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Next-Generation Stent Retriever Meets Primary Endpoints in Penumbra 3D Trial
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A next-generation stent retriever used in combination with aspiration devices was noninferior to aspiration alone for endovascular treatment of patients with acute ischemic stroke with a large vessel occlusion.
New data from the Penumbra 3D trial of the Penumbra 3D Revascularization Device were presented as a late-breaking clinical trial at the Society of NeuroInterventional Surgery Annual Meeting, according to a company press release.
The prospective, randomized, controlled, noninferiority trial compared safety and efficacy of the Penumbra 3D Revascularization Device used in conjunction with the Penumbra System aspiration devices vs. Penumbra System aspiration devices alone in patients with acute ischemic stroke. Researchers enrolled 198 patients at 25 U.S. centers. The primary study endpoints were core lab-adjudicated angiographic revascularization and safety, according to the release.
Results showed noninferior revascularization rates according to the FDA-defined primary effectiveness measure of TICI 2-3 in the stent retriever plus aspiration group compared with aspiration alone (88.5% vs. 85.9%). In addition, the revascularization measure of TICI 2b/3 showed noninferiority between the stent retriever plus aspiration group vs. the aspiration alone group (83.9% vs. 74.1%), according to the release.
Rates of device-related and procedure-related serious adverse events were not significantly different between the treatment groups (P = .1 and P = .492, respectively), according to the release.
In other results, patients in both groups experienced similar rates of return to functional independence based on a modified Rankin Scale of 2 at 90 days (41.6% in the stent retriever plus aspiration group vs. 48.8% in the aspiration alone group; P = .426), according to the release.
“The results of the Penumbra 3D trial speak positively on the use of Penumbra’s 3D Revascularization Device in combination with the Penumbra System aspiration devices, as well as on the use of Penumbra System aspiration devices alone,” Donald Frei, MD, lead investigator of the trial and director of neurointerventional surgery at Radiology Imaging Associates/Swedish Medical Center in Englewood, Colorado. “The data also suggest that the revascularization rate in the Penumbra 3D plus aspiration device arm and the aspiration device-only arm ... compare favorably to the 71% revascularization rate published in the HERMES meta-analysis of five major randomized controlled trials in acute ischemic stroke.”
The Penumbra 3D Revascularization Device is approved for investigational use only in the United States.
Disclosure: Cardiology Today’s Intervention could not confirm relevant financial disclosures.