Lewis Sedina, Glen Jessica, Dawoud Dalia, Dias Sofia, Cobb Jill, Griffin Xavier L, Rossiter Nigel, Reed Michael, Sharpin Carlos, Stansby Gerard, Barry Peter
National Guideline Centre, Royal College of Physicians, London, UK.
Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt; Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, London, UK.
Lancet Haematol. 2019 Oct;6(10):e530-e539. doi: 10.1016/S2352-3026(19)30155-3. Epub 2019 Aug 20.
Hospital-associated venous thromboembolism is a major patient safety concern. Provision of prophylaxis to patients admitted for elective total knee replacement surgery has been proposed as an effective strategy to reduce the incidence of venous thromboembolism. We aimed to assess the relative efficacy and safety of all available prophylaxis strategies in this setting.
We did a systematic review and Bayesian network meta-analyses of randomised controlled trials to assess the relative efficacy and safety of venous thromboembolism prophylaxis strategies and to populate an economic model that assessed the cost-effectiveness of these strategies and informed the updated National Institute for Health and Care Excellence (NICE) guideline recommendations for patients undergoing elective total knee replacement surgery. The Cochrane Library (CENTRAL), Embase, and Medline were last searched on June 19, 2017, with key terms relating to the population (venous thromboembolism and total knee replacement) and the interventions compared, including available pharmacological and mechanical interventions. Outcomes of interest were deep vein thrombosis (symptomatic and asymptomatic), pulmonary embolism, and major bleeding. Risk of bias was assessed, and relevant data extracted from the included randomised controlled trials for the network meta-analyses. Relative risks (RR; with 95% credible intervals [95% CrI]) compared to no prophylaxis, median ranks (with 95% CrI), and the probability of being the best intervention were calculated. The study was done in accordance with PRISMA guidelines.
25 randomised controlled trials were included in the network meta-analyses. 23 trials (19 interventions; n=15 028) were included in the deep vein thrombosis network, 12 in the pulmonary embolism network (13 interventions; n=15 555), and 19 in the major bleeding network (11 interventions; n=19 797). Risk of bias ranged from very low to high. Rivaroxaban ranked first for prevention of deep vein thrombosis (RR 0·12 [95% CrI 0·06-0·22]). Low molecular weight heparin (LMWH; standard prophylactic dose, 28-35 days) ranked first in the pulmonary embolism network (RR 0·02 [95% CrI 0·00-3·86]) and LMWH (low prophylactic dose, 10-14 days) ranked first in the major bleeding network (odds ratio 0·08 [95% CrI 0·00-1·76]), but the results for pulmonary embolism and major bleeding are highly uncertain.
Single prophylaxis strategies are more effective in prevention of deep vein thrombosis in the elective total knee replacement population than combination strategies, with rivaroxaban being the most effective. The results of the pulmonary embolism and major bleeding meta-analyses are uncertain and no clear conclusion can be made other than what is biologically plausible (eg, that no prophylaxis and mechanical prophylaxis strategies should have the lowest risk of major bleeding).
National Institute for Health and Care Excellence.
医院相关静脉血栓栓塞是一个重大的患者安全问题。为接受择期全膝关节置换手术的患者提供预防措施已被提议作为降低静脉血栓栓塞发生率的有效策略。我们旨在评估在这种情况下所有可用预防策略的相对疗效和安全性。
我们对随机对照试验进行了系统评价和贝叶斯网络荟萃分析，以评估静脉血栓栓塞预防策略的相对疗效和安全性，并构建一个经济模型，该模型评估这些策略的成本效益，并为英国国家卫生与临床优化研究所（NICE）关于接受择期全膝关节置换手术患者的最新指南建议提供依据。对Cochrane图书馆（CENTRAL）、Embase和Medline的检索截至2017年6月19日，检索词涉及研究人群（静脉血栓栓塞和全膝关节置换）以及所比较的干预措施，包括可用的药物和机械干预措施。感兴趣的结局为深静脉血栓形成（有症状和无症状）、肺栓塞和大出血。评估了偏倚风险，并从纳入的随机对照试验中提取相关数据用于网络荟萃分析。计算了与不进行预防相比的相对风险（RR；95%可信区间[95% CrI]）、中位数排名（95% CrI）以及成为最佳干预措施的概率。本研究按照PRISMA指南进行。
网络荟萃分析纳入了25项随机对照试验。深静脉血栓形成网络纳入了23项试验（19种干预措施；n = 15028），肺栓塞网络纳入了12项试验（13种干预措施；n = 15555），大出血网络纳入了19项试验（11种干预措施；n = 19797）。偏倚风险从极低到高不等。利伐沙班在预防深静脉血栓形成方面排名第一（RR 0.12 [95% CrI 0.06 - 0.22]）。低分子量肝素（LMWH；标准预防剂量，28 - 35天）在肺栓塞网络中排名第一（RR 0.02 [95% CrI 0.00 - 3.86]），LMWH（低预防剂量，10 - 14天）在大出血网络中排名第一（优势比0.08 [95% CrI 0.00 - 1.76]），但肺栓塞和大出血的结果高度不确定。
在择期全膝关节置换人群中，单一预防策略在预防深静脉血栓形成方面比联合策略更有效，利伐沙班最为有效。肺栓塞和大出血荟萃分析的结果不确定，除了生物学上合理的结论（例如，不进行预防和机械预防策略的大出血风险应该最低）外，无法得出明确结论。
英国国家卫生与临床优化研究所。
