In a real-world retrospective analysis, symptomatic intracranial hemorrhage (sICH) rates vary by NIHSS score

See data from a retrospective study and review rates from your own institution

The NINDS clinical trial program reported the incidence of sICH in patients treated with Activase. To further analyze the incidence of sICH following Activase treatment, a retrospective study was conducted in 2009-2010 leveraging the Get With The Guidelines (GWTG)–Stroke registry. 6,40

Data from parts 1 and 2 of the pivotal NINDS trial 6

NINDS was a 2-part randomized trial of Activase® (alteplase) vs placebo for the treatment of acute ischemic stroke. Part 1 (n=291) assessed changes in neurological deficits 24 hours after the onset of stroke. Part 2 (n=333) assessed if treatment with Activase resulted in clinical benefit at 3 months, defined as minimal or no disability using 4 stroke assessment. 6

In part 1, median baseline NIHSS score was 14 (min: 1; max: 37) for Activase- and 14 (min: 1; max: 32) for placebo-treated patients. In part 2, median baseline NIHSS score was 14 (min: 2; max: 37) for Activase- and 15 (min: 2; max: 33) for placebo-treated patients. 14

Patient identification required positive numerical assessment of NIHSS resulting in exclusion of patients with NIHSS of 0. 14

sICH incidence at 36 hours 6*

*sICH within 36 hours was defined as the occurrence of sudden neurological worsening followed by subsequent verification of intracranial hemorrhage through imaging. 6,40
NIHSS=National Institutes of Health Stroke Scale; NINDS=National Institute of Neurological Disorders and Stroke.

Data from a 2012 real-world analysis using the GWTG-Stroke registry 40
  • Retrospective analysis of 10,242 patients with acute ischemic stroke (AIS) who received Activase within 3 hours of symptom onset from January 2009 to June 2010. Data were extracted from the GWTG-Stroke registry
  • Median baseline National Institutes of Health Stroke Scale (NIHSS) score was 11 (interquartile range: 7-18). The numbers of patients stratified by NIHSS score were as follows: score of 0-5, 1875 (18.3%); score of 6-10, 2876 (28.1%); score of 11-15, 2146 (21.0%); score of 16-20, 1803 (17.6%); score of >20, 1542 (15.1%)
  • Patient identification utilized varying diagnostic methods resulting in inclusion of patients with NIHSS of 0
Real-world sICH incidence at 36 hours categorized by NIHSS score 40

A retrospective analysis using real-world evidence is observational in nature. These types of studies are more likely to contain inherent bias and confounding variables than a prospective clinical study, which limits the ability to draw conclusions about the causal effect of any particular factor or intervention. Limitations of this study are patients and hospitals included may not be entirely representative, sICH was determined by a treating physician versus central review, and 11.1% of patients were excluded due to missing information. Study also showed additional variables that contribute to the overall risk for sICH in patients, including blood pressure, age, ethnicity, blood glucose, and gender. 40

Download the data from the pivotal clinical trials and real-world analyses.