ASTER Evaluates Penumbra’s Aspiration System in Acute Ischemic Stroke
February 22, 2017—Penumbra, Inc. announced the presentation of results from the ASTER trial at the International Stroke Conference in Houston, Texas. ASTER is comparing the safety and efficacy of Penumbra’s aspiration system to stent retrievers.
According to the company, the trial provides additional evidence of Penumbra’s aspiration system as an effective frontline thrombectomy approach for acute ischemic stroke as part of the ADAPT (A Direct Aspiration, First Pass Technique) technique. Penumbra provided an institutional grant to support the ASTER trial.
The primary endpoint was end-of-procedure revascularization (thrombolysis in cerebral infarction [TICI] 2b/3). The study enrolled 381 patients at eight centers in France over 12 months beginning in October 2015.
According to Penumbra, the data showed that the ADAPT technique compared favorably to a stent retriever strategy: 85.4% of patients treated with the Penumbra aspiration system achieved the primary endpoint of TICI 2b/3 at the end of the procedure compared with 83.1% of patients treated with stent retrievers (P = .53). Moreover, 63% of patients treated with Penumbra’s aspiration system achieved the secondary endpoint of TICI 2b/3 after frontline treatment compared to 67.7% with stent retrievers (P = .33). Secondary safety endpoints including embolization in a new territory and symptomatic intracranial hemorrhage were not statistically different between the two arms.
Michel Piotin, MD, Principal Investigator of ASTER, commented in the company's announcement, "The ASTER study provides evidence that starting with Penumbra aspiration first as part of the ADAPT technique is similar to the stent retriever technique. The ADAPT technique offers the possibility to easily add a stent retriever following Penumbra aspiration if needed, leading to time savings.”
Bertrand Lapergue, MD, the Scientific Coordinator for the study, added, "The ASTER trial shows no significant difference in revascularization rate and safety using either thrombectomy technique—Penumbra aspiration and stent retrievers—for acute ischemic stroke patients with large vessel occlusions. The broad eligibility criteria achieved in the ASTER trial make the results generalizable to the majority of stroke patients with large vessel occlusions."
The company noted that the Penumbra system consists of large diameter, highly flexible, and reliably trackable reperfusion catheters that utilize the full aspiration power of the Penumbra Pump Max through its Hi-Flow aspiration tubing to remove stroke-causing blood clots from the brain safely and effectively. The Penumbra system is cleared by the US Food and Drug Administration for revascularization in ischemic stroke patients.