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

Abstract Background Survivors of pulmonary embolism (PE) frequently experience functional limitations and compromised quality of life (QOL) that persist despite initial treatment. This analysis from the STRIKE-PE study reports 1-year functional outcomes and QOL in PE patients treated with computer assisted vacuum thrombectomy (CAVT). Methods STRIKE-PE is a single-arm, prospective, international, multicentre study that will enrol up to 1500 patients with intermediate-risk or high-risk PE, symptoms of ≤14 days, and a right-to-left ventricular (RV/LV) ratio of ≥0.9. The primary performance endpoint is the change in RV/LV ratio at 48 hours postprocedure and the primary safety endpoint is major adverse events at 48 hours—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 includes 595 patients with periprocedural data and 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 (Figure 1) and QOL (Figure 2) significantly improved from baseline to 90 days; these gains were either sustained or further improved from 90 days to 1 year. From baseline to 90 days to 1 year, Borg dyspnoea scale at rest changed from 4.0 to 0.0 to 0.0, Borg dyspnoea scale after the 6-minute walk test (6MWT) changed from 2.0 to 1.0 to 1.0, 6MWT distance changed from 245.8 to 339.5 to 359.1 metres, EQ-5D-5L index value changed from 0.474 to 0.804 to 0.829, EQ visual analog scale (VAS) changed from 50.1 to 76.1 to 79.0, and total Pulmonary Embolism Quality of Life questionnaire (PEmb-QoL) score changed 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 continued improvement in functional status and QOL to 1 year postprocedure while maintaining safety and efficacy. These outcomes highlight additional benefits after CAVT treatment, including reduced dyspnoea, increased walking distance, restored NYHA Classification distribution, and less effect of PE on daily life.