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The STRIKE-PE study is evaluating real-world safety, performance, and long-term quality of life (QOL) outcomes of computer-assisted vacuum thrombectomy (CAVT) for the treatment of pulmonary embolism (PE). The current interim analysis reports periprocedural changes in right heart strain and thrombus burden and changes in QOL at 90 days for the first 150 patients. STRIKE-PE is a prospective, international, multicenter study that will enroll up to 600 patients with acute PE symptoms of ≤14 days and a right ventricle/left ventricle (RV/LV) ratio of ≥0.9 who receive treatment using CAVT with the Indigo Aspiration System (Penumbra Inc, Alameda, CA). This interim analysis included 150 patients (mean age, 61.3 years, 54.7% male, 5.3% with high-risk PE, 94.7% with intermediate-risk PE) treated with Lightning CAVT. Patients presented with indicators of right heart strain and with high thrombus burden, characterized by a modified Miller score (MMS) of ≥12, in 80.7% of cases. Median thrombectomy time was 33.5 minutes and ICU length of stay postprocedure was 1 day, with 38.0% of patients requiring no ICU stay. Median estimated blood loss was 300.0 mL. Major adverse events within 48 hours occurred in 4 patients (2.7%). The RV/LV ratio significantly decreased from 1.33 at baseline to 0.98 at 48 hours post-thrombectomy (Δ 25.2%, P 42 mm, and McConnell's sign) significantly improved (P < .001). Systolic pulmonary artery pressure significantly decreased from 48.0 mm Hg at baseline to 39.0 mm Hg at on-table post-thrombectomy (Δ 16.7%, P < .001). The MMS significantly decreased from 15.8 at baseline to 14.0 at 48 hours post-thrombectomy (Δ 11.1%, P < .001). From baseline to 90-day follow-up, significant improvements were observed for the QOL assessments of EQ-5D-5L dimensions, EQ-5D-5L index value (0.59 to 0.90; Δ 0.23), EQ VAS (visual analog scale, 54.0 to 76.9; Δ 22.9), and overall Pemb-QoL (Pulmonary Embolism Quality of Life questionnaire, 37.1% to 12.6%; Δ 18.9%). STRIKE-PE interim results, of patients with high-risk and intermediate-risk PE, demonstrated rapid, safe, statistically significant improvements in indicators of right heart strain and in thrombus burden. At 90-day follow-up, treatment with Lightning 12 CAVT improved both generic and disease-specific QOL measures, functional status, and clinical symptoms.
Moriarty et al. (Wed,) studied this question.