Schmidt-Lucke Caroline, Paar W Dieter, Stellbrink Christoph, Nixdorff Uwe, Hofmann Thomas, Meurer Jürgen, Grewe Rolf, Daniel Werner Günther, Hanrath Peter, Mügge Andreas, Klein Helmut U, Schmidt-Lucke Jan André
Molecular Cardiology, JW Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt, Germany.
Thromb Res. 2007;119(1):27-34. doi: 10.1016/j.thromres.2005.11.016. Epub 2006 Jan 27.
Anticoagulation in cardioversion for atrial fibrillation is performed using unfractionated heparin and oral anticoagulants. TEE-guided cardioversion, after achievement of therapeutic anticoagulation (1-3 days), may be an alternative to the traditional procedure (3-week anticoagulation followed by cardioversion). The quality of anticoagulation in atrial fibrillation has not been investigated in a randomised trial with TEE-guided cardioversion. We analysed respective data from the ACE trial on the quality of conventional anticoagulation, where most participating centres chose the TEE-guided approach.
In a randomised, prospective, multicentre trial, we analysed the efficacy of unfractionated heparin plus phenprocoumon in 248 patients on an intention-to-treat basis. There were 2373 evaluable anticoagulation measurements (out of 2925 measurements) and 4 categories of anticoagulation quality (under-, target, over- and severe over-anticoagulation). Of patients with evaluable measurements, 88% received short-term anticoagulation (4 weeks) in TEE-guided cardioversion.
The median time to achieve therapeutic anticoagulation (aPTT> or =60 and <80 s or INR> or =2 and <3) was 3 days. Anticoagulation values were out of therapeutic range in 69.5% of measurements during 4- or 7-week follow-up, and never within therapeutic range in 10% of patients. Of the 15 primary endpoints observed (death, thromboembolism and major bleeding complications), only 3 were in patients with anticoagulation measurements within therapeutic range.
In this study setting, with predominance of 4 weeks anticoagulation in TEE-guided cardioversion for atrial fibrillation, therapeutic anticoagulation was reached within 3 days using conventional anticoagulation. Despite careful dose adjustments, anticoagulation was out of therapeutic range in almost 70% of total measurements and 80% of primary endpoints.
心房颤动复律时的抗凝治疗采用普通肝素和口服抗凝剂。在达到治疗性抗凝(1 - 3天)后,经食管超声心动图(TEE)引导下的复律可能是传统方法(3周抗凝后复律)的一种替代方案。在TEE引导下复律的随机试验中,尚未对心房颤动抗凝质量进行研究。我们分析了ACE试验中关于传统抗凝质量的相关数据,该试验中大多数参与中心选择了TEE引导的方法。
在一项随机、前瞻性、多中心试验中,我们在意向性治疗基础上分析了248例患者使用普通肝素加苯丙香豆素的疗效。共有2925次抗凝测量值,其中2373次可评估,抗凝质量分为4类(抗凝不足、达标、抗凝过度和严重抗凝过度)。在可评估测量值的患者中,88%在TEE引导下复律时接受了短期抗凝(4周)。
达到治疗性抗凝(活化部分凝血活酶时间[aPTT]≥60且<80秒或国际标准化比值[INR]≥2且<3)的中位时间为3天。在4周或7周随访期间,69.5%的测量值抗凝值超出治疗范围,10%的患者抗凝值从未处于治疗范围内。在观察到的15个主要终点(死亡、血栓栓塞和大出血并发症)中,只有3个发生在抗凝测量值处于治疗范围内的患者。
在本研究中,心房颤动TEE引导下复律以4周抗凝为主,采用传统抗凝方法3天内可达到治疗性抗凝。尽管仔细调整了剂量,但几乎70%的总测量值和80%的主要终点抗凝值超出治疗范围。