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Half-dose enoxaparin vs. full-dose enoxaparin for postoperative bridging therapy in patients after cardiac surgery: Which dose regimen should be preferred?

机译:半剂量依诺肝素与全剂量依诺肝素在心脏手术后患者的术后桥接治疗中的应用:应首选哪种剂量方案?

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BACKGROUND: Patients who require oral anticoagulation (OAC) after cardiac surgery due to an increased risk for thromboembolic events should receive bridging therapy with heparin until the INR is in a therapeutic range. For this purpose, unfractionated heparin (UFH) or low molecular weight heparin (LMWH) can be used. Recently published studies have demonstrated the safety and efficiency of therapeutic dose LMWH as bridging anticoagulant in cardiac surgery. The present study compares a full-therapeutic dose regimen with a half-therapeutic dose regimen of LMWH looking for safety and efficiency. PATIENTS AND METHODS: This study represents a retrospective, single-center cohort study. In a period of 19 months all patients in whom a postoperative bridging therapy after cardiac surgery was necessary (atrial fibrillation, mechanical heart valve replacement, tricuspid valve repair, intracardiac patch implantation, excision of intracardiac tumors) were selected. In the first part of the study, patients received full-dose (FD = 1 mg/kg bodyweight twice daily) LMWH (Enoxaparin). Analogously, patients in the second part of the study were treated with half-dose (HD = 0.5 mg/kg bodyweight twice daily) LMWH. In case of renal insufficiency (GFR <30 ml/min) the dose was adjusted to one daily application. The duration of follow-up was the patients' entire stay in hospital. Main outcome parameters were bleeding, thromboembolic events, and death. The first dose of LMWH was given on the morning of the first postoperative day, considered that the bleeding risk was acceptable. OAC (Phenprocoumon) was started on the evening of the first postoperative day. RESULTS: Altogether 402 out of 3133 patients met the inclusion criteria (201 patients in each group). Despite a reduced renal function in the HD-group (p = 0.002) both groups were well matched. Mortality was significantly higher in the HD-group than in the FD-group (5.5% vs. 0.5%, p = 0.003) but not related to the anticoagulation regimen. We observed more bleeding events in the FD-group (11 vs. 5, p = 0.126) but vice versa more thromboembolic events in the HD-group (9 vs. 5, p = 0.277). In the HD-group postoperative dialysis was required more often (29 vs. 12, p = 0.011) and there was a higher incidence of patients who were psychic disorientated (42 vs. 26, p = 0.033). The hospital stay was longer in the FD-group (FD: 15.1 ± 9.3 days, HD 12.5 ± 8.1 days, p = 0.003). CONCLUSION: This study shows that a bridging therapy with LMWH is feasible and safe no matter which dose-regimen is used. The differences observed seem not to be related to the anticoagulation. The decision of using a full-dose or half-dose LMWH bridging regimen should be determined by the individual risk of the patient and the general bleeding risk of the procedure.
机译:背景:由于血栓栓塞事件风险增加而在心脏手术后需要口服抗凝(OAC)的患者应接受肝素桥接治疗,直到INR达到治疗范围。为此,可以使用普通肝素(UFH)或低分子量肝素(LMWH)。最近发表的研究表明,在心脏外科手术中,LMWH作为桥接抗凝剂的安全性和有效性。本研究比较了LMWH的全治疗剂量方案和半治疗剂量方案,以寻找安全性和有效性。患者与方法:本研究代表一项回顾性单中心队列研究。在19个月的时间内,选择了所有需要在心脏手术后进行术后桥接治疗的患者(房颤,机械性心脏瓣膜置换,三尖瓣修复,心内膜植入术,心内肿瘤切除术)。在研究的第一部分,患者接受全剂量(每日两次,FD = 1 mg / kg体重)LMWH(依诺肝素)。类似地,研究第二部分的患者接受半剂量(每日两次,HD = 0.5 mg / kg体重)LMWH治疗。如果出现肾功能不全(GFR <30 ml / min),则将剂量调整为每天一次。随访时间是患者整个住院时间。主要预后参数是出血,血栓栓塞事件和死亡。 LMWH的首剂在术后第一天的早晨服用,认为出血风险可以接受。术后第一天晚上开始使用OAC(苯丙酮)。结果:3133名患者中共有402名符合纳入标准(每组201名患者)。尽管HD组肾功能降低(p = 0.002),但两组均匹配良好。 HD组的死亡率显着高于FD组(5.5%比0.5%,p = 0.003),但与抗凝方案无关。我们在FD组中观察到更多的出血事件(11 vs. 5,p = 0.126),但在HD组中观察到更多的血栓栓塞事件(9 vs. 5,p = 0.277)。在HD组中,术后透析的频率更高(29比12,p = 0.011),精神错乱的患者发生率更高(42比26,p = 0.033)。 FD组的住院时间更长(FD:15.1±9.3天,HD 12.5±8.1天,p = 0.003)。结论:这项研究表明,无论使用哪种剂量方案,LMWH桥接治疗都是可行和安全的。观察到的差异似乎与抗凝作用无关。使用全剂量或半剂量LMWH桥接方案的决定应由患者的个人风险和手术的一般出血风险决定。

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