Sekulic Igor, Dzudovic Boris, Matijasevic Jovan, Batranovic Uros, Rusovic Sinisa, Mihajlovic Miodrag, Miladinovic Uros, Rancic Nemanja, Subotic Bojana, Novicic Natasa, Gavrilovic Srdjan, Boskovic-Sekulic Jelena, Obradovic Slobodan
Institute for Radiology, Military Medical Academy, Belgrade, Serbia.
Clinic of Cardiology and Emergency Internal Medicine, Military Medical Academy, Belgrade, Serbia.
Acta Cardiol. 2020 Nov;75(7):623-630. doi: 10.1080/00015385.2019.1646850. Epub 2019 Aug 1.
Systemic thrombolytic therapy is not recommended for patients with intermediate-risk pulmonary embolism (PE) because of major bleeding and intracranial bleeding overcomes the benefit of reperfusion. A total of 342 PE patients with intermediate-risk PE from the multicenter Serbian PE registry were involved in the study. Of this group, 227 were not treated with reperfusion therapy (anticoagulation only), 91 were treated with conventional thrombolysis protocols at the discretion of their physicians and 24 patients were treated with ultrasound assisted catheter thrombolysis (USACT) with the EKOS® system. All patients treated with USACT had at least one factor which is associated with an increased risk of bleeding. Other patient characteristics were similar across the treatment groups. All-cause and PE-related mortality at 30 days and rate of major bleeding at 7 days were the main efficacy and safety outcomes of the study. The 30-day all-cause mortality were 11.5% versus 17.6% versus 0.0% for no reperfusion, conventional thrombolysis protocols and USACT groups ( 0.056), respectively. The difference between the rate of 30-day PE-related mortality was in a favour of EKOS and no reperfusion compare to conventional protocols (0.0% vs. 3.5% vs. 11.0%, 0.013, respectively). Major bleeding at 7 days, was presented in 1.8% versus 7.7% versus 8.0% ( 0.021) in no reperfusion, conventional thrombolysis and USACT groups with no intracranial bleeding. In the patients with intermediate-risk PE and at least one bleeding factor, USACT could be an alternative treatment to anticoagulant therapy only and conventional thrombolytic protocols.
对于中度风险的肺栓塞（PE）患者，不建议进行全身溶栓治疗，因为严重出血和颅内出血超过了再灌注带来的益处。来自塞尔维亚多中心PE注册研究的342例中度风险PE患者参与了该研究。在这组患者中，227例未接受再灌注治疗（仅抗凝），91例由医生酌情决定采用传统溶栓方案治疗，24例患者采用EKOS®系统进行超声辅助导管溶栓（USACT）治疗。所有接受USACT治疗的患者至少有一个与出血风险增加相关的因素。各治疗组的其他患者特征相似。30天全因死亡率和PE相关死亡率以及7天严重出血发生率是该研究的主要疗效和安全性指标。无再灌注组、传统溶栓方案组和USACT组的30天全因死亡率分别为11.5%、17.6%和0.0%（ 0.056）。30天PE相关死亡率方面，与传统方案相比，EKOS组和无再灌注组更具优势（分别为0.0%、3.5%和11.0%， 0.013）。7天严重出血发生率在无再灌注组、传统溶栓组和USACT组分别为1.8%、7.7%和8.0%（ 0.021），均无颅内出血。对于中度风险PE且至少有一个出血因素的患者，USACT可能是仅采用抗凝治疗和传统溶栓方案之外的另一种治疗选择。
