BACKGROUND: Patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA) are at risk of venous thromboembolism (VTE). Australian orthopaedic guidelines recommend aspirin and low-molecular-weight heparin (e.g. enoxaparin) for VTE prophylaxis; however, there is debate in the international literature around the use of aspirin as VTE prophylaxis. This review assesses the risks and benefits of aspirin compared to enoxaparin as VTE prophylaxis for patients undergoing THA or TKA.
METHODS: A systematic review was conducted to identify relevant randomized controlled trials. Studies comparing enoxaparin, aspirin and/or placebo for VTE prophylaxis in THA or TKA patients were included. Network meta-analysis (NMA) was performed to calculate risk ratios (RRs) and confidence intervals (CIs). Quality appraisal was conducted by assessing risk of bias and the strength of the evidence.
RESULTS: Nine randomized controlled trials were eligible for inclusion. The NMA found no statistically significant differences for the investigated outcomes: total DVT rates (RR = 1.21, 95% CI 0.86, 1.72), symptomatic pulmonary embolism (PE) rates (RR = 1.02, 95% CI 0.02, 50.86), major haemorrhage (RR = 0.97, 95% CI 0.02, 50.99) and wound complication (RR = 0.73, 95% CI 0.17, 3.20). The occurrence of PE was rare. Due to limited data, sub-group analysis was not possible. The overall quality of evidence in the NMA is considered to be very low.
CONCLUSION: This review did not find statistically significant differences between aspirin and enoxaparin. Future studies should identify more evidence, particularly for rare outcomes such as PE, as this might help decision-makers to get consensus on the use of aspirin as VTE prophylaxis.
Background: Patients who undergo knee or hip arthroplasty are at a significant risk of venous thromboembolism (VTE) development (pulmonary embolism and/or deep-vein thrombosis). Many different thromboprophylactic strategies have been used for the prevention of VTE in these patients with different outcomes. Therefore, our aim was to evaluate the efficacy and safety of aspirin prophylaxis when compared with placebo or anticoagulants in this population of patients. Methods: A comprehensive electronic database search was conducted for all randomized controlled trials (RCTs) comparing the clinical outcomes of aspirin versus placebo or anticoagulants for the prevention of VTE after knee or hip arthroplasty. The primary outcome was VTE incidence. Secondary outcomes included any bleeding, major bleeding and mortality. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) using a random-effects model at the longest possible follow-up period. Results: We included 13 RCTs with a total of 20,115 patients with a mean age of 67.15 ± 9.54 and 24.39% males. Aspirin was found to be associated with a non-significantly reduced VTE events compared with other thromboprophylactic methods (RR 0.87; 95% CI: 0.61–1.23; P = 0.43). Compared with placebo, aspirin was associated with significant reduction of VTE (RR 0.65; 95% CI: 0.47–0.89; P = 0.008). There were no significant differences in the clinical outcomes between all groups with regard to mortality (RR 0.98; 95% CI: 0.86–1.11; P = 0.72), major bleeding events (RR 0.96; 95% CI: 0.50–1.84; P = 0.91), and any bleeding events (RR: 1.09; 95% CI: 0.82–1.44; P = 0.56). Conclusion: Among patients who underwent knee or hip arthroplasty, aspirin prophylaxis was found to be associated with similar efficacy and safety outcomes when compared with anticoagulants. When compared with placebo, aspirin prophylaxis was associated with significantly reduced VTE and a comparable safety profile.
ESSENTIALS: Despite trial data, guidelines have not endorsed direct oral Xa inhibitors above other options. We provide profiles of venous thromboembolism and hemorrhage risk for 12 options. Direct oral Xa inhibitors had a favorable profile compared with low-molecular-weight heparin. Other options did not have favorable profiles compared with low-molecular-weight heparin.
SUMMARY:
BACKGROUND: There are numerous trials and several meta-analyses comparing venous thromboembolism (VTE) prophylaxis options after total hip and knee replacement (THR and TKR). None have included simultaneous comparison of new with older options. Objective To measure simultaneously the relative risk of VTE and hemorrhage for 12 prophylaxis options. METHODS: We abstracted VTE and hemorrhage information from randomized controlled trials published between January 1990 and June 2016 comparing 12 prophylaxis options. We then constructed networks to compute the relative risk for each option, relative to once-daily dosing with low-molecular-weight heparin (LMWH) Low. RESULTS MAIN: Relative to LMWH Low, direct oral Xa inhibitors had the lowest risk of total deep vein thrombosis (DVT)-asymptomatic and symptomatic- (odds ratio [OR], 0.45; 95% confidence interval [CI], 0.35-0.57), translating to 53-139 fewer DVTs per 1000 patients. Vitamin K antagonists (VKAs) titrated to International Normalized Ratio [INR] 2-3 predicted 56% more DVT events (OR, 1.56; 95% CI, 1.14-2.14). Aspirin performed similarly (OR, 0.80; 95% CI, 0.34-1.86), although small numbers prohibit firm conclusions. Direct oral Xa inhibitors did not lead to significantly more bleeding (OR, 1.21; 95% CI, 0.79-1.90). Secondary: Relative to LMWH Low, direct oral Xa inhibitors prevented 4-fold more symptomatic DVTs (OR, 0.25; 95% CI, 0.13-0.47). CONCLUSIONS: Relative to LMWH Low, direct oral Xa inhibitors had a more favorable profile of VTE and hemorrhage risk, whereas VKAs had a less favorable profile. The profile of other agents was not more or less favorable. Clinicians should consider these profiles when selecting prophylaxis options.
BACKGROUND: A symptomatic pulmonary embolism (PE) after total joint arthroplasty has been described as a "never event." Despite potent anticoagulants and improvements in patient care, PE continues to occur following total hip arthroplasty (THA). This study evaluates symptomatic PE rates over time in THA patients enrolled in multicenter randomized clinical trials (RCTs) assessing the efficacy of venous thromboembolism prophylaxis regimens.
METHODS: The MEDLINE and Cochrane Central Register of Controlled Trials were searched to identify clinical trials assessing prophylactic anticoagulation in patients undergoing THA between January 1995 and December 2015. Inclusion criteria consisted of RCTs evaluating prophylactic anticoagulation in patients undergoing THA. A random effect model was used to combine PE rates across studies.
RESULTS: A total of 21 studies (34,764 patients) were included. Patients were administered low molecular weight heparin (13,590 patients), oral factor Xa inhibitors (6609 patients), oral direct thrombin inhibitors (5965 patients), indirect factors Xa/IIa inhibitors (3444 patients), aspirin (2427 patients), and warfarin (489 patients). Mobile compression was used in 199 patients, and placebo was used in 2041 patients. Across all included studies, the estimated PE rate was 0.21% (95% confidence interval: 0.13%, 0.32%). Between 1997 and 2013, the proportion of PEs did not change in regression analysis.
CONCLUSION: Although the PE rate was low, it was consistent throughout the 17 years spanning these RCTs, which excluded patients with significant morbidity. These results suggest that even healthy THA patients receiving aggressive anticoagulation still have a risk for PE, and the "never event" designation requires reassessment.
BACKGROUND: Venous thromboembolism (VTE) comprises pulmonary embolism and deep vein thrombosis and is a complication of particular concern in lower limb arthroplasty. In recent years, aspirin has emerged as a potential alternative thromboprophylactic agent, particularly after its acceptance as a recommended agent by the American College of Chest Physicians. Aspirin is favorable due to its relative cost-effectiveness and convenience compared to novel oral anticoagulants and warfarin. However, its efficacy since its inclusion in the American College of Chest Physicians guidelines remains unclear. The present systematic review aimed to establish the efficacy of aspirin in preventing VTE in total hip and knee arthroplasty.
METHODS: Electronic searches were performed using 6 databases from up to June 2015, identifying all relevant studies. Data were extracted and meta-analyzed.
RESULTS: Eleven relevant studies were identified for inclusion in the present meta-analysis. The overall rate of deep vein thrombosis and pulmonary embolism in both hip and knee arthroplasty was 1.2% and 0.6%, respectively. The rate of major bleeding was 0.3%. Pooled mortality rate was 0.2%. All findings demonstrated a high and significant degree of heterogeneity.
CONCLUSION: Aspirin, both alone and in multimodal approaches to thromboprophylaxis, confers a low rate of VTE, with a low risk of major bleeding complications. However, the evidence for its use is limited by the low quality of studies and variation in dose in dosing regimes. Future randomized controlled trials should investigate the efficacy of aspirin, as well as the ideal dosing protocol for its use in thromboprophylaxis in arthroplasty.
CONTEXTE: l'acide acétylsalicylique à faible dose (LDA, 75 mg / jour à 325 mg / jour) est recommandé pour la prévention primaire et secondaire des événements cardiovasculaires, mais a été associée à un risque accru de saignement gastro-intestinal supérieur (UGIB).
Objectif: analyser l'ampleur de l'effet de l'utilisation LDA sur le risque UGIB. Méthodes: Les bases de données PubMed et Embase ont cherché des essais contrôlés randomisés (ECR) les taux de déclaration UGIB chez les personnes recevant LDA et études observationnelles d'utilisation LDA chez les patients atteints UGIB. Des études ont été regroupées pour l'analyse des taux UGIB.
RÉSULTATS: Dix-huit études ont été incluses. Sept ECR ont rapporté des taux UGIB chez les personnes assignées au hasard à recevoir LDA (n = 22.901) ou un placebo (n = 22,923). Dix études cas-témoins ont analysé LDA Utilisation chez les patients UGIB (n = 10.816) et des contrôles sans UGIB (n = 30,519), une étude de cohorte a signalé 207 cas UGIB traités avec LDA seulement. Toutes les études ont montré LDA utiliser pour être associée à un risque accru de UGIB. Le nombre moyen de cas de UGIB supplémentaires associés à l'utilisation LDA dans les ECR était de 1,2 pour 1000 patients par an (IC 0,7 à 1,8 à 95%). Le nombre nécessaire pour nuire était de 816 (IC 560-1500 95%) pour les essais cliniques randomisés et 819 (95% CI 617-1119) pour les études observationnelles. La méta-analyse des données RCT a montré que l'utilisation LDA a été associée à une augmentation de 50% du risque UGIB (OR 1,5 [IC 95 de 1,2 à 1,8%]). Risque UGIB a été plus prononcée dans les études observationnelles (OR 3,1 [IC 95% 2.5 à 3.7]).
CONCLUSIONS: L'utilisation LDA a été associée à un risque accru de UGIB.
Lignes directrices diffèrent quant à l'acide acétylsalicylique (AAS, aspirine) doit être utilisé pour la prophylaxie chez les patients à haut risque de thromboembolie veineuse (TEV), principalement en raison de différences dans les perceptions de son efficacité. ASA est une option thérapeutique séduisante, car elle est peu coûteuse, facile à administrer et ne nécessitent pas de surveillance. Nous critique réévalué la preuve d'essais contrôlés randomisés de l'efficacité de l'AAS dans la prévention des ETEV. ASA est clairement efficace dans la prévention de la TEV par rapport à un placebo ou aucun traitement, mais semble être moins efficace que les héparines de bas poids moléculaire dans des petits essais. Il ya peu de données pour l'AAS en comparaison avec l'héparine non fractionnée et de la warfarine. Une grande étude randomisée et contrôlée est nécessaire pour clarifier le rôle de l'ASA par rapport aux stratégies anticoagulantes contemporains pour la prévention de la TEV.
Le traitement antiplaquettaire a fait l'objet de vastes études cliniques au cours des deux dernières décennies. Une variété d'agents et les régimes ont été avancées pour la prévention et le traitement des maladies vasculaires. En dépit de la preuve de sauver des vies avantages cliniques de plaquettes inhibant, cette thérapie est associée à un risque accru de saignement. L'objectif de cette étude était de déterminer le risque d'hémorragie dans les classes majeures d'agents antiplaquettaires. Les données des essais cliniques publiés 1988-2002 en anglais ont été récupérées à partir MEDLINE, OVID, et CARDIOSOURCE. Seules les études dans lesquelles les patients ont eu un suivi clinique pendant au moins 1 mois et dans lequel une description complète des complications hémorragiques a été signalé ont été inclus. Information sur la taille de l'échantillon, conception de l'étude, la durée, l'agent, les caractéristiques des patients, et des saignements de gravité a été indépendamment et en aveugle en revue. Les données de 51 essais cliniques avec un total de 338,191 patients ont été analysés. Les agents antiplaquettaires ont été divisés en 6 groupes: l'aspirine (ASA) <100 mg; ASA> ou = 100 mg; dipyridamole, les thiénopyridines; par voie intraveineuse et orale GP IIb / IIIa. L'estimation de la variance et les intervalles de confiance ont été calculés pour chaque mission le traitement. Aspirine à faible dose et de la thérapie dipyridamole ont été associés à la plus faible risque de saignement (3,6% et 6,7%, respectivement). Le taux le plus élevé de complications hémorragiques (44,6%) a été associée avec les GP IIa / IIIb inhibiteurs. Malgré des différences substantielles dans les modèles de déclaration de complications hémorragiques, AAS à faible dose et de dipyridamole traitement étaient associées au plus faible risque. Étonnamment, les doses d'ASA> / = 100 mg causé un taux d'événements relativement élevé hémorragique, qui était comparable à celle de l'ADP-bloquants. Ces résultats doivent être considérés lors de l'utilisation bithérapie antiplaquettaire et / ou anticoagulant avec des doses conventionnelles de l'AAS.
Patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA) are at risk of venous thromboembolism (VTE). Australian orthopaedic guidelines recommend aspirin and low-molecular-weight heparin (e.g. enoxaparin) for VTE prophylaxis; however, there is debate in the international literature around the use of aspirin as VTE prophylaxis. This review assesses the risks and benefits of aspirin compared to enoxaparin as VTE prophylaxis for patients undergoing THA or TKA.
METHODS:
A systematic review was conducted to identify relevant randomized controlled trials. Studies comparing enoxaparin, aspirin and/or placebo for VTE prophylaxis in THA or TKA patients were included. Network meta-analysis (NMA) was performed to calculate risk ratios (RRs) and confidence intervals (CIs). Quality appraisal was conducted by assessing risk of bias and the strength of the evidence.
RESULTS:
Nine randomized controlled trials were eligible for inclusion. The NMA found no statistically significant differences for the investigated outcomes: total DVT rates (RR = 1.21, 95% CI 0.86, 1.72), symptomatic pulmonary embolism (PE) rates (RR = 1.02, 95% CI 0.02, 50.86), major haemorrhage (RR = 0.97, 95% CI 0.02, 50.99) and wound complication (RR = 0.73, 95% CI 0.17, 3.20). The occurrence of PE was rare. Due to limited data, sub-group analysis was not possible. The overall quality of evidence in the NMA is considered to be very low.
CONCLUSION:
This review did not find statistically significant differences between aspirin and enoxaparin. Future studies should identify more evidence, particularly for rare outcomes such as PE, as this might help decision-makers to get consensus on the use of aspirin as VTE prophylaxis.
