In a new subgroup analysis of the EXTRACT-PE trial, the Indigo aspiration system (Penumbra) was effective at improving clinical outcomes for submassive pulmonary embolism (PE) patients regardless of emboli location. In addition, clot burden was significantly reduced in both groups. These findings were recently presented at the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany).
According to Penumbra, this latest subanalysis from the prospective, single-arm, multicentre EXTRACT-PE showed the following:
- A right ventricle to left ventricle (RV/LV) ratio reduction of 28.2% in the main pulmonary artery and a 26.8% reduction in the branch vessels
- Systolic pulmonary artery pressures reduced by 8.1% in the main and 8.4% in the branch vessels
Salah Qanadli (Lausanne University Hospital, Lausanne, Switzerland) et al write in their abstract from LINC that the EXTRACT-PE trial evaluated the safety and performance of the Indigo aspiration system with an 8F system for the treatment of PE without the use of thrombolytics. This subgroup analysis evaluated performance outcomes of patients with main pulmonary artery emboli versus discrete unilateral or bilateral pulmonary artery emboli without main pulmonary artery involvement.
Qanadli and colleagues note that emboli location was collected at the time of enrolment, and that patients were then grouped based on whether emboli involved the main pulmonary artery (with or without branch vessels) or not (branch vessels alone).
Of the 119 patients enrolled, 44 (37%) had emboli that involved the main pulmonary artery and 75 (63%) branch emboli. The investigators report in their LINC abstract that no significant difference was observed between these groups for procedural device time, changes in RV/LV ratio or for systolic pulmonary artery pressure from before to after treatment. In addition, they note that mean absolute reduction in clot burden was significant in both groups, main pulmonary artery 3.6 (p=0.029) and branch vessels 5.8 (p<0.001).
James F Benenati, chief medical officer at Penumbra, commented on these latest findings: “The data from this study suggest that the Indigo catheter system is an excellent device for the treatment of PE. The Indigo system can be used equally effectively for proximal and distal aspiration thrombectomy in the pulmonary arteries.”