Impact of Protocol Deviations in Acute Ischemic Stroke Treated With Intravenous rt-PA Within 4.5 Hours After Symptom Onset

Y. J. Alderazi, J. Chang, K. Chapple, J. P. Yang, M. Teleb, A. Awad, Lucas Restrepo

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background: There is limited experience in the community with intravenous tissue plasminogen activator (rt-PA) administered 3 to 4.5 hours after acute ischemic stroke (AIS) onset. Many patients do not meet entry criteria of pivotal clinical trials because of severe stroke, age >80, severe hypertension (sHTN), or history of previous stroke and diabetes. Whether rt-PA benefits these patients is unclear. Thus, we investigated the outcomes of stroke patients treated with rt-PA with or without these adverse clinical characteristics. Methods: Chart review of patients with AIS treated with intravenous rt-PA at a single institution. Outcomes at discharge were compared between patients with severe stroke, age >80, sHTN, or previous stroke/diabetes and those without these characteristics. Good outcome was defined as modified Rankin score (mRS) of 0 to 1. Analysis of variance and t tests were used to compare the outcomes. Results: Of the 118 cases analyzed, 103 (87%) were treated ≤3 hours and 15 (13%) between 3 and 4.5 hours. Sixty-three (53%) patients had severe stroke, age >80, sHTN, or previous stroke/diabetes, whereas 55 (47%) did not. Compared to controls, patients with these adverse characteristics were less likely to have good outcomes (35% vs 56%, p =.02). No patients treated within the 3- to 4.5-hour window experienced symptomatic intracranial hemorrhage (sICH). Eight patients treated between 3 and 4.5 hours had severe stroke, age >80, sHTN, or previous stroke/diabetes. Of these, 6 had poor outcomes. Conclusions: In a highly selected group of patients treated with intravenous rt-PA, lack of adherence to current guidelines did not improve stroke outcomes. This was related to more severe strokes at baseline, not sICH. Prospective studies of this patient group are needed.

Original languageEnglish (US)
Pages (from-to)82-86
Number of pages5
JournalThe Neurohospitalist
Volume2
Issue number3
DOIs
StatePublished - 2012

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Stroke
Hypertension
Intracranial Hemorrhages
Tissue Plasminogen Activator
Analysis of Variance
Clinical Trials
Prospective Studies
Guidelines

Keywords

  • cerebrovascular disorders
  • outcomes
  • quality
  • safety
  • stroke
  • techniques
  • techniques
  • techniques

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Impact of Protocol Deviations in Acute Ischemic Stroke Treated With Intravenous rt-PA Within 4.5 Hours After Symptom Onset. / Alderazi, Y. J.; Chang, J.; Chapple, K.; Yang, J. P.; Teleb, M.; Awad, A.; Restrepo, Lucas.

In: The Neurohospitalist, Vol. 2, No. 3, 2012, p. 82-86.

Research output: Contribution to journalArticle

Alderazi, Y. J. ; Chang, J. ; Chapple, K. ; Yang, J. P. ; Teleb, M. ; Awad, A. ; Restrepo, Lucas. / Impact of Protocol Deviations in Acute Ischemic Stroke Treated With Intravenous rt-PA Within 4.5 Hours After Symptom Onset. In: The Neurohospitalist. 2012 ; Vol. 2, No. 3. pp. 82-86.
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AU - Yang, J. P.

AU - Teleb, M.

AU - Awad, A.

AU - Restrepo, Lucas

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AB - Background: There is limited experience in the community with intravenous tissue plasminogen activator (rt-PA) administered 3 to 4.5 hours after acute ischemic stroke (AIS) onset. Many patients do not meet entry criteria of pivotal clinical trials because of severe stroke, age >80, severe hypertension (sHTN), or history of previous stroke and diabetes. Whether rt-PA benefits these patients is unclear. Thus, we investigated the outcomes of stroke patients treated with rt-PA with or without these adverse clinical characteristics. Methods: Chart review of patients with AIS treated with intravenous rt-PA at a single institution. Outcomes at discharge were compared between patients with severe stroke, age >80, sHTN, or previous stroke/diabetes and those without these characteristics. Good outcome was defined as modified Rankin score (mRS) of 0 to 1. Analysis of variance and t tests were used to compare the outcomes. Results: Of the 118 cases analyzed, 103 (87%) were treated ≤3 hours and 15 (13%) between 3 and 4.5 hours. Sixty-three (53%) patients had severe stroke, age >80, sHTN, or previous stroke/diabetes, whereas 55 (47%) did not. Compared to controls, patients with these adverse characteristics were less likely to have good outcomes (35% vs 56%, p =.02). No patients treated within the 3- to 4.5-hour window experienced symptomatic intracranial hemorrhage (sICH). Eight patients treated between 3 and 4.5 hours had severe stroke, age >80, sHTN, or previous stroke/diabetes. Of these, 6 had poor outcomes. Conclusions: In a highly selected group of patients treated with intravenous rt-PA, lack of adherence to current guidelines did not improve stroke outcomes. This was related to more severe strokes at baseline, not sICH. Prospective studies of this patient group are needed.

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