Rapid learning curve for Solitaire FR stent retriever therapy: evidence from roll-in and randomised patients in the SWIFT trial. J Neurointerv Surg 2016 Apr;8(4):347-52
Date
02/14/2015Pubmed ID
25676147Pubmed Central ID
PMC4955564DOI
10.1136/neurintsurg-2014-011627Scopus ID
2-s2.0-84962568402 (requires institutional sign-in at Scopus site) 9 CitationsAbstract
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.
Author List
Sheth SA, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO, Saver JL, SWIFT TrialistsMESH terms used to index this publication - Major topics in bold
AgedAged, 80 and over
Brain Ischemia
Female
Humans
Learning Curve
Male
Middle Aged
Prospective Studies
Stents
Stroke
Survival Rate
Thrombectomy