January 25, 2018
COMPASS Compares Penumbra's Aspiration System to Stent Retrievers in Acute Ischemic Stroke
January 25, 2018—Penumbra, Inc. announced the presentation of results from the COMPASS trial, showing that the use of Penumbra's aspiration system was noninferior to stent retrievers for patients with acute ischemic stroke. The COMPASS trial was featured in the main event plenary session at ISC 2018: the International Stroke Conference held January 24–26 in Los Angeles, California.
According to the company, the independent, prospective, multicenter randomized trial adds to the growing body of evidence demonstrating that 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, comparing direct aspiration versus stent retriever use as a first approach, is an independent, prospective, randomized trial that compared mechanical thrombectomy with the ADAPT approach to stent retrievers in patients presenting with acute ischemic stroke within 6 hours of symptom onset.
The primary objective of the trial was to show that acute ischemic stroke patients, with appropriate image selection, treated with the ADAPT approach within 6 hours of symptom onset do not have inferior clinical outcomes to those treated with a first-line stent retriever with 90-day global disability assessed via the modified Rankin Scale (mRS) score and analyzed using success criteria of mRS 0 to 2.
The company-funded study enrolled 270 patients at 20 centers in the United States.
As summarized by Penumbra, the data showed that the ADAPT technique was noninferior to stent retrievers for treatment of large vessel occlusions: 52% of patients treated with Penumbra's aspiration system achieved the primary endpoint of mRS 0 to 2 at 90 days compared with 49% of patients treated with stent retrievers. Final revascularization rates were also similar for the two study arms: 92% of patients treated with ADAPT using Penumbra's aspiration system achieved modified treatment in cerebral infarction (mTICI) score 2b–3 revascularization compared to 89% with stent retrievers (P = .54). Moreover, the percentage of patients achieving TICI 3 was 38% for the ADAPT arm and 29% in the stent retriever arm (P = .15). The trial also revealed a nonsignificant trend in revascularization speed that favored aspiration with a 10-minute numeric advantage in achieving reperfusion success (P = .0194).
The secondary safety endpoints presented, including embolization in new territory and symptomatic intracranial hemorrhage, were not statistically different between the two arms.
Penumbra noted that the COMPASS trial reaffirmed the results of two previous multicenter randomized controlled trials—Penumbra's 3D trial and the independent ASTER trial—demonstrating improvements in procedure and technique while maintaining a strong safety profile and 90-day clinical outcomes for Penumbra's aspiration system.
In Penumbra's announcement, J Mocco, MD, commented, "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. An aspiration first approach to clot removal is now a proven approach for improving severe stroke patients' outcomes." Dr. Mocco is Vice Chair of Neurosurgery and Director, Cerebrovascular Center, Icahn School of Medicine at Mount Sinai in New York, New York.
COMPASS Principal Investigator Aquilla Turk, DO, added, "The COMPASS trial validates what we have believed for a long time: an aspiration first approach is very fast, effective, and safe. The preliminary results presented reinforce the metrics we experienced in single-arm studies that drove us to do this trial." Dr. Turk is Director of the Neurointerventional Surgery Section, Departments of Radiology and Neurosurgery, Medical University of South Carolina in Charleston, South Carolina.
Adnan Siddiqui, MD, stated, "In my mind, these two approaches not only show equivalent revascularization and outcomes but also are complementary. 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." Dr. Siddiqui is Professor of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo in Buffalo, New York.