Abstract：
OBJECTIVE: We hypothesized that ultrasound-assisted thrombolysis (USAT) is non-inferior to surgical pulmonary embolectomy (SPE) to improve right ventricular (RV) function in patients with acute pulmonary embolism (PE).
METHODS: In a single-centre, non-inferiority trial, we randomly assigned 27 patients with intermediate-high or high-risk acute PE to undergo either USAT or SPE stratified by PE risk. Primary and secondary outcomes were the baseline-to-72-h difference in right-to-left ventricular (RV/LV) ratio and the Qanadli pulmonary occlusion score, respectively, by contrast-enhanced chest-computed tomography assessed by a blinded CoreLab.
RESULTS: The trial was prematurely terminated due to slow enrolment. Mean age was 62.6 (SD 12.4) years, 26% were women, and 15% had high-risk PE. Mean change in RV/LV ratio was -0.34 (95% CI -0.50 to -0.18) in the USAT and -0.53 (95% CI -0.68 to -0.38) in the SPE group (mean difference: 0.152; 95% CI 0.032-0.271; Pnon-inferiority = 0.80; Psuperiority = 0.013). Mean change in Qanadli pulmonary occlusion score was -7.23 (95% CI -9.58 to -4.88) in the USAT and -11.36 (95% CI -15.27 to -7.44) in the SPE group (mean difference: 5.00; 95% CI 0.44-9.56, P = 0.032). Clinical and functional outcomes were similar between the 2 groups up to 12 months.
CONCLUSIONS: In patients with intermediate-high and high-risk acute PE, USAT was not non-inferior when compared with SPE in reducing RV/LV ratio within the first 72 h. In a post hoc superiority analysis, SPE resulted in greater improvement of RV overload and reduction of thrombus burden.
METHODS: In a single-centre, non-inferiority trial, we randomly assigned 27 patients with intermediate-high or high-risk acute PE to undergo either USAT or SPE stratified by PE risk. Primary and secondary outcomes were the baseline-to-72-h difference in right-to-left ventricular (RV/LV) ratio and the Qanadli pulmonary occlusion score, respectively, by contrast-enhanced chest-computed tomography assessed by a blinded CoreLab.
RESULTS: The trial was prematurely terminated due to slow enrolment. Mean age was 62.6 (SD 12.4) years, 26% were women, and 15% had high-risk PE. Mean change in RV/LV ratio was -0.34 (95% CI -0.50 to -0.18) in the USAT and -0.53 (95% CI -0.68 to -0.38) in the SPE group (mean difference: 0.152; 95% CI 0.032-0.271; Pnon-inferiority = 0.80; Psuperiority = 0.013). Mean change in Qanadli pulmonary occlusion score was -7.23 (95% CI -9.58 to -4.88) in the USAT and -11.36 (95% CI -15.27 to -7.44) in the SPE group (mean difference: 5.00; 95% CI 0.44-9.56, P = 0.032). Clinical and functional outcomes were similar between the 2 groups up to 12 months.
CONCLUSIONS: In patients with intermediate-high and high-risk acute PE, USAT was not non-inferior when compared with SPE in reducing RV/LV ratio within the first 72 h. In a post hoc superiority analysis, SPE resulted in greater improvement of RV overload and reduction of thrombus burden.
摘要：
目的：我们假设超声辅助溶栓（USAT）在改善急性肺栓塞（PE）患者右心室（RV）功能方面不劣于外科肺栓塞切除术（SPE）。
方法：在单中心，非劣效性试验,我们随机分配了27例中度高危或高危急性PE患者接受USAT或SPE治疗,并按PE风险分层.主要和次要结果是右心室与左心室（RV/LV）比值和Qanadli肺闭塞评分的基线到72小时差异，分别,通过盲法CoreLab评估的对比增强胸部计算机断层扫描。
结果：本试验因纳入缓慢而提前终止。平均年龄为62.6（SD12.4）岁，26%是女性,15%有高风险PE。在USAT组中，RV/LV比值的平均变化为-0.34（95％CI-0.50至-0.18），在SPE组中为-0.53（95％CI-0.68至-0.38）（平均差异：0.152；95％CI0.032至0.271；p值-劣等=0.80；p值-优势=0.013）。USAT组Qanadli肺闭塞评分的平均变化为-7.23（95％CI-9.58至-4.88），SPE组为-11.36（95％CI-15.27至-7.44）（平均差异：5.00；95％CI0.44至9.56，p值=0.032）。两组在12个月内的临床和功能结果相似。
结论：中高风险急性PE患者，在前72小时内，USAT在降低RV/LV比率方面与SPE相比并不逊色。在事后优势分析中，SPE导致RV过载的更大改善和血栓负担的减少。
背景：https://www.clinicaltrials.gov；NCT03218410。
方法：在单中心，非劣效性试验,我们随机分配了27例中度高危或高危急性PE患者接受USAT或SPE治疗,并按PE风险分层.主要和次要结果是右心室与左心室（RV/LV）比值和Qanadli肺闭塞评分的基线到72小时差异，分别,通过盲法CoreLab评估的对比增强胸部计算机断层扫描。
结果：本试验因纳入缓慢而提前终止。平均年龄为62.6（SD12.4）岁，26%是女性,15%有高风险PE。在USAT组中，RV/LV比值的平均变化为-0.34（95％CI-0.50至-0.18），在SPE组中为-0.53（95％CI-0.68至-0.38）（平均差异：0.152；95％CI0.032至0.271；p值-劣等=0.80；p值-优势=0.013）。USAT组Qanadli肺闭塞评分的平均变化为-7.23（95％CI-9.58至-4.88），SPE组为-11.36（95％CI-15.27至-7.44）（平均差异：5.00；95％CI0.44至9.56，p值=0.032）。两组在12个月内的临床和功能结果相似。
结论：中高风险急性PE患者，在前72小时内，USAT在降低RV/LV比率方面与SPE相比并不逊色。在事后优势分析中，SPE导致RV过载的更大改善和血栓负担的减少。
背景：https://www.clinicaltrials.gov；NCT03218410。
