Inari PEERLESS II RCT Will Compare FlowTriever Versus Anticoagulation in PE Patients

May 22, 2023—Inari Medical, Inc. announced the planned enrollment of PEERLESS II, the company’s third randomized controlled trial (RCT) in venous thromboembolism (VTE).

According to the company, PEERLESS II is a prospective, global, multicenter RCT comparing the outcomes of intermediate-risk pulmonary embolism (PE) patients treated with Inari’s FlowTriever system versus anticoagulation alone. The study will enroll up to 1,200 patients at up to 100 global centers. The trial design was presented at the SCAI 2023 Scientific Sessions held May 18-20 in Phoenix, Arizona.

The trial is led by Global Principal Investigators Jay Giri, MD, and Frances Mae West, MD. The European Principal Investigators are Professor Felix Mahfoud, MD, and Professor Bernhard Gebauer, MD.

“PEERLESS II is a groundbreaking trial in terms of its robust size, randomized design, and potential to shape PE treatment guidelines,” commented Dr. Giri in Inari’s press release. “The primary outcome for the trial is a hierarchical composite of clinical outcomes including mortality, clinical deterioration, hospital readmission, and dyspnea. These meaningful endpoints go beyond historical surrogate measures such as [right ventricular/left ventricular] ratio to definitively answer critical questions about intervention in PE with the FlowTriever system.”

Dr. West, who serves as a board member of the PERT Consortium, added, “Conservative treatment with anticoagulation alone has been the guideline-recommended practice for intermediate-risk PE for decades, and outcomes in PE patients have remained consistently poor. With the availability of new purpose-built tools for PE thrombectomy, it is time we begin to think more critically about whether a conservative approach to PE should remain standard of care. PEERLESS II was designed by a multispecialty global steering committee to answer this important question.”

Dr. Giri is Cardiovascular Catheterization Laboratories Associate Director and Assistant Professor of Medicine at the Hospital of the University of Pennsylvania in Philadelphia, Pennsylvania. Dr. West is Associate Professor of Medicine and Program Director of the Division of Pulmonary & Critical Care Medicine Fellowship at Thomas Jefferson University in Philadelphia.

Prof. Mahfoud is Leading Senior Consultant at the Department of Internal Medicine and Cardiology, University Hospital Saarland in Homburg, Germany. Prof. Gebauer is Head of Section, Interventional Radiology, at University Hospital Charité in Berlin, Germany.

Inari’s Chief Medical Officer Thomas Tu, MD, stated in the press release, “PEERLESS II will build off Inari’s FLASH registry, the largest prospective registry ever conducted in PE thrombectomy evaluating the FlowTriever system in 1,000 patients. With over 1,700 patients across PEERLESS and PEERLESS II, Inari is now set to enroll more PE RCT patients than all industry and nonindustry RCTs combined. Inari’s three RCTs in VTE all aim to study meaningful, patient-centric clinical endpoints. We are thankful for the partnership of our steering committee and the commitment of our investigators dedicated to generating high-quality clinical evidence.”