A multicenter study of the safety and effectiveness of mechanical thrombectomy for patients with acute ischemic stroke not meeting top-tier evidence criteria

Nitin Goyal, Georgios Tsivgoulis, Donald Frei, Aquilla Turk, Blaise Baxter, Michael T. Froehler, J. Mocco, Jay Vachhani, Daniel Hoit, Lucas Elijovich, David Loy, Raymond D. Turner, Justin Mascitelli, Kiersten Espaillat, Andrei Alexandrov, Anne Alexandrov, Adam Arthur

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Background While mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke (AIS) with emergent large-vessel occlusions (ELVO), recently published guidelines appropriately award top-tier evidence to the same selective criteria that were employed in completed clinical trials. We sought to evaluate the safety and effectiveness of MT in patients with AIS with ELVO who do not meet top-tier evidence criteria (TTEC). Methods We conducted an observational study on consecutive patients with AIS with ELVO who underwent MT at six high-volume endovascular centers. Standard safety outcomes (3-month mortality, symptomatic intracranial hemorrhage) and effectiveness outcomes (3-month functional independence: modified Rankin Scale scores of 0–2) were compared between patients meeting and failing TTEC. Results The sample consisted of 349 (60%) controls fulfilling TTEC and 234 (40%) non- TTEC patients. Control patients meeting TTEC for MT tended to have higher functional independence rates at 3 months (47% vs 39%; p=0.055), while the rates of symptomatic intracerebral hemorrhage (sICH) were similar (9%) in both groups (p=0.983). In multivariable logistic regression models, adherence to TTEC for MT was not independently related to any safety outcome (sICH: OR 0.71, 95% CI 0.30 to 1.68, p=0.434; 3-month mortality: OR 1.27, 95% CI 0.69 to 2.33, p=0.448) or effectiveness outcome (3-month functional independence: OR 0.81, 95% CI 0.48 to 1.37, p=0.434; 3-month functional improvement: OR 0.73, 95% CI 0.48 to 1.11, p=0.138) after adjusting for potential confounders. Conclusions Approximately 40% of patients with AIS with ELVO offered MT do not fulfill TTEC for MT. Patients who did not meet TTEC had high rates of good clinical outcome and low complication rates.

Original languageEnglish (US)
Pages (from-to)10-16
Number of pages7
JournalJournal of neurointerventional surgery
Volume10
Issue number1
DOIs
StatePublished - Jan 1 2018

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Thrombectomy
Multicenter Studies
Stroke
Safety
Cerebral Hemorrhage
Logistic Models
Mortality
Intracranial Hemorrhages
Standard of Care
Observational Studies
Clinical Trials
Guidelines

All Science Journal Classification (ASJC) codes

  • Surgery
  • Clinical Neurology

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A multicenter study of the safety and effectiveness of mechanical thrombectomy for patients with acute ischemic stroke not meeting top-tier evidence criteria. / Goyal, Nitin; Tsivgoulis, Georgios; Frei, Donald; Turk, Aquilla; Baxter, Blaise; Froehler, Michael T.; Mocco, J.; Vachhani, Jay; Hoit, Daniel; Elijovich, Lucas; Loy, David; Turner, Raymond D.; Mascitelli, Justin; Espaillat, Kiersten; Alexandrov, Andrei; Alexandrov, Anne; Arthur, Adam.

In: Journal of neurointerventional surgery, Vol. 10, No. 1, 01.01.2018, p. 10-16.

Research output: Contribution to journalArticle

Goyal, Nitin ; Tsivgoulis, Georgios ; Frei, Donald ; Turk, Aquilla ; Baxter, Blaise ; Froehler, Michael T. ; Mocco, J. ; Vachhani, Jay ; Hoit, Daniel ; Elijovich, Lucas ; Loy, David ; Turner, Raymond D. ; Mascitelli, Justin ; Espaillat, Kiersten ; Alexandrov, Andrei ; Alexandrov, Anne ; Arthur, Adam. / A multicenter study of the safety and effectiveness of mechanical thrombectomy for patients with acute ischemic stroke not meeting top-tier evidence criteria. In: Journal of neurointerventional surgery. 2018 ; Vol. 10, No. 1. pp. 10-16.
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abstract = "Background While mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke (AIS) with emergent large-vessel occlusions (ELVO), recently published guidelines appropriately award top-tier evidence to the same selective criteria that were employed in completed clinical trials. We sought to evaluate the safety and effectiveness of MT in patients with AIS with ELVO who do not meet top-tier evidence criteria (TTEC). Methods We conducted an observational study on consecutive patients with AIS with ELVO who underwent MT at six high-volume endovascular centers. Standard safety outcomes (3-month mortality, symptomatic intracranial hemorrhage) and effectiveness outcomes (3-month functional independence: modified Rankin Scale scores of 0–2) were compared between patients meeting and failing TTEC. Results The sample consisted of 349 (60{\%}) controls fulfilling TTEC and 234 (40{\%}) non- TTEC patients. Control patients meeting TTEC for MT tended to have higher functional independence rates at 3 months (47{\%} vs 39{\%}; p=0.055), while the rates of symptomatic intracerebral hemorrhage (sICH) were similar (9{\%}) in both groups (p=0.983). In multivariable logistic regression models, adherence to TTEC for MT was not independently related to any safety outcome (sICH: OR 0.71, 95{\%} CI 0.30 to 1.68, p=0.434; 3-month mortality: OR 1.27, 95{\%} CI 0.69 to 2.33, p=0.448) or effectiveness outcome (3-month functional independence: OR 0.81, 95{\%} CI 0.48 to 1.37, p=0.434; 3-month functional improvement: OR 0.73, 95{\%} CI 0.48 to 1.11, p=0.138) after adjusting for potential confounders. Conclusions Approximately 40{\%} of patients with AIS with ELVO offered MT do not fulfill TTEC for MT. Patients who did not meet TTEC had high rates of good clinical outcome and low complication rates.",
author = "Nitin Goyal and Georgios Tsivgoulis and Donald Frei and Aquilla Turk and Blaise Baxter and Froehler, {Michael T.} and J. Mocco and Jay Vachhani and Daniel Hoit and Lucas Elijovich and David Loy and Turner, {Raymond D.} and Justin Mascitelli and Kiersten Espaillat and Andrei Alexandrov and Anne Alexandrov and Adam Arthur",
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T1 - A multicenter study of the safety and effectiveness of mechanical thrombectomy for patients with acute ischemic stroke not meeting top-tier evidence criteria

AU - Goyal, Nitin

AU - Tsivgoulis, Georgios

AU - Frei, Donald

AU - Turk, Aquilla

AU - Baxter, Blaise

AU - Froehler, Michael T.

AU - Mocco, J.

AU - Vachhani, Jay

AU - Hoit, Daniel

AU - Elijovich, Lucas

AU - Loy, David

AU - Turner, Raymond D.

AU - Mascitelli, Justin

AU - Espaillat, Kiersten

AU - Alexandrov, Andrei

AU - Alexandrov, Anne

AU - Arthur, Adam

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background While mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke (AIS) with emergent large-vessel occlusions (ELVO), recently published guidelines appropriately award top-tier evidence to the same selective criteria that were employed in completed clinical trials. We sought to evaluate the safety and effectiveness of MT in patients with AIS with ELVO who do not meet top-tier evidence criteria (TTEC). Methods We conducted an observational study on consecutive patients with AIS with ELVO who underwent MT at six high-volume endovascular centers. Standard safety outcomes (3-month mortality, symptomatic intracranial hemorrhage) and effectiveness outcomes (3-month functional independence: modified Rankin Scale scores of 0–2) were compared between patients meeting and failing TTEC. Results The sample consisted of 349 (60%) controls fulfilling TTEC and 234 (40%) non- TTEC patients. Control patients meeting TTEC for MT tended to have higher functional independence rates at 3 months (47% vs 39%; p=0.055), while the rates of symptomatic intracerebral hemorrhage (sICH) were similar (9%) in both groups (p=0.983). In multivariable logistic regression models, adherence to TTEC for MT was not independently related to any safety outcome (sICH: OR 0.71, 95% CI 0.30 to 1.68, p=0.434; 3-month mortality: OR 1.27, 95% CI 0.69 to 2.33, p=0.448) or effectiveness outcome (3-month functional independence: OR 0.81, 95% CI 0.48 to 1.37, p=0.434; 3-month functional improvement: OR 0.73, 95% CI 0.48 to 1.11, p=0.138) after adjusting for potential confounders. Conclusions Approximately 40% of patients with AIS with ELVO offered MT do not fulfill TTEC for MT. Patients who did not meet TTEC had high rates of good clinical outcome and low complication rates.

AB - Background While mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke (AIS) with emergent large-vessel occlusions (ELVO), recently published guidelines appropriately award top-tier evidence to the same selective criteria that were employed in completed clinical trials. We sought to evaluate the safety and effectiveness of MT in patients with AIS with ELVO who do not meet top-tier evidence criteria (TTEC). Methods We conducted an observational study on consecutive patients with AIS with ELVO who underwent MT at six high-volume endovascular centers. Standard safety outcomes (3-month mortality, symptomatic intracranial hemorrhage) and effectiveness outcomes (3-month functional independence: modified Rankin Scale scores of 0–2) were compared between patients meeting and failing TTEC. Results The sample consisted of 349 (60%) controls fulfilling TTEC and 234 (40%) non- TTEC patients. Control patients meeting TTEC for MT tended to have higher functional independence rates at 3 months (47% vs 39%; p=0.055), while the rates of symptomatic intracerebral hemorrhage (sICH) were similar (9%) in both groups (p=0.983). In multivariable logistic regression models, adherence to TTEC for MT was not independently related to any safety outcome (sICH: OR 0.71, 95% CI 0.30 to 1.68, p=0.434; 3-month mortality: OR 1.27, 95% CI 0.69 to 2.33, p=0.448) or effectiveness outcome (3-month functional independence: OR 0.81, 95% CI 0.48 to 1.37, p=0.434; 3-month functional improvement: OR 0.73, 95% CI 0.48 to 1.11, p=0.138) after adjusting for potential confounders. Conclusions Approximately 40% of patients with AIS with ELVO offered MT do not fulfill TTEC for MT. Patients who did not meet TTEC had high rates of good clinical outcome and low complication rates.

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