A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism The OPTALYSE PE Trial
A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism The OPTALYSE PE Trial
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DOI：
10.1016/j.jcin.2018.04.008
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发表时间：
2018-07-23
影响因子：
11.3
通讯作者：
Goldhaber, Samuel Z.
中科院分区：
文献类型：
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作者：
Tapson, Victor F.;Sterling, Keith;Goldhaber, Samuel Z.
本研究的目的是确定使用超声辅助导管直接溶栓（USCDT）治疗急性中危患者的最低最佳组织纤溶酶原激活剂（tPA）剂量和输送持续时间。（次大质量）USCDT的先前试验使用tPA在12至24小时内以20至24 mg的剂量用于急性肺栓塞。经计算机断层扫描血管造影证实的急性中危肺栓塞患者被随机分配到该前瞻性多中心平行组试验中。患者接受4种USCDT方案中的1种治疗。tPA剂量范围为4 - 12 mg/肺，输注持续时间为2 - 6 h。主要疗效终点是通过计算机断层扫描血管造影术降低右心室与左心室直径比。一个主要的次要终点是栓塞负荷的改良米勒评分，测量的计算机断层血管造影后48小时开始USCDT.结果101例患者被随机分组，并改善右心室与左心室直径比如下：组1（4毫克/肺/2小时），0.40（24%; p = 0.0001）;第2组（4 mg/肺/4 h），0.35（22.6%; p = 0.0001）;组3（6 mg/肺/6 h），0.42（26.3%; p = 0.0001）;组4（12 mg/肺/6 h），0.48（25.5%; p = 0.0001）。在所有组中也观察到改良改良米勒评分改善。4例患者发生大出血（4%）。在2例颅内出血事件中，1例归因于USCDT提供的tPA。结论：与基线相比，USCDT使用较短的输送时间和较低剂量的tPA治疗与右心室功能改善和血凝块负荷降低相关。大出血发生率较低，但确实发生了1起由USCDT输送tPA引起的颅内出血事件。(c)2018作者由爱思唯尔代表美国心脏病学会基金会出版。这是一个在CC BY-NC-ND许可证下的开放获取文章（http：//creativecommons.org/licenses/by-nc-nd/4.0/）。
OBJECTIVES The aim of this study was to determine the lowest optimal tissue plasminogen activator (tPA) dose and delivery duration using ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk (submassive) pulmonary embolism.BACKGROUND Previous trials of USCDT used tPA over 12 to 24 h at doses of 20 to 24 mg for acute pulmonary embolism.METHODS Hemodynamically stable adults with acute intermediate-risk pulmonary embolism documented by computed tomographic angiography were randomized into this prospective multicenter, parallel-group trial. Patients received treatment with 1 of 4 USCDT regimens. The tPA dose ranged from 4 to 12 mg per lung and infusion duration from 2 to 6 h. The primary efficacy endpoint was reduction in right ventricular-to-left ventricular diameter ratio by computed tomographic angiography. A major secondary endpoint was embolic burden by refined modified Miller score, measured on computed tomographic angiography 48 h after initiation of USCDT.RESULTS One hundred one patients were randomized, and improvements in right ventricular-to-left ventricular diameter ratio were as follows: arm 1 (4 mg/lung/2 h), 0.40 (24%; p = 0.0001); arm 2 (4 mg/lung/4 h), 0.35 (22.6%; p = 0.0001); arm3 (6 mg/lung/6 h), 0.42 (26.3%; p = 0.0001); and arm4 (12 mg/lung/6 h), 0.48 (25.5%; p = 0.0001). Improvement in refined modified Miller score was also seen in all groups. Four patients experienced major bleeding (4%). Of 2 intracranial hemorrhage events, 1 was attributed to tPA delivered by USCDT.CONCLUSIONS Treatment with USCDT using a shorter delivery duration and lower-dose tPA was associated with improved right ventricular function and reduced clot burden compared with baseline. The major bleeding rate was low, but 1 intracranial hemorrhage event due to tPA delivered by USCDT did occur. (c) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).