Is routine chemoprophylaxis necessary for prevention of venous thromboembolism following knee arthroplasty in a low incidence population?
Is routine chemoprophylaxis necessary for prevention of venous thromboembolism following knee arthroplasty in a low incidence population?
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DOI：
10.1007/s00402-013-1691-z
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发表时间：
2013-04-01
影响因子：
2.3
通讯作者：
Jin, Wook
中科院分区：
文献类型：
--
作者：
Cho, Kye-Youl;Kim, Kang-Il;Jin, Wook
考虑到药物预防的风险和低发病率本身，标准血栓预防指南尚未在深静脉血栓（DVT）低发病率地区普遍应用。我们评估了DVT的患病率，药物预防的有效性和安全性，以及药物预防DVT低发病率population.148例患者接受单侧全膝关节置换术（TKA）的必要性前瞻性随机接受安慰剂或2.5 mg磺达肝癸钠，每日一次，持续5天。术前和术后7天进行多普勒超声检查。主要疗效结局为第7天DVT的患病率。次要疗效结局为第90天症状性静脉血栓栓塞（VTE）的患病率。主要和次要安全性结局分别为大出血和小出血的发生率，安慰剂组总DVT的患病率为25.7%，磺达肝癸钠组为6.8%（p = 0.002），两组近端DVT的患病率较低，无统计学差异。直至第90天，两组均无症状性VTE。虽然没有发生大出血，但磺达肝癸钠组的轻微出血事件显著增加（p < 0.001）。即使没有药物预防，东亚人TKA后VTE的发生率仍然很低。虽然短期磺达肝癸钠方案可以降低总体DVT的发生率，但由于极罕见的近端DVT和症状性PE和药物相关出血并发症，其常规使用似乎存在争议。然而，修改和选择性使用化学预防将是相当高的风险患者。
Standard thromboprophylaxis guidelines have not been applied universally in regions with low incidence of deep-vein thrombosis (DVT) considering risks of chemoprophylaxis and low incidence itself. We evaluated the prevalence of DVT, efficacy and safety of chemoprophylaxis, and necessity of pharmacological prevention in a low DVT incidence population.One hundred and forty-eight patients undergoing unilateral total knee arthroplasty (TKA) were prospectively randomized to receive either a placebo or 2.5 mg of fondaparinux once daily for 5 days. Doppler ultrasonography was performed preoperatively and 7 days after surgery. The primary efficacy outcome was prevalence of DVT up to day 7. Secondary efficacy outcome was prevalence of symptomatic venous thromboembolism (VTE) up to day 90. Primary and secondary safety outcomes were incidence of major and minor bleeding, respectively.The prevalence of total DVT was 25.7 % in placebo group and 6.8 % in fondaparinux group (p = 0.002) and the prevalence of proximal DVT was lower in both groups with no statistical difference. There was no symptomatic VTE in either group up to day 90. Although no major bleeding was developed, fondaparinux group had a significant increase of minor bleeding events (p < 0.001).There remains low incidence of VTE following TKA in East Asians even without chemoprophylaxis. Although short-term fondaparinux protocol could reduce the incidence of overall DVT, its routine use seems debatable due to extremely rare proximal DVT and symptomatic PE and drug-related bleeding complication. However, modified and selective use of chemoprophylaxis would be considerable in high risk patients.