Department of Cardiology, Third Faculty of Medicine, Charles University, University Hospital Královské Vinohrady, Prague, Czech Republic.
Department of Radiology, Third Faculty of Medicine, Charles University, University Hospital Královské Vinohrady, Prague, Czech Republic.
EuroIntervention. 2022 Oct 7;18(8):e639-e646. doi: 10.4244/EIJ-D-21-01080.
Intermediate-high risk acute pulmonary embolism (PE) remains associated with substantial mortality despite anticoagulation therapy.
The aim of this randomised pilot study was to compare catheter-directed thrombolysis to standard anticoagulation therapy.
Intermediate-high risk acute PE patients were admitted to a tertiary care centre (November 2019 to April 2021) and randomised in a 1:1 ratio to catheter-directed thrombolysis (CDT) or standard anticoagulation. Two catheters were used for the infusion of alteplase (1 mg/hr/catheter; total dose 20 mg) in the CDT group. The primary efficacy endpoint targeted improvement of right ventricular (RV) function, a decrease in pulmonary pressure, and a reduction of thrombus burden.
Twenty-three patients were included (12 in the CDT group and 11 in the standard care group). The primary efficacy endpoint was achieved more frequently in the CDT group than in the standard care group (7 of 12 patients vs 1 of 11 patients, p=0.0004). An RV/left ventricular ratio reduction ≥25% (evident on computed tomography angiography) was achieved in 7 of 12 patients in the CDT group vs 2 of 11 patients in the standard care group (p=0.03). A systolic pulmonary artery pressure decrease of ≥30% or normotension at 24 hrs after randomisation was present in 10 of 12 patients in the CDT group vs 2 of 11 patients in the standard care group (p=0.001). There was no intracranial or life-threatening bleeding (type 5 or 3c bleeding, according to the Bleeding Academic Research Consortium classification).
CDT for intermediate-high risk acute PE appears to be safe and effective. Further research is warranted to assess clinical endpoints.
尽管进行了抗凝治疗，中高危急性肺栓塞（PE）仍然与大量死亡相关。
本随机试点研究的目的是比较导管定向溶栓与标准抗凝治疗。
中高危急性 PE 患者于 2019 年 11 月至 2021 年 4 月入住三级医疗中心，并以 1:1 的比例随机分为导管定向溶栓（CDT）组或标准抗凝治疗组。CDT 组使用两根导管输注阿替普酶（1 mg/hr/导管；总剂量 20 mg）。主要疗效终点靶向改善右心室（RV）功能、降低肺动脉压和减少血栓负荷。
共纳入 23 例患者（CDT 组 12 例，标准治疗组 11 例）。CDT 组比标准治疗组更频繁地达到主要疗效终点（12 例患者中有 7 例，11 例患者中有 1 例，p=0.0004）。CDT 组 12 例患者中有 7 例 RV/左心室比值降低≥25%（计算机断层血管造影可见），而标准治疗组 11 例患者中有 2 例（p=0.03）。CDT 组 12 例患者中有 10 例收缩期肺动脉压下降≥30%或随机分组后 24 小时血压正常，而标准治疗组 11 例患者中有 2 例（p=0.001）。无颅内或危及生命的出血（根据 Bleeding Academic Research Consortium 分类为 5 型或 3c 型出血）。
CDT 治疗中高危急性 PE 似乎是安全有效的。需要进一步研究以评估临床终点。
