Kültürsay Barkın, Keskin Berhan, Tanyeri Seda, Tokgöz Hacer Ceren, Hakgör Aykun, Buluş Çağdaş, Mutlu Deniz, Sekban Ahmet, Sırma Dicle, Külahçıoğlu Şeyhmus, Uslu Abdulkadir, Karagöz Ali, Tanboğa İbrahim Halil, Özdemir Nihal, Kaymaz Cihangir
Department of Cardiology, Tunceli State Hospital, Tunceli, Türkiye.
Department of Cardiology, Kocaeli City Hospital, Kocaeli, Türkiye.
Anatol J Cardiol. 2025 Apr 7;29(6):312-20. doi: 10.14744/AnatolJCardiol.2025.5127.
Given the bleeding risk associated with full-dose intravenous thrombolytic treatment and the absence of randomized clinical trial evidence, current guidelines do not recommend reperfusion treatments as first-line therapy for intermediate-high risk (IHR) pulmonary embolism (PE). The aim of this study was to evaluate the effectiveness and safety of ultrasound-assisted catheter-directed thrombolysis (USAT) compared to anticoagulation therapy alone in patients with IHR PE.
A total of 425 patients diagnosed with acute PE and determined as IHR, 203 of whom underwent USAT, and 222 patients receiving only anticoagulants as the control group, were included. Baseline and post-treatment right ventricle (RV) function in echocardiography, tomographic RV/left ventricle (RV/LV) ratio, Qanadli score (Qs), and % changes from baseline were taken as primary effectiveness outcomes. For safety outcomes, major and minor bleeding and in-hospital all-cause death were adopted. Propensity score analysis was performed to reduce confounders and bias.
The USAT treatment was found to be associated with improved RV function and decreased Qs, but no significant effect was observed on the RV/LV ratio and its change. Bleeding events were more frequent in the USAT group (P < .001 for both), and no difference was observed in terms of mortality.
The study, based on real-life data, has shown that a moderate-dose, slow-infusion tissue-type plasminogen activator regimen is superior to anticoagulant therapy alone in terms of reducing pulmonary arterial thrombus burden, restoring RV dysfunction, and improving clinical outcomes in acute PE patients at IHR. However, it has also resulted in a slight increase in bleeding events.
鉴于全剂量静脉溶栓治疗存在出血风险且缺乏随机临床试验证据,当前指南不推荐将再灌注治疗作为中高危(IHR)肺栓塞(PE)的一线治疗方法。本研究的目的是评估超声辅助导管定向溶栓(USAT)与单纯抗凝治疗相比,在IHR PE患者中的有效性和安全性。
共纳入425例诊断为急性PE且确定为IHR的患者,其中203例接受USAT治疗,222例仅接受抗凝治疗作为对照组。将超声心动图检查中的基线和治疗后右心室(RV)功能、断层扫描RV/左心室(RV/LV)比值、卡纳德利评分(Qs)以及相对于基线的变化百分比作为主要有效性指标。对于安全性指标,采用严重和轻微出血以及院内全因死亡情况。进行倾向评分分析以减少混杂因素和偏倚。
发现USAT治疗与RV功能改善和Qs降低相关,但对RV/LV比值及其变化未观察到显著影响。USAT组的出血事件更频繁(两者P均<.001),在死亡率方面未观察到差异。
基于真实生活数据的该研究表明,在减轻肺动脉血栓负荷、恢复RV功能障碍以及改善IHR急性PE患者的临床结局方面,中等剂量、缓慢输注的组织型纤溶酶原激活剂方案优于单纯抗凝治疗。然而,它也导致出血事件略有增加。