We conducted a randomized clinical trial to compare the effectiveness of the A-V Impulse System foot pump for reducing the incidence of deep-vein thrombosis (DVT) after total knee arthroplasty (TKA) in patients under edoxaban thromboprophylaxis. Patients undergoing primary TKA at our institution between September 2013 and March 2015 were enrolled after obtaining informed consent. The patients were randomized to use the foot pump (n = 58) and not to use the foot pump (n = 62). Both groups were given prophylactic edoxaban. Primary outcomes were any DVT as detected by bilateral ultrasonography up to postoperative day 10 (POD10) and pulmonary embolism (PE) up to POD28. The safety outcomes were bleeding and death of any cause up to POD28. Plasma D-dimer levels were measured before TKA and on POD10 after TKA. Immunoglobulin G (IgG)-class anti-PF4/heparin antibodies were measured using an IgG-specific enzyme-linked immunosorbent assay. The incidences of any DVT up to POD28 were 31.0% and 17.7% in patients with or without the foot pump, respectively. The incidences of major bleeding up to POD28 were 5.1% and 4.8% in patients with or without the foot pump, respectively. Foot pump use did not significantly reduce the incidence of DVTs in patients undergoing TKA under edoxaban thromboprophylaxis. Although seroconversion of anti-PF4/heparin antibodies was confirmed in one-fourth of patients, the seroconversion rates did not differ between patients with (20.7%) or without (25.8%) foot pump use. This study shows that the A-V Impulse system foot pump did not affect the incidence of DVT under edoxaban thromboprophylaxis in patients undergoing TKA. Seroconversion of anti-PF4/heparin antibodies was detected in a significant number of patients who underwent TKA under antithrombotic prophylaxis using edoxaban.

译文

:我们进行了一项随机临床试验,以比较A-V脉冲系统脚踏泵在接受edoxaban血栓预防性治疗的患者中,降低全膝关节置换术(TKA)后深静脉血栓形成(DVT)的发生率。在获得知情同意后,于2013年9月至2015年3月在我们机构接受原发性TKA的患者入选。患者被随机分配使用脚踏泵(n = 58),而不使用脚踏泵(n = 62)。两组均给予预防性依多沙班治疗。主要结局是术后10天(POD10)通过双侧超声检查发现的任何DVT,以及POD28之前通过肺栓塞(PE)进行的检查。安全结果是出血和任何原因致死,直至POD28。在TKA之前和TKA之后在POD10上测量血浆D-二聚体水平。使用IgG特异性酶联免疫吸附测定法测量了免疫球蛋白G(IgG)类抗PF4 /肝素抗体。有或没有脚踏泵的患者中,直至POD28的任何DVT的发生率分别为31.0%和17.7%。有或没有脚踏泵的患者中,直至POD28的大出血发生率分别为5.1%和4.8%。在使用依多沙班预防血栓形成的TKA患者中,脚踏泵的使用并没有显着降低DVT的发生率。尽管在四分之一的患者中证实了抗PF4 /肝素抗体的血清转化,但在使用(20.7%)或不使用(25.8%)脚踏泵的患者之间,血清转化率没有差异。这项研究表明,接受TKA的患者在依多沙班血栓预防措施下,A-V脉冲系统脚踏泵不会影响DVT的发生率。在使用依多沙班进行抗血栓预防的TKA患者中,有大量患者检测到抗PF4 /肝素抗体的血清转化。

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