From the Department of Radiology, NYU Grossman School of Medicine, New York, New York, USA.
From the Department of Radiology, NYU Grossman School of Medicine, New York, New York, USA.
JACC Cardiovasc Interv. 2021 Feb 8;14(3):319-329. doi: 10.1016/j.jcin.2020.09.053. Epub 2021 Jan 13.
This study sought to prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE).
PE treatment with thrombolytics has bleeding risks. Aspiration thrombectomy can remove thrombus without thrombolytics, but data are lacking.
This study was a prospective, single-arm, multicenter study that enrolled patients with symptomatic acute PE ≤14 days, systolic blood pressure ≥90 mm Hg, and right ventricular-to-left ventricular (RV/LV) ratio >0.9. The primary efficacy endpoint was change in RV/LV ratio from baseline to 48 h post-procedure on core lab-adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48-h major adverse events: device-related death, major bleeding, and device-related serious adverse events (clinical deterioration, pulmonary vascular, or cardiac injury). All sites received Institutional Review Board approval.
A total of 119 patients (mean age 59.8 ± 15.0 years) were enrolled at 22 U.S. sites between November 2017 and March 2019. Median device insertion to removal time was 37.0 (interquartile range: 23.5 to 60.0) min. Two (1.7%) patients received intraprocedural thrombolytics. Mean RV/LV ratio reduction from baseline to 48 h post-procedure was 0.43 (95% confidence interval: 0.38 to 0.47; p < 0.0001). Two (1.7%) patients experienced 3 major adverse events. Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 h were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively.
In this prospective, multicenter study the Indigo aspiration system was associated with a significant reduction in the RV/LV ratio and a low major adverse event rate in submassive PE patients. Intraprocedural thrombolytic drugs were avoided in 98.3% of patients. (Evaluating the Safety and Efficacy of the Indigo aspiration system in Acute Pulmonary Embolism [EXTRACT-PE]; NCT03218566).
本研究旨在前瞻性评估 Indigo 抽吸系统在亚大块急性肺栓塞（PE）中的安全性和疗效。
PE 溶栓治疗存在出血风险。抽吸血栓切除术可在不使用溶栓药物的情况下清除血栓，但数据有限。
这是一项前瞻性、单臂、多中心研究，纳入了症状性急性 PE 发病后≤14 天、收缩压≥90mmHg 和右心室与左心室（RV/LV）比值>0.9 的患者。主要疗效终点是核心实验室判定的计算机断层血管造影术（CTA）上从基线到术后 48 小时 RV/LV 比值的变化。主要安全性终点是 48 小时内的复合主要不良事件：器械相关死亡、大出血和器械相关严重不良事件（临床恶化、肺血管或心脏损伤）。所有站点均获得机构审查委员会批准。
2017 年 11 月至 2019 年 3 月期间，在美国 22 个地点共纳入了 119 例患者（平均年龄 59.8±15.0 岁）。中位器械插入至移除时间为 37.0（四分位间距：23.5 至 60.0）min。2 例（1.7%）患者术中接受了溶栓治疗。与基线相比，术后 48 小时 RV/LV 比值平均降低 0.43（95%置信区间：0.38 至 0.47；p<0.0001）。2 例（1.7%）患者发生 3 例主要不良事件。48 小时时心脏损伤、肺血管损伤、临床恶化、大出血和器械相关死亡的发生率分别为 0%、1.7%、1.7%、1.7%和 0.8%。
在这项前瞻性、多中心研究中，Indigo 抽吸系统与亚大块 PE 患者的 RV/LV 比值显著降低和低主要不良事件发生率相关。98.3%的患者避免了术中使用溶栓药物。（EXTRACT-PE 评估急性肺栓塞中 Indigo 抽吸系统的安全性和疗效：NCT03218566）
