Safety and Efficacy of a 3-Dimensional Stent Retriever With Aspiration-Based Thrombectomy vs Aspiration-Based Thrombectomy Alone in Acute Ischemic Stroke Intervention: A Randomized Clinical Trial | Cerebrovascular Disease | JAMA Neurology | JAMA Network
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Original Investigation
March 2018

Safety and Efficacy of a 3-Dimensional Stent Retriever With Aspiration-Based Thrombectomy vs Aspiration-Based Thrombectomy Alone in Acute Ischemic Stroke Intervention: A Randomized Clinical Trial

Author Affiliations
  • 1Department of Neurology, Emory University School of Medicine, Atlanta, Georgia
  • 2Swedish Medical Center, Englewood, Colorado
  • 3Department of Neurology, John F. Kennedy Medical Center, Edison, New Jersey
  • 4Department of Neurosurgery, St Vincent Mercy Medical Center, Toledo, Ohio
  • 5Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois
  • 6Department of Neurosurgery, Medical University of South Carolina, Charleston, South Carolina
  • 7Forsyth Medical Center, Winston-Salem, North Carolina
  • 8Physicians Regional Medical Group, Naples, Florida
  • 9Department of Neurosurgery, University at Buffalo, State University of New York, Buffalo
  • 10Department of Neurosurgery, Gates Vascular Institute, Kaleida Health, Buffalo, New York
  • 11Department of Neurology, Froedtert Hospital, Milwaukee, Wisconsin
  • 12Division of Neuroradiology, Universitätsklinikum Erlangen, Erlangen, Germany
  • 13Department of Radiology, Texas Stroke Institute, Dallas
  • 14Department of Radiology, University of Iowa, Iowa City
  • 15Department of Neurology, Massachusetts General Hospital, Boston
  • 16Department of Neurosurgery, Lenox Hill Hospital, Northwell Hofstra School of Medicine, New York, New York
JAMA Neurol. 2018;75(3):304-311. doi:10.1001/jamaneurol.2017.3967
Key Points

Question  What are the treatment effects of a 3-dimensional stent retriever in conjunction with local aspiration-based mechanical thrombectomy vs aspiration-based thrombectomy alone as a primary modality for endovascular stroke intervention?

Findings  In this randomized clinical trial of 198 patients, aspiration-assisted stent retrieval was demonstrated to be noninferior in safety and effectiveness compared with direct aspiration for stroke intervention.

Meaning  Aspiration is a reasonable frontline therapy choice in stroke thrombectomy, in addition to stent retrieval.

Abstract

Importance  The treatment effects of individual mechanical thrombectomy devices in large-vessel acute ischemic stroke (AIS) remain unclear.

Objective  To determine whether the novel 3-dimensional (3-D) stent retriever used in conjunction with an aspiration-based mechanical thrombectomy device (Penumbra System; Penumbra) is noninferior to aspiration-based thrombectomy alone in AIS.

Design, Setting, and Participants  This randomized, noninferiority clinical trial enrolled patients at 25 North American centers from May 19, 2012, through November 19, 2015, with follow-up for 90 days. Adjudicators of the primary end points were masked to treatment allocation. Patients with large-vessel intracranial occlusion AIS presenting with a National Institutes of Health Stroke Scale (NIHSS) score of at least 8 within 8 hours of onset underwent 1:1 randomization to 3-D stent retriever with aspiration or aspiration alone. The primary analyses were conducted in the intention-to-treat population.

Interventions  Mechanical thrombectomy using intracranial aspiration with or without the 3-D stent retriever.

Main Outcomes and Measures  The primary effectiveness end point was the rate of a modified Thrombolysis in Cerebral Infarction (mTICI) grade of 2 to 3 with a 15% noninferiority margin. Device- and procedure-related serious adverse events at 24 hours were the primary safety end points.

Results  Of 8082 patients screened, 198 patients were enrolled (111 women [56.1%] and 87 men [43.9%]; mean [SD] age, 66.9 [13.0] years) and randomized, including 98 in the 3-D stent retriever with aspiration group and 100 in the aspiration alone group; an additional 238 patients were eligible but not enrolled. The median baseline NIHSS score was 18.0 (interquartile range, 14.0-23.0). Eighty-two of 94 patients in the 3-D stent retriever and aspiration group (87.2%) had an mTICI grade of 2 to 3 compared with 79 of 96 in the aspiration alone group (82.3%; difference, 4.9%; 90% CI, −3.6% to 13.5%). None of the other measures were significantly different between the 2 groups. Device-related serious adverse events were reported by 4 of 98 patients in the 3-D stent retriever with aspiration group (4.1%) vs 5 of 100 patients in the aspiration only group (5.0%); procedure-related serious adverse events, 10 of 98 (10.2%) vs 14 of 100 (14.0%). A 90-day modified Rankin Scale score of 0 to 2 was reported by 39 of 86 patients in the 3-D stent retriever with aspiration group (45.3%) vs 44 of 96 patients in the aspiration only group (45.8%).

Conclusions and Relevance  The present study provides class 1 evidence for the noninferiority of the 3-D stent retriever with aspiration vs aspiration alone in AIS. Future trials should evaluate whether these results can be generalized to other stent retrievers.

Trial Registration  clinicaltrials.gov Identifier: NCT01584609

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