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. doi: 10.1136/neurintsurg-2014-011627. Epub 2015 Feb 12.


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.

Trial registration: ClinicalTrials.gov NCT01054560.

Keywords: Angiography; Intervention; Stroke; Technique; Thrombectomy.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Brain Ischemia / diagnosis
  • Brain Ischemia / mortality
  • Brain Ischemia / surgery*
  • Female
  • Humans
  • Learning Curve*
  • Male
  • Middle Aged
  • Prospective Studies
  • Stents*
  • Stroke / diagnosis
  • Stroke / mortality
  • Stroke / surgery*
  • Survival Rate / trends
  • Thrombectomy / methods*
  • Thrombectomy / mortality
  • Thrombectomy / trends

Associated data

  • ClinicalTrials.gov/NCT01054560