Inari Medical's FlowTriever system has shown promising results in the treatment of pulmonary embolism (PE), outperforming catheter-directed thrombolytics (CDT) in the recent PEERLESS trial. The study, presented at Transcatheter Cardiovascular Therapeutics (TCT) 2024, highlights FlowTriever's potential to reduce clinical deterioration and improve patient outcomes.
PEERLESS Trial: Key Findings
The PEERLESS trial, a prospective, randomized study, enrolled 550 intermediate-risk PE patients across 57 centers globally. Patients were randomized to receive either FlowTriever thrombectomy or CDT. The primary outcome assessed a composite endpoint of clinical deterioration or therapy escalation. The study excluded patients with absolute contraindications to thrombolytics and enrolled very few patients with relative contraindications.
The results indicated that FlowTriever patients experienced three times fewer clinical deteriorations and/or therapy escalations compared to CDT. Furthermore, patients in the FlowTriever arm demonstrated greater improvement in clinical symptoms and hemodynamics within 24 hours, along with fewer 30-day readmissions, indicating a faster recovery.
Clinical Impact and Safety Profile
Beyond the primary endpoint, the PEERLESS trial revealed additional benefits associated with FlowTriever. Patients treated with FlowTriever had significantly fewer ICU admissions, shorter ICU stays, and shorter overall hospital stays. Notably, the FlowTriever arm reported zero patient deaths at discharge or seven days, zero deteriorations related to cardiac arrest, high-grade AV block, or respiratory failure, and a low 0.4% all-cause mortality rate at 30-day follow-up.
Expert Commentary
"These results are crucial to guiding optimal PE treatment decisions, providing strong evidence that FlowTriever may reduce clinical deterioration and the need for reintervention through more effective early thrombus resolution," said Dr. Wissam Jaber, co-principal investigator. "As the only randomized trial evaluating mechanical thrombectomy in PE, PEERLESS allows us to now confidently say that treatment with FlowTriever is safe, effective, and superior to CDT."
Implications for PE Treatment
The PEERLESS trial marks a significant advancement in the treatment of pulmonary embolism, offering a potential alternative to traditional thrombolytic approaches. The findings suggest that FlowTriever could become the primary interventional tool for intermediate-risk PE, potentially setting a new standard for clinically meaningful endpoints in PE treatment. According to Dr. Thomas Tu, Inari’s chief medical officer, this study "reiterates our commitment to practice- and guideline-changing research and sets the new standard for clinically meaningful endpoints."
