Penumbra’s Indigo Lightning 12 System Evaluated in Real-World STRIKE-PE Study

November 4, 2022—Computer-aided mechanical aspiration thrombectomy with the Indigo Lightning 12 aspiration system (Penumbra, Inc.) for the treatment of pulmonary embolism (PE) was evaluated for real-world safety, performance, and functional outcomes in the STRIKE-PE study.

STRIKE-PE is a prospective, multicenter study of adult patients with clinical symptoms consistent with acute PE of ≤ 14 days and right ventricular/left ventricular (RV/LV) ratio ≥ 0.9 who received frontline endovascular treatment with Lightning 12.

Periprocedural and patient-reported quality-of-life outcomes from an interim analysis of the STRIKE-PE study were presented by Ido Weinberg, MD, in the second of three Late-Breaking Clinical Trials sessions at the VIVA22 conference held by the VIVA Foundation on October 31 to November 3 in Las Vegas, Nevada.

As summarized in the VIVA Foundation press release, this interim analysis included 60 patients. The mean patient age was 59.4 years, 43.3% were women, and 95% had submassive PE.
Of those patients with an intensive care unit (ICU) stay, the median ICU length of stay was 1 day; 34.5% (19/55) did not require an ICU stay.

At VIVA22, Dr. Weinberg reported the following findings:

• From baseline to 48 hours, the median improvement in RV/LV ratio was 0.27 (P < .001)—a reduction of 24.3%
• From before to after thrombectomy, mean improvement in systolic pulmonary artery pressure (sPAP) was 10.6 mm Hg (P < .001)—a reduction of 19.9%
• From discharge to 90 days, the median overall improvement in PE Quality of Life Questionnaire score was 19.4 points (P < .001)
• From baseline to 90 days, the median improvement in EQ-5D-5L visual analog scale was 10 points (P < .001)
• At 90-day follow-up, the mean improvement in EQ-5D-5L index value for health status was 0.14 points (P = .041) and each EQ-5D-5L profile dimension had improved

Treating acute PE with computer-aided mechanical aspiration thrombectomy with Lightning 12 resulted in periprocedural reduction in RV/LV ratio and sPAP, as well as improvement of patient-reported quality of life at 90-day follow-up, concluded Dr. Weinberg in the VIVA Foundation press release.