they perceived good quality of care, with the patients in the physiotherapist-led triage reporting significantly higher perceived quality of care than those in the standard practice group. This model of care seems to meet patients' expectations and result in a greater intention to follow advice and instructions for self-management. Our findings are in line with existing literature that this model of care provides an opportunity to shape patient-centered care that can improve access and offer care on the most appropriate level, with maintained good quality of care.Trial registrationClinical Trials NCT02265172 . Registered 10 June 2014.

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Rivaroxaban compared with standard thromboprophylaxis after major orthopaedic surgery: co-medication interactions.

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Rivaroxaban compared with standard thromboprophylaxis after major orthopaedic surgery: co-medication interactions.

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