STRIKE-PE: Impact of syncope on functional outcomes and quality of life to 90 days for acute pulmonary embolism patients treated with computer assisted vacuum thrombectomy

Background Syncope is a severe symptom of acute pulmonary embolism (PE) and is associated with a higher prevalence of hemodynamic instability and increased short-term mortality. The STRIKE-PE study is evaluating safety and effectiveness of computer assisted vacuum thrombectomy (CAVT) for the treatment of PE. Purpose This subanalysis of 595 patients from STRIKE-PE compares outcomes of acute PE patients with vs without syncope at presentation. Methods STRIKE-PE is a prospective, international, multicentre study that will enrol up to 1500 patients with acute PE symptoms of ≤14 days and a right-to-left ventricular (RV/LV) ratio of ≥0.9. Patients with (n = 141) vs without (n = 454) syncope at presentation were compared. Results At baseline, the syncope group had higher percentages of patients who were Black (33.7% vs 23.6%, P = .049) and had elevated thrombus burden (modified Miller score ≥12; 91.5% vs 81.7%, P = .006), elevated biomarker (99.3% vs 91.9%, P = .002), and high-risk PE (12.1% vs 6.8%, P = .046). No significant between-group differences were detected for baseline RV/LV ratio (1.42 vs 1.35), thrombectomy time (32 vs 30 min), procedure time (61 vs 61 min), and functional outcomes (Figure 1) and quality of life (QOL; Figure 2) at baseline. The RV/LV ratio improved from baseline to 48 hours postprocedure (primary effectiveness endpoint) for both groups (P < .001); improvement was significantly greater for patients with syncope (−0.47 vs −0.37, P = .004). The RV/LV ratio at 48 hours was similar for both groups (0.95 vs 0.98). No significant difference was observed between the groups for rate of composite major adverse events within 48 hours (primary safety endpoint; 0.7% vs 2.2%). For patients with and without syncope, Borg dyspnoea scale, 6-minute walk test (6MWT) distance, and all QOL measures improved out to 90 days (P ≤ .014 for within-group changes over time), with similar magnitudes of improvement over time for each group (Figures 1, 2). Median Borg dyspnoea scale at rest improved by −4.0 vs −4.5 from baseline to discharge and by −4.3 vs −5.0 from baseline to 90 days. Median Borg dyspnoea scale after 6MWT improved by 0.0 vs −1.0 from discharge to 90 days. Mean 6MWT distance improved by +135.9 vs +116.9 metres from discharge to 90 days. From baseline to 90 days, mean EQ visual analog scale improved by +25.0 vs +26.8, mean EQ-5D-5L index value improved by +0.283 vs +0.340, and mean total PEmb-QoL score improved by −19.7 vs −22.8. The NYHA classification distribution was similar between the groups at discharge and 90 days. Conclusion In this STRIKE-PE subanalysis, CAVT improved RV/LV ratio comparably in patients with and without syncope. Clinical and functional outcomes and QOL were similar between groups, and syncope did not affect procedural time or safety. These data demonstrate that intermediate-risk and high-risk patients with syncope can be treated safely and effectively.