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J Neurointerv Surg. 2016 Apr;8(4):347-52. doi: 10.1136/neurintsurg-2014-011627. Epub 2015 Feb 12.

Rapid learning curve for Solitaire FR stent retriever therapy: evidence from roll-in and randomised patients in the SWIFT trial.

Author information

1
Department of Radiology and Stroke Center, University of California, Los Angeles, Los Angeles, California, USA.
2
Department of Neurosurgery, Millard Fillmore Hospital, Buffalo, New York, USA.
3
Department of Neurology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
4
Department of Radiology, Erlanger Hospital, Chattanooga, Tennessee, USA.
5
Department of Neurology, Emory University, Atlanta, Georgia, USA.
6
Department of Neurology, Oregon Health Science University, Portland, Oregon, USA.
7
Department of Radiology, Riverside Methodist Hospital, Columbus, Ohio, USA.
8
Department of Neurology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
9
Department of Neurology and Stroke Center, University of California, Los Angeles, Los Angeles, California, USA.

Abstract

BACKGROUND:

In light of recent positive trial data for endovascular therapy in acute ischemic stroke (AIS), stent retriever use by practitioners without prior experience with these devices may become more common.

OBJECTIVE:

To assess the safety and efficacy of thrombectomy for AIS using Solitaire for patients treated in the roll-in period of the Solitaire With the Intention For Thrombectomy (SWIFT) trial, which represented the first clinical use of the device for these interventionalists.

METHODS:

Prospectively collected demographic, clinical, and angiographic data on patients treated in the initial roll-in and subsequent randomized phases of the SWIFT study were collected and analyzed. Key statistical analyses were validated by an independent external statistician.

RESULTS:

Patients in the roll-in period achieved equivalently high rates of reperfusion (55%) compared with those treated with the device in the randomized phase (61%). Rates of adverse events were comparable (13% vs. 9%). Rates of good neurological outcome were equivalent between the roll-in and randomized patients treated with Solitaire (63% vs. 58%). Including the roll-in patients strengthened the conclusions of the study, that reperfusion rates without symptomatic hemorrhage with Solitaire were greater than with Merci (59% vs. 24%, p<0.001).

CONCLUSIONS:

Thrombectomy in AIS using the Solitaire stent retriever device can be performed safely and effectively when used by experienced neurointerventionalists without previous experience with the device.

TRIAL REGISTRATION NUMBER:

The SWIFT study is registered with ClinicalTrials.gov, number NCT 01054560.

KEYWORDS:

Angiography; Intervention; Stroke; Technique; Thrombectomy

PMID:
25676147
PMCID:
PMC4955564
DOI:
10.1136/neurintsurg-2014-011627
[Indexed for MEDLINE]
Free PMC Article

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