Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-1392. doi: 10.1016/j.jcin.2015.04.020.
This study conducted a prospective, single-arm, multicenter trial to evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis, using the EkoSonic Endovascular System (EKOS, Bothell, Washington).
Systemic fibrinolysis for acute pulmonary embolism (PE) reduces cardiovascular collapse but causes hemorrhagic stroke at a rate exceeding 2%.
Eligible patients had a proximal PE and a right ventricular (RV)-to-left ventricular (LV) diameter ratio ≥0.9 on chest computed tomography (CT). We included 150 patients with acute massive (n = 31) or submassive (n = 119) PE. We used 24 mg of tissue-plasminogen activator (t-PA) administered either as 1 mg/h for 24 h with a unilateral catheter or 1 mg/h/catheter for 12 h with bilateral catheters. The primary safety outcome was major bleeding within 72 h of procedure initiation. The primary efficacy outcome was the change in the chest CT-measured RV/LV diameter ratio within 48 h of procedure initiation.
Mean RV/LV diameter ratio decreased from baseline to 48 h post-procedure (1.55 vs. 1.13; mean difference, -0.42; p < 0.0001). Mean pulmonary artery systolic pressure (51.4 mm Hg vs. 36.9 mm Hg; p < 0.0001) and modified Miller Index score (22.5 vs. 15.8; p < 0.0001) also decreased post-procedure. One GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries)-defined severe bleed (groin hematoma with transient hypotension) and 16 GUSTO-defined moderate bleeding events occurred in 15 patients (10%). No patient experienced intracranial hemorrhage.
Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis decreased RV dilation, reduced pulmonary hypertension, decreased anatomic thrombus burden, and minimized intracranial hemorrhage in patients with acute massive and submassive PE. (A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE) [SEATTLE II]; NCT01513759).
本研究开展了一项前瞻性、单臂、多中心试验，旨在评估使用 EkoSonic 血管内系统（EKOS，华盛顿州 Bothell）行超声辅助、导管引导、小剂量溶栓的安全性和疗效。
全身溶栓治疗急性肺栓塞（PE）可降低心血管崩溃的风险，但导致脑出血的发生率超过 2%。
符合条件的患者胸部 CT 显示近端 PE 和右心室（RV）-左心室（LV）直径比≥0.9。共纳入 150 例急性大块（n=31）或次大块（n=119）PE 患者。我们使用 24mg 组织型纤溶酶原激活剂（t-PA），单侧导管给药方案为 1mg/h 持续 24 小时，或双侧导管给药方案为 1mg/h/导管 12 小时。主要安全性结局为起始治疗后 72 小时内的大出血。主要疗效结局为起始治疗后 48 小时内胸部 CT 测量的 RV/LV 直径比的变化。
RV/LV 直径比从基线到治疗后 48 小时（1.55 比 1.13；平均差异，-0.42；p<0.0001）降低。平均肺动脉收缩压（51.4mmHg 比 36.9mmHg；p<0.0001）和改良 Miller 指数评分（22.5 比 15.8；p<0.0001）也在治疗后降低。15 例患者（10%）发生 1 例 GUSTO（全球溶栓和组织型纤溶酶原激活剂用于闭塞性冠状动脉疾病）定义的严重出血（腹股沟血肿伴短暂低血压）和 16 例 GUSTO 定义的中度出血事件。无患者发生颅内出血。
在急性大块和次大块 PE 患者中，超声辅助、导管引导、小剂量溶栓可减轻 RV 扩张、降低肺动脉高压、减少解剖血栓负荷，并最大限度减少颅内出血。（EkoSonic®血管内系统和 Activase 治疗急性肺栓塞（PE）的前瞻性、单臂、多中心试验 [SEATTLE II]；NCT01513759）。
