Randomized, Controlled Trial of Ultrasound-Assisted Catheter-Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism
Randomized, Controlled Trial of Ultrasound-Assisted Catheter-Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism
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DOI：
10.1161/circulationaha.113.005544
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发表时间：
2014-01-28
期刊：
影响因子：
37.8
通讯作者：
Baumgartner, Iris
中科院分区：
文献类型：
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作者：
Kucher, Nils;Boekstegers, Peter;Baumgartner, Iris
背景：在急性肺栓塞患者中，全身性溶栓可改善右心室（RV）扩张，与大出血相关，在许多有风险的患者中不采用。这项多中心随机对照试验研究了超声辅助导管定向溶栓（USAT）在逆转中危患者右心室扩张方面是否优于单独抗凝。方法与结果59例（63±14岁）急性主叶或下叶肺栓塞，超声心动图左室径（RV/LV）比值≥1.0的患者随机分为两组，分别接受非分割肝素治疗和USAT治疗，USAT组为10 ~ 20mg重组组织型纤溶酶原激活剂，治疗时间为15小时（n=30； USAT组）或单独使用非分割肝素治疗（n=29；肝素组）。主要转归是从基线到24小时的RV/LV比值的差异。安全性指标包括90天死亡、大出血和轻微出血以及静脉血栓栓塞复发。在USAT组，平均RV/LV比值从基线时的1.28±0.19降至24小时时的0.99±0.17 (P<0.001)；肝素组平均RV/LV比值分别为1.20±0.14和1.17±0.20 （P=0.31）。从基线到24小时，RV/LV比值的平均下降分别为0.30±0.20和0.03±0.16 （P<0.001）。90 d时，有1例死亡（肝素组），无大出血，4例小出血（USAT组3例，肝素组1例；P=0.61），无静脉血栓栓塞复发。结论在中度危险的肺栓塞患者中，标准化USAT方案在24小时逆转右心室扩张方面优于单用肝素抗凝，且未增加出血并发症。临床试验注册网址：http://www.clinicaltrials.gov。唯一标识符：NCT01166997。
BackgroundIn patients with acute pulmonary embolism, systemic thrombolysis improves right ventricular (RV) dilatation, is associated with major bleeding, and is withheld in many patients at risk. This multicenter randomized, controlled trial investigated whether ultrasound-assisted catheter-directed thrombolysis (USAT) is superior to anticoagulation alone in the reversal of RV dilatation in intermediate-risk patients.Methods and ResultsFifty-nine patients (63±14 years) with acute main or lower lobe pulmonary embolism and echocardiographic RV to left ventricular dimension (RV/LV) ratio ≥1.0 were randomized to receive unfractionated heparin and an USAT regimen of 10 to 20 mg recombinant tissue plasminogen activator over 15 hours (n=30; USAT group) or unfractionated heparin alone (n=29; heparin group). Primary outcome was the difference in the RV/LV ratio from baseline to 24 hours. Safety outcomes included death, major and minor bleeding, and recurrent venous thromboembolism at 90 days. In the USAT group, the mean RV/LV ratio was reduced from 1.28±0.19 at baseline to 0.99±0.17 at 24 hours (P<0.001); in the heparin group, mean RV/LV ratios were 1.20±0.14 and 1.17±0.20, respectively (P=0.31). The mean decrease in RV/LV ratio from baseline to 24 hours was 0.30±0.20 versus 0.03±0.16 (P<0.001), respectively. At 90 days, there was 1 death (in the heparin group), no major bleeding, 4 minor bleeding episodes (3 in the USAT group and 1 in the heparin group;P=0.61), and no recurrent venous thromboembolism.ConclusionsIn patients with pulmonary embolism at intermediate risk, a standardized USAT regimen was superior to anticoagulation with heparin alone in reversing RV dilatation at 24 hours, without an increase in bleeding complications.Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01166997.