One-year functional outcomes and quality of life after treatment of pulmonary embolism with computer assisted vacuum thrombectomy: interim analysis of the STRIKE-PE study

Abstract Purpose Report 1-year functional outcomes and quality of life (QOL) after treatment of pulmonary embolism (PE) with computer assisted vacuum thrombectomy (CAVT; Penumbra Inc). Background Survivors of PE frequently experience functional limitations and compromised QOL that persist despite initial treatment. This analysis from the STRIKE-PE study is the first report of 1-year functional outcomes and QOL in PE patients treated with CAVT. Methods STRIKE-PE is a single-arm, prospective, international, multicenter study that will enroll up to 1500 patients with intermediate-risk or high-risk PE, symptoms of ≤14 days, and a right-toleft ventricular (RV/LV) ratio of ≥ 0.9. The primary performance endpoint is the change in RV/LV ratio at 48hrs post-procedure and the primary safety endpoint is major adverse events at 48 hrs, a composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury. Functional outcomes and QOL were measured at baseline, 90 days, and 1 year. This interim analysis of 595 patients includes 252 patients with 1-year follow-up data. Results For the 595 patients in this interim analysis, mean patient age was 61.9 years and 52.9% were male. Median thrombectomy time with CAVT was 30 minutes. Between baseline and 48 hours, mean RV/LV ratio significantly decreased from 1.37 to 0.97 (∆ 26.7%, P < .001). The rate of composite major adverse events within 48 hours was 1.8%. Functional outcomes and QOL significantly improved from baseline to 90 days; these gains were either sustained or further improved from 90 days to 1 year (Figure). From baseline to 90 days to 1 year, Borg dyspnea scale at rest changed from 4.0 to 0.0 to 0.0; and after the 6-minute walk test (6MWT), from 2.0 to 1.0 to 1.0; 6MWT distance, from 245.8 to 339.5 to 359.1 meters; EQ-5D-5L index value, from 0.474 to 0.804 to 0.829; and Pulmonary Embolism Quality of Life (PEmb-QoL), from 42.9% to 21.5% to 13.7% of daily life affected by PE. The distribution of New York Heart Association (NYHA) Classification at 90 days was restored to that of before the PE event, and recovery continued at 1 year. Conclusion This interim analysis of STRIKE-PE demonstrated progressive improvement in functional status and QOL to 1-year post-procedure while maintaining safety and efficacy. These outcomes highlight additional benefits after CAVT treatment, including reduced dyspnea, restored functional capacity, increased walking distance, and less effect of PE on daily life.Changes in functional outcomes and QoLFor image description, please refer to the figure legend and surrounding text.