Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced the presentation of the results of the COMPASS Trial, an independent, prospective, multi-center randomized trial that showed the use of Penumbra’s aspiration system was non-inferior to stent retrievers for patients with acute ischemic stroke. The COMPASS Trial results were featured in the main event plenary session at the International Stroke Conference and add to the growing body of evidence demonstrating Penumbra’s aspiration system is an effective frontline thrombectomy approach for acute ischemic stroke as part of the ADAPT (A Direct Aspiration, First Pass Technique) approach.
"The COMPASS Trial met its primary objective, demonstrating that acute ischemic stroke patients treated with the ADAPT approach do not have inferior outcomes to those treated with a first-line stent retriever," stated J Mocco, M.D., M.S., vice chair of neurosurgery, director, Cerebrovascular Center, Icahn School of Medicine at Mount Sinai, New York. "An aspiration first approach to clot removal is now a proven approach for improving severe stroke patients’ outcomes."
The data showed that the ADAPT technique was non-inferior to stent retrievers for treatment of large vessel occlusions: 52 percent of patients treated with Penumbra’s aspiration system achieved the primary endpoint of modified Rankin Score (mRS) 0-2 at 90 days compared with 49 percent of patients treated with stent retrievers. Final revascularization rates were also similar for the two study arms: 92 percent of patients treated with ADAPT using Penumbra’s aspiration system achieved mTICI 2b-3 revascularization compared to 89 percent with stent retrievers (p=0.54). Moreover, the percentage of patients achieving TICI 3 was 38 percent for the ADAPT arm and 29 percent in the stent retriever arm (p=0.15). The trial also revealed a non-significant trend in revascularization speed that favored aspiration with a 10-minute numeric advantage in achieving reperfusion success (p=0.0194).
"The COMPASS Trial validates what we have believed for a long time: an aspiration first approach is very fast, effective and safe," stated Aquilla Turk, D.O., director of neurointerventional surgery section, Departments of Radiology and Neurosurgery, Medical University of South Carolina. "The preliminary results presented reinforce the metrics we experienced in single arm studies that drove us to do this trial."
Secondary safety endpoints presented, including embolization in new territory (ENT) and symptomatic intracranial hemorrhage (sICH), were not statistically different between the two arms.
"In my mind, these two approaches not only show equivalent revascularization and outcomes but also are complementary," said Adnan Siddiqui, M.D., Ph.D., professor of neurosurgery, Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, Buffalo, N.Y. "When used in conjunction, these approaches will open blood vessels and help improve the outcomes of the vast majority of patients with acute ischemic stroke."
The COMPASS Trial reaffirmed the results of two previous multi-center randomized controlled trials – Penumbra’s 3D Trial and the independent ASTER (Adapt versus StEnt Retriever) Trial – demonstrating improvements in procedure and technique while maintaining a strong safety profile and 90-day clinical outcomes for Penumbra’s aspiration system. COMPASS is the first of the three randomized trials to study the company’s latest reperfusion catheter, ACE™68 with the Penumbra System®.
"The COMPASS Trial, together with the PROMISE, ASTER, and 3D Trial results, provides overwhelming evidence that the ADAPT technique with the Penumbra System is a proven frontline approach," said Adam Elsesser, chairman, chief executive officer and president of Penumbra. "Notwithstanding this great data, Penumbra will continue to innovate and improve its Penumbra System; however, all of us in the stroke field now have an obligation to ensure all ischemic stroke patients have access to hospitals that offer mechanical thrombectomy for the best possible outcomes."
About COMPASS Trial
The COMPASS Trial: A Comparison of Direct Aspiration vs. Stent Retriever as a First Approach is an independent, prospective, randomized...
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