Clinical, Functional, and Quality-of-Life Outcomes after Computer-Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study

Abstract

PurposeTo report the first interim analysis of the STRIKE-PE study, evaluating the safety and effectiveness of computer-regulated aspiration thrombectomy for the treatment of acute pulmonary embolism (PE). Materials and MethodsThis prospective, international, multicenter study will enroll 600 adult patients with acute PE of ≤14 days and a right ventricle (RV)–to–left ventricle (LV) ratio of ≥0.9 who receive first-line endovascular treatment with computer-assisted vacuum thrombectomy (CAVT) using the Indigo Lightning system (Penumbra, Alameda, California). Primary endpoints are change in RV/LV ratio and incidence of composite major adverse events (MAEs) within 48 hours. Secondary endpoints include functional and quality-of-life (QoL) assessments. ResultsThe first 150 consecutive patients were treated with 12-F catheter CAVT. Mean age was 61.3 years, 54.7% were men, 94.7% presented with intermediate-risk PE, and 5.3% presented with high-risk PE. Median thrombectomy and procedure times were 33.5 minutes and 70.0 minutes, respectively, resulting in a mean reduction in systolic pulmonary artery pressure of 16.3% (P < .001). Mean RV/LV ratio decreased from 1.39 to 1.01 at 48 hours, a 25.7% reduction (P < .001). Four (2.7%) patients experienced a composite MAE within 48 hours. At 90-day follow-up, patients exhibited statistically significant improvements in the Borg dyspnea scale scores and QoL measures, and the New York Heart Association class distribution returned to that reported before the index PE. ConclusionsInterim results from the STRIKE-PE study demonstrate a significant reduction in pulmonary artery pressure and RV/LV ratio, procedure times of <2 hours, composite MAE rate of 2.7%, and significant improvements in 90-day functional and QoL outcomes.