Clinical deterioration following improvement in the NINDS rt-PA stroke trial

J. C. Grotta, K. M A Welch, S. C. Fagan, M. Lu, M. R. Frankel, Thomas G Brott, S. R. Levine, P. D. Lyden

Research output: Contribution to journalArticle

155 Citations (Scopus)

Abstract

Background and Purpose - Little is known in regard to cerebral arterial reocclusion after successful thrombolysis. In the absence of arteriographic information, the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial investigators prospectively identified clinical deterioration following improvement (DFI) as a possible surrogate marker of cerebral arterial reocclusion after rt-PA-induced recanalization. Also, we identified any significant clinical deterioration (CD) even if not preceded by improvement. This observational analysis was designed to determine the incidence of DFI and CD in each treatment group, to identify baseline or posttreatment variables predictive of DFI or CD, and to determine any relationship between DFI, CD, and clinical outcome. Methods - DFI was defined as any 2-point deterioration on the NIH Stroke Scale after an initial 2-point improvement after treatment. CD was defined as any 4-point worsening after treatment compared with baseline. All data were collected prospectively by investigators blinded to treatment allocation. A noncontrast brain CT was mandated when a 2-point deterioration occurred. All cases were validated by a central review committee. Results - DFI was identified in 81 of the 624 patients (13%); 44 were treated with rt-PA and 37 were treated with placebo (P=0.48). DFI occurred more often in patients with a higher baseline NIH Stroke Scale score. CD within the first 24 hours occurred in 98 patients (16% of all patients); 43 were given rt-PA and 55 were given placebo (P=0.19). Baseline variables associated with CD included a less frequent use of prestroke aspirin and a higher incidence of early CT changes of edema or mass effect or dense middle cerebral artery sign. Patients with CD had higher rates of increased serum glucose and fibrin degradation products, and they also had higher rates of symptomatic intracranial hemorrhage and death. Patients who experienced either DFI or CD were less likely to have a 3-month favorable outcome. Conclusions - We found no association between DFI, CD, and rt-PA treatment, and no clinical evidence to suggest reocclusion. Deterioration was strongly associated with stroke severity and poor outcome and was less frequent in patients whose stroke occurred while they were on aspirin.

Original languageEnglish (US)
JournalStroke
Volume32
Issue number3
StatePublished - 2001
Externally publishedYes

Fingerprint

National Institute of Neurological Disorders and Stroke
Stroke
Aspirin
Placebos
Research Personnel
Fibrin Fibrinogen Degradation Products
Therapeutics
Intracranial Hemorrhages
Incidence
Middle Cerebral Artery
Advisory Committees
Edema
Biomarkers
Glucose
Brain

Keywords

  • Deterioration
  • Reocclusion
  • Stroke
  • Thrombolysis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Neuroscience(all)

Cite this

Grotta, J. C., Welch, K. M. A., Fagan, S. C., Lu, M., Frankel, M. R., Brott, T. G., ... Lyden, P. D. (2001). Clinical deterioration following improvement in the NINDS rt-PA stroke trial. Stroke, 32(3).

Clinical deterioration following improvement in the NINDS rt-PA stroke trial. / Grotta, J. C.; Welch, K. M A; Fagan, S. C.; Lu, M.; Frankel, M. R.; Brott, Thomas G; Levine, S. R.; Lyden, P. D.

In: Stroke, Vol. 32, No. 3, 2001.

Research output: Contribution to journalArticle

Grotta, JC, Welch, KMA, Fagan, SC, Lu, M, Frankel, MR, Brott, TG, Levine, SR & Lyden, PD 2001, 'Clinical deterioration following improvement in the NINDS rt-PA stroke trial', Stroke, vol. 32, no. 3.
Grotta JC, Welch KMA, Fagan SC, Lu M, Frankel MR, Brott TG et al. Clinical deterioration following improvement in the NINDS rt-PA stroke trial. Stroke. 2001;32(3).
Grotta, J. C. ; Welch, K. M A ; Fagan, S. C. ; Lu, M. ; Frankel, M. R. ; Brott, Thomas G ; Levine, S. R. ; Lyden, P. D. / Clinical deterioration following improvement in the NINDS rt-PA stroke trial. In: Stroke. 2001 ; Vol. 32, No. 3.
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T1 - Clinical deterioration following improvement in the NINDS rt-PA stroke trial

AU - Grotta, J. C.

AU - Welch, K. M A

AU - Fagan, S. C.

AU - Lu, M.

AU - Frankel, M. R.

AU - Brott, Thomas G

AU - Levine, S. R.

AU - Lyden, P. D.

PY - 2001

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N2 - Background and Purpose - Little is known in regard to cerebral arterial reocclusion after successful thrombolysis. In the absence of arteriographic information, the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial investigators prospectively identified clinical deterioration following improvement (DFI) as a possible surrogate marker of cerebral arterial reocclusion after rt-PA-induced recanalization. Also, we identified any significant clinical deterioration (CD) even if not preceded by improvement. This observational analysis was designed to determine the incidence of DFI and CD in each treatment group, to identify baseline or posttreatment variables predictive of DFI or CD, and to determine any relationship between DFI, CD, and clinical outcome. Methods - DFI was defined as any 2-point deterioration on the NIH Stroke Scale after an initial 2-point improvement after treatment. CD was defined as any 4-point worsening after treatment compared with baseline. All data were collected prospectively by investigators blinded to treatment allocation. A noncontrast brain CT was mandated when a 2-point deterioration occurred. All cases were validated by a central review committee. Results - DFI was identified in 81 of the 624 patients (13%); 44 were treated with rt-PA and 37 were treated with placebo (P=0.48). DFI occurred more often in patients with a higher baseline NIH Stroke Scale score. CD within the first 24 hours occurred in 98 patients (16% of all patients); 43 were given rt-PA and 55 were given placebo (P=0.19). Baseline variables associated with CD included a less frequent use of prestroke aspirin and a higher incidence of early CT changes of edema or mass effect or dense middle cerebral artery sign. Patients with CD had higher rates of increased serum glucose and fibrin degradation products, and they also had higher rates of symptomatic intracranial hemorrhage and death. Patients who experienced either DFI or CD were less likely to have a 3-month favorable outcome. Conclusions - We found no association between DFI, CD, and rt-PA treatment, and no clinical evidence to suggest reocclusion. Deterioration was strongly associated with stroke severity and poor outcome and was less frequent in patients whose stroke occurred while they were on aspirin.

AB - Background and Purpose - Little is known in regard to cerebral arterial reocclusion after successful thrombolysis. In the absence of arteriographic information, the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial investigators prospectively identified clinical deterioration following improvement (DFI) as a possible surrogate marker of cerebral arterial reocclusion after rt-PA-induced recanalization. Also, we identified any significant clinical deterioration (CD) even if not preceded by improvement. This observational analysis was designed to determine the incidence of DFI and CD in each treatment group, to identify baseline or posttreatment variables predictive of DFI or CD, and to determine any relationship between DFI, CD, and clinical outcome. Methods - DFI was defined as any 2-point deterioration on the NIH Stroke Scale after an initial 2-point improvement after treatment. CD was defined as any 4-point worsening after treatment compared with baseline. All data were collected prospectively by investigators blinded to treatment allocation. A noncontrast brain CT was mandated when a 2-point deterioration occurred. All cases were validated by a central review committee. Results - DFI was identified in 81 of the 624 patients (13%); 44 were treated with rt-PA and 37 were treated with placebo (P=0.48). DFI occurred more often in patients with a higher baseline NIH Stroke Scale score. CD within the first 24 hours occurred in 98 patients (16% of all patients); 43 were given rt-PA and 55 were given placebo (P=0.19). Baseline variables associated with CD included a less frequent use of prestroke aspirin and a higher incidence of early CT changes of edema or mass effect or dense middle cerebral artery sign. Patients with CD had higher rates of increased serum glucose and fibrin degradation products, and they also had higher rates of symptomatic intracranial hemorrhage and death. Patients who experienced either DFI or CD were less likely to have a 3-month favorable outcome. Conclusions - We found no association between DFI, CD, and rt-PA treatment, and no clinical evidence to suggest reocclusion. Deterioration was strongly associated with stroke severity and poor outcome and was less frequent in patients whose stroke occurred while they were on aspirin.

KW - Deterioration

KW - Reocclusion

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KW - Thrombolysis

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