Key result
Vertex pulmonary embolectomy reduces RV/LV ratio by ~0.39 with a ~2% 48-hour MAE rate in intermediate-risk PE.
Why the study?
Does mechanical aspiration thrombectomy with the Vertex Pulmonary Embolectomy System safely and effectively reduce the RV/LV ratio in patients with acute intermediate-risk pulmonary embolism?
Does mechanical aspiration thrombectomy with the Vertex Pulmonary Embolectomy System safely and effectively reduce the RV/LV ratio in patients with acute intermediate-risk pulmonary embolism?
In the single-arm SPIRARE II pivotal trial, the Vertex Pulmonary Embolectomy System met its prespecified safety and effectiveness performance goals by achieving a 2.4% 48-hour MAE rate and a 0.39 mean reduction in the RV/LV ratio in patients with acute intermediate-risk PE.
New TFX catheter may enable safer RV unloading in acute PE; leaves open superiority versus existing devices in larger trials.
BACKGROUND: Percutaneous aspiration thrombectomy can rapidly reduce afterload in acute pulmonary embolism (PE), but catheter stiffness and instability may limit access and prevent effective right ventricle (RV) unloading. The Vertex Pulmonary Embolectomy System with Transforming Fixation (TFX) technology is designed to address current limitations of existing catheter-based systems by separating the flexibility necessary for safe navigation from the support that is essential for procedural control. AIMS: We aimed to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System for mechanical aspiration thrombectomy in acute intermediate-risk PE. METHODS: SPIRARE II was a prospective, single-arm, multicentre pivotal investigation conducted at 19 sites in the United States and Europe. Eligible patients had acute PE (≤14 days), a computed tomography angiography-assessed RV to left ventricle (RV/LV) ratio>0.9, and haemodynamic stability (systolic blood pressure ≥90 mmHg). Co-primary endpoints were composite major adverse events (MAE) within 48 hours and core laboratory-assessed RV/LV change from baseline to 48 hours. Prespecified secondary endpoints were collected immediately pre- and post-procedure in all patients including mean pulmonary artery pressure, total pulmonary vascular resistance, and cardiac index. RESULTS: In 123 patients, the 48-hour composite MAE rate was 2.4% (3/123), meeting the prespecified performance goal (one-sided p<0.0001). The mean RV/LV diameter ratio decreased from 1.44±0.33 at baseline to 1.05±0.21 at 48 hours, a mean reduction of 0.39±0.33, exceeding the prespecified performance goal (p<0.0001). CONCLUSIONS: The Vertex Pulmonary Embolectomy System met its prespecified safety and effectiveness endpoints in acute intermediate-risk PE. TFX delivered precise, stable control with reliable vessel access, enabling consistent right ventricular unloading. (ClinicalTrials.gov: NCT06576427).
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Sayfo et al. (2026) studied Acute intermediate-risk pulmonary embolism (n=123). Vertex Pulmonary Embolectomy System vs. Prespecified performance goal was evaluated on Co-primary endpoints of composite major adverse events (MAE) within 48 hours and core laboratory-assessed RV/LV change from baseline to 48 hours (MD 0.39, p=<0.0001). The Vertex Pulmonary Embolectomy System achieved a 2.4% 48-hour major adverse event rate and a 0.39±0.33 mean RV/LV ratio reduction in acute intermediate-risk PE (both p<0.0001 vs performance goals).
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