North American Solitaire Stent Retriever Acute Stroke registry

Post-marketing revascularization and clinical outcome results

Osama O. Zaidat, Alicia C. Castonguay, Rishi Gupta, Chung Huan J Sun, Coleman Martin, William E. Holloway, Nils Mueller-Kronast, Joey D. English, Italo Linfante, Guilherme Dabus, Tim W. Malisch, Franklin A. Marden, Hormozd Bozorgchami, Andrew Xavier, Ansaar T. Rai, Michael T. Froehler, Aamir Badruddin, Thanh N. Nguyen, M. Asif Taqi, Michael G. Abraham & 11 others Vallabh Janardhan, Hashem Shaltoni, Roberta Novakovic, Albert J. Yoo, Alex Abou-Chebl, Peng R. Chen, Gavin W. Britz, Ritesh Kaushal, Ashish Nanda, Mohammad A. Issa, Raul G. Nogueira

Research output: Contribution to journalArticle

72 Citations (Scopus)

Abstract

Background Limited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials. Methods The investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage. Results 354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3% (315/354) and TICI ≥2a rate of 87.5% (310/354) compared with the operator reported TIMI ≥2 rate of 83% in SWIFT and TICI ≥2a rate of 85% in TREVO 2. Clinical outcome: 42% (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37% (SWIFT) and 40% (TREVO 2). 90 day mortality was 30≥2% (95/315) versus 17≥2% (SWIFT) and 29% (TREVO 2). Conclusions The NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.

Original languageEnglish (US)
Pages (from-to)584-588
Number of pages5
JournalJournal of NeuroInterventional Surgery
Volume6
Issue number8
DOIs
StatePublished - Oct 1 2014

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Thrombectomy
Marketing
United States National Aeronautics and Space Administration
Stents
Registries
Stroke
Cerebral Infarction
Myocardial Ischemia
Equipment and Supplies
Mortality
Groin
Intracranial Hemorrhages
Fluoroscopy
Therapeutics
Punctures
Research Personnel

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology
  • Medicine(all)

Cite this

North American Solitaire Stent Retriever Acute Stroke registry : Post-marketing revascularization and clinical outcome results. / Zaidat, Osama O.; Castonguay, Alicia C.; Gupta, Rishi; Sun, Chung Huan J; Martin, Coleman; Holloway, William E.; Mueller-Kronast, Nils; English, Joey D.; Linfante, Italo; Dabus, Guilherme; Malisch, Tim W.; Marden, Franklin A.; Bozorgchami, Hormozd; Xavier, Andrew; Rai, Ansaar T.; Froehler, Michael T.; Badruddin, Aamir; Nguyen, Thanh N.; Taqi, M. Asif; Abraham, Michael G.; Janardhan, Vallabh; Shaltoni, Hashem; Novakovic, Roberta; Yoo, Albert J.; Abou-Chebl, Alex; Chen, Peng R.; Britz, Gavin W.; Kaushal, Ritesh; Nanda, Ashish; Issa, Mohammad A.; Nogueira, Raul G.

In: Journal of NeuroInterventional Surgery, Vol. 6, No. 8, 01.10.2014, p. 584-588.

Research output: Contribution to journalArticle

Zaidat, OO, Castonguay, AC, Gupta, R, Sun, CHJ, Martin, C, Holloway, WE, Mueller-Kronast, N, English, JD, Linfante, I, Dabus, G, Malisch, TW, Marden, FA, Bozorgchami, H, Xavier, A, Rai, AT, Froehler, MT, Badruddin, A, Nguyen, TN, Taqi, MA, Abraham, MG, Janardhan, V, Shaltoni, H, Novakovic, R, Yoo, AJ, Abou-Chebl, A, Chen, PR, Britz, GW, Kaushal, R, Nanda, A, Issa, MA & Nogueira, RG 2014, 'North American Solitaire Stent Retriever Acute Stroke registry: Post-marketing revascularization and clinical outcome results', Journal of NeuroInterventional Surgery, vol. 6, no. 8, pp. 584-588. https://doi.org/10.1136/neurintsurg-2013-010895
Zaidat, Osama O. ; Castonguay, Alicia C. ; Gupta, Rishi ; Sun, Chung Huan J ; Martin, Coleman ; Holloway, William E. ; Mueller-Kronast, Nils ; English, Joey D. ; Linfante, Italo ; Dabus, Guilherme ; Malisch, Tim W. ; Marden, Franklin A. ; Bozorgchami, Hormozd ; Xavier, Andrew ; Rai, Ansaar T. ; Froehler, Michael T. ; Badruddin, Aamir ; Nguyen, Thanh N. ; Taqi, M. Asif ; Abraham, Michael G. ; Janardhan, Vallabh ; Shaltoni, Hashem ; Novakovic, Roberta ; Yoo, Albert J. ; Abou-Chebl, Alex ; Chen, Peng R. ; Britz, Gavin W. ; Kaushal, Ritesh ; Nanda, Ashish ; Issa, Mohammad A. ; Nogueira, Raul G. / North American Solitaire Stent Retriever Acute Stroke registry : Post-marketing revascularization and clinical outcome results. In: Journal of NeuroInterventional Surgery. 2014 ; Vol. 6, No. 8. pp. 584-588.
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title = "North American Solitaire Stent Retriever Acute Stroke registry: Post-marketing revascularization and clinical outcome results",
abstract = "Background Limited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials. Methods The investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage. Results 354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3{\%} (315/354) and TICI ≥2a rate of 87.5{\%} (310/354) compared with the operator reported TIMI ≥2 rate of 83{\%} in SWIFT and TICI ≥2a rate of 85{\%} in TREVO 2. Clinical outcome: 42{\%} (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37{\%} (SWIFT) and 40{\%} (TREVO 2). 90 day mortality was 30≥2{\%} (95/315) versus 17≥2{\%} (SWIFT) and 29{\%} (TREVO 2). Conclusions The NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.",
author = "Zaidat, {Osama O.} and Castonguay, {Alicia C.} and Rishi Gupta and Sun, {Chung Huan J} and Coleman Martin and Holloway, {William E.} and Nils Mueller-Kronast and English, {Joey D.} and Italo Linfante and Guilherme Dabus and Malisch, {Tim W.} and Marden, {Franklin A.} and Hormozd Bozorgchami and Andrew Xavier and Rai, {Ansaar T.} and Froehler, {Michael T.} and Aamir Badruddin and Nguyen, {Thanh N.} and Taqi, {M. Asif} and Abraham, {Michael G.} and Vallabh Janardhan and Hashem Shaltoni and Roberta Novakovic and Yoo, {Albert J.} and Alex Abou-Chebl and Chen, {Peng R.} and Britz, {Gavin W.} and Ritesh Kaushal and Ashish Nanda and Issa, {Mohammad A.} and Nogueira, {Raul G.}",
year = "2014",
month = "10",
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pages = "584--588",
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TY - JOUR

T1 - North American Solitaire Stent Retriever Acute Stroke registry

T2 - Post-marketing revascularization and clinical outcome results

AU - Zaidat, Osama O.

AU - Castonguay, Alicia C.

AU - Gupta, Rishi

AU - Sun, Chung Huan J

AU - Martin, Coleman

AU - Holloway, William E.

AU - Mueller-Kronast, Nils

AU - English, Joey D.

AU - Linfante, Italo

AU - Dabus, Guilherme

AU - Malisch, Tim W.

AU - Marden, Franklin A.

AU - Bozorgchami, Hormozd

AU - Xavier, Andrew

AU - Rai, Ansaar T.

AU - Froehler, Michael T.

AU - Badruddin, Aamir

AU - Nguyen, Thanh N.

AU - Taqi, M. Asif

AU - Abraham, Michael G.

AU - Janardhan, Vallabh

AU - Shaltoni, Hashem

AU - Novakovic, Roberta

AU - Yoo, Albert J.

AU - Abou-Chebl, Alex

AU - Chen, Peng R.

AU - Britz, Gavin W.

AU - Kaushal, Ritesh

AU - Nanda, Ashish

AU - Issa, Mohammad A.

AU - Nogueira, Raul G.

PY - 2014/10/1

Y1 - 2014/10/1

N2 - Background Limited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials. Methods The investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage. Results 354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3% (315/354) and TICI ≥2a rate of 87.5% (310/354) compared with the operator reported TIMI ≥2 rate of 83% in SWIFT and TICI ≥2a rate of 85% in TREVO 2. Clinical outcome: 42% (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37% (SWIFT) and 40% (TREVO 2). 90 day mortality was 30≥2% (95/315) versus 17≥2% (SWIFT) and 29% (TREVO 2). Conclusions The NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.

AB - Background Limited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials. Methods The investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage. Results 354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3% (315/354) and TICI ≥2a rate of 87.5% (310/354) compared with the operator reported TIMI ≥2 rate of 83% in SWIFT and TICI ≥2a rate of 85% in TREVO 2. Clinical outcome: 42% (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37% (SWIFT) and 40% (TREVO 2). 90 day mortality was 30≥2% (95/315) versus 17≥2% (SWIFT) and 29% (TREVO 2). Conclusions The NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.

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U2 - 10.1136/neurintsurg-2013-010895

DO - 10.1136/neurintsurg-2013-010895

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JO - Journal of NeuroInterventional Surgery

JF - Journal of NeuroInterventional Surgery

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