Murray R D, Shah A, Jasper S E, Goodman A, Deitcher S R, Katz W E, Malouf J F, Stoddard M F, Grimm R A, Klein A L
Steering and Publications Committee of ACUTE II, Cleveland, Ohio, USA.
Am Heart J. 2000 Jun;139(6):E1-7. doi: 10.1067/mhj.2000.106628.
Patients with atrial fibrillation >2 days' duration for whom immediate cardioversion is desired or required are commonly hospitalized for 4 or more days of antithrombotic therapy with intravenous unfractionated heparin and commencement of oral warfarin. For these early cardioversion patients, self-administered low-molecular-weight heparin (enoxaparin sodium) as "bridge" therapy to warfarin may obviate the need for hospitalization and activated partial thromboplastin time monitoring and thus potentially lower costs and enhance utility.
To compare feasibility and safety of a transesophageal echocardiography (TEE)-guided enoxaparin strategy with those of a TEE-guided unfractionated heparin strategy in patients with atrial fibrillation of >2 days' duration undergoing early electrical or chemical cardioversion.
This is a randomized, multicenter clinical trial at 11 hospitals in the United States.
Two hundred patients with atrial fibrillation >2 days' duration requiring early chemical or electric cardioversion will be enrolled. TEE-guided intravenous unfractionated heparin bridge therapy will be compared with TEE-guided subcutaneous enoxaparin bridge therapy.
Feasibility outcomes are time to hospital discharge, patient quality of life/utility, treatment costs, and sinus rhythm. Safety outcomes are ischemic stroke, transient ischemic attack, systemic embolization, major and minor bleeding, clinical hemodynamic instability, and cardiac and cardioversion-related death for a 5-week period from enrollment.
The results of this pilot study will have important clinical and economic implications for the antithrombotic management of patients with atrial fibrillation undergoing TEE-guided cardioversion.
对于病程超过2天且需要或期望立即进行心脏复律的房颤患者，通常需住院接受4天或更长时间的静脉普通肝素抗栓治疗，并开始口服华法林。对于这些早期心脏复律患者，使用自我注射的低分子肝素（依诺肝素钠）作为华法林的“桥接”治疗，可能无需住院及监测活化部分凝血活酶时间，从而有可能降低成本并提高效用。
比较经食管超声心动图（TEE）引导下依诺肝素策略与TEE引导下普通肝素策略在病程超过2天的房颤患者早期电复律或化学复律中的可行性和安全性。
这是一项在美国11家医院进行的随机、多中心临床试验。
将纳入200例病程超过2天需要早期化学或电复律的房颤患者。比较TEE引导下静脉普通肝素桥接治疗与TEE引导下皮下依诺肝素桥接治疗。
可行性指标包括出院时间、患者生活质量/效用、治疗成本和窦性心律。安全性指标包括入选后5周内的缺血性卒中、短暂性脑缺血发作、全身性栓塞、严重和轻微出血、临床血流动力学不稳定以及心脏和复律相关死亡。
这项初步研究的结果将对接受TEE引导复律的房颤患者的抗栓管理具有重要的临床和经济意义。
