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JAMA Neurol. 2018 Mar 1;75(3):304-311. doi: 10.1001/jamaneurol.2017.3967.

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 information

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

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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