Design and rationale of a randomized trial comparing standard versus ultrasound-assisted thrombolysis for submassive pulmonary embolism
Design and rationale of a randomized trial comparing standard versus ultrasound-assisted thrombolysis for submassive pulmonary embolism
复制标题
DOI：
10.1016/j.jvsv.2017.09.004
复制
发表时间：
2018-01-01
影响因子：
3.2
通讯作者：
Chaer, Rabih A.
中科院分区：
文献类型：
--
作者：
Avgerinos, Efthymios D.;Mohapatra, Abhisekh;Chaer, Rabih A.
背景：用于治疗次大面积肺栓塞 (sPE) 患者的导管导向干预措施已显示出在快速改善右心劳损和预防大面积肺栓塞失代偿方面的前景。在各种导管干预措施中，超声辅助溶栓（USAT）因其潜在的更有效的溶解作用而引起人们的兴趣，可以更快地实现溶栓并减少溶解剂量。然而，根据临床证据，尚不清楚 USAT 是否优于标准导管定向溶栓 (SCDT)。我们在此描述了标准与超声辅助导管溶栓治疗次大面积肺栓塞 (SUNSET sPE) 试验的研究设计，这是一项正在进行的随机临床试验，旨在解决这个问题。方法：考虑将就诊或转诊至我们机构的 sPE 成人纳入该试验。根据治疗团队的判断，所有患者均接受导管引导干预以及伴随的抗凝治疗。参与者按 1:1 的比例随机分配至 USAT 导管或 SCDT 导管。研究评估者对治疗组不知情。主要结果是肺血栓负荷的清除，通过术后计算机断层扫描血管造影进行评估。次要结果包括通过超声心动图解决右心室应变；改善肺动脉压力； 3 个月和 12 个月超声心动图的改善。功能能力和生活质量衡量标准。该研究旨在检测肺动脉血栓清除率提高 50%。我们的入组目标是每个治疗组 40 名患者。结论：SUNSET sPE 是一项正在进行的随机、头对头、单盲临床试验，目的是评估 USAT 与 SCDT 相比，对于 sPE 患者是否能产生更好的血栓清除效果。我们希望我们的研究结果能够为未来针对这一具有挑战性的患者群体选择溶栓方式的指南提供信息。
Background: Catheter-directed interventions for the treatment of patients with submassive pulmonary embolism (sPE) have shown promise in rapidly improving right-sided heart strain and preventing decompensation to massive pulmonary embolism. Among various catheter interventions, ultrasound-assisted thrombolysis (USAT) has attracted interest as potentially having more efficient lytic effect that could achieve thrombolysis faster and with a reduced lytic dose. However, based on clinical evidence, it is unclear whether USAT is superior to standard catheter-directed thrombolysis (SCDT). We herein describe the study design of the Standard vs UltrasouNd-assiSted CathEter Thrombolysis for Sub massive Pulmonary Embolism (SUNSET sPE) trial, an ongoing randomized clinical trial designed to address this question.Methods: Adults with sPE presenting or referred to our institution are considered for enrollment in the trial. At the discretion of the treatment team, all patients undergo a catheter-directed intervention plus concomitant therapeutic anticoagulation. Participants are randomized 1:1 to a USAT catheter or an SCDT catheter. Study assessors are blinded to treatment group. The primary outcome is clearance of pulmonary thrombus burden, assessed by postprocedure computed tomography angiography. Secondary outcomes include resolution of right ventricular strain by echocardiography; improvement in pulmonary artery pressures; and 3- and 12-month improvement in echocardiographic. functional capacity, and quality of life measures. The study is powered to detect a 50% improvement in pulmonary artery thrombus clearance. Our enrollment target is 40 patients per treatment arm.Conclusions: SUNSET sPE is an ongoing randomized, head-to-head, single-blinded clinical trial with the goal of assessing whether USAT results in superior thrombus clearance compared with SCDT in patients with sPE. We expect the results of our study to inform future guidelines on choice of thrombolysis modality in this population of challenging patients.