Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): A randomised, parallel-group, non-inferiority trial

Jeffrey L. Saver, Reza Jahan, Elad I. Levy, Tudor G. Jovin, Blaise Baxter, Raul G. Nogueira, Wayne Clark, Ronald Budzik, Osama O. Zaidat

Research output: Contribution to journalArticle

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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 stratifi ed by centre and stroke severity). The primary endpoint was Thrombolysis In Myocardial Ischemia (TIMI) scale 2 or 3 fl ow 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-inferioritysuperiority= 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; diff erence -21% [-39 to -3], OR 0·34 [0·14-0·81]; p non-inferiority= 0·0001, p superiority=0·02). Interpretation 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.

Original languageEnglish (US)
Pages (from-to)1241-1249
Number of pages9
JournalThe Lancet
Volume380
Issue number9849
DOIs
StatePublished - Oct 2012

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Stroke
Equipment and Supplies
Thrombectomy
Odds Ratio
Safety
Intracranial Hemorrhages
Random Allocation
Brain Ischemia
France
Stents
Myocardial Ischemia
Mortality
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

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Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT) : A randomised, parallel-group, non-inferiority trial. / Saver, Jeffrey L.; Jahan, Reza; Levy, Elad I.; Jovin, Tudor G.; Baxter, Blaise; Nogueira, Raul G.; Clark, Wayne; Budzik, Ronald; Zaidat, Osama O.

In: The Lancet, Vol. 380, No. 9849, 10.2012, p. 1241-1249.

Research output: Contribution to journalArticle

Saver, Jeffrey L. ; Jahan, Reza ; Levy, Elad I. ; Jovin, Tudor G. ; Baxter, Blaise ; Nogueira, Raul G. ; Clark, Wayne ; Budzik, Ronald ; Zaidat, Osama O. / Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT) : A randomised, parallel-group, non-inferiority trial. In: The Lancet. 2012 ; Vol. 380, No. 9849. pp. 1241-1249.
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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 stratifi ed by centre and stroke severity). The primary endpoint was Thrombolysis In Myocardial Ischemia (TIMI) scale 2 or 3 fl ow 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-inferioritysuperiority= 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; diff erence -21{\%} [-39 to -3], OR 0·34 [0·14-0·81]; p non-inferiority= 0·0001, p superiority=0·02). Interpretation 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.",
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T1 - Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT)

T2 - A randomised, parallel-group, non-inferiority trial

AU - Saver, Jeffrey L.

AU - Jahan, Reza

AU - Levy, Elad I.

AU - Jovin, Tudor G.

AU - Baxter, Blaise

AU - Nogueira, Raul G.

AU - Clark, Wayne

AU - Budzik, Ronald

AU - Zaidat, Osama O.

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N2 - 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 stratifi ed by centre and stroke severity). The primary endpoint was Thrombolysis In Myocardial Ischemia (TIMI) scale 2 or 3 fl ow 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-inferioritysuperiority= 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; diff erence -21% [-39 to -3], OR 0·34 [0·14-0·81]; p non-inferiority= 0·0001, p superiority=0·02). Interpretation 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.

AB - 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 stratifi ed by centre and stroke severity). The primary endpoint was Thrombolysis In Myocardial Ischemia (TIMI) scale 2 or 3 fl ow 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-inferioritysuperiority= 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; diff erence -21% [-39 to -3], OR 0·34 [0·14-0·81]; p non-inferiority= 0·0001, p superiority=0·02). Interpretation 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.

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