title: Impact of Protocol Deviations in Acute Ischemic Stroke Treated With Intravenous rt-PA Within 4.5 Hours After Symptom Onset.
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.
authors: Department of Neurology, University of Texas Houston, TX, USA.
authors: Y J
authors: YJ
authors: Alderazi
authors: J
authors: J
authors: Chang
authors: J P
authors: JP
authors: Yang
authors: M
authors: M
authors: Teleb
authors: K
authors: K
authors: Chapple
authors: A
authors: A
authors: Awad
authors: Lucas
authors: L
authors: Restrepo
keywords: cerebrovascular disorders; outcomes; quality; safety; stroke; techniques
references: Stroke. 2010 Oct;41(10):2259-64
references: 20829516
references: Lancet Neurol. 2009 Dec;8(12):1095-102
references: 19850525
references: Lancet. 2004 Mar 6;363(9411):768-74
references: 15016487
references: Stroke. 2011 Aug;42(8):2257-62
references: 21719767
references: Stroke. 2009 Aug;40(8):2945-8
references: 19478221
references: Lancet. 2008 Oct 11;372(9646):1303-9
references: 18790527
references: Stroke. 2009 Jul;40(7):2433-7
references: 19498197
references: Stroke. 2000 Apr;31(4):858-62
references: 10753988
references: Stroke. 2011 Oct;42(10):2838-43
references: 21852612
references: Stroke. 1993 Jan;24(1):35-41
references: 7678184
references: Stroke. 2011 Jan;42(1):30-6
references: 21127299
references: Stroke. 1996 Oct;27(10):1765-9
references: 8841326
references: Stroke. 2009 Jul;40(7):2438-41
references: 19478213
references: N Engl J Med. 2008 Sep 25;359(13):1317-29
references: 18815396