Safety and effectiveness of the Vertex Pulmonary Embolectomy System in acute intermediate-risk pulmonary embolism: the SPIRARE II pivotal trial.
Sameh Sayfo, Jakub Stępniewski, Vincent Gallo et al.
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In 30 seconds
SPIRARE II was a prospective, single-arm, multicentre pivotal trial evaluating the Vertex Pulmonary Embolectomy System for aspiration thrombectomy in patients with acute intermediate-risk pulmonary embolism. Among 123 patients, the 48-hour composite major adverse event rate was 2.4% (3/123), meeting the prespecified performance goal. The mean right ventricle/left ventricle diameter ratio fell from 1.44±0.33 at baseline to 1.05±0.21 at 48 hours, a mean reduction of 0.39±0.33 that also exceeded its performance goal. The study reports that both co-primary endpoints were met.
Key findings
- The 48-hour composite major adverse event rate was 2.4% (3/123), meeting the prespecified performance goal (one-sided p<0.0001).
- Mean RV/LV diameter ratio decreased from 1.44±0.33 at baseline to 1.05±0.21 at 48 hours.
- The mean RV/LV ratio reduction was 0.39±0.33, exceeding the prespecified performance goal (p<0.0001).
Why it matters
The findings provide prospective multicentre evidence on the short-term safety and effectiveness of a mechanical aspiration system in haemodynamically stable patients with acute intermediate-risk PE. The observed reduction in RV/LV ratio is relevant to right ventricular unloading, while the reported adverse-event rate informs assessment of procedural safety. These results concern performance against prespecified goals, not comparison with another treatment.
What to keep in mind
The study was single-arm, so it cannot establish comparative effectiveness against other treatments. Outcomes reported here were assessed through 48 hours.