Objective

Acute peripheral arterial occlusions can be treated by catheter directed thrombolysis (CDT). However, CDT is time consuming and accompanied by the risk of bleeding complications. The addition of contrast enhanced ultrasound and microbubbles could improve thrombus susceptibility to thrombolytic agents and potentially shorten treatment time with a lowered risk of bleeding complications. This article reports the outcomes of the safety and feasibility of this novel technique.

Methods

In this single arm phase II trial, 20 patients with acute lower limb ischaemia received CDT combined with an intravenous infusion of microbubbles and locally applied ultrasound during the first hour of standard intra-arterial thrombolytic therapy. The primary endpoint was safety, i.e., occurrence of serious adverse events (haemorrhagic complications and/or amputation) and death within one year. Secondary endpoints included angiographic and clinical success, thrombolysis duration, additional interventions, conversion, and quality of life.

Results

The study included 20 patients (16 men; median age 68.0 years; range, 50.0 – 83.0; and 40% native artery and 60% bypass graft). In all patients, the use of microbubble contrast enhanced sonothrombolysis could be applied successfully. There were no serious adverse events related to the experimental treatment. Duplex examination showed flow distal from the occlusion after 23.1 hours (range 3.1 – 46.5) with a median thrombolysis time of 47.5 hours (range 6.0 – 81.0). The short term ABI and pain scores significantly improved; however, no changes were observed before or after thrombolysis in the microcirculation. Overall mortality and amputation rates were both 2% within one year. The one year patency rate was 55%.

Conclusion

Treatment of patients with acute peripheral arterial occlusions with contrast enhanced sonothrombolysis is feasible and safe to perform in patients. Further research is necessary to investigate the superiority of this new treatment over standard treatment.

中文翻译：

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微泡和超声加速溶栓治疗外周动脉闭塞：单臂 II 期试验的结果

客观的

急性外周动脉闭塞可以通过导管定向溶栓 (CDT) 进行治疗。然而，CDT 耗时且伴有出血并发症的风险。添加对比增强超声和微泡可以改善血栓对溶栓剂的敏感性，并可能缩短治疗时间，降低出血并发症的风险。本文报告了这种新技术的安全性和可行性的结果。

方法

在这项单臂 II 期试验中，20 名急性下肢缺血患者在标准动脉内溶栓治疗的第一个小时内接受了 CDT 联合微泡静脉滴注和局部超声。主要终点是安全性，即一年内发生严重不良事件（出血并发症和/或截肢）和死亡。次要终点包括血管造影和临床成功、溶栓持续时间、额外干预、转换和生活质量。

结果

该研究包括 20 名患者（16 名男性；中位年龄 68.0 岁；范围为 50.0 – 83.0；40% 的自体动脉和 60% 的旁路移植术）。在所有患者中，使用微泡对比增强超声溶栓可以成功应用。没有与实验治疗相关的严重不良事件。双重检查显示 23.1 小时（范围 3.1 – 46.5）后血流从闭塞远端流出，中位溶栓时间为 47.5 小时（范围 6.0 – 81.0）。短期 ABI 和疼痛评分显着改善；然而，溶栓前后微循环均未见变化。一年内的总体死亡率和截肢率均为 2%。一年通畅率为55%。

结论

用造影剂增强超声溶栓治疗急性外周动脉闭塞患者是可行且安全的。需要进一步的研究来调查这种新疗法相对于标准疗法的优越性。