Aspirin or enoxaparin for VTE prophylaxis after primary partial, total or revision hip or knee arthroplasty: A secondary analysis from the CRISTAL cluster randomized trial
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PROVIDER: S-EPMC11020928 | biostudies-literature | 2024 Jan
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Project description:ImportanceThere remains a lack of randomized trials investigating aspirin monotherapy for symptomatic venous thromboembolism (VTE) prophylaxis following total hip arthroplasty (THA) or total knee arthroplasty (TKA).ObjectiveTo determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE after THA or TKA.Design, setting, and participantsCluster-randomized, crossover, registry-nested trial across 31 hospitals in Australia. Clusters were hospitals performing greater than 250 THA or TKA procedures annually. Patients (aged ≥18 years) undergoing hip or knee arthroplasty procedures were enrolled at each hospital. Patients receiving preoperative anticoagulation or who had a medical contraindication to either study drug were excluded. A total of 9711 eligible patients were enrolled (5675 in the aspirin group and 4036 in the enoxaparin group) between April 20, 2019, and December 18, 2020. Final follow-up occurred on August 14, 2021.InterventionsHospitals were randomized to administer aspirin (100 mg/d) or enoxaparin (40 mg/d) for 35 days after THA and for 14 days after TKA. Crossover occurred after the patient enrollment target had been met for the first group. All 31 hospitals were initially randomized and 16 crossed over prior to trial cessation.Main outcomes and measuresThe primary outcome was symptomatic VTE within 90 days, including pulmonary embolism and deep venous thrombosis (DVT) (above or below the knee). The noninferiority margin was 1%. Six secondary outcomes are reported, including death and major bleeding within 90 days. Analyses were performed by randomization group.ResultsEnrollment was stopped after an interim analysis determined the stopping rule was met, with 9711 patients (median age, 68 years; 56.8% female) of the prespecified 15 562 enrolled (62%). Of these, 9203 (95%) completed the trial. Within 90 days of surgery, symptomatic VTE occurred in 256 patients, including pulmonary embolism (79 cases), above-knee DVT (18 cases), and below-knee DVT (174 cases). The symptomatic VTE rate in the aspirin group was 3.45% and in the enoxaparin group was 1.82% (estimated difference, 1.97%; 95% CI, 0.54%-3.41%). This failed to meet the criterion for noninferiority for aspirin and was significantly superior for enoxaparin (P = .007). Of 6 secondary outcomes, none were significantly better in the enoxaparin group compared with the aspirin group.Conclusions and relevanceAmong patients undergoing hip or knee arthroplasty for osteoarthritis, aspirin compared with enoxaparin resulted in a significantly higher rate of symptomatic VTE within 90 days, defined as below- or above-knee DVT or pulmonary embolism. These findings may be informed by a cost-effectiveness analysis.Trial registrationANZCTR Identifier: ACTRN12618001879257.
| S-EPMC9399863 | biostudies-literature
Project description:ImportanceIschemic heart disease remains the leading cause of mortality following hip and knee arthroplasty. Due to its antiplatelet and cardioprotective properties, aspirin has been proposed as an agent that could reduce mortality when used as venous thromboembolism (VTE) prophylaxis following these procedures.ObjectiveTo compare aspirin with enoxaparin in reducing 90-day mortality for patients undergoing hip or knee arthroplasty procedures.Design, setting, and participantsThis study was a planned secondary analysis of the CRISTAL cluster randomized, crossover, registry-nested trial performed across 31 participating hospitals in Australia between April 20, 2019, and December 18, 2020. The aim of the CRISTAL trial was to determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE following hip or knee arthroplasty. The primary study restricted the analysis to patients undergoing total hip or knee arthroplasty for a diagnosis of osteoarthritis only. This study includes all adult patients (aged ≥18 years) undergoing any hip or knee arthroplasty procedure at participating sites during the course of the trial. Data were analyzed from June 1 to September 6, 2021.InterventionsHospitals were randomized to administer all patients oral aspirin (100 mg daily) or subcutaneous enoxaparin (40 mg daily) for 35 days after hip arthroplasty and 14 days after knee arthroplasty procedures.Main outcomes and measuresThe primary outcome was mortality within 90 days. The between-group difference in mortality was estimated using cluster summary methods.ResultsA total of 23 458 patients from 31 hospitals were included, with 14 156 patients allocated to aspirin (median [IQR] age, 69 [62-77] years; 7984 [56.4%] female) and 9302 patients allocated to enoxaparin (median [IQR] age, 70 [62-77] years; 5277 [56.7%] female). The mortality rate within 90 days of surgery was 1.67% in the aspirin group and 1.53% in the enoxaparin group (estimated difference, 0.04%; 95% CI, -0.05%-0.42%). For the subgroup of 21 148 patients with a nonfracture diagnosis, the mortality rate was 0.49% in the aspirin group and 0.41% in the enoxaparin group (estimated difference, 0.05%; 95% CI, -0.67% to 0.76%).Conclusions and relevanceIn this secondary analysis of a cluster randomized trial comparing aspirin with enoxaparin following hip or knee arthroplasty, there was no significant between-group difference in mortality within 90 days when either drug was used for VTE prophylaxis.Trial registrationhttp://anzctr.org.au Identifier: ACTRN12618001879257.
| S-EPMC10257098 | biostudies-literature
Project description:AbstractAspirin as an agent for thromboprophylaxis in patients with total knee replacement (TKR) and total hip replacement (THR) is gaining a lot of importance owing to its efficacy and safety in preventing venous thromboembolism (VTE) complications. The current guidelines do not recommend aspirin over other anticoagulants as the data from the meta-analysis of randomized controlled trails (RCTs) lacked a significant sample to draw conclusive results. The present study was aimed to carry out a systematic review and meta-analysis of nonrandomized studies (NRSs) to determine the effect of aspirin as prophylaxis for VTE. A complete electronic search was conducted at PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar for relevant articles published till March 2021. Any postsurgical VTE event (deep vein thrombosis and/or pulmonary embolism) is considered the primary outcome and adverse events as secondary outcomes. Both efficacy and safety outcomes were reported as pooled risk estimates with 95% confidence interval (CI) with a level of significance at P < 0.05. A total of 21 studies were identified for the analysis. The overall risk of occurrence of VTE among the patients taking aspirin was not significantly different from anticoagulants (risk ratio [RR]: 0.78, 95% CI: 0.52-1.15). Patients who underwent THR had a higher risk for VTE with aspirin (RR: 1.50, 95% CI: 1.35-1.61), whereas the patients who underwent TKR showed a lower risk of VTE with aspirin (RR: 0.80, 95% CI: 0.75-0.85). Meta-analysis of NRS advocates the role of aspirin as a prophylactic agent for VTE, especially for patients who are in need for TKR. Further RCTs are required to reestablish the role of aspirin, especially in patients undergoing THR.
| S-EPMC11913339 | biostudies-literature
Project description:IntroductionVenous thromboembolism (VTE) is a serious complication following hip arthroplasty (HA) and knee arthroplasty (KA). This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA.Methods and analysisThis is a cluster randomised, crossover, non-inferiority, trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will consist of Australian hospitals performing at least 250 HA and/or KA procedures per annum. All adult patients undergoing HA or KA will be included. The intervention will be aspirin, orally, 85-150 mg daily. The comparator will be LMWH (enoxaparin) 40 mg, subcutaneously, daily. Both drugs will commence within 24 hours postoperatively and continue for 35 days after HA and 14 days after KA. Each hospital will be randomised to commence with aspirin or LMWH and then crossover to the alternative treatment after meeting the recruitment target. Data will be collected through the AOANJRR via patient-reported surveys. The primary outcome is symptomatic VTE within 90 days post surgery, verified by AOANJRR staff. The primary analysis will include only patients undergoing elective primary total hip arthroplasty and total knee arthroplasty for osteoarthritis. Secondary outcomes will include symptomatic VTE for all HA and KA (including partial and revision) within 90 days, readmission, reoperation, major bleeding and death within 90 days and reoperation, death and patient-reported pain, function and health status at 6 months. If aspirin is found to be inferior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 15 562 patients from 31 hospitals.Ethics and disseminationEthics approval has been granted. Trial results will be submitted for publication. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001879257, pre-results) and is endorsed by the Australia and New Zealand Musculoskeletal Clinical Trials Network.
| S-EPMC6858170 | biostudies-literature
Project description:Venous thromboembolism (VTE) is a common complication following total hip arthroplasty (THA) and total knee arthroplasty (TKA). Many guidelines advise on the ideal pharmacological thromboprophylaxis strategy; however, despite its use, approximately 1.5% of patients still develop symptomatic VTE. Considering the large number of THAs and TKAs performed worldwide (2.5 million in total), the impact of VTE following these interventions is enormous. This paper discusses a concept how to further lower rates of VTE and bleeding complications following surgery. By stratifying patients according to their risk, we can optimize the balance between VTE and bleeding for each individual. This way, low-risk patients may be safely withheld from treatment (and avoid unnecessary bleeding complications and costs), whereas high-risk patients should receive adequate therapy (for instance, an increased thromboprophylaxis dosage and duration). An individualized strategy requires a well-functioning VTE prediction model following THA and TKA to help physicians to decide on optimal thromboprophylaxis therapy.
| S-EPMC7839761 | biostudies-literature
Project description: Not available
| S-EPMC9249566 | biostudies-literature
Project description:BackgroundSurgical site infection (SSI) and venous thromboembolism (VTE) are associated with high burden and cost and are considered largely preventable following total knee or hip arthroplasty (TKA, THA). The risk of developing VTE and SSI is reduced when prophylaxis is compliant with evidence-based clinical guidelines. However, the association between VTE and antibiotic prophylaxis clinical guideline compliance and patient-reported outcome measures (PROMs) after THA/TKA is unknown. This study aims to explore whether care that is non-compliant with VTE and antibiotic guideline recommendations is associated with PROMs (Oxford Hip/Knee Score and EQ-5D Index scores) at 90- and 365-days after surgery.MethodsThis prospective observational study included high-volume arthroplasty public and private sites and consenting eligible participants undergoing elective primary THA/TKA. We conducted multiple linear regression and linear mixed-effects modelling to explore the associations between non-compliance with VTE and antibiotic guidelines, and PROMs.ResultsThe sample included 1838 participants. Compliance with VTE and antibiotic guidelines was 35% and 13.2% respectively. In adjusted modelling, non-compliance with VTE guidelines was not associated with 90-day Oxford score (β = - 0.54, standard error [SE] = 0.34, p = 0.112) but was significantly associated with lower (worse) 365-day Oxford score (β = - 0.76, SE = 0.29, p = 0.009), lower EQ-5D Index scores at 90- (β = - 0.02 SE = 0.008, p = 0.011) and 365-days (β = - 0.03, SE = 0.008, p = 0.002).. The changes in Oxford and EQ-5D Index scores were not clinically important. Noncompliance with antibiotic guidelines was not associated with either PROM at 90- (Oxford: β = - 0.45, standard error [SE] = 0.47, p = 0.341; EQ-5D: β = - 0.001, SE = 0.011, p = 0.891) or 365-days (Oxford score: β = - 0.06, SE = 0.41, p = 0.880 EQ-5D: β = - 0.010, SE = 0.012, p = 0.383). Results were consistent when complications were included in the model and in linear mixed-effects modelling with the insurance sector as a random effect.ConclusionsNon-compliance with VTE prophylaxis guidelines, but not antibiotic guidelines, is associated with statistically significant but not clinically meaningful differences in Oxford scores and EQ-5D Index scores at 365 days.
| S-EPMC9556685 | biostudies-literature
Project description:BackgroundHeterotopic ossification (HO) is a known complication of total hip arthroplasty (THA) that can lead to persistent pain, stiffness, nerve impingement, and instability. Aspirin (ASA) has become an increasingly popular method of venous thromboembolism (VTE) prophylaxis, given its availability, ease of use, and relative safety. Although indomethacin has been commonly used for HO prophylaxis, we wanted to determine whether ASA, given the similar mechanism of action, may be effective in reducing the risk of HO in routine unilateral, primary THA when already being used for VTE prophylaxis.MethodsThe postoperative radiographs of 222 consecutive patients undergoing unilateral, primary THA with cementless fixation were evaluated for HO formation using the Brooker classification immediately before and after surgeon protocol shifted to routine utilization of ASA as VTE prophylaxis in low-risk patients.ResultsHO was detected in 13 of 99 (13.1%) THAs prescribed ASA for VTE prophylaxis (11 grade I, 1 grade II, 1 grade III) compared with 38 of 123 (30.9%) THAs prescribed non-ASA chemoprophylaxis (26 grade I, 7 grade II, 4 grade III, 1 grade IV). Significantly more THAs in the non-ASA cohort developed HO (P < .01). There was no significant difference in the distribution of HO severity between cohorts (P = .61).ConclusionsASA may be effective as monotherapy for both VTE and HO reduction in low-risk patients undergoing unilateral primary arthroplasty with cementless fixation.
| S-EPMC7303487 | biostudies-literature
Project description:IntroductionVenous thromboembolism (VTE) and bleeding events following total knee and hip arthroplasty (TKA/THA) are associated with significant morbidity. Clinical guidelines recommend administration of pharmacologic VTE prophylaxis post-operatively, although controversy exists regarding optimal prophylactic strategies.MethodsWe performed a retrospective cohort study in patients who underwent elective TKA/TKA in an academic medical center. Patients were stratified by surgery type (TKA/THA) and VTE risk determined by a novel risk stratification protocol and compared pre- and post-protocol implementation. Patients received warfarin pre-protocol and either aspirin or warfarin post-protocol for VTE prophylaxis. Natural language processing identified VTE events and ICD codes were used to identify bleeding events, with all events validated manually.ResultsA total of 1379 surgeries were included for analysis, 839 TKAs and 540 THAs. Post-protocol implementation, 445 (94.1%) patients following TKA and 294 (97.4%) patients following THA received aspirin for VTE prophylaxis. A significant reduction in bleeding events (hazard ratio [HR] = 0.19, p = 0.048) was observed in low-risk THA patients treated with aspirin (post-protocol) compared patients treated with warfarin (pre-protocol). Bleeding events did not differ significantly between low-risk TKA patients treated with aspirin or warfarin. No significant differences in VTE events were observed following the protocol implementation.ConclusionsThe use of a novel risk stratification system to guide VTE prophylaxis selection between aspirin or warfarin following TKA and THA appears safe and effective. Among low-risk patients, aspirin use was associated with fewer bleeding events following THA, without an observed increase in VTE events.
| S-EPMC10510472 | biostudies-literature
Project description:Optimal prophylaxis for prevention of venous thromboembolism (VTE) after total joint arthroplasty (TJA) remains debated. The purpose of this study was to compare postoperative complications in patients receiving different VTE chemoprophylactic regimens. Using a nationwide healthcare database, 72,670 THA patients without a history of VTE were identified. Study cohorts received VTE prophylaxis within 30 days postoperatively. Odds ratios and 95% confidence intervals were used to assess 30-day and 90-day postoperative complications (hematoma, hemorrhage, transfusion, pulmonary embolism (PE), VTE, prosthetic joint infection (PJI), and incision/drainage (I&D)). Of the 72,670 THA patients, 25,966 received single medication VTE prophylaxis; 551 (2.12%) aspirin, 6791 (26.15%) enoxaparin, 12,008 (46.25%) warfarin, 5403 (20.81%) rivaroxaban, 876 (3.37%) fondaparinux and 337 (1.30%) apixaban. 30-day complications included; aspirin: I&D; warfarin: I&D, hematoma, hemorrhage, transfusion, PJI, PE and DVT; apixaban: hematoma and hemorrhage. 90-day complications included; aspirin: I&D; warfarin: I&D, hematoma, hemorrhage, transfusion, PJI, PE and DVT. Warfarin was the only anticoagulant associated with a higher risk for DVT, and the highest risk for 30-day and 90-day complications. Aspirin had the highest risk for I&D. Despite three times increased 30-day risk for bleeding, apixaban was effective in preventing VTE during the high-risk 3-month-period. Enoxaparin had the lowest risk for PE and DVT while rivaroxaban had the lowest risk for PJI, hematoma, I&D, hemorrhage and transfusion.
| S-EPMC5574820 | biostudies-literature