Bleeding complications of thromboprophylaxis with dabigatran, nadroparin or rivaroxaban for 6 weeks after total knee arthroplasty surgery: a randomised pilot study

Veen, L. van; Segers, Marijn; Raay, Jos Jam van; Gerritsma-Bleeker, Carina L E; Brouwer, Reinoud W; Veeger, Nic J. G. M.; Hulst, Marinus van

doi:10.1136/bmjopen-2020-040336

Cited by 12 publications

(13 citation statements)

References 24 publications

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“…However, anticoagulant chemoprophylaxis puts patients at risk for bleeding after TKA. Bleeding complications (including ecchymosis) following total joint arthroplasty are not acceptable, as they can lead to more important complications, such as infection, wound healing problems, dysfunction and loosening of the joints, with a high likelihood of affecting the surgical outcome ( 20 ). Rivaroxaban, a direct oral factor Xa inhibitor, is commonly prescribed for the prevention of VTE after TKA due to its effectiveness, high safety and convenience of use ( 3 , 21 ).…”

Section: Discussionmentioning

confidence: 99%

Changes in Thromboelastography to Predict Ecchymosis After Knee Arthroplasty: A Promising Guide for the Use of Anticoagulants

et al. 2022

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BackgroundEcchymosis is one of the worrisome complications after total knee arthroplasty (TKA) and interferes with functional rehabilitation. Current clinical guidelines do not provide individualized approaches for patients with ecchymoses.MethodsIn this study, we used thromboelastography (TEG) to determine the coagulation state after TKA and to then explore markers that predict the occurrence of ecchymosis events after TKA. In our cohort, patients were divided into ecchymosis (n = 55) and non-ecchymosis (n = 137) groups according to whether ecchymosis events occurred after TKA. Rivaroxaban 10 mg/d was taken orally for thromboprophylaxis after surgery. All patients completed TEG testing. Correlation analysis was used to determine the risk factors for ecchymosis after TKA, and receiver operating characteristic (ROC) curves for variables with significant correlation were plotted.ResultsIn all, 55 of the 192 patients (28.65%) developed ecchymosis surrounding the surgical site. Multivariate analysis showed that hidden blood loss (OR = 1.003 and p = 0.005) and changes in the coagulation index (ΔCI) values (OR = 0.351 and p = 0.001) were risk factors for ecchymosis after TKA. Using the Youden index, 0.1805 was determined as the optimal threshold value of ΔCI for predicting the occurrence of ecchymosis, with a sensitivity of 74.55% and specificity of 72.99%. ΔCI is a promising marker as an alarm for the occurrence of ecchymosis after TKA.Trial RegistrationThe study was registered in the Chinese Clinical Trial Registry (ChiCTR1800017245). Registered name: The role of thrombelastography in monitoring the changes of coagulation function during perioperative period of arthroplasty. Registered 19 July 2018. http://www.chictr.org.cn/showproj.aspx?proj=29220

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Section: Discussionmentioning

confidence: 99%

Changes in Thromboelastography to Predict Ecchymosis After Knee Arthroplasty: A Promising Guide for the Use of Anticoagulants

et al. 2022

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“…Effective perioperative and postoperative management is a hot issue for its importance of improving recovery and reducing complications after THA or TKA, 43,44 while complications including thromboembolism, bleeding and infection remain the major causes of delayed functional rehabilitation. Thus, how to minimize the risk of thromboembolic events while not placing the patient at an increased risk for wound complications associated with anticoagulation is a major research focus for orthopaedic surgeons.…”

Section: Discussionmentioning

confidence: 99%

“…We retrieved 1683 studies from 3 databases, of which 20 studies published between 2006 and 2021 were finally eligible for inclusion. [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44] Figure 1 shows the detailed study selection process and results. The detailed information of the included studies is showed in Table 1.…”

Section: General Information About the Included Studiesmentioning

confidence: 99%

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Wound complications and bleeding with new oral anticoagulants in patients undergoing total joint arthroplasty: A systematic review and meta‐analysis of randomized controlled trials

Wang

Xie

Zheng

et al. 2021

Brit J Clinical Pharma

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Aims The results of associations between new oral anticoagulants (NOACs) and wound complications after total joint arthroplasty remain inconsistent. We conducted a systematic review and meta‐analysis of randomized controlled trials to make comparisons with low molecular weight heparins (LMWH) on the clinical outcomes of total wound complications, together with other efficacy and safety endpoints to further evaluate the safety and efficacy of NOACs. Methods This meta‐analysis was conducted based on a published protocol (PROSPERO: CRD42019140841). We searched for available articles in PubMed, Embase and Cochrane Library through Jun 62 021. Random‐effects meta‐analyses, including subgroup analyses, were conducted to estimate the pooled relative risk (RR) and 95% confidence interval (CI) for specific doses of NOACs. Results We retrieved 1683 studies, of which 20 were eligible for inclusion. We found that apixaban was associated with a lower incidence of total wound complications compared with LMWH (RR = 0.81; 95% CI: 0.65–1.00), while dabigatran and rivaroxaban did not increase the risk of total wound complications. In addition, apixaban was associated with a reduction in the risk of major/clinically relevant nonmajor bleeding events compared to LMWH (RR = 0.80, 95% CI: 0.65–0.99), while rivaroxaban increased the risk for major/clinically relevant nonmajor bleeding events (RR = 1.23, 95% CI: 1.02–1.50). Moreover, all 4 NOACs were associated with lower incidences of major venous thromboembolism compared with LMWH. Conclusion A lower risk of wound complications was detected for apixaban, while dabigatran and rivaroxaban did not increase the risk when compared with LMWH. The efficacy of 4 NOACs was broadly similar.

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“…Our SUCRA probabilities showed that nadroparin performed best in decreasing the risk of bleeding. A recent pilot study indicates that nadroparin, in comparison with dabigatran or rivaroxaban, showed no difference in bleeding complications in patients with total knee arthroplasty surgery (van der Veen et al, 2021). A retrospective study compared the safety and efficacy of tinzaparin and nadroparin in neurosurgery and showed no significant difference in bleeding events and incidence of VTE (Wilhelmy et al, 2021).…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Low Molecular Weight Heparin for Thromboprophylaxis in the Elderly: A Network Meta-Analysis of Randomized Clinical Trials

Yang

Liu

et al. 2021

Front. Pharmacol.

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Background: Given their changing pathophysiology, elderly patients carry a high risk of embolism and bleeding events; hence, use of appropriate anticoagulants is very important. Low molecular weight heparin (LMWH) is one of the most widely used anticoagulants although LMWHs differ in their anti-Xa, antithrombin, and anticoagulant activities. To date, no study has directly compared the safety and efficacy of different LMWHs in the elderly. We aimed to compare such differences by conducting a network meta-analysis.Methods: We searched the Pubmed, Embase, and Cochrane databases for randomized controlled trials (RCTs) of LMWHs that included patients ≥60 years old up to July 22, 2020. Safety outcomes included venous thromboembolism (VTE) or VTE-related death, deep thrombus embolism, and pulmonary embolism. Safety outcomes were clinically relevant bleeding, major bleeding, minor bleeding, and all-cause death. We calculated relative ratios (RR) and 95% confidence intervals (CI) for all outcomes. The cumulative ranking probabilities (SUCRA) were conducted to rank the comparative effects and safety of all LMWHs.Results: We included 27 RCTs (30,441 elderly), comprising five LMWHs. LMWH was more effective than placebo in preventing VTE or VTE-related death (RR 0.36, 95% CI 0.25–0.53) but less effective than a novel oral anticoagulant (RR 1.59, 95% CI 1.33–1.91) and safer than acenocoumarol regarding risk of clinically relevant bleeding (RR 0.67, 95% CI 0.49–0.90). However, indirect comparison of efficacy and safety of the five LMWHs showed no significant difference in our network analysis, and the subgroup analyses (such as in patients with deep venous thrombosis, cardiac disease, or age >65 years old) supported the results. The SUCRA showed that tinzaparin performed best in preventing VTE or VTE-related death (SUCRA 68.8%, cumulative probability 42.3%) and all-cause death (SUCRA 84.2%, cumulative probability 40.7%), whereas nadroparin was predominant in decreasing the risk of clinically relevant bleeding (SUCRA 84.8%, cumulative probability 77.0%).Conclusions: On present evidence, there are no significant differences in the efficacy and safety of different LMWHs for the elderly. According to the rank probability analysis, nadroparin seems to be safer for the elderly with a high risk of bleeding, whereas tinzaparin is more effective for those with low bleeding risk.

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Bleeding complications of thromboprophylaxis with dabigatran, nadroparin or rivaroxaban for 6 weeks after total knee arthroplasty surgery: a randomised pilot study

Cited by 12 publications

References 24 publications

Changes in Thromboelastography to Predict Ecchymosis After Knee Arthroplasty: A Promising Guide for the Use of Anticoagulants

Changes in Thromboelastography to Predict Ecchymosis After Knee Arthroplasty: A Promising Guide for the Use of Anticoagulants

Wound complications and bleeding with new oral anticoagulants in patients undergoing total joint arthroplasty: A systematic review and meta‐analysis of randomized controlled trials

Safety and Efficacy of Low Molecular Weight Heparin for Thromboprophylaxis in the Elderly: A Network Meta-Analysis of Randomized Clinical Trials

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