Rapid learning curve for Solitaire FR stent retriever therapy: evidence from roll-in and randomised patients in the SWIFT trial.
Publication/Presentation Date
4-1-2016
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.
Volume
8
Issue
4
First Page
347
Last Page
352
ISSN
1759-8486
Published In/Presented At
Sheth, S. A., Jahan, R., Levy, E. I., Jovin, T. G., Baxter, B., Nogueira, R. G., Clark, W., Budzik, R., Zaidat, O. O., Saver, J. L., & SWIFT Trialists (2016). Rapid learning curve for Solitaire FR stent retriever therapy: evidence from roll-in and randomised patients in the SWIFT trial. Journal of neurointerventional surgery, 8(4), 347–352. https://doi.org/10.1136/neurintsurg-2014-011627
Disciplines
Diagnosis | Medicine and Health Sciences | Other Analytical, Diagnostic and Therapeutic Techniques and Equipment | Radiology
PubMedID
25676147
Department(s)
Department of Radiology and Diagnostic Medical Imaging
Document Type
Article