STRIKE-PE: Interim Analysis of the First 300 Patients Using Lightning Flash
An Interview With Brian Schiro, MD, RPVI, FSIR
An Interview With Brian Schiro, MD, RPVI, FSIR
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Miami Cardiac & Vascular Institute, Florida
VASCULAR DISEASE MANAGEMENT. 2025;22(3):E22-E23
At ISET 2025, Interventional Radiologist Brian Schiro, MD, RPVI, FSIR, from the Miami Cardiac & Vascular Institute in Florida, gave a presentation entitled “Interim Analysis of STRIKE-PE: Periprocedural Outcomes and Initial Outcomes of Lightning Flash”. Vascular Disease Management spoke with Dr Schiro about STRIKE-PE, a prospective, multicenter study that evaluated the efficacy and long-term safety outcomes of treating pulmonary embolism (PE) with the Indigo Aspiration System with Lightning Flash technology (Penumbra). The interim findings suggest that this computer-assisted thrombectomy device is a safe and effective treatment for acute PE.
The interim analysis of the first 300 patients in STRIKE-PE demonstrated significant improvements in right ventricle to left ventricle (RV-LV) ratio, systolic pulmonary artery pressure, and Borg dyspnea score. What are your thoughts about these results?
One of the great things about the STRIKE-PE study is that it is looking at the important primary endpoints of change in RV-LV ratio and also some safety endpoints. But to me, what is most exciting is that we have additional secondary endpoints looking at functional outcomes. What I am most interested in, and what is missing most from the PE literature, is what happens to these patients after we do an intervention. Are we really providing functional improvement in these patients? Is it easier for these patients to breathe? Do they have good quality of life afterwards? Is there an increased risk of PE after the patients have their intervention? Or is there a protective element, that doing an intervention is going to decrease the chances of 30-day mortality or symptomatic recurrence of PE at 30 days? These are the things that we are trying to answer with the STRIKE-PE study.
In the study, many patients were treated with the Penumbra Indigo Lightning Flash device. This is a more current iteration of the device that is available to treat these patients. Some of the earlier patients were treated with a smaller bore catheter (12F); Lightning Flash is a 16F device. We see better outcomes as far as thrombectomy time as well as persistently low rates of complications, significant improvement in RV-LV ratio, decreased pulmonary artery pressure, decreased Borg dyspnea score, and low rates of potential adverse events. It is very exciting to highlight this new technology that is going to be included in the STRIKE-PE analysis.
The study reported a low incidence of major adverse events within 48 hours post-procedure including major bleeding, device-related complications and mortality. Were there any specific patient subgroups that exhibited higher safety concerns? And how do these findings compare with other mechanical thrombectomy studies?
The safety profile associated with the devices used in the STRIKE-PE study is extremely impressive. Complication rates are very, very low. Compared with some of the other trials, complication rates are lower than many other devices that are currently available. We see very low rates of pulmonary artery injury, very low rates of access complications such as hematomas, and very low rates of requirements for blood transfusion; because of that, the safety profile in particular is something that we should be very happy with.
Given the promising outcomes in the interim analysis, do you see a potential for expanding STRIKE-PE to include additional patient populations?
It is important to have additional patient populations in the STRIKE-PE study. In particular, what I would like to see is more patients with a cancer diagnosis. A large percentage of patients who present with PE have a concurrent diagnosis of cancer. Because of that, we really need to know what the outcomes are in these patients. Expanding the data set to include cancer patients is something that I would like to see down the road. n
