title: Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial.
abstract: BACKGROUND
  The Solitaire Flow Restoration Device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia. We compared the efficacy and safety of Solitaire with the standard, predicate mechanical thrombectomy device, the Merci Retrieval System.
  
  
  METHODS
  In this randomised, parallel-group, non-inferiority trial, we enrolled patients from 18 sites (17 in the USA and one in France). Patients were eligible for inclusion if they had acute ischaemic stroke with moderate to severe neurological deficits and were treatable by thrombectomy within 8 h of stroke symptom onset. We used a computer-generated randomisation sequence to randomly allocate patients to receive thrombectomy treatment with either Solitaire or Merci (1:1; block sizes of four and stratified by centre and stroke severity). The primary endpoint was Thrombolysis In Myocardial Ischemia (TIMI) scale 2 or 3 flow in all treatable vessels without symptomatic intracranial haemorrhage, after up to three passes of the assigned device, as assessed by an independent core laboratory, which was masked to study assignment. Primary analysis was done by intention to treat. A prespecified efficacy stopping rule triggered an early halt to the trial. The study is registered with ClinicalTrials.gov, number NCT 01054560.
  
  
  RESULTS
  Between February, 2010, and February, 2011, we randomly allocated 58 patients to the Solitaire group and 55 patients to the Merci group. The primary efficacy outcome was achieved more often in the Solitaire group than it was in the Merci group (61%vs 24%; difference 37% [95% CI 19-53], odds ratio [OR] 4·87 [95% CI 2·14-11·10]; p(non-inferiority)<0·0001, p(superiority)=0·0001). More patients had good 3-month neurological outcome with Solitaire than with Merci (58%vs 33%; difference 25% [6-43], OR 2·78 [1·25-6·22]; p(non-inferiority)=0·0001, p(superiority)=0·02). 90-day mortality was lower in the Solitaire group than it was in the Merci group (17 vs 38; difference -21% [-39 to -3], OR 0·34 [0·14-0·81]; p(non-inferiority)=0·0001, p(superiority)=0·02).
  
  
  CONCLUSIONS
  The Solitaire Flow Restoration Device achieved substantially better angiographic, safety, and clinical outcomes than did the Merci Retrieval System. The Solitaire device might be a future treatment of choice for endovascular recanalisation in acute ischaemic stroke.
  
  
  BACKGROUND
  Covidien/ev3.
authors.affiliation: Department of Neurology and Stroke Center, University of California, Los Angeles, CA 90095, USA. jsaver@ucla.edu
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Saver
authors.forename: Reza
authors.initials: R
authors.lastname: Jahan
authors.forename: Elad I
authors.initials: EI
authors.lastname: Levy
authors.forename: Tudor G
authors.initials: TG
authors.lastname: Jovin
authors.forename: Blaise
authors.initials: B
authors.lastname: Baxter
authors.forename: Raul G
authors.initials: RG
authors.lastname: Nogueira
authors.forename: Wayne
authors.initials: W
authors.lastname: Clark
authors.forename: Ronald
authors.initials: R
authors.lastname: Budzik
authors.forename: Osama O
authors.initials: OO
authors.lastname: Zaidat
mesh_terms: D000368:Aged; D002545:Brain Ischemia / Q000503:physiopathology / Q000601:surgery*; D002560:Cerebrovascular Circulation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020521:Stroke / Q000503:physiopathology / Q000601:surgery*; D017131:Thrombectomy / Q000295:instrumentation; D016896:Treatment Outcome