Unit of Vascular Surgery, Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy.
Unit of Vascular Surgery, Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy -
J Cardiovasc Surg (Torino). 2023 Jun;64(3):247-254. doi: 10.23736/S0021-9509.23.12668-1. Epub 2023 Apr 20.
Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischemia (ALLI) is becoming a fundamental alternative to surgical and intra-arterial thrombolysis. The INDIAN UP trial represents the second phase of the Italian national multicenter trial evaluating the safety and effectiveness of the device in the treatment of ALLI.
To assess vessel patency, the TIPI (Thrombo-aspiration In Peripheral Ischemia), is used. The TIPI flow in three different moments: at presentation, immediately after thromboaspiration, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularization TIPI 2 - 3. Safety and clinical success rate were collected at one month follow-up.
A total of 250 patients were enrolled. The mean age was 72.2±13.1 years and 72.1% were male. Rutherford grade on enrolment was I in 10.8%, IIa in 34.9%, and IIb in 54.4%. Primary technical success (TIPI 2-3 flow) was achieved in 90.8% of patients. Adjunctive procedures were needed in 158 cases. After all interventions, assisted primary technical success was 96.4%. No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, survival rate was 97.2%, limb salvage was 97.6%. Primary patency was 89.6% and 13 (5.4%) reinterventions were registered.
The updated results of the INDIAN UP trial have confirmed the high value of the mechanical thromboaspiration device Indigo Penumbra in the treatment of ALLI in a large variety of clinical and anatomical settings.
Penumbra/Indigo 抽吸血栓切除术系统（Penumbra Inc.）在急性下肢缺血（ALLI）患者中正成为手术和动脉内溶栓治疗的基本替代方法。INDIAN UP 试验代表了评估该设备在 ALLI 治疗中的安全性和有效性的意大利国家多中心试验的第二阶段。
为了评估血管通畅性，使用了 TIPI（外周缺血中的血栓抽吸）。TIPI 在三个不同时刻的血流：就诊时、血栓抽吸后立即和所有辅助治疗后。主要结果是使用研究系统进行血栓抽吸的技术成功，定义为接近完全或完全再血管化 TIPI 2-3。在一个月的随访中收集了安全性和临床成功率。
共纳入 250 例患者。平均年龄为 72.2±13.1 岁，72.1%为男性。入组时的 Rutherford 分级为 I 级 10.8%、IIa 级 34.9%和 IIb 级 54.4%。90.8%的患者达到了主要技术成功（TIPI 2-3 血流）。158 例患者需要辅助治疗。所有干预后，辅助主要技术成功率为 96.4%。未报告全身性出血并发症或与器械相关的严重不良事件。一个月随访时，存活率为 97.2%，肢体挽救率为 97.6%。主要通畅率为 89.6%，有 13 例（5.4%）进行了再次介入。
INDIAN UP 试验的更新结果证实了机械血栓抽吸装置 Indigo Penumbra 在治疗各种临床和解剖学环境下 ALLI 中的高价值。
